erlotinib hydrochloride profile

ID Source	ID
PubMed CID	176871
CHEMBL ID	1079742
CHEBI ID	53509
MeSH ID	M0493669

Synonym
AC-400
erlotinib hydrochloride ,
erlotinib (hydrochloride)
HY-12008
erlotinib hcl (osi-744)
c22h24cln3o4
AKOS015849087
183319-69-9
e-4007
ro-50-8231
cp-358774
n-(3-ethynylphenyl)-6,7-bis(1-methoxyethoxy)-4-quinazolinamine hydrochloride
[6,7-bis(2-methoxy-ethoxy)-quinazolin-4-yl]-(3-ethynyl- phenyl)amine hydrochloride
nsc718781
tarceva (osi)
erlotinib hcl ,
nsc-718781
osi 774
4-quinazolinamine, n-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-, monohydrochloride
erlotinib hydrochloride [usan]
cp 358774
4-(m-ethynylanilino)-6,7-bis(2-methoxyethoxy)quinazoline monohydrochloride
EC-000.2313
FT-0651479
cp-358774-01
cp-358,774-01
CHEMBL1079742
cp-358 ,
CHEBI:53509 ,
n-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine hydrochloride
unii-da87705x9k
erlotinib hydrochloride [usan:inn]
da87705x9k ,
BCP9000658
4-quinazolinamine, n-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-, hydrochloride (1:1)
MLS004774139
6,7-bis(2-methoxyethoxy)-4-(3-ethynylanilino)quinazoline hcl
6,7-bis-(2-methoxyethoxy)-4-(3-ethynylanilino)quinazoline hydrochloride
183319-69-9 pound not183321-74-6
BCPP000238
smr002529980
erlotinib hydrochloride,cp-358774, osi-774, nsc 718781
MLS003899192
PB30965
erlotinib hydrochloride [usp-rs]
n-(3-ethenylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine hydrochloride
erlotinib hydrochloride [jan]
erlotinib hydrochloride [who-dd]
erlotinib hydrochloride [mi]
erlotinib hydrochloride [orange book]
erlotinib hydrochloride [mart.]
CS-0123
S1023
BP-30224
AM20090622
KS-1202
n-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine, monohydrochloride
GTTBEUCJPZQMDZ-UHFFFAOYSA-N
F0001-2385
[6,7-bis-(2-methoxy-ethoxy)-quinazolin-4-yl]-(3-ethynyl-phenyl)-amine hydrochloride
6,7-bis(2-methoxyethoxy)-4-(3-ethynylanilino)quinazoline hydrochloride
tarceva (erlotinib hydrochloride)
mfcd07781272
DTXSID10171412 ,
n-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine;hydrochloride
hydrochloride, erlotinib
hcl, erlotinib
EX-A064
n-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine monohydrochloride.
183319-69-9 (hcl)
(cp358774
nsc 718781) hcl
erlotinib(osi-744)
Q27124083
BCP02600
SB16917
CCG-269002
n-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-quinazolin-4-amine hydrochloride
erlotinib hydrochloride is known as a egfr kinase inhibitor.
erlotinib, hydrochloride salt
erlotinib hydrochloride (tarceva)
EN300-123054
BE164421
erlotinib hydrochlroide
n-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine monohydrochloride
dtxcid7093903
erlotinib hydrochloride (usp-rs)
erlotinib hydrochloride (mart.)
erlotinib 13c6 hcl

Excerpt	Reference	Relevance
"Erlotinib hydrochloride is a small molecule inhibitor of epidermal growth factor receptor (EGFR). "	( The plasma and cerebrospinal fluid pharmacokinetics of erlotinib and its active metabolite (OSI-420) after intravenous administration of erlotinib in non-human primates. Balis, FM; Fox, E; McCully, C; Meany, HJ; Tucker, C, 2008)	1.79

Excerpt	Reference	Relevance
"Erlotinib hydrochloride can cause severe skin toxicities, and DATS prevents skin toxicities, its mechanism may be related to DATS reduced erlotinib-induced inflammatory injury."	( Preventive effect of Diallyl Trisulfide on cutaneous toxicities induced by EGFR inhibitor. Chen, Y; Gu, Y; Jiang, X; Liu, Y, 2019)	1.24
"Erlotinib hydrochloride (Tarceva) can inhibit the intracellular phosphorylation of tyrosine kinases."	( Chronopharmacodynamics and mechanisms of antitumor effect induced by erlotinib in xenograft-bearing nude mice. An, F; Li, M; Lin, P; Liu, J; Liu, L; Liu, N; Wang, L; Wang, P; Xu, X; Zhao, L, 2015)	1.14

Excerpt	Reference	Relevance
" A specific adverse effect common to this class of agent is a papulopustular rash, usually on the face and upper torso, which generally occurs in a dose-dependent manner."	( Cutaneous adverse effects with HER1/EGFR-targeted agents: is there a silver lining? Peréz-Soler, R; Saltz, L, 2005)	0.33
" The most frequent erlotinib-related adverse events were rash (68%) and diarrhea (38%)."	( Efficacy and safety of erlotinib HCl, an epidermal growth factor receptor (HER1/EGFR) tyrosine kinase inhibitor, in patients with advanced ovarian carcinoma: results from a phase II multicenter study. Barrett, E; Crozier, M; Edwards, RP; Finkler, N; Garcia, AA; Gordon, AN; Irwin, DH, )	0.13
"The most common side effect of anti-EGFR therapy is skin toxicity, which is generally mild to moderate, but may be severe in up to 18% of patients."	( Common side effects of anti-EGFR therapy: acneform rash. Sipples, R, 2006)	0.33
" Effects of covariates on erlotinib clearance and correlations with adverse event severity were provided to aid in the detection of a treatment-emergent effect."	( Clinical pharmacokinetics of erlotinib in patients with solid tumors and exposure-safety relationship in patients with non-small cell lung cancer. Bruno, R; Eppler, SM; Hamilton, M; Lu, JF; Lum, BL; Rakhit, A; Wolf, J, 2006)	0.33
" Our aim was to describe key clinical features of common dermatologic adverse reactions among EGFR inhibitors, focusing mainly on skin toxicity, as well as to discuss the pathology, possible causes, and suggested treatments for these reactions."	( Dermatologic side effects associated with the epidermal growth factor receptor inhibitors. Agero, AL; Benvenuto-Andrade, C; Busam, KJ; Dusza, SW; Halpern, AC; Myskowski, P, 2006)	0.33
" To our knowledge, the periorbital rash resulting in bilateral lower eyelid ectropion associated with epiphora is a newly recognized side effect of erlotinib that is completely reversible with discontinuation of the drug."	( Newly recognized ocular side effects of erlotinib. Gausas, RE; Methvin, AB, )	0.13
" Both therapeutic agents were suspected as a possible cause of this adverse event."	( Severe lung and skin toxicity during treatment with gemcitabine and erlotinib for metastatic pancreatic cancer. Boeck, S; Hausmann, A; Heinemann, V; Reibke, R; Schulz, C, 2007)	0.34
" The adverse pulmonary effects of erlotinib are less well known."	( Pulmonary toxicity associated with erlotinib. Azzoli, CG; Ginsberg, MS; Kris, MG; Liu, V; Miller, VA; Travis, W; White, DA; Zakowski, MF, 2007)	0.34
"Skin toxicity is a common adverse effect of erlotinib and other anti-epidermal growth factor receptor (EGFR) agents."	( Markers in the epidermal growth factor receptor pathway and skin toxicity during erlotinib treatment. Nguyen, D; Parr, AL; Steinberg, SM; Tan, AR; Yang, SX, 2008)	0.35
" No unexpected adverse events were noted."	( Phase II study of efficacy and safety of bevacizumab in combination with chemotherapy or erlotinib compared with chemotherapy alone for treatment of recurrent or refractory non small-cell lung cancer. Belani, CP; Bonomi, PD; Fehrenbacher, L; Hart, L; Herbst, RS; Lin, M; Melnyk, O; O'Neill, VJ; Ramies, D; Sandler, A, 2007)	0.34
"The target of novel signal transduction inhibitors may be present on normal as well as tumor cells, resulting in mechanistic adverse effects (AE) in addition to antitumor activity."	( Validation of treatment induced specific adverse effect as a predictor of treatment benefit: a case study of NCIC CTG BR21. Ding, K; Pater, J; Seymour, L; Shepherd, FA; Whitehead, M, 2008)	0.35
" Common adverse events were diarrhea, rash, dry skin, asthenia, nausea, anorexia."	( Efficacy and safety of erlotinib in patients with locally advanced or metastatic breast cancer. Cobleigh, MA; Dickler, MN; Klein, PM; Miller, KD; Winer, EP, 2009)	0.35
" Discontinuation due to adverse events occurred in 11 patients (18%)."	( Efficacy and safety of erlotinib monotherapy for Japanese patients with advanced non-small cell lung cancer: a phase II study. Fukuoka, M; Hida, T; Katakami, N; Kawahara, M; Kubota, K; Matsui, K; Nakagawa, K; Nishiwaki, Y; Noda, K; Saijo, N; Takeda, K; Tamura, T; Watanabe, K; Yokoyama, A, 2008)	0.35
" It is a dose-dependent side effect of certain cytostatic drugs."	( [Hand-foot syndrome: A new side effect of erlotinib]. Descourt, R; Misery, L; Roguedas, AM; Rouxel, AM, 2008)	0.35
" Papulopustular eruptions are the most frequent adverse effect, their occurrence being associated with increased survival in some studies."	( Description and management of cutaneous side effects during erlotinib and cetuximab treatment in lung and colorectal cancer patients: a prospective and descriptive study of 19 patients. Baptista, A; Barroso, A; de Noronha e Menezes, NM; Lima, R; Moreira, A; Parente, B; Varela, P, )	0.13
" Skin rash is a well-known side effect related with all EGFR blocking agents."	( Staphylococcus aureus bacteremia related with erlotinib skin toxicity in a patient with pancreatic cancer. Kaley, K; Li, J; Peccerillo, J; Saif, MW, 2009)	0.35
" Progression-free survival was assessed and adverse reactions were recorded in the medical records."	( [Effectiveness and safety of erlotinib in 2 patients with carcinoma of the cervix]. Albornoz López, R; Fernández García, I; Pérez Rodrigo, I; Soto Rojas, M; Torres Degayón, V, )	0.13
" The adverse reactions to the treatment were slight."	( [Effectiveness and safety of erlotinib in 2 patients with carcinoma of the cervix]. Albornoz López, R; Fernández García, I; Pérez Rodrigo, I; Soto Rojas, M; Torres Degayón, V, )	0.13
"Erlotinib presented some similar results to those obtained from cisplatin doublets in women with refractory cervical cancer, with minor adverse effects."	( [Effectiveness and safety of erlotinib in 2 patients with carcinoma of the cervix]. Albornoz López, R; Fernández García, I; Pérez Rodrigo, I; Soto Rojas, M; Torres Degayón, V, )	0.13
"Addition of bevacizumab to various chemotherapy agents or erlotinib in patients with NSCLC and treated brain metastases seems to be safe and is associated with a low incidence of CNS hemorrhage."	( Safety of bevacizumab in patients with non-small-cell lung cancer and brain metastases. Akerley, W; Compton, P; Huang, JE; Kolb, MM; Langer, CJ; Socinski, MA; Wang, L, 2009)	0.35
" No side effect was observed."	( [A case of non-small cell lung cancer treated safely by whole brain radiation therapy and erlotinib]. Nagai, A; Shiroma, T; Yamaguchi, M, 2009)	0.35
" Their cutaneous toxicity is a specific and frequent side effect that has shown to be correlated to the antitumoral effect."	( [Cutaneous side effects of EGF receptor inhibitors]. Aractingi, S; Nassar, D; Soutou, B, 2009)	0.35
" Our results show that Erlotinib-HCl delivered in the form of nanoparticles has less toxic effect than the free drug in experimental rats."	( Poly(D,L-lactic-co-glycolic acid) nanoencapsulation reduces Erlotinib-induced subacute toxicity in rat. Franklin, G; Kalaichelvan, VK; Manavalan, R; Marslin, G; Reddy, PN; Sheeba, CJ, 2009)	0.35
"To observe the efficacy and the adverse effects of erlotinib in the treatment for advanced non-small cell lung cancer (NSCLC) in Chinese patients."	( [Efficacy and safety of Erlotinib in the treatment for advanced non-small cell lung cancer in Chinese patients]. Liao, ML; Qin, SK; Sun, Y; Wu, YL; Zhou, CC, 2010)	0.36
" The major erlotinib treatment-related adverse events (AE) were mild (CTC AE 1/2), only 3 cases had severe adverse effect, 1 case had interstitial lung disease and died of respiratory failure."	( [Efficacy and safety of Erlotinib in the treatment for advanced non-small cell lung cancer in Chinese patients]. Liao, ML; Qin, SK; Sun, Y; Wu, YL; Zhou, CC, 2010)	0.36
"The study presents excellent response rates, time to progression and overall survival of erlotinib treatment for advanced NSCLC in Chinese patients, and its adverse events are tolerable."	( [Efficacy and safety of Erlotinib in the treatment for advanced non-small cell lung cancer in Chinese patients]. Liao, ML; Qin, SK; Sun, Y; Wu, YL; Zhou, CC, 2010)	0.36
" Discontinuation was predominantly due to disease progression, rather than adverse events, in both the whole cohort (82% vs."	( Association between poor performance status and risk for toxicity during erlotinib monotherapy in Japanese patients with non-small cell lung cancer: Okayama Lung Cancer Study Group experience. Hotta, K; Inoue, K; Kishino, D; Kiura, K; Okada, T; Suzuki, E; Tabata, M; Takigawa, N; Tanimoto, M; Ueoka, H; Yoshioka, H, 2010)	0.36
"The most common adverse events (AEs) were skin rash (96%) and diarrhea (32%)."	( [Efficacy and safety of erlotinib as monotherapy for advanced non-small cell lung cancer]. Li, LY; Wang, MZ; Xu, LY; Zhang, L; Zhang, XT; Zhang, XY; Zhong, W, 2010)	0.36
"Erlotinib monotherapy is safe and effective for some Chinese NSCLC patients after failure of prior chemotherapy."	( [Efficacy and safety of erlotinib as monotherapy for advanced non-small cell lung cancer]. Li, LY; Wang, MZ; Xu, LY; Zhang, L; Zhang, XT; Zhang, XY; Zhong, W, 2010)	0.36
" Diarrhea and rash were the most common adverse events (AEs); 23% of patients experienced grade 3-4 drug-related AEs."	( Safety and efficacy of erlotinib in first-relapse glioblastoma: a phase II open-label study. Cloughesy, TF; Gilbert, MR; Klencke, B; Nghiemphu, P; Prados, MD; Reardon, DA; Vredenburgh, JJ; Yung, WK, 2010)	0.36
" Among the 6580 patients included in the safety analysis, 799 (12%) experienced one or more erlotinib-related adverse events (AEs, other than prespecified AEs defined in the protocol), and only 4% experienced an erlotinib-related serious AE."	( Erlotinib in advanced non-small cell lung cancer: efficacy and safety findings of the global phase IV Tarceva Lung Cancer Survival Treatment study. Allan, S; Baliko, Z; Gridelli, C; Heigener, D; Krzakowski, M; Reck, M; Rischin, D; van Zandwijk, N, 2010)	0.36
" Seventeen percent of these patients experienced one or more erlotinib-related adverse event (AE) (other than the most frequently occurring AEs prespecified in the protocol) and 2% experienced an erlotinib-related serious AE."	( Efficacy and safety of erlotinib in 1242 East/South-East Asian patients with advanced non-small cell lung cancer. Au, JS; Mok, T; Park, K; Perng, RP; Wu, YL; Zhang, L; Zhou, C, 2010)	0.36
" The most common adverse events were rash and diarrhoea."	( Safety and efficacy of the combination of erlotinib and sirolimus for the treatment of metastatic renal cell carcinoma after failure of sunitinib or sorafenib. Breaker, K; Costa, LJ; Crighton, F; Drabkin, H; Flaig, TW; Gustafson, DL; Kim, FJ; Schultz, MK, 2010)	0.36
" The main adverse events of rash and diarrhea are typically mild or moderate in severity, and rarely lead to treatment withdrawal."	( Reviewing the safety of erlotinib in non-small cell lung cancer. Heigener, D; Mok, T; Reck, M; Wolf, J; Wu, YL, 2011)	0.37
" The severe hematological adverse events related to EGFR TKIs treatment were rare."	( The safety and efficacy of EGFR TKIs monotherapy versus single-agent chemotherapy using third-generation cytotoxics as the first-line treatment for patients with advanced non-small cell lung cancer and poor performance status. Chen, B; Liu, S; Wang, D; Wang, Y; Wu, J; Zhao, W, 2011)	0.37
" Significantly different adverse events have been associated with gefitinib and erlotinib."	( Differences in adverse events between 250 mg daily gefitinib and 150 mg daily erlotinib in Japanese patients with non-small cell lung cancer. Fujita, S; Fukuhara, A; Hatachi, Y; Kim, YH; Masago, K; Mio, T; Mishima, M; Nagai, H; Sakamori, Y; Togashi, Y, 2011)	0.37
"A retrospective investigation examining the adverse events and tolerances of 250 mg daily gefitinib and 150 mg daily erlotinib in Japanese patients with non-small cell lung cancer (NSCLC) was performed."	( Differences in adverse events between 250 mg daily gefitinib and 150 mg daily erlotinib in Japanese patients with non-small cell lung cancer. Fujita, S; Fukuhara, A; Hatachi, Y; Kim, YH; Masago, K; Mio, T; Mishima, M; Nagai, H; Sakamori, Y; Togashi, Y, 2011)	0.37
"More adverse events including skin disorders, diarrhea, oral mucositis, asthenic conditions, anorexia, nausea, vomiting, and gastrointestinal bleeding were observed in the erlotinib group."	( Differences in adverse events between 250 mg daily gefitinib and 150 mg daily erlotinib in Japanese patients with non-small cell lung cancer. Fujita, S; Fukuhara, A; Hatachi, Y; Kim, YH; Masago, K; Mio, T; Mishima, M; Nagai, H; Sakamori, Y; Togashi, Y, 2011)	0.37
" Although agents such as gefitinib, erlotinib, cetuximab, lapatinib, and panitumumab have less systemic side-effects than traditional cytotoxic chemotherapy, dermatologic adverse events from EGFRIs are significantly more common."	( Prophylaxis and treatment of dermatologic adverse events from epidermal growth factor receptor inhibitors. Anadkat, MJ; Balagula, Y; Lacouture, ME; Wu, PA, 2011)	0.37
"This review provides a symptom-based treatment approach to the common dermatologic adverse effects seen with the epidermal growth factor receptor antagonists: papulopustular rash, xerosis, pruritus as well as hair, nail, and mucosal changes."	( Prophylaxis and treatment of dermatologic adverse events from epidermal growth factor receptor inhibitors. Anadkat, MJ; Balagula, Y; Lacouture, ME; Wu, PA, 2011)	0.37
"Although the field continues to evolve, this review presents the most up-to-date information on managing dermatologic adverse effects of EGFRIs."	( Prophylaxis and treatment of dermatologic adverse events from epidermal growth factor receptor inhibitors. Anadkat, MJ; Balagula, Y; Lacouture, ME; Wu, PA, 2011)	0.37
"Objective of this indirect economic comparison was to estimate and compare management costs of grade 3/4 adverse events (AEs) reported for first-line erlotinib or pemetrexed maintenance therapy in patients with advanced non-small cell lung cancer (NSCLC)."	( Comparison of treatment costs of grade 3/4 adverse events associated with erlotinib or pemetrexed maintenance therapy for patients with advanced non-small-cell lung cancer (NSCLC) in Germany, France, Italy, and Spain. Banz, K; Bischoff, H; Brunner, M; Chouaid, C; de Castro Carpeño, J; de Marinis, F; Grossi, F; Vergnenègre, A; Walzer, S, 2011)	0.37
" Adverse drug reactions of erlotinib in Japanese, which may be very different from those in Caucasians because of differences in genetic background, have not been fully reported."	( Safety of erlotinib treatment in outpatients with previously treated non-small-cell lung cancer in Japan. Date, H; Mishima, M; Nagai, H; Niimi, M; Sasaki, T; Seo, N; Tanaka, S; Yanagihara, K; Yasuda, H, 2011)	0.37
" Erlotinib 150 mg/day was administered until progressive disease or discontinuation due to adverse events."	( Safety of erlotinib treatment in outpatients with previously treated non-small-cell lung cancer in Japan. Date, H; Mishima, M; Nagai, H; Niimi, M; Sasaki, T; Seo, N; Tanaka, S; Yanagihara, K; Yasuda, H, 2011)	0.37
" However, these adverse events were well controllable in outpatients treated with erlotinib."	( Safety of erlotinib treatment in outpatients with previously treated non-small-cell lung cancer in Japan. Date, H; Mishima, M; Nagai, H; Niimi, M; Sasaki, T; Seo, N; Tanaka, S; Yanagihara, K; Yasuda, H, 2011)	0.37
" Toxicity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE)."	( [Efficacy and toxicity of erlotinib in non-small cell lung cancer treatment]. Arias-Santos, I; Constenla-Caramés, L; Lago-Rivero, N; Mucientes-Molina, A; Pedrido-Reino, E; Romero-Ventosa, EY, )	0.13
"Survival analysis findings suggest lower efficacy in our patient population in comparison with data seen in other publications, and adverse events followed the expected pattern."	( [Efficacy and toxicity of erlotinib in non-small cell lung cancer treatment]. Arias-Santos, I; Constenla-Caramés, L; Lago-Rivero, N; Mucientes-Molina, A; Pedrido-Reino, E; Romero-Ventosa, EY, )	0.13
"Historically, skin toxicity has been assessed in prospective clinical trials using the clinician-reported National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)."	( Using the Skindex-16 and Common Terminology Criteria for Adverse Events to assess rash symptoms: results of a pooled-analysis (N0993). Atherton, PJ; Burger, KN; Jatoi, A; Loprinzi, CL; Miller, RC; Neben Wittich, MA; Sloan, JA, 2012)	0.38
" Statistical procedures, including Pearson correlations, were utilized to determine relationships between adverse event (AE) grades and Skindex-16 scores."	( Using the Skindex-16 and Common Terminology Criteria for Adverse Events to assess rash symptoms: results of a pooled-analysis (N0993). Atherton, PJ; Burger, KN; Jatoi, A; Loprinzi, CL; Miller, RC; Neben Wittich, MA; Sloan, JA, 2012)	0.38
"To review the cutaneous adverse events related to EGFR inhibitors."	( The management of EGFR inhibitor adverse events: a case series and treatment paradigm. Chachoua, A; Cohen, DE; de Souza, A; Wnorowski, AM, 2012)	0.38
"A retrospective chart review of all cases referred for the management of cutaneous adverse events after the initiation of EGFR inhibitor therapy between the years of 2006 and 2009 was performed."	( The management of EGFR inhibitor adverse events: a case series and treatment paradigm. Chachoua, A; Cohen, DE; de Souza, A; Wnorowski, AM, 2012)	0.38
"Four men and 11 women had cutaneous adverse events while receiving erlotinib (mean dose: 112."	( The management of EGFR inhibitor adverse events: a case series and treatment paradigm. Chachoua, A; Cohen, DE; de Souza, A; Wnorowski, AM, 2012)	0.38
"The most common cutaneous adverse event in our cohort was papulopustular rash, followed by eczema and xerosis."	( The management of EGFR inhibitor adverse events: a case series and treatment paradigm. Chachoua, A; Cohen, DE; de Souza, A; Wnorowski, AM, 2012)	0.38
" Rash (98/196 [50%] in the erlotinib group vs 10/213 [5%] in the chemotherapy group for all grades; nine [5%] vs none for grade 3 or 4) and diarrhoea (36 [18%] vs four [2%] for all grades; five [3%] vs none for grade 3 or 4) were the most common treatment-related adverse events with erlotinib, whereas alopecia (none vs 23 [11%] for all grades; none vs one [<1%] for grade 3/4) was the most common treatment-related adverse event with chemotherapy."	( Efficacy and safety of erlotinib versus chemotherapy in second-line treatment of patients with advanced, non-small-cell lung cancer with poor prognosis (TITAN): a randomised multicentre, open-label, phase 3 study. Cicenas, S; Ciuleanu, T; Gonzalez, EE; Grigorescu, AC; Hillenbach, C; Johannsdottir, HK; Klughammer, B; Miliauskas, S; Stelmakh, L, 2012)	0.38
" The most common treatment-related adverse events were rash, diarrhea and pruritus."	( Efficacy and safety of maintenance erlotinib in Asian patients with advanced non-small-cell lung cancer: a subanalysis of the phase III, randomized SATURN study. Kim, JH; Klingelschmitt, G; Ng, C; Park, K; Wu, YL; Zaatar, A, 2012)	0.38
" Treatment-emergent adverse events were generally mild and included fatigue, nausea, vomiting, and chills."	( Safety and pharmacokinetics of ganitumab (AMG 479) combined with sorafenib, panitumumab, erlotinib, or gemcitabine in patients with advanced solid tumors. Chan, E; Deng, H; Friberg, G; Gilbert, J; Hwang, YC; Mahalingam, D; McCaffery, I; Michael, SA; Mita, AC; Mita, MM; Mulay, M; Puzanov, I; Rosen, LS; Sarantopoulos, J; Shubhakar, P; Zhu, M, 2012)	0.38
"Ganitumab up to 12 mg/kg was well tolerated, without adverse effects on pharmacokinetics in combination with either sorafenib, panitumumab, erlotinib, or gemcitabine."	( Safety and pharmacokinetics of ganitumab (AMG 479) combined with sorafenib, panitumumab, erlotinib, or gemcitabine in patients with advanced solid tumors. Chan, E; Deng, H; Friberg, G; Gilbert, J; Hwang, YC; Mahalingam, D; McCaffery, I; Michael, SA; Mita, AC; Mita, MM; Mulay, M; Puzanov, I; Rosen, LS; Sarantopoulos, J; Shubhakar, P; Zhu, M, 2012)	0.38
" Eighty-seven subpopulation patients (18%) had an erlotinib-related AE; other than the protocol-defined frequent adverse events (AEs); 4% had a grade ≥3 erlotinib-related AE, 7% had an erlotinib-related serious AE."	( Efficacy and safety of first-line erlotinib in elderly patients with advanced non-small cell lung cancer. Au, JS; Cheng, CK; Merimsky, O; Reck, M; von Pawel, J, 2012)	0.38
"Rash, liver dysfunction, and diarrhea are known as adverse events of erlotinib and gefitinib."	( Comparison of adverse events of erlotinib with those of gefitinib in patients with non-small cell lung cancer: a case-control study in a Japanese population. Hirata, K; Kimura, T; Kira, Y; Kudoh, S; Mitsuoka, S; Nagata, M; Suzumura, T; Tanaka, H; Umekawa, K; Yoshimura, N, 2012)	0.38
"The frequency of each adverse event was evaluated in a case-control study on Japanese patients who were treated with gefitinib or erlotinib."	( Comparison of adverse events of erlotinib with those of gefitinib in patients with non-small cell lung cancer: a case-control study in a Japanese population. Hirata, K; Kimura, T; Kira, Y; Kudoh, S; Mitsuoka, S; Nagata, M; Suzumura, T; Tanaka, H; Umekawa, K; Yoshimura, N, 2012)	0.38
" Reduced function of CYP2D6 was not associated with an increased risk of any adverse events in both gefitinib and erlotinib cohorts."	( Comparison of adverse events of erlotinib with those of gefitinib in patients with non-small cell lung cancer: a case-control study in a Japanese population. Hirata, K; Kimura, T; Kira, Y; Kudoh, S; Mitsuoka, S; Nagata, M; Suzumura, T; Tanaka, H; Umekawa, K; Yoshimura, N, 2012)	0.38
" However, the efficacy of these agents against EGFR wild-type (-wt) NSCLC remains unclear, and the frequency of adverse events (AEs) appears to differ between them at each approved dose."	( Comparison of adverse events and efficacy between gefitinib and erlotinib in patients with non-small-cell lung cancer: a retrospective analysis. Abe, H; Azuma, K; Hattori, S; Hoshino, T; Kage, M; Kawahara, A; Yamada, K; Yamashita, F; Yoshida, T; Zaizen, Y, 2013)	0.39
" The adverse effects (AEs) were also considered."	( Comparison of the efficacy and safety of single-agent erlotinib and doublet molecular targeted agents based on erlotinib in advanced non-small cell lung cancer (NSCLC): a systematic review and meta-analysis. Ke, S; Pan, G; Zhao, J, 2013)	0.39
" The 3 drugs clinically associated with severe cardiac adverse events (crizotinib, sunitinib, nilotinib) all proved to be cardiotoxic in our in vitro tests while the relatively cardiac-safe drug erlotinib showed only minor changes in cardiac cell health."	( Multi-parameter in vitro toxicity testing of crizotinib, sunitinib, erlotinib, and nilotinib in human cardiomyocytes. Bacus, S; Brown, AM; Doherty, KR; Kramer, JW; Moran, DM; Shell, SA; Talbert, DR; Trusk, PB; Wappel, RL, 2013)	0.39
"The dermatologic side effects are the most common adverse effects associated with Epidermal Growth Factor Receptor tyrosine kinase inhibitors."	( IL-33/IL-31 axis: a new pathological mechanisms for EGFR tyrosine kinase inhibitors-associated skin toxicity. Adamo, V; David, A; Franchina, T; Gangemi, S; Kennez, I; Minciullo, PL; Profita, M; Zanghì, M, 2013)	0.39
" Patients were evaluated for adverse events (AEs)."	( Phase I safety and pharmacokinetic study of the PI3K/mTOR inhibitor SAR245409 (XL765) in combination with erlotinib in patients with advanced solid tumors. Cohen, RB; Engelman, JA; Felip, E; Jänne, PA; Laird, AD; Macé, S; Martinez, P; Rockich, K; Ruiz-Soto, R; Shapiro, GI; Xu, J, 2014)	0.4
" The most common treatment-emergent adverse events (TEAEs) were diarrhea (74 %), nausea (51 %), fatigue (51 %), rash (51 %), and injection-site reactions (49 %)."	( Antitumor activity and safety of combination therapy with the Toll-like receptor 9 agonist IMO-2055, erlotinib, and bevacizumab in advanced or metastatic non-small cell lung cancer patients who have progressed following chemotherapy. Bexon, AS; Boyd, TE; Conkling, P; de La Bourdonnaye, G; Mita, AC; Nemunaitis, JJ; Richards, DA; Smith, DA; Wages, D, 2014)	0.4
" From a literature review and this observation, arguments have been provided to justify erlotinib as a safe and well-tolered alternative for patients who have to stop gefitinib after a severe hepatotoxicity."	( [Treatment with erlotinib after gefitinib induced hepatotoxicity: literature review and case report]. Durand, M; Fonrose, X; Logerot, S; Schir, E, )	0.13
" This low transplacental transfer is an important report, as potential side effect toxicity on the fetus is likely correlated to gefitinib blood concentration."	( Efficacy and safety of gefitinib during pregnancy: case report and literature review. Ayoubi, JM; Broutin, S; Couderc, LJ; Friard, S; Gil, S; Goetgheluck, J; Paci, A; Picone, O; Tcherakian, C, 2014)	0.4
" In a cell-based model, sunitinib reduced CDK5 phosphorylation (pCDK5), calpain-dependent p35/p25 conversion and protected neuronal cells from the toxic effects of gp120."	( Neuroprotective effects of the anti-cancer drug sunitinib in models of HIV neurotoxicity suggests potential for the treatment of neurodegenerative disorders. Crews, LA; Gonzales, T; Kouznetsova, VL; Masliah, E; Overk, CR; Patrick, C; Paulino, A; Price, D; Rockenstein, E; Stocking, E; Tsigelny, IF; Wrasidlo, W, 2014)	0.4
" Herein, the authors emphasize the importance of recognizing this side effect in order to avoid from severe complications such as corneal ulcers in uncared patients."	( Ocular side effects and trichomegaly of eyelashes induced by erlotinib: a case report and review of the literature. Celik, T; Kosker, M, 2015)	0.42
" Most of the patients on erlotinib show cutaneous adverse effects."	( Erlotinib-induced cutaneous toxicity: findings on 18F-FDG PET/CT imaging. Bal, C; Gupta, RK; Kumar, K; Kumar, R; Singh, H, 2015)	0.42
" Overall survival, progression-free survival, and occurrence of adverse drug reactions were secondary endpoints."	( Final safety and efficacy of erlotinib in the phase 4 POLARSTAR surveillance study of 10 708 Japanese patients with non-small-cell lung cancer. Ando, M; Arakawa, H; Ebina, M; Fukuda, Y; Fukuoka, M; Gemma, A; Inoue, Y; Ishii, T; Johkoh, T; Kudoh, S; Kusumoto, M; Kuwano, K; Nakagawa, K; Ohe, Y; Sakai, F; Seki, A; Taniguchi, H; Yamazaki, N, 2014)	0.4
" However, few studies focused on the risk and adverse events (AEs) of combined targeted therapy."	( Safety profile of combined therapy inhibiting EFGR and VEGF pathways in patients with advanced non-small-cell lung cancer: A meta-analysis of 15 phase II/III randomized trials. Huang, J; Ji, LJ; Liu, H; Liu, Y; Ma, W; Qi, X; Xu, M; Zhu, Y, 2015)	0.42
" Common treatment-related adverse events were dermatitis acneiform, diarrhea, and paronychia; there were no treatment-related grade 4 or 5 adverse events."	( Safety and efficacy of dacomitinib in korean patients with KRAS wild-type advanced non-small-cell lung cancer refractory to chemotherapy and erlotinib or gefitinib: a phase I/II trial. Ahn, MJ; Campbell, AK; Cho, BC; Gernhardt, D; Giri, N; Heo, DS; Kim, DW; Lee, SY; Letrent, SP; O'Connell, J; Park, K; Taylor, I; Zhang, H, 2014)	0.4
" We compared the frequencies of severe adverse events (AEs) among EGFR mutation-positive NSCLC patients treated with these three EGFR-TKIs."	( Pooled safety analysis of EGFR-TKI treatment for EGFR mutation-positive non-small cell lung cancer. Nakagawa, K; Okamoto, I; Takeda, M, 2015)	0.42
"Previous reports regarding the cutaneous adverse events of epidermal growth factor receptor inhibitors are mostly limited to small case reports and case series, mainly involving Caucasian patients."	( Cutaneous adverse events of epidermal growth factor receptor inhibitors: A retrospective review of 99 cases. Chanprapaph, K; Pongcharoen, P; Vachiramon, V, )	0.13
"We describe the trends in the clinical presentation of Asian patients who had cutaneous adverse events induced by epidermal growth factor receptor inhibitors and to explore the relationship between skin adverse events and tumor response."	( Cutaneous adverse events of epidermal growth factor receptor inhibitors: A retrospective review of 99 cases. Chanprapaph, K; Pongcharoen, P; Vachiramon, V, )	0.13
" Cutaneous adverse events occurred in 43 (57."	( Cutaneous adverse events of epidermal growth factor receptor inhibitors: A retrospective review of 99 cases. Chanprapaph, K; Pongcharoen, P; Vachiramon, V, )	0.13
"The limitations of study include its retrospective nature, and the initial screening of cutaneous adverse events was done by non-dermatologists."	( Cutaneous adverse events of epidermal growth factor receptor inhibitors: A retrospective review of 99 cases. Chanprapaph, K; Pongcharoen, P; Vachiramon, V, )	0.13
"Cutaneous adverse events due to epidermal growth factor receptor inhibitors are not uncommon in the Asian population."	( Cutaneous adverse events of epidermal growth factor receptor inhibitors: A retrospective review of 99 cases. Chanprapaph, K; Pongcharoen, P; Vachiramon, V, )	0.13
"No dose-limiting toxicities or MEHD7945A-related grade ≥ 4 adverse events (AE) were reported in dose-escalation (n = 30) or expansion (n = 36) cohorts."	( Safety and Pharmacokinetics/Pharmacodynamics of the First-in-Class Dual Action HER3/EGFR Antibody MEHD7945A in Locally Advanced or Metastatic Epithelial Tumors. Amler, LC; Baselga, J; Blumenschein, GR; Bohórquez, SS; Calles, A; Cervantes, A; Dienstmann, R; Hidalgo, M; Jimeno, A; Juric, D; Kapp, AV; Leddy, C; Littman, C; Messersmith, W; Penuel, E; Pirzkall, A; Roda, D; Shames, DS; Tabernero, J; Wang, X, 2015)	0.42
" TKIs plus radiotherapy significantly prolong the CNS-TTP and MOS of patients without enhancing overall severe adverse events."	( Evaluation on efficacy and safety of tyrosine kinase inhibitors plus radiotherapy in NSCLC patients with brain metastases. Chen, L; Chen, X; Luo, S; Xie, X, 2015)	0.42
"Erlotinib appears to be a useful second-line option in PS0/1 patients with EGFR mutation-negative advanced non-squamous NSCLC given its mild adverse effects."	( Retrospective efficacy and safety analyses of erlotinib, pemetrexed, and docetaxel in EGFR-mutation-negative patients with previously treated advanced non-squamous non-small-cell lung cancer. Fujita, S; Hata, A; Iwasaku, M; Katakami, N; Korogi, Y; Mori, M; Morita, S; Namba, Y; Nishino, K; Nishiyama, A; Okuyama, T; Otsuka, K; Takeshita, J; Uchida, J; Yoshioka, H, 2015)	0.42
"Treatment with erlotinib, an epidermal growth factor receptor tyrosine kinase inhibitor used for treating non-small-cell lung cancer (NSCLC) and other cancers, is frequently associated with adverse events (AE)."	( A Modeling and Simulation Framework for Adverse Events in Erlotinib-Treated Non-Small-Cell Lung Cancer Patients. Frechen, S; Fuhr, U; Jaehde, U; Kocher, M; Nogova, L; Scheffler, M; Suleiman, AA; Wolf, J; Zander, T, 2015)	0.42
" The most common treatment-related adverse events were diarrhea, nausea, vomiting, and decreased appetite."	( Safety, efficacy, and pharmacokinetics of navitoclax (ABT-263) in combination with erlotinib in patients with advanced solid tumors. Arzt, J; Busman, TA; Holen, KD; Kirschbrown, W; Lian, G; LoRusso, P; Rosen, LS; Rudersdorf, NS; Tolcher, AW; Vanderwal, CA, 2015)	0.42
" As for the toxicity profile, the most common adverse events (AEs) were hematologic reactions, skin rash, and gastrointestinal reactions."	( Efficacy and safety of gemcitabine plus erlotinib for locally advanced or metastatic pancreatic cancer: a systematic review and meta-analysis. Guo, J; Han, X; Hu, GF; Liu, LY; Tang, N; Wang, X; Wang, Y; Wang, ZH; Zhang, QQ, 2016)	0.43
" The main outcome measures included overall survival (OS), progression-free survival (PFS), overall response rate (ORR) and adverse events."	( Efficacy and safety of bevacizumab plus erlotinib versus bevacizumab or erlotinib alone in the treatment of non-small-cell lung cancer: a systematic review and meta-analysis. Cai, F; Mao, XD; Wang, HT; Xu, J; Zhang, S, 2016)	0.43
" The incidence of grade 3/4 adverse events such as rash and diarrhoea was higher in the combination group than in the monotherapy group."	( Efficacy and safety of bevacizumab plus erlotinib versus bevacizumab or erlotinib alone in the treatment of non-small-cell lung cancer: a systematic review and meta-analysis. Cai, F; Mao, XD; Wang, HT; Xu, J; Zhang, S, 2016)	0.43
"All patients prescribed erlotinib within UC San Diego Health System between February 26, 2011, and February 28, 2014, were assessed for eligibility, survival outcomes and adverse events."	( Association of concurrent acid-suppression therapy with survival outcomes and adverse event incidence in oncology patients receiving erlotinib. Capparelli, EV; Kurzrock, R; Lam, LH, 2016)	0.43
" Patients treated with erlotinib and PPI/H2RA therapy had shorter PFS, but similar OS and adverse event profile compared to those who did not receive acid-suppression."	( Association of concurrent acid-suppression therapy with survival outcomes and adverse event incidence in oncology patients receiving erlotinib. Capparelli, EV; Kurzrock, R; Lam, LH, 2016)	0.43
"Recently, the need for maintenance chemotherapy arose as a result of the significantly improved survival of patients with metastatic colorectal cancer (mCRC) without increasing adverse events."	( Survival Benefit and Safety of Bevacizumab in Combination with Erlotinib as Maintenance Therapy in Patients with Metastatic Colorectal Cancer: A Meta-Analysis. Cao, C; Chen, J; Gong, Y; Kuang, M; Tang, C; Wu, P; Xu, W, 2017)	0.46
" The drug's most frequently reported side effect as a result of EGFR inhibition is skin rash (SR), a symptom which has been associated with a better therapeutic response to the drug."	( Identification of gene expression profiling associated with erlotinib-related skin toxicity in pancreatic adenocarcinoma patients. Aranda, E; Benavides, M; Caba, O; Gallego, J; Guillen-Ponce, C; Irigoyen, A; Jimenez-Luna, C; Ortuño, FM; Prados, J; Rojas, I; Torres, C, 2016)	0.43
" Our algorithm, based on partial least squares-discriminant analysis (PLS-DA) and cross-validation by bootstrapping, discriminated to variable degrees spectra from patient suffering and not suffering cutaneous adverse events."	( A Novel Spectroscopically Determined Pharmacodynamic Biomarker for Skin Toxicity in Cancer Patients Treated with Targeted Agents. Azan, A; Bakker Schut, TC; Besse, B; Boutros, C; Caspers, PJ; Eggermont, AM; Kamsu Kom, N; Koljenović, S; Lanoy, E; Mateus, C; Mir, LM; Noordhoek Hegt, V; Paci, A; Planchard, D; Puppels, GJ; Robert, C; Routier, E; Roy, S; Seck, A; Texier, M; Tomasic, G, 2017)	0.46
"To systematically review relevant literature comparing the oncological outcomes and adverse events of different systemic therapies for patients with metastatic non-ccRCC."	( A Systematic Review and Meta-analysis Comparing the Effectiveness and Adverse Effects of Different Systemic Treatments for Non-clear Cell Renal Cell Carcinoma. Albiges, L; Bensalah, K; Bex, A; Canfield, SE; Dabestani, S; Fernández-Pello, S; Giles, RH; Hofmann, F; Hora, M; Kuczyk, MA; Lam, TB; Ljungberg, B; Marconi, L; Merseburger, AS; Powles, T; Staehler, M; Tahbaz, R; Volpe, A, 2017)	0.46
" Sunitinib was associated with more Grade 3-4 adverse events than everolimus, although this was not statistically significant."	( A Systematic Review and Meta-analysis Comparing the Effectiveness and Adverse Effects of Different Systemic Treatments for Non-clear Cell Renal Cell Carcinoma. Albiges, L; Bensalah, K; Bex, A; Canfield, SE; Dabestani, S; Fernández-Pello, S; Giles, RH; Hofmann, F; Hora, M; Kuczyk, MA; Lam, TB; Ljungberg, B; Marconi, L; Merseburger, AS; Powles, T; Staehler, M; Tahbaz, R; Volpe, A, 2017)	0.46
" We sought to use lasers and light devices to treat recalcitrant cutaneous adverse effects related to cancer treatment."	( Mitigation of epidermal growth factor receptor inhibitor-induced side effects utilizing melanin and vascular-specific lasers: A case report series. Kuo, KY; Kwong, B; Rahman, Z, 2017)	0.46
" All patients experienced at least one adverse event (AE)."	( A Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of Pictilisib in Combination with Erlotinib in Patients with Advanced Solid Tumors. Bowles, DW; Lackner, MR; Leong, S; Moss, RA; Schellens, JHM; Schutzman, JL; Shankar, G; Spoerke, JM; van der Noll, R; Voest, EE; Ware, JA; Zhou, J, 2017)	0.46
"Our objective is to provide updated analyses of safety and the assessment of manageability of specific adverse events."	( Erlotinib Plus Bevacizumab Phase ll Study in Patients with Advanced Non-small-Cell Lung Cancer (JO25567): Updated Safety Results. Goto, K; Kato, T; Khaznadar, T; Nishio, M; Okamoto, I; Seki, A; Seto, T; Shibata, M; Tajima, K; Tao, L; Yamamoto, N; Yu, W, 2018)	0.48
" Adverse event frequency rates, predictability and manageability, reasons for discontinuation, time to onset, and outcomes of specific adverse events were analyzed."	( Erlotinib Plus Bevacizumab Phase ll Study in Patients with Advanced Non-small-Cell Lung Cancer (JO25567): Updated Safety Results. Goto, K; Kato, T; Khaznadar, T; Nishio, M; Okamoto, I; Seki, A; Seto, T; Shibata, M; Tajima, K; Tao, L; Yamamoto, N; Yu, W, 2018)	0.48
" There was no difference in overall incidence of serious adverse events between arms, but more grade 3 or higher adverse events were reported with erlotinib plus bevacizumab (90."	( Erlotinib Plus Bevacizumab Phase ll Study in Patients with Advanced Non-small-Cell Lung Cancer (JO25567): Updated Safety Results. Goto, K; Kato, T; Khaznadar, T; Nishio, M; Okamoto, I; Seki, A; Seto, T; Shibata, M; Tajima, K; Tao, L; Yamamoto, N; Yu, W, 2018)	0.48
"Determinants of interindividual variability in erlotinib pharmacokinetics (PK) and adverse events remain to be elucidated."	( Population Pharmacokinetics and Adverse Events of Erlotinib in Japanese Patients with Non-small-cell Lung Cancer: Impact of Genetic Polymorphisms in Metabolizing Enzymes and Transporters. Endo-Tsukude, C; Fujii, S; Hamada, A; Hayashi, M; Inaba, M; Isobe, T; Iwamoto, N; Kai, Y; Kashiwabara, K; Kishi, H; Kohrogi, H; Saeki, S; Saito, H; Sasaki, JI; Semba, H; Tsubata, Y; Ushijima, S, 2018)	0.48
" Antitumor effectiveness (overall survival [OS], progression-free survival [PFS], objective response rate [ORR] and disease control rate [DCR]) and adverse effects [AEs]) were assessed."	( Gefitinib provides similar effectiveness and improved safety than erlotinib for advanced non-small cell lung cancer: A meta-analysis. Peng, J; Wei, Y; Xu, J; Yu, D; Zhang, W, 2018)	0.48
" Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and adverse effects (AEs) were analyzed as primary endpoints."	( Gefitinib provides similar effectiveness and improved safety than erlotinib for east Asian populations with advanced non-small cell lung cancer: a meta-analysis. Peng, J; Wei, Y; Xu, J; Yu, D; Zhang, W, 2018)	0.48
" The network meta-analysis is applied to compare the efficacies and adverse events of five targeted agents (erlotinib, gefitinib, vandetanib, dacomitinib, and icotinib) for advanced or metastatic NSCLC."	( Efficacy and adverse events of five targeted agents in the treatment of advanced or metastatic non-small-cell lung cancer: A network meta-analysis of nine eligible randomized controlled trials involving 5,059 patients. Li, XF; Liu, GF; Miao, YY; Yu, SN; Zhang, SH, 2019)	0.51
" We extracted data from these studies to evaluate the relative risk (RR) of overall response rate (ORR) and grade 3/4 treatment-related adverse events (AEs), the hazard ratios (HRs) of overall survival (OS), and progression-free survival (PFS)."	( Combination strategies based on epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors for cancer patients: Pooled analysis and subgroup analysis of efficacy and safety. Ju, Q; Shao, H; Shi, H; Xu, R; Zhu, J, 2019)	0.51
" Adverse events were recorded."	( Second-line erlotinib after failure of pemetrexed-containing chemotherapy in advanced non-small cell lung cancer (NSCLC): Real-world effectiveness, safety and tolerability. Germonpré, P; Van den Wyngaert, T, 2019)	0.51
"9%) of patients due to adverse events, which were treatment related in 7%."	( Second-line erlotinib after failure of pemetrexed-containing chemotherapy in advanced non-small cell lung cancer (NSCLC): Real-world effectiveness, safety and tolerability. Germonpré, P; Van den Wyngaert, T, 2019)	0.51
" The continued exposure revealed that the difference in cardiotoxicity between cardiotoxic doxorubicin and less toxic erlotinib was more evident after 8 days of treatment than with 3 days of treatment, suggesting that continued exposure improved the predictive power for cardiotoxicity of anti-cancer drugs."	( Continued exposure of anti-cancer drugs to human iPS cell-derived cardiomyocytes can unmask their cardiotoxic effects. Iwasaki, N; Kurokawa, J; Sakamoto, K; Sakatoku, K; Sano, Y; Sugimoto, S; Yamaguchi, M, 2019)	0.51
"Clinical trials with first- and second-generation epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) reported severe adverse events (SAEs) in 6%-49% of patients with EGFR-mutated non-small cell lung cancer."	( The rate of occurrence, healthcare resource use and costs of adverse events among metastatic non-small cell lung cancer patients treated with first- and second-generation epidermal growth factor receptor tyrosine kinase inhibitors. DerSarkissian, M; Duh, MS; Fernandes, AW; Laliberté, F; Pavilack, M; Subramanian, J, 2019)	0.51
" The incidence of ocular toxicities as adverse effects (AE) of erlotinib is relatively common."	( Bilateral acute anterior uveitis: a rare ocular side effect of erlotinib. Ahern, E; Chan, S; Chaudhry, S; Hughes, B, 2019)	0.51
" These adverse events may be so severe that they impair the patient's compliance with the treatment or even cause its discontinuation."	( Substance P receptor blocker, aprepitant, inhibited cutaneous and other neurogenic inflammation side effects of the EGFR1-TKI, erlotinib. Chmielinska, JJ; Kramer, JH; Mak, IT; Spurney, CF; Weglicki, WB, 2020)	0.56
" In particular, combining erlotinib with the VEGF antibody bevacizumab has therapeutic value in NSCLC, but the drugs' separate effects as monotherapy and any adverse outcomes of combination therapy remain unclear."	( Efficacy and safety of erlotinib combined with bevacizumab in the treatment of non-small cell lung cancer: A systematic review and meta-analysis. Ding, L; Guo, W; Zhao, S; Zhou, K, 2020)	0.56
"We reviewed randomized controlled trials on the use of erlotinib combined with bevacizumab in adult patients with NSCLC, including data on outcome measures of overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and adverse events."	( Efficacy and safety of erlotinib combined with bevacizumab in the treatment of non-small cell lung cancer: A systematic review and meta-analysis. Ding, L; Guo, W; Zhao, S; Zhou, K, 2020)	0.56
"Compared with erlotinib or bevacizumab monotherapy, their combination effectively prolongs PFS but increases incidence of adverse events in NSCLC patients."	( Efficacy and safety of erlotinib combined with bevacizumab in the treatment of non-small cell lung cancer: A systematic review and meta-analysis. Ding, L; Guo, W; Zhao, S; Zhou, K, 2020)	0.56
" We conducted a disproportionality analysis of the adverse events (AEs) of EGFR-TKIs (gefitinib, erlotinib, afatinib, osimertinib) by data mining using the FDA adverse event reporting system (AERS) database, and by calculating the reporting odds ratios (ROR) with 95% confidence intervals."	( Safety Profile of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors: A Disproportionality Analysis of FDA Adverse Event Reporting System. Chen, H; Huang, J; Luo, Z; Meng, L; Sun, S; Yang, B, 2020)	0.56
" However, one of the major adverse effects associated with this therapy is skin toxicity, which impacts the patient's quality of life."	( Effects of tyrosine kinase inhibitor therapy on skin toxicity and skin-related quality of life in patients with lung cancer: An observational study. Chen, KH; Tseng, LC; Wang, CL; Weng, LC, 2020)	0.56
" We also evaluated the power and sensitivity of the method for detecting toxic effects of drugs by conducting a set of experiments using known toxicants and other methods of screening for cytotoxic effects."	( Quantifying drug-induced structural toxicity in hepatocytes and cardiomyocytes derived from hiPSCs using a deep learning method. Dame, K; Grafton, F; Loewke, K; Maddah, M; Mandegar, MA; Ribeiro, AJS, 2020)	0.56
" We collected and compared RCTs on antiangiogenic drugs combined with erlotinib (A + E) for NSCLC, and analyzed outcomes including overall survival (OS), objective response rate (ORR), progression-free survival (PFS), and incidence of severe adverse events (grade ≥3 AEs)."	( Efficacy and safety of anti-angiogenic drugs combined with erlotinib in the treatment of advanced non-small cell lung cancer: a meta-analysis of randomized clinical trials. Cao, P; Chen, Z; Jiang, S; Li, J; Li, X; Liu, L; Xin, Y; Zhang, J; Zhang, L, 2021)	0.62
" Although combination therapy was found to carry an increased incidence of grade 3 or higher adverse events including diarrhea and proteinuria, these remained within controllable levels."	( Efficacy and safety of anti-angiogenic drugs combined with erlotinib in the treatment of advanced non-small cell lung cancer: a meta-analysis of randomized clinical trials. Cao, P; Chen, Z; Jiang, S; Li, J; Li, X; Liu, L; Xin, Y; Zhang, J; Zhang, L, 2021)	0.62
" Safety was evaluated based on reported treatment-emergent adverse events (AEs) and clinical laboratory assessments."	( RELAY, Ramucirumab Plus Erlotinib Versus Placebo Plus Erlotinib in Patients with Untreated, Epidermal Growth Factor Receptor Mutation-Positive, Metastatic Non-Small-Cell Lung Cancer: Safety Profile and Manageability. Barrett, E; Frimodt-Moller, B; Garon, EB; Horinouchi, H; Kollmeier, J; Lipkovich, O; Nadal, E; Nakagawa, K; Novello, S; Reck, M; Shih, JY; Visseren-Grul, C; Wei, YF, 2022)	0.72
" One grade 3 adverse event was reported in the placebo group (liver enzymes elevation), leading to treatment discontinuation and patient replacement, and 1 in the erlotinib 100 mg/d group (pericarditis), which was not considered to be treatment-related."	( Safety and Antiviral Activity of EGFR Inhibition by Erlotinib in Chronic Hepatitis C Patients: A Phase Ib Randomized Controlled Trial. Baumert, TF; Doffoël, M; Habersetzer, F; Lupberger, J; Saviano, A; Schmidt-Mutter, C; Schuster, C; Simo-Noumbissie, P, 2022)	0.72
"Erlotinib demonstrated to be safe in noncirrhotic CHC patients."	( Safety and Antiviral Activity of EGFR Inhibition by Erlotinib in Chronic Hepatitis C Patients: A Phase Ib Randomized Controlled Trial. Baumert, TF; Doffoël, M; Habersetzer, F; Lupberger, J; Saviano, A; Schmidt-Mutter, C; Schuster, C; Simo-Noumbissie, P, 2022)	0.72
" No dose-limiting toxicities or grade 4 or 5 treatment-related adverse events occurred."	( Safety and clinical activity of atezolizumab plus erlotinib in patients with non-small-cell lung cancer. Besse, B; Cervantes, A; Cha, E; Costa, DB; Dowlati, A; Gettinger, S; Heist, R; Li, S; Ma, B; Riely, GJ; Rudin, CM; Schmid, P; Spahn, J; Villaflor, VM, 2023)	0.91

Excerpt	Reference	Relevance
"Pharmacokinetic and pharmacodynamic studies have an important role in the optimization of targeted agents."	( Pharmacokinetics and pharmacodynamics: maximizing the clinical potential of Erlotinib (Tarceva). Bloedow, D; Hidalgo, M, 2003)	0.32
" This study evaluated the pharmacodynamic effects of OSI-774 in normal skin tissues collected from patients treated with the agent in a Phase I study."	( Pharmacodynamic evaluation of the epidermal growth factor receptor inhibitor OSI-774 in human epidermis of cancer patients. Bacus, S; Brattain, MG; deGraffenried, L; Hammond, LA; Hidalgo, M; Kreisberg, JI; Malik, SN; Rizzo, J; Rowinsky, EK; Siu, LL, 2003)	0.32
"OSI-774 exerted pharmacodynamic effects in skin tissues of 30-50% of patients treated with the agent."	( Pharmacodynamic evaluation of the epidermal growth factor receptor inhibitor OSI-774 in human epidermis of cancer patients. Bacus, S; Brattain, MG; deGraffenried, L; Hammond, LA; Hidalgo, M; Kreisberg, JI; Malik, SN; Rizzo, J; Rowinsky, EK; Siu, LL, 2003)	0.32
" Pharmacokinetic sampling was also obtained."	( Evaluation of biologic end points and pharmacokinetics in patients with metastatic breast cancer after treatment with erlotinib, an epidermal growth factor receptor tyrosine kinase inhibitor. Bacharach, SL; Berman, A; Brahim, JS; Carrasquillo, JA; Chow, C; Ettenberg, SA; Figg, WD; Hewitt, SM; Lepper, ER; Lipkowitz, S; Parr, AL; Sparreboom, A; Steinberg, SM; Swain, SM; Tan, AR; Whatley, M; Yang, X, 2004)	0.32
"To compare the pharmacokinetic variables of erlotinib in current smokers with nonsmokers after receiving a single oral 150 or 300 mg dose of erlotinib."	( Effects of smoking on the pharmacokinetics of erlotinib. Beard, SE; Cagnoni, PJ; Clark, GM; Hamilton, M; Rusk, J; Witt, K; Wolf, JL, 2006)	0.33
"This was a single-center, open-label pharmacokinetic study in healthy male subjects."	( Effects of smoking on the pharmacokinetics of erlotinib. Beard, SE; Cagnoni, PJ; Clark, GM; Hamilton, M; Rusk, J; Witt, K; Wolf, JL, 2006)	0.33
" Herein we provide the preclinical and clinical rationale for studies examining the concept of pharmacodynamic separation as a means for overcoming hypothesized antagonism of EGFR TKIs and chemotherapy."	( Pharmacodynamic separation of epidermal growth factor receptor tyrosine kinase inhibitors and chemotherapy in non-small-cell lung cancer. Davies, AM; Gandara, DR; Gumerlock, PH; Ho, C; Lara, PN; Mack, P, 2006)	0.33
"The population pharmacokinetic analysis was performed by use of NONMEM based on 4068 concentration samples from 1047 patients receiving erlotinib as a single agent or in combination with chemotherapy."	( Clinical pharmacokinetics of erlotinib in patients with solid tumors and exposure-safety relationship in patients with non-small cell lung cancer. Bruno, R; Eppler, SM; Hamilton, M; Lu, JF; Lum, BL; Rakhit, A; Wolf, J, 2006)	0.33
" The median erlotinib half-life based on this patient population was 36."	( Clinical pharmacokinetics of erlotinib in patients with solid tumors and exposure-safety relationship in patients with non-small cell lung cancer. Bruno, R; Eppler, SM; Hamilton, M; Lu, JF; Lum, BL; Rakhit, A; Wolf, J, 2006)	0.33
"The long half-life of erlotinib supports the current once-daily dosing regimen at 150 mg/d."	( Clinical pharmacokinetics of erlotinib in patients with solid tumors and exposure-safety relationship in patients with non-small cell lung cancer. Bruno, R; Eppler, SM; Hamilton, M; Lu, JF; Lum, BL; Rakhit, A; Wolf, J, 2006)	0.33
"To assess the feasibility of administering erlotinib, an inhibitor of epidermal growth factor receptor (EGFR) tyrosine kinase, in combination with paclitaxel and carboplatin, and to identify pharmacokinetic interactions, evaluate downstream effects of EGFR inhibition on surrogate tissues, and seek preliminary evidence for clinical activity."	( Phase I, pharmacokinetic, and biological study of erlotinib in combination with paclitaxel and carboplatin in patients with advanced solid tumors. Beeram, M; Hamilton, M; Hammond, LA; Hidalgo, M; Kreisberg, JI; Mita, MM; Nadler, P; Patnaik, A; Rowinsky, EK; Schwartz, G; Tolcher, AW; Wolf, J; Wood, D, 2006)	0.33
" There was no evidence of pharmacokinetic interactions between paclitaxel and erlotinib; however, total carboplatin exposure trended higher in the presence of erlotinib."	( Phase I, pharmacokinetic, and biological study of erlotinib in combination with paclitaxel and carboplatin in patients with advanced solid tumors. Beeram, M; Hamilton, M; Hammond, LA; Hidalgo, M; Kreisberg, JI; Mita, MM; Nadler, P; Patnaik, A; Rowinsky, EK; Schwartz, G; Tolcher, AW; Wolf, J; Wood, D, 2006)	0.33
"The purpose of the study was to evaluate the effects of erlotinib on epidermal growth factor receptor (EGFR)-related signaling elements in tumor and skin from patients with advanced squamous cell carcinoma of the head and neck (HNSCC) and seek relationships between relevant clinical, biological, and pharmacokinetic parameters."	( Assessment of erlotinib pharmacodynamics in tumors and skin of patients with head and neck cancer. Baillargeon, GM; Calvo, E; Chin, SF; Hidalgo, M; Irish, J; Kreisberg, JI; Malik, SN; Rowinsky, EK; Santabarbara, P; Siu, LL, 2007)	0.34
" Erlotinib and OSI-420 plasma pharmacokinetic variables on days 8 and 34 overlapped to suggest that steady state had been reached."	( Plasma and cerebrospinal fluid pharmacokinetics of erlotinib and its active metabolite OSI-420. Bai, F; Broniscer, A; Fraga, C; Gajjar, A; Krasin, MJ; O'Shaughnessy, M; Panetta, JC; Stewart, CF, 2007)	0.34
"The objectives of this phase I dose-finding study of erlotinib were to investigate the toxicity profile, to confirm the acceptable toxicity of doses up to 150 mg/day, and to assess the pharmacokinetic (PK) profile and antitumor activity in Japanese patients with solid tumors."	( Phase I dose-finding and pharmacokinetic study of the oral epidermal growth factor receptor tyrosine kinase inhibitor Ro50-8231 (erlotinib) in Japanese patients with solid tumors. Fujisaka, Y; Horiike, A; Murakami, H; Shimoyama, T; Tamura, T; Yamada, Y; Yamamoto, N, 2008)	0.35
"PURPOSE Pharmacodynamic tissue studies were conducted on a phase I/II trial of erlotinib and cisplatin in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)."	( Predictive and pharmacodynamic biomarker studies in tumor and skin tissue samples of patients with recurrent or metastatic squamous cell carcinoma of the head and neck treated with erlotinib. Agulnik, M; Chen, EX; Chen, H; Chen, S; da Cunha Santos, G; Dancey, J; Dos Reis, PP; Hedley, D; Ho, J; Kamel-Reid, S; Marrano, P; Nicklee, T; Pond, GR; Shyr, Y; Siu, LL; Soulieres, D; Squire, JA; Tsao, MS; Winquist, E, 2007)	0.34
" Pharmacokinetic parameters were estimated using non-compartmental and compartmental methods."	( The plasma and cerebrospinal fluid pharmacokinetics of erlotinib and its active metabolite (OSI-420) after intravenous administration of erlotinib in non-human primates. Balis, FM; Fox, E; McCully, C; Meany, HJ; Tucker, C, 2008)	0.35
" We hypothesize that cell cycle arrest induced by erlotinib accounts for these findings in the presence of wild-type EGFR and that pharmacodynamic separation of the 2 drug classes will ameliorate these effects."	( Schedule-dependent apoptosis in K-ras mutant non-small-cell lung cancer cell lines treated with docetaxel and erlotinib: rationale for pharmacodynamic separation. Davies, AM; Gandara, DR; Gumerlock, PH; Holland, W; Lara, PN; Mack, PC; Mahaffey, CM; Pryde, B, 2007)	0.34
"To assess the pharmacogenomic and pharmacokinetic determinants of skin rash and diarrhea, the two primary dose-limiting toxicities of the epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor erlotinib."	( Pharmacogenomic and pharmacokinetic determinants of erlotinib toxicity. Armstrong, DK; Brahmer, JR; Carducci, MA; Chen, P; Das, S; Desai, A; Fackenthal, DL; Fleming, GF; Janisch, L; Jiang, X; Karrison, T; Liu, W; Poonkuzhali, B; Ramirez, J; Ratain, MJ; Rudin, CM; Schuetz, E; Vokes, EE, 2008)	0.35
"A novel diplotype of two polymorphic loci in the ABCG2 promoter involving -15622C/T and 1143C/T was identified, with alleles conferring lower ABCG2 levels associated with higher erlotinib pharmacokinetic parameters, including area under the curve (P = ."	( Pharmacogenomic and pharmacokinetic determinants of erlotinib toxicity. Armstrong, DK; Brahmer, JR; Carducci, MA; Chen, P; Das, S; Desai, A; Fackenthal, DL; Fleming, GF; Janisch, L; Jiang, X; Karrison, T; Liu, W; Poonkuzhali, B; Ramirez, J; Ratain, MJ; Rudin, CM; Schuetz, E; Vokes, EE, 2008)	0.35
"Although exploratory in nature, this combined pharmacogenomic and pharmacokinetic model helps to define and differentiate the primary determinants of skin and gastrointestinal toxicity of erlotinib."	( Pharmacogenomic and pharmacokinetic determinants of erlotinib toxicity. Armstrong, DK; Brahmer, JR; Carducci, MA; Chen, P; Das, S; Desai, A; Fackenthal, DL; Fleming, GF; Janisch, L; Jiang, X; Karrison, T; Liu, W; Poonkuzhali, B; Ramirez, J; Ratain, MJ; Rudin, CM; Schuetz, E; Vokes, EE, 2008)	0.35
"We conducted a phase I and pharmacokinetic study of the epidermal growth factor receptor (EGFR) inhibitor erlotinib as a single agent and in combination with temozolomide in children with refractory solid tumors."	( Pediatric phase I and pharmacokinetic study of erlotinib followed by the combination of erlotinib and temozolomide: a Children's Oncology Group Phase I Consortium Study. Adamson, PC; Blaney, SM; Dancey, JE; Gilbertson, RJ; Hamilton, M; Ingle, AM; Jakacki, RI; Krailo, MD; Tersak, J; Voss, SD, 2008)	0.35
" Pharmacokinetic studies and ERBB-receptor expression and signaling studies were performed."	( Pediatric phase I and pharmacokinetic study of erlotinib followed by the combination of erlotinib and temozolomide: a Children's Oncology Group Phase I Consortium Study. Adamson, PC; Blaney, SM; Dancey, JE; Gilbertson, RJ; Hamilton, M; Ingle, AM; Jakacki, RI; Krailo, MD; Tersak, J; Voss, SD, 2008)	0.35
" Pharmacokinetic studies were obtained after first dose and on day 8 of therapy."	( Phase I and pharmacokinetic studies of erlotinib administered concurrently with radiotherapy for children, adolescents, and young adults with high-grade glioma. Baker, SJ; Broniscer, A; Ellison, DW; Endersby, R; Gajjar, A; Kocak, M; Laningham, FH; Merchant, TE; Morris, EB; Schaiquevich, P; Stewart, CF, 2009)	0.35
" The pharmacokinetic variables of erlotinib and OSI-420 in children were similar to those described in adults."	( Phase I and pharmacokinetic studies of erlotinib administered concurrently with radiotherapy for children, adolescents, and young adults with high-grade glioma. Baker, SJ; Broniscer, A; Ellison, DW; Endersby, R; Gajjar, A; Kocak, M; Laningham, FH; Merchant, TE; Morris, EB; Schaiquevich, P; Stewart, CF, 2009)	0.35
"Although the MTD of erlotinib in children with newly diagnosed high-grade glioma was 120 mg/m(2) per day, pharmacokinetic studies showed wide interpatient variability in drug exposure."	( Phase I and pharmacokinetic studies of erlotinib administered concurrently with radiotherapy for children, adolescents, and young adults with high-grade glioma. Baker, SJ; Broniscer, A; Ellison, DW; Endersby, R; Gajjar, A; Kocak, M; Laningham, FH; Merchant, TE; Morris, EB; Schaiquevich, P; Stewart, CF, 2009)	0.35
" Pharmacodynamic separation by intermittent delivery of epidermal growth factor receptor tyrosine kinase inhibitors with chemotherapy may increase efficacy by overcoming hypothesized antagonism."	( Intermittent erlotinib in combination with pemetrexed: phase I schedules designed to achieve pharmacodynamic separation. Beckett, L; Davies, AM; Gandara, DR; Ho, C; Lara, PN; Lau, D; Perkins, N; Scudder, SA, 2009)	0.35
" Pharmacokinetic studies were conducted to assess the effect of pancreatic enzyme deficiency and intestinal malabsorption secondary to cystic fibrosis on the bioavailability of orally administered erlotinib, a lipophilic drug."	( Pharmacokinetics of erlotinib for the treatment of high-grade glioma in a pediatric patient with cystic fibrosis: case report and review of the literature. Broniscer, A; Christiansen, SR; Panetta, JC; Stewart, CF, 2009)	0.35
" Post marketing study commitments have been made upon (accelerated) approval such as additional pharmacokinetic studies in patients with renal- or hepatic impairment, in children, additional interactions studies and studies on the relative or absolute bioavailability."	( Clinical pharmacokinetics of tyrosine kinase inhibitors. Gelderblom, H; Guchelaar, HJ; van Erp, NP, 2009)	0.35
" To determine possible drug-drug interaction with this combination, a subset of 24 (12 erlotinib, 12 placebo) patients were enrolled onto an intensive pharmacokinetic (IPK) substudy group at a single site."	( Pharmacokinetic study of the phase III, randomized, double-blind, multicenter trial (TRIBUTE) of paclitaxel and carboplatin combined with erlotinib or placebo in patients with advanced Non-small Cell Lung Cancer (NSCLC). Blumenschein, GR; Herbst, RS; Kim, ES; Lu, C; Lum, BL; Malik, M; Oh, YW; Papadimitrakopoulou, VA; Tran, HT; Zinner, RG, 2011)	0.37
"Complete blood sampling for pharmacokinetic analysis was obtained in 21 of 24 patients."	( Pharmacokinetic study of the phase III, randomized, double-blind, multicenter trial (TRIBUTE) of paclitaxel and carboplatin combined with erlotinib or placebo in patients with advanced Non-small Cell Lung Cancer (NSCLC). Blumenschein, GR; Herbst, RS; Kim, ES; Lu, C; Lum, BL; Malik, M; Oh, YW; Papadimitrakopoulou, VA; Tran, HT; Zinner, RG, 2011)	0.37
"The aims of this study were to further define the safety of sorafenib and erlotinib, given at their full approved monotherapy doses, and to correlate pharmacokinetic and pharmacodynamic markers with clinical outcome."	( Phase I combination of sorafenib and erlotinib therapy in solid tumors: safety, pharmacokinetic, and pharmacodynamic evaluation from an expansion cohort. Bandarchi-Chamkhaleh, B; Chen, EX; Do, T; Duran, I; Le Tourneau, C; MacLean, M; Mak, TW; Metser, U; Nayyar, R; Pham, NA; Quintela-Fandino, M; Siu, LL; Tsao, M; Tusche, MW; Wang, L; Wright, JJ, 2010)	0.36
" Pharmacokinetics were studied with LC-MS/MS, standard, and population pharmacokinetic methods."	( Phase I and pharmacokinetic study of erlotinib (OSI-774) in combination with docetaxel in squamous cell carcinoma of the head and neck (SSCHN). Agrawal, A; Aimiumu, J; Chan, KK; Chen, P; Cheng, H; Dancey, J; Grever, MR; Kraut, EH; Lang, J; Rhoades, C; Young, DC; Zhang, Y, 2011)	0.37
" In 24 patients, the mean Cmax and AUC erlotinib values increased with dose and following cumulative dosing (days 7 and 8 vs."	( Phase I and pharmacokinetic study of erlotinib (OSI-774) in combination with docetaxel in squamous cell carcinoma of the head and neck (SSCHN). Agrawal, A; Aimiumu, J; Chan, KK; Chen, P; Cheng, H; Dancey, J; Grever, MR; Kraut, EH; Lang, J; Rhoades, C; Young, DC; Zhang, Y, 2011)	0.37
" The effect of several covariates and single nucleotide polymorphisms (SNP) in ABCB1, ABCG2, and CYP3A5 on pharmacokinetic parameters was evaluated."	( Population analysis of erlotinib in adults and children reveals pharmacokinetic characteristics as the main factor explaining tolerance particularities in children. Chatelut, E; Civade, E; Delord, JP; Geoerger, B; Hennebelle, I; Le Deley, MC; Thomas, F; Vassal, G; White-Koning, M, 2011)	0.37
"The nonlinear population approach applied to pharmacokinetic data combined with a pharmacokinetic-pharmacodynamic analysis revealed that the higher recommended dose in children (125 mg/m(2)/day) compared with adults (90 mg/m(2)/day) is mainly due to pharmacokinetic rather than pharmacodynamic particularities."	( Population analysis of erlotinib in adults and children reveals pharmacokinetic characteristics as the main factor explaining tolerance particularities in children. Chatelut, E; Civade, E; Delord, JP; Geoerger, B; Hennebelle, I; Le Deley, MC; Thomas, F; Vassal, G; White-Koning, M, 2011)	0.37
" On the basis of preclinical models, we hypothesized pharmacodynamic separation, achieved by intermittent delivery of epidermal growth factor receptor tyrosine kinase inhibitors intercalated with chemotherapy, as a reasonable strategy to deliver combination therapy."	( Intercalated erlotinib-docetaxel dosing schedules designed to achieve pharmacodynamic separation: results of a phase I/II trial. Beckett, LA; Davies, AM; Gandara, DR; Hesketh, PJ; Lara, PN; Lau, D; Li, T; Mack, PC; Perkins, N; Sangha, R, 2011)	0.37
" The MTD for arm B was chosen for phase II evaluation given the feasibility of administration, number of responses (one complete response and three partial responses), and achievement of pharmacodynamic separation."	( Intercalated erlotinib-docetaxel dosing schedules designed to achieve pharmacodynamic separation: results of a phase I/II trial. Beckett, LA; Davies, AM; Gandara, DR; Hesketh, PJ; Lara, PN; Lau, D; Li, T; Mack, PC; Perkins, N; Sangha, R, 2011)	0.37
"To compare the pharmacokinetic (PK) parameters of a single dose of erlotinib in cancer patients with moderate hepatic impairment (MHI) to those of cancer patients with adequate hepatic function (AHF)."	( An open-label study to describe pharmacokinetic parameters of erlotinib in patients with advanced solid tumors with adequate and moderately impaired hepatic function. Belani, C; Boinpally, R; Evans, J; Franke, A; Gail Eckhardt, S; Haluska, P; Leong, S; O'Bryant, CL; Ramalingam, S; Ramanathan, RK; Rosen, L; Venugopal, B; Witt, K, 2012)	0.38
"We used mathematical modeling and available clinical trial data to predict how different pharmacokinetic parameters (fast versus slow metabolism) and dosing schedules (low dose versus high dose; missed doses with and without make-up doses) might affect the evolution of T790M-mediated resistance in mixed populations of tumor cells."	( Effects of pharmacokinetic processes and varied dosing schedules on the dynamics of acquired resistance to erlotinib in EGFR-mutant lung cancer. Chmielecki, J; Foo, J; Michor, F; Pao, W, 2012)	0.38
" Erlotinib and sorafenib have significant pharmacokinetic interactions that may negatively impact the efficacy of the combination regimen."	( NABTT 0502: a phase II and pharmacokinetic study of erlotinib and sorafenib for patients with progressive or recurrent glioblastoma multiforme. Ahluwalia, MS; Grossman, SA; Hilderbrand, SL; Mikkelsen, T; Nabors, LB; Peereboom, DM; Phuphanich, S; Rosenfeld, MR; Supko, JG; Ye, X, 2013)	0.39
"Erlotinib shows large inter-patient pharmacokinetic variability, but the impact of early drug exposure and genetic variations on the clinical outcomes of erlotinib remains fully investigated."	( Population pharmacokinetics/pharmacodynamics of erlotinib and pharmacogenomic analysis of plasma and cerebrospinal fluid drug concentrations in Japanese patients with non-small cell lung cancer. Fukudo, M; Ikemi, Y; Inui, K; Katsura, T; Kim, YH; Masago, K; Mio, T; Mishima, M; Terada, T; Teramukai, S; Togashi, Y, 2013)	0.39
" Population pharmacokinetic analysis was performed with the nonlinear mixed-effects modelling program NONMEM."	( Population pharmacokinetics/pharmacodynamics of erlotinib and pharmacogenomic analysis of plasma and cerebrospinal fluid drug concentrations in Japanese patients with non-small cell lung cancer. Fukudo, M; Ikemi, Y; Inui, K; Katsura, T; Kim, YH; Masago, K; Mio, T; Mishima, M; Terada, T; Teramukai, S; Togashi, Y, 2013)	0.39
" We conducted a phase I and pharmacokinetic study with the erlotinib and celecoxib combination in patients with advanced premalignant lesions."	( Chemoprevention of head and neck cancer with celecoxib and erlotinib: results of a phase ib and pharmacokinetic study. Beitler, JJ; Chen, AY; Chen, Z; Chen, ZG; Grandis, JR; Grist, W; Hurwitz, SJ; Khuri, FR; Kono, SA; Lewis, M; Moore, CE; Moreno-Williams, R; Müller, S; Nannapaneni, S; Owonikoko, TK; Ramalingam, S; Saba, NF; Shin, DM; Shin, HJ; Sica, G; Yang, CS; Zhao, Y, 2014)	0.4
" In this paper, the pharmacokinetic characteristics (absorption, distribution, metabolism and excretion) and drug-drug interactions of the approved TKIs are reviewed."	( [Clinical pharmacokinetics of small molecule tyrosine kinase inhibitors]. Ding, JF; Zhong, DF, 2013)	0.39
" Several explanations have been suggested, including pharmacokinetic and pharmacogenomic variability."	( Correlation between erlotinib pharmacokinetics, cutaneous toxicity and clinical outcomes in patients with advanced non-small cell lung cancer (NSCLC). Andreoli, R; Ardizzoni, A; Azzoni, C; Bartolotti, M; Bortesi, B; De Palma, G; Gelsomino, F; Goldoni, M; Mozzoni, P; Mutti, A; Silini, EM; Tiseo, M, 2014)	0.4
"These findings suggest that the pharmacokinetics and metabolism of erlotinib are related to skin toxicity and may support further studies where erlotinib dosing is tailored according to pharmacokinetic parameters."	( Correlation between erlotinib pharmacokinetics, cutaneous toxicity and clinical outcomes in patients with advanced non-small cell lung cancer (NSCLC). Andreoli, R; Ardizzoni, A; Azzoni, C; Bartolotti, M; Bortesi, B; De Palma, G; Gelsomino, F; Goldoni, M; Mozzoni, P; Mutti, A; Silini, EM; Tiseo, M, 2014)	0.4
" Correlative studies confirmed panobinostat's pharmacodynamic effect in blood, FPB, and tumor samples."	( A phase I, pharmacokinetic, and pharmacodynamic study of panobinostat, an HDAC inhibitor, combined with erlotinib in patients with advanced aerodigestive tract tumors. Akar, A; Altiok, S; Bepler, G; Chiappori, A; Gray, JE; Haura, E; Kish, JA; Kreahling, J; Lush, R; Neuger, A; Pinder-Schenck, M; Schell, MJ; Tanvetyanon, T; Tetteh, L; Williams, CC; Zhao, X, 2014)	0.4
" Additional evaluations included pharmacokinetics, pharmacodynamic effects on PI3K and EGFR/mitogen-activated protein kinase signaling pathways in tumor and skin samples, and tumor response."	( Phase I safety and pharmacokinetic study of the PI3K/mTOR inhibitor SAR245409 (XL765) in combination with erlotinib in patients with advanced solid tumors. Cohen, RB; Engelman, JA; Felip, E; Jänne, PA; Laird, AD; Macé, S; Martinez, P; Rockich, K; Ruiz-Soto, R; Shapiro, GI; Xu, J, 2014)	0.4
" No major pharmacokinetic interaction between SAR245409 and erlotinib was noted."	( Phase I safety and pharmacokinetic study of the PI3K/mTOR inhibitor SAR245409 (XL765) in combination with erlotinib in patients with advanced solid tumors. Cohen, RB; Engelman, JA; Felip, E; Jänne, PA; Laird, AD; Macé, S; Martinez, P; Rockich, K; Ruiz-Soto, R; Shapiro, GI; Xu, J, 2014)	0.4
"MTDs of SAR245409 and erlotinib were below the single-agent doses of either agent, despite the lack of major pharmacokinetic interaction."	( Phase I safety and pharmacokinetic study of the PI3K/mTOR inhibitor SAR245409 (XL765) in combination with erlotinib in patients with advanced solid tumors. Cohen, RB; Engelman, JA; Felip, E; Jänne, PA; Laird, AD; Macé, S; Martinez, P; Rockich, K; Ruiz-Soto, R; Shapiro, GI; Xu, J, 2014)	0.4
"71 L/h, elimination half-life to 21."	( Erlotinib: another candidate for the therapeutic drug monitoring of targeted therapy of cancer? A pharmacokinetic and pharmacodynamic systematic review of literature. Buclin, T; Decosterd, LA; Gairard-Dory, AC; Gourieux, B; Guidi, M; Petit-Jean, E; Quoix, E; Ubeaud-Séquier, G; Widmer, N, 2015)	0.42
" We tested a pharmacodynamic separation approach for erlotinib plus gemcitabine and interrogated EGFR signaling intermediates as potential surrogates for the efficacy of this strategy."	( Pharmacodynamic separation of gemcitabine and erlotinib in locally advanced or metastatic pancreatic cancer: therapeutic and biomarker results. Barzi, A; Beckett, L; Burich, RA; Gong, IY; Holland, W; Hutchins, IM; Kim, EJ; Lara, PN; Lenz, HJ; Mack, P; Semrad, T; Snyder-Solis, L; Tanaka, M, 2015)	0.42
" Individual empirical Bayesian estimates (EBEs) of apparent oral clearance (CL/F) and Cmax were compared between the patients who developed and did not develop ILD-like events."	( Population pharmacokinetics of erlotinib in Japanese patients with advanced non-small cell lung cancer. Emoto-Yamamoto, Y; Fukuoka, M; Iida, S; Kawanishi, T, 2015)	0.42
" No differences in CL/F and Cmax were observed between the patients with ILD-like events and those without ILD-like events."	( Population pharmacokinetics of erlotinib in Japanese patients with advanced non-small cell lung cancer. Emoto-Yamamoto, Y; Fukuoka, M; Iida, S; Kawanishi, T, 2015)	0.42
" Pharmacokinetic parameters, including maximum plasma concentration (C(max)), area under the plasma concentration-time curve to the last sampling time (AUC(t)), AUC from time zero to infinity (AUC(∞)), and time to reach C(max) (t(max)), were measured, and all treatment-emergent adverse events and their relationships with the study medications were recorded throughout the study."	( Pharmacokinetic properties of two erlotinib 150 mg formulations with a genetic effect evaluation in healthy Korean subjects. Cho, SJ; Choi, HG; Im, YJ; Jeon, JY; Kim, MG; Kim, Y; Seo, YH; Song, EK, 2015)	0.42
" Both formulations had very similar C(max), AUC, terminal half-life (t ½) and t(max) values."	( Pharmacokinetic properties of two erlotinib 150 mg formulations with a genetic effect evaluation in healthy Korean subjects. Cho, SJ; Choi, HG; Im, YJ; Jeon, JY; Kim, MG; Kim, Y; Seo, YH; Song, EK, 2015)	0.42
"This study suggests that the test and reference formulations of 150 mg erlotinib have similar pharmacokinetic characteristics."	( Pharmacokinetic properties of two erlotinib 150 mg formulations with a genetic effect evaluation in healthy Korean subjects. Cho, SJ; Choi, HG; Im, YJ; Jeon, JY; Kim, MG; Kim, Y; Seo, YH; Song, EK, 2015)	0.42
"The aim of this study was to evaluate the effect of coadministration of acid-reducing agents on the pharmacokinetic exposure of orally administered epidermal growth factor receptor inhibitor erlotinib, a drug that displays pH-dependent solubility."	( Effect of gastric pH on erlotinib pharmacokinetics in healthy individuals: omeprazole and ranitidine. Abt, M; Ducray, PS; Giraudon, M; Hamilton, M; Kletzl, H; Lum, BL, 2015)	0.42
"We conducted a cross-over pharmacokinetic study to compare the fed bioequivalence in the two conditions."	( Comparison of the pharmacokinetics of erlotinib administered in complete fasting and 2 h after a meal in patients with lung cancer. Fujiwara, Y; Goto, Y; Hamada, A; Horinouchi, H; Kanda, S; Katsuya, Y; Nokihara, H; Ohe, Y; Osawa, S; Sunami, K; Takashima, Y; Tamura, T; Utsumi, H; Yamamoto, N, 2015)	0.42
" Plasma samples, tumor biopsies, FDG-PET were obtained for assessment of pharmacokinetics, and pharmacodynamic modulation downstream of EGFR and HER3."	( Safety and Pharmacokinetics/Pharmacodynamics of the First-in-Class Dual Action HER3/EGFR Antibody MEHD7945A in Locally Advanced or Metastatic Epithelial Tumors. Amler, LC; Baselga, J; Blumenschein, GR; Bohórquez, SS; Calles, A; Cervantes, A; Dienstmann, R; Hidalgo, M; Jimeno, A; Juric, D; Kapp, AV; Leddy, C; Littman, C; Messersmith, W; Penuel, E; Pirzkall, A; Roda, D; Shames, DS; Tabernero, J; Wang, X, 2015)	0.42
" Pharmacodynamic data indicated target inhibition in 25% of evaluable patients."	( Safety and Pharmacokinetics/Pharmacodynamics of the First-in-Class Dual Action HER3/EGFR Antibody MEHD7945A in Locally Advanced or Metastatic Epithelial Tumors. Amler, LC; Baselga, J; Blumenschein, GR; Bohórquez, SS; Calles, A; Cervantes, A; Dienstmann, R; Hidalgo, M; Jimeno, A; Juric, D; Kapp, AV; Leddy, C; Littman, C; Messersmith, W; Penuel, E; Pirzkall, A; Roda, D; Shames, DS; Tabernero, J; Wang, X, 2015)	0.42
"MEHD7945A was well-tolerated as single agent with evidence of tumor pharmacodynamic modulation and antitumor activity in SCCHN."	( Safety and Pharmacokinetics/Pharmacodynamics of the First-in-Class Dual Action HER3/EGFR Antibody MEHD7945A in Locally Advanced or Metastatic Epithelial Tumors. Amler, LC; Baselga, J; Blumenschein, GR; Bohórquez, SS; Calles, A; Cervantes, A; Dienstmann, R; Hidalgo, M; Jimeno, A; Juric, D; Kapp, AV; Leddy, C; Littman, C; Messersmith, W; Penuel, E; Pirzkall, A; Roda, D; Shames, DS; Tabernero, J; Wang, X, 2015)	0.42
" Pharmacokinetic analysis showed no apparent interactions between co-administered navitoclax and erlotinib."	( Safety, efficacy, and pharmacokinetics of navitoclax (ABT-263) in combination with erlotinib in patients with advanced solid tumors. Arzt, J; Busman, TA; Holen, KD; Kirschbrown, W; Lian, G; LoRusso, P; Rosen, LS; Rudersdorf, NS; Tolcher, AW; Vanderwal, CA, 2015)	0.42
" There were no apparent pharmacokinetic interactions between erlotinib and navitoclax."	( Safety, efficacy, and pharmacokinetics of navitoclax (ABT-263) in combination with erlotinib in patients with advanced solid tumors. Arzt, J; Busman, TA; Holen, KD; Kirschbrown, W; Lian, G; LoRusso, P; Rosen, LS; Rudersdorf, NS; Tolcher, AW; Vanderwal, CA, 2015)	0.42
" Statistically significant differences between the groups were revealed for almost all analysed pharmacokinetic parameters for erlotinib and OSI420."	( The alteration of pharmacokinetics of erlotinib and OSI420 in type 1 diabetic rabbits. Grabowski, T; Grześkowiak, E; Karbownik, A; Sobańska, K; Szałek, E; Wolc, A, 2016)	0.43
"In patients with unselected or EGFR wild-type advanced nonsquamous NSCLC, pharmacodynamic separation of pemetrexed and intercalated erlotinib had promising antitumor activity without new safety concerns."	( Randomized Phase 2 Trial of Pharmacodynamic Separation of Pemetrexed and Intercalated Erlotinib Versus Pemetrexed Alone for Advanced Nonsquamous, Non-small-cell Lung Cancer. Bathini, VG; Beckett, LA; Gajavelli, S; Gandara, DR; Gucalp, R; Haigentz, M; Kim, M; Lara, PN; Li, T; Pasquinelli, PB; Perez-Soler, R; Piperdi, B; Sreedhara, M; Walsh, WV; Wen, H; Xie, X; Zhou, K, 2017)	0.46
" Our objective was to simulate DDIs between the antineoplastics erlotinib and gefitinib with key antiretroviral drugs and to predict dose adjustments using a physiologically based pharmacokinetic (PBPK) model."	( Use of a physiologically based pharmacokinetic model to simulate drug-drug interactions between antineoplastic and antiretroviral drugs. Back, D; Clotet, B; Miranda, C; Moltó, J; Owen, A; Rajoli, R; Siccardi, M; Valle, M, 2017)	0.46
"In vitro data describing chemical properties and pharmacokinetic processes of each drug and their effect on cytochrome P450 isoforms were obtained from the literature."	( Use of a physiologically based pharmacokinetic model to simulate drug-drug interactions between antineoplastic and antiretroviral drugs. Back, D; Clotet, B; Miranda, C; Moltó, J; Owen, A; Rajoli, R; Siccardi, M; Valle, M, 2017)	0.46
"The main objective of this study was to develop a pharmacokinetic model in order to describe the intestinal absorption of erlotinib in rat and to quantify the interaction of levofloxacin on this process in well- and under-nourished rats."	( Levofloxacin effect on erlotinib absorption. Evaluation of the interaction in undernutrition situations through population pharmacokinetic analysis in rats. Guglieri-López, B; Merino, V; Merino-Sanjuan, M; Nacher, A; Pérez-Pitarch, A, 2017)	0.46
" Since green tea polyphenols (GTP) are known to be inhibitors of receptor tyrosine kinases, GTE could likely potentiate the anticancer effect of TKIs, but with a possibility of pharmacokinetic (PK) interaction with co-administered TKIs."	( UPLC-ESI-MS/MS study of the effect of green tea extract on the oral bioavailability of erlotinib and lapatinib in rats: Potential risk of pharmacokinetic interaction. Abahussain, AO; Alzoman, NZ; Maher, HM; Shehata, SM, 2017)	0.46
" In whole animal studies, erlotinib and docetaxel were given to WT and KO rats individually or jointly, and the pharmacokinetic profiles of these two drugs were analyzed and compared among different groups."	( Cytochrome P450 3A selectively affects the pharmacokinetic interaction between erlotinib and docetaxel in rats. Liu, M; Lu, J; Qin, X; Wang, P; Wang, X; Xu, P, 2017)	0.46
" The effects of HYT on pharmacokinetics of the two drugs were estimated by non-compartmental analysis and pharmacokinetic modeling."	( Alterations in Pharmacokinetics of Gemcitabine and Erlotinib by Concurrent Administration of Hyangsayukgunja-Tang, a Gastroprotective Herbal Medicine. Bulitta, JB; Jeong, SW; Joo, SH; Kim, S; Kim, TH; Kwon, DR; Lee, DY; Ma, E; Park, GY; Shin, BS; Shin, S; Weon, KY; Yoo, SD, 2017)	0.46
" Additionally, a physiologically based pharmacokinetic (PBPK) model was created to assess such variations in silico."	( Monitoring of erlotinib in pancreatic cancer patients during long-time administration and comparison to a physiologically based pharmacokinetic model. Buchner, P; Czejka, M; Dittrich, C; Gruber, A; Kirchbaumer Baroian, N; Kitzmueller, M; Sahmanovic Hrgovcic, A, 2018)	0.48
" To exploit the full potential of PET, quantitative pharmacokinetic models are required."	( Towards Improved Pharmacokinetic Models for the Analysis of Transporter-Mediated Hepatic Disposition of Drug Molecules with Positron Emission Tomography. Bauer, M; Blaickner, M; Hacker, M; Hernández Lozano, I; Karch, R; Langer, O; Matsuda, A; Wulkersdorfer, B; Zeitlinger, M, 2019)	0.51
"A randomized, open-label, 2-period crossover study was performed to evaluate the pharmacokinetic properties and bioequivalence of 2 erlotinib hydrochloride tablets (a test formulation and a reference formulation) in healthy Chinese subjects."	( Pharmacokinetics and Bioequivalence Evaluation of Erlotinib Hydrochloride Tablets: Randomized, Open-Label, 2-Period Crossover Study in Healthy Chinese Subjects. Chen, J; Guan, Y; Hu, Y; Jiang, B; Liang, J; Ruan, Z; Shao, R; Wang, L; Xu, Y; Yang, D, 2021)	1.08
" During the 7 days prior to pharmacokinetic sampling, erlotinib was taken daily with 250 mL of either water or milk."	( Influence of Cow's Milk and Esomeprazole on the Absorption of Erlotinib: A Randomized, Crossover Pharmacokinetic Study in Lung Cancer Patients. Aerts, JGJV; Belderbos, HNA; Broerse, SD; Dingemans, AC; Hussaarts, KGAM; Koolen, SLW; Landa, KD; Mathijssen, RHJ; Oomen-de Hoop, E; Paats, MS; Peric, R; Rutten, HB; Steendam, CMJ; van der Leest, CH; van Gelder, T; van Leeuwen, RWF; Veerman, GDM, 2021)	0.62
" The aims of this study were to describe the pharmacokinetic profile of erlotinib in unselected patients with NSCLC, to quantify and explain its variability, to challenge the standard recommended dose in older patients, and to propose clinical recommendations for the therapeutic management of patients taking erlotinib."	( Population Pharmacokinetics of Erlotinib in Patients With Non-small Cell Lung Cancer: Its Application for Individualized Dosing Regimens in Older Patients. Arrondeau, J; Blanchet, B; Csajka, C; Fabre, E; Guidi, M; Khoudour, N; Schneider, MP; Tlemsani, C; Vidal, M; Wagner, AD; Widmer, N, 2020)	0.56
"A population pharmacokinetic model was developed using erlotinib plasma concentrations collected from patients with NSCLC participating in a routine therapeutic drug monitoring program (with the nonlinear mixed effect modeling program NONMEM)."	( Population Pharmacokinetics of Erlotinib in Patients With Non-small Cell Lung Cancer: Its Application for Individualized Dosing Regimens in Older Patients. Arrondeau, J; Blanchet, B; Csajka, C; Fabre, E; Guidi, M; Khoudour, N; Schneider, MP; Tlemsani, C; Vidal, M; Wagner, AD; Widmer, N, 2020)	0.56
" A previously verified physiologically-based pharmacokinetic (PBPK) model of rivaroxaban established how its multiple pathways of elimination via both CYP3A4/2J2-mediated hepatic metabolism and organic anion transporter 3 (OAT3)/P-glycoprotein-mediated renal secretion predisposes rivaroxaban to drug-drug-disease interactions (DDDIs) with clinically relevant protein kinase inhibitors (PKIs)."	( Application of a physiologically based pharmacokinetic model of rivaroxaban to prospective simulations of drug-drug-disease interactions with protein kinase inhibitors in cancer-associated venous thromboembolism. Chan, ECY; Cheong, EJY; Chin, SY; Ng, DZW; Wang, Z, 2022)	0.72
" Boosting pharmacokinetic exposure of KIs metabolized by cytochrome P450 (CYP)3A4 with ritonavir might result in lower doses needed and subsequently reduces treatment costs."	( Ritonavir-Boosted Exposure of Kinase Inhibitors: an Open Label, Cross-over Pharmacokinetic Proof-of-Concept Trial with Erlotinib. Baas, P; Beijnen, JH; Boosman, RJ; Burgers, JA; de Gooijer, CJ; Groenland, SL; Huitema, ADR; Steeghs, N; van der Noort, V, 2022)	0.72
" Complete pharmacokinetic profiles at steady-state were taken up to 24 h after erlotinib intake for both dosing strategies."	( Ritonavir-Boosted Exposure of Kinase Inhibitors: an Open Label, Cross-over Pharmacokinetic Proof-of-Concept Trial with Erlotinib. Baas, P; Beijnen, JH; Boosman, RJ; Burgers, JA; de Gooijer, CJ; Groenland, SL; Huitema, ADR; Steeghs, N; van der Noort, V, 2022)	0.72

Excerpt	Reference	Relevance
" Erlotinib was combined with chemotherapy to determine if it could improve the outcome of patients with NSCLC."	( TRIBUTE: a phase III trial of erlotinib hydrochloride (OSI-774) combined with carboplatin and paclitaxel chemotherapy in advanced non-small-cell lung cancer. Fehrenbacher, L; Herbst, RS; Hermann, R; Johnson, BE; Johnson, DH; Klein, P; Kris, MG; Li, X; Miller, VA; Prager, D; Ramies, D; Sandler, A; Tran, HT, 2005)	0.62
"TRIBUTE randomly assigned patients with good performance status and previously untreated advanced (stage IIIB/IV) NSCLC to erlotinib 150 mg/d or placebo combined with up to six cycles of carboplatin and paclitaxel, followed by maintenance monotherapy with erlotinib."	( TRIBUTE: a phase III trial of erlotinib hydrochloride (OSI-774) combined with carboplatin and paclitaxel chemotherapy in advanced non-small-cell lung cancer. Fehrenbacher, L; Herbst, RS; Hermann, R; Johnson, BE; Johnson, DH; Klein, P; Kris, MG; Li, X; Miller, VA; Prager, D; Ramies, D; Sandler, A; Tran, HT, 2005)	0.62
" Erlotinib in combination with capecitabine was not associated with significantly increased toxicity compared with single-agent therapy."	( Antitumor activity of erlotinib in combination with capecitabine in human tumor xenograft models. Ouchi, KF; Sekiguchi, F; Tanaka, Y; Yanagisawa, M, 2006)	0.33
" The findings of this study support clinical evaluation of erlotinib, both as a single agent and in combination with capecitabine, for the treatment of CRC and breast cancer."	( Antitumor activity of erlotinib in combination with capecitabine in human tumor xenograft models. Ouchi, KF; Sekiguchi, F; Tanaka, Y; Yanagisawa, M, 2006)	0.33
" Patients with stable or progressive malignant primary glioma received erlotinib alone or combined with temozolomide in this dose-escalation study."	( Phase 1 study of erlotinib HCl alone and combined with temozolomide in patients with stable or recurrent malignant glioma. Burton, E; Butowski, N; Chang, S; Fedoroff, A; Kapadia, A; Kelley, SK; Lamborn, KR; Malec, M; Page, MS; Prados, MD; Rabbitt, J; Xie, D, 2006)	0.33
" Primary end points included evaluation of toxicity and determination of the OBD of celecoxib when combined with erlotinib."	( A phase I trial to determine the optimal biological dose of celecoxib when combined with erlotinib in advanced non-small cell lung cancer. Dubinett, SM; Elashoff, RM; Figlin, RA; Krysan, K; Milne, GL; Morrow, JD; Newman, RA; Reckamp, KL; Tucker, C, 2006)	0.33
"This study defines the OBD of celecoxib when combined with a fixed dose of EGFR TKI."	( A phase I trial to determine the optimal biological dose of celecoxib when combined with erlotinib in advanced non-small cell lung cancer. Dubinett, SM; Elashoff, RM; Figlin, RA; Krysan, K; Milne, GL; Morrow, JD; Newman, RA; Reckamp, KL; Tucker, C, 2006)	0.33
"To assess the feasibility of administering erlotinib, an inhibitor of epidermal growth factor receptor (EGFR) tyrosine kinase, in combination with paclitaxel and carboplatin, and to identify pharmacokinetic interactions, evaluate downstream effects of EGFR inhibition on surrogate tissues, and seek preliminary evidence for clinical activity."	( Phase I, pharmacokinetic, and biological study of erlotinib in combination with paclitaxel and carboplatin in patients with advanced solid tumors. Beeram, M; Hamilton, M; Hammond, LA; Hidalgo, M; Kreisberg, JI; Mita, MM; Nadler, P; Patnaik, A; Rowinsky, EK; Schwartz, G; Tolcher, AW; Wolf, J; Wood, D, 2006)	0.33
"A dose level of erlotinib 125 mg combined with paclitaxel 225 mg/m(2) and carboplatin AUC 6 mg."	( Phase I, pharmacokinetic, and biological study of erlotinib in combination with paclitaxel and carboplatin in patients with advanced solid tumors. Beeram, M; Hamilton, M; Hammond, LA; Hidalgo, M; Kreisberg, JI; Mita, MM; Nadler, P; Patnaik, A; Rowinsky, EK; Schwartz, G; Tolcher, AW; Wolf, J; Wood, D, 2006)	0.33
" This trial assessed the maximum tolerated dose (MTD), safety, preliminary efficacy, and pharmacokinetics of erlotinib combined with FOLFOX."	( Phase 1b dose escalation study of erlotinib in combination with infusional 5-Fluorouracil, leucovorin, and oxaliplatin in patients with advanced solid tumors. Bolling, C; Brennscheidt, U; Cassidy, J; Díaz-Rubio, E; Fettner, S; Feyereislova, A; Hanauske, AR; Jones, RJ; Rakhit, A; Sastre, J, 2007)	0.34
" This phase III, randomized, double-blind, placebo-controlled, multicenter trial evaluated the efficacy and safety of erlotinib in combination with cisplatin and gemcitabine as first-line treatment for advanced non-small-cell lung cancer (NSCLC)."	( Phase III study of erlotinib in combination with cisplatin and gemcitabine in advanced non-small-cell lung cancer: the Tarceva Lung Cancer Investigation Trial. De Rosa, F; Gatzemeier, U; Janaskova, T; Karnicka-Mlodkowski, H; Kaukel, E; Manikhas, GM; Milanowski, J; Pesek, M; Pluzanska, A; Ramlau, R; Roubec, J; Serwatowski, P; Strausz, J; Szczesna, A; Vansteenkiste, J; Von Pawel, J, 2007)	0.34
"Patients received erlotinib (150 mg/d) or placebo, combined with up to six 21-day cycles of chemotherapy (gemcitabine 1,250 mg/m2 on days 1 and 8 and cisplatin 80 mg/m2 on day 1)."	( Phase III study of erlotinib in combination with cisplatin and gemcitabine in advanced non-small-cell lung cancer: the Tarceva Lung Cancer Investigation Trial. De Rosa, F; Gatzemeier, U; Janaskova, T; Karnicka-Mlodkowski, H; Kaukel, E; Manikhas, GM; Milanowski, J; Pesek, M; Pluzanska, A; Ramlau, R; Roubec, J; Serwatowski, P; Strausz, J; Szczesna, A; Vansteenkiste, J; Von Pawel, J, 2007)	0.34
"Bevacizumab (Bev) has clinical activity in advanced renal cell carcinoma (RCC), and, when combined with erlotinib (Erl), has shown encouraging objective response rate (ORR) and progression-free survival (PFS)."	( Randomized phase II study of erlotinib combined with bevacizumab compared with bevacizumab alone in metastatic renal cell cancer. Bukowski, RM; Drabkin, HA; Dutcher, J; Figlin, RA; Flaherty, K; Kabbinavar, FF; McDermott, D; Ryba, S; Scappaticci, FA; Srinivas, S; Vaishampayan, U; Xia, Q, 2007)	0.34
"One hundred four patients received intravenous Bev (10 mg/kg) every 2 weeks in combination with oral Erl (150 mg) or placebo daily."	( Randomized phase II study of erlotinib combined with bevacizumab compared with bevacizumab alone in metastatic renal cell cancer. Bukowski, RM; Drabkin, HA; Dutcher, J; Figlin, RA; Flaherty, K; Kabbinavar, FF; McDermott, D; Ryba, S; Scappaticci, FA; Srinivas, S; Vaishampayan, U; Xia, Q, 2007)	0.34
" The MTD for erlotinib in combination with twice weekly gemcitabine-based chemoradiation was 100 mg/day."	( A phase I study of erlotinib in combination with gemcitabine and radiation in locally advanced, non-operable pancreatic adenocarcinoma. Capanu, M; Duffy, A; Kelsen, DP; Kortmansky, J; Minsky, B; O'Reilly, EM; Puleio, S; Saltz, L; Schwartz, GK, 2008)	0.35
"In combination with fixed dose gemcitabine at 40 mg/m(2) twice weekly and radiation at 180 cGy/day, the MTD of erlotinib was found to be 100 mg/day."	( A phase I study of erlotinib in combination with gemcitabine and radiation in locally advanced, non-operable pancreatic adenocarcinoma. Capanu, M; Duffy, A; Kelsen, DP; Kortmansky, J; Minsky, B; O'Reilly, EM; Puleio, S; Saltz, L; Schwartz, GK, 2008)	0.35
"This study aimed to define the maximum tolerated dose of weekly docetaxel combined with daily erlotinib, an oral epidermal growth factor receptor tyrosine kinase inhibitor."	( A phase I and pharmacokinetic trial of erlotinib in combination with weekly docetaxel in patients with taxane-naive malignancies. Al Omari, AS; Chiorean, EG; Fife, KL; Foster, AE; Jones, DR; Murry, DJ; Porter, JM; Strother, RM; Sweeney, CJ; Yoder, CA; Yu, M, 2008)	0.35
"Although no maximum tolerated dose was reached in cycle 1 with 35 mg/m(2) docetaxel, repetitive dosing proved intolerable in a substantial number of patients; thus, the recommended phase II dose of weekly docetaxel is 30 mg/m(2) when combined with 150 mg of daily erlotinib."	( A phase I and pharmacokinetic trial of erlotinib in combination with weekly docetaxel in patients with taxane-naive malignancies. Al Omari, AS; Chiorean, EG; Fife, KL; Foster, AE; Jones, DR; Murry, DJ; Porter, JM; Strother, RM; Sweeney, CJ; Yoder, CA; Yu, M, 2008)	0.35
"In a modified Fibonacci design, the study aimed to study three cohorts of at least three patients receiving escalating doses of erlotinib (50/100/150 mg) combined with cisplatin (40 mg/m(2), weekly, 5 cycles) and radiotherapy (external beam 4,500 cGy in 25 fractions, followed by 4 fractions/600 cGy/weekly of brachytherapy) in squamous cell cervical carcinoma patients, stage IIB to IIIB."	( Phase I trial of erlotinib combined with cisplatin and radiotherapy for patients with locally advanced cervical squamous cell cancer. Camisão, C; do Carmo, CC; Erlich, F; Ferreira, CG; Fontão, K; Herchenhorn, D; Lima, R; Martins, RG; Moralez, GM; Nogueira-Rodrigues, A; Small, IA; Viegas, C, 2008)	0.35
" In this study, we evaluate whether MP470, a novel receptor tyrosine kinase inhibitor alone or in combination with Erlotinib has inhibitory effect on prostate cancer in vitro and in vivo."	( MP470, a novel receptor tyrosine kinase inhibitor, in combination with Erlotinib inhibits the HER family/PI3K/Akt pathway and tumor growth in prostate cancer. Bearss, D; Cooke, LS; Croce, KD; Mahadevan, D; Qi, W; Riley, C; Saldanha, JW; Stejskal, A, 2009)	0.35
" Additive effects on both cytotoxicity and induction of apoptosis were observed when LNCaP were treated with MP470 in combination with Erlotinib."	( MP470, a novel receptor tyrosine kinase inhibitor, in combination with Erlotinib inhibits the HER family/PI3K/Akt pathway and tumor growth in prostate cancer. Bearss, D; Cooke, LS; Croce, KD; Mahadevan, D; Qi, W; Riley, C; Saldanha, JW; Stejskal, A, 2009)	0.35
"We aimed to investigate and compare the effects of erlotinib and gefitinib on UDP-glucuronosyltransferase (UGT) activities and to quantitatively evaluate their drug-drug interaction (DDI) potential due to UGT inhibition."	( Comparison of the drug-drug interactions potential of erlotinib and gefitinib via inhibition of UDP-glucuronosyltransferases. House, L; Liu, Y; Ramírez, J; Ratain, MJ, 2010)	0.36
"To assess the pharmacokinetics and evaluate potential drug-drug interactions between erlotinib, paclitaxel and carboplatin."	( Pharmacokinetic study of the phase III, randomized, double-blind, multicenter trial (TRIBUTE) of paclitaxel and carboplatin combined with erlotinib or placebo in patients with advanced Non-small Cell Lung Cancer (NSCLC). Blumenschein, GR; Herbst, RS; Kim, ES; Lu, C; Lum, BL; Malik, M; Oh, YW; Papadimitrakopoulou, VA; Tran, HT; Zinner, RG, 2011)	0.37
"1,079 previously untreated patients with advanced NSCLC were enrolled and randomized in a phase III trial (TRIBUTE) to receive either erlotinib or placebo in combination with paclitaxel 200 mg/m2 IV over 3 h and carboplatin at a calculated dose to achieve an AUC 6 mg∙min/mL."	( Pharmacokinetic study of the phase III, randomized, double-blind, multicenter trial (TRIBUTE) of paclitaxel and carboplatin combined with erlotinib or placebo in patients with advanced Non-small Cell Lung Cancer (NSCLC). Blumenschein, GR; Herbst, RS; Kim, ES; Lu, C; Lum, BL; Malik, M; Oh, YW; Papadimitrakopoulou, VA; Tran, HT; Zinner, RG, 2011)	0.37
" In cellular models of wild-type or mutant EGFR (L858R and T790M mutations), SNX-2112 alone and in combination with erlotinib inhibited EGF activation of pAKT(473) and pSTAT3(705)."	( Targeting of multiple signaling pathways by the Hsp90 inhibitor SNX-2112 in EGFR resistance models as a single agent or in combination with erlotinib. Barabasz, A; Fadden, P; Foley, B; Hall, S; Huang, K; Rice, JW; Scott, A; Steed, P; Veal, JM, 2009)	0.35
"To investigate the feasibility and efficacy of concurrent chemoradiation in combination with erlotinib for locally advanced esophageal carcinoma."	( Phase II study of concurrent chemoradiation in combination with erlotinib for locally advanced esophageal carcinoma. Deng, X; Hu, W; Li, G; Wang, J; Wu, S; Xie, C; Zhang, P; Zhang, X, 2010)	0.36
"Application of concurrent chemoradiotherapy in combination with erlotinib for locally advanced esophageal carcinoma yielded satisfactory 2-year overall survival and local-regional control."	( Phase II study of concurrent chemoradiation in combination with erlotinib for locally advanced esophageal carcinoma. Deng, X; Hu, W; Li, G; Wang, J; Wu, S; Xie, C; Zhang, P; Zhang, X, 2010)	0.36
" The in vitro migration of H1299 cells, which expressed high levels of both VEGF ligands and receptors, was inhibited by treatment with sorafenib, and this effect was significantly increased by the combination with anti-EGFR drugs."	( Synergistic antitumor activity of sorafenib in combination with epidermal growth factor receptor inhibitors in colorectal and lung cancer cells. Berrino, L; Capasso, A; Ciardiello, F; De Vita, F; Eckhardt, SG; Martinelli, E; Morelli, MP; Morgillo, F; Orditura, M; Rodolico, G; Santoro, M; Troiani, T; Tuccillo, C; Vecchione, L; Vitagliano, D, 2010)	0.36
"To evaluate the efficacy,clinical benefits and toxicities of gemcitabine combined with erlotinib for advanced pancreatic cancer."	( [Efficacy of gemcitabine combined with erlotinib in patients with advanced pancreatic cancer]. Bai, CM; Cheng, YJ; Zhang, ZJ, 2010)	0.36
"Gemcitabine combined with erlotinib is an effective regimen for pancreatic cancer with good clinical tolerance."	( [Efficacy of gemcitabine combined with erlotinib in patients with advanced pancreatic cancer]. Bai, CM; Cheng, YJ; Zhang, ZJ, 2010)	0.36
"Apricoxib, a novel once-daily selective cyclooxygenase-2 inhibitor, was investigated in combination with erlotinib for recurrent stage IIIB/IV nonsmall cell lung cancer to determine the maximum tolerated dose, dose-limiting toxicity, and recommended phase II dose (RP2D) based on changes in urinary prostaglandin E₂ metabolite (PGE-M)."	( Biomarker-based phase I dose-escalation, pharmacokinetic, and pharmacodynamic study of oral apricoxib in combination with erlotinib in advanced nonsmall cell lung cancer. Chen, LC; Gitlitz, B; Jezior, D; Milne, G; Patel, R; Reckamp, K; Syto, M; Zaknoen, S, 2011)	0.37
"Patients received escalating doses of apricoxib (100, 200, and 400 mg/day) in combination with erlotinib 150 mg/day until disease progression or unacceptable toxicity."	( Biomarker-based phase I dose-escalation, pharmacokinetic, and pharmacodynamic study of oral apricoxib in combination with erlotinib in advanced nonsmall cell lung cancer. Chen, LC; Gitlitz, B; Jezior, D; Milne, G; Patel, R; Reckamp, K; Syto, M; Zaknoen, S, 2011)	0.37
"VEGF, mTOR, and EGFR inhibitors have demonstrated anti-tumor and anti-angiogenic effects alone and in combination with each other."	( A phase I study of bevacizumab (B) in combination with everolimus (E) and erlotinib (E) in advanced cancer (BEE). Bendell, JC; Blobe, GC; Broadwater, G; Bullock, KE; Gockerman, JP; Howard, LA; Hurwitz, HI; Lager, JJ; Meadows, KL; Morse, MA; O'Neill, MM; Petros, WP; Truax, R; Uronis, HE; Younis, I; Zafar, SY, 2011)	0.37
" The aim of this multicenter, randomized phase II study was to evaluate clinical activity and safety of sorafenib in combination with erlotinib or gemcitabine in unselected untreated elderly patients with non-small-cell lung cancer (NSCLC)."	( Sorafenib in combination with erlotinib or with gemcitabine in elderly patients with advanced non-small-cell lung cancer: a randomized phase II study. Cerea, G; Chella, A; Ciardiello, F; de Marinis, F; Di Maio, M; Fasano, M; Favaretto, A; Gridelli, C; Maione, P; Mattioli, R; Morgillo, F; Pasello, G; Ricciardi, S; Rossi, A; Tortora, G, 2011)	0.37
"To confirm the efficacy and toxicity of Erlotinib in combination with Gemcitabine and Capecitabine when used as a first-line therapy in metastatic/recurrent pancreatic cancer (PC)."	( A phase II trial of erlotinib in combination with gemcitabine and capecitabine in previously untreated metastatic/recurrent pancreatic cancer: combined analysis with translational research. Bang, YJ; Kang, HJ; Kim, BS; Kim, JS; Lee, KH; Lee, KW; Oh, DY; Park, YS; Ryoo, HM; Sohn, CH; Song, HS; Zang, DY, 2012)	0.38
" Thus, the targeted approach against HER1/EGFR likely requires a synergistic drug combination strategy to ultimately become successful in this disease."	( Drug combinations enhancing the antineoplastic effects of erlotinib in high-grade glioma. Halatsch, ME; Karpel-Massler, G; Wirtz, CR, 2011)	0.37
"Patients with advanced or metastatic cancer were treated with escalating doses of LY2334737 monotherapy or in combination with continuous daily administration of 100 mg erlotinib."	( Phase I study of Oral gemcitabine prodrug (LY2334737) alone and in combination with erlotinib in patients with advanced solid tumors. Beijnen, JH; Benhadji, KA; Callies, S; Garcia-Ribas, I; Jansen, RS; Koolen, SL; Kronemeijer, RH; Langenberg, MH; Nol, A; Schellens, JH; Slapak, CA; Voest, EE; Witteveen, PO, 2011)	0.37
"This phase 1b study assessed the maximum tolerated dose (MTD), safety, and pharmacokinetics of motesanib (a small-molecule antagonist of VEGF receptors 1, 2, and 3; platelet-derived growth factor receptor; and Kit) administered once daily (QD) or twice daily (BID) in combination with erlotinib and gemcitabine in patients with solid tumors."	( Safety and pharmacokinetics of motesanib in combination with gemcitabine and erlotinib for the treatment of solid tumors: a phase 1b study. Adewoye, AH; Desai, J; Johnson, J; Kotasek, D; McCoy, S; Price, T; Siu, LL; Sun, YN; Tebbutt, N; Welch, S, 2011)	0.37
"Patients received weekly intravenous gemcitabine (1000 mg/m2) and erlotinib (100 mg QD) alone (control cohort) or in combination with motesanib (50 mg QD, 75 mg BID, 125 mg QD, or 100 mg QD; cohorts 1-4); or erlotinib (150 mg QD) in combination with motesanib (100 or 125 mg QD; cohorts 5 and 6)."	( Safety and pharmacokinetics of motesanib in combination with gemcitabine and erlotinib for the treatment of solid tumors: a phase 1b study. Adewoye, AH; Desai, J; Johnson, J; Kotasek, D; McCoy, S; Price, T; Siu, LL; Sun, YN; Tebbutt, N; Welch, S, 2011)	0.37
" The MTD of motesanib in combination with gemcitabine and erlotinib was 100 mg QD."	( Safety and pharmacokinetics of motesanib in combination with gemcitabine and erlotinib for the treatment of solid tumors: a phase 1b study. Adewoye, AH; Desai, J; Johnson, J; Kotasek, D; McCoy, S; Price, T; Siu, LL; Sun, YN; Tebbutt, N; Welch, S, 2011)	0.37
" Motesanib 125 mg QD was tolerable only in combination with erlotinib alone."	( Safety and pharmacokinetics of motesanib in combination with gemcitabine and erlotinib for the treatment of solid tumors: a phase 1b study. Adewoye, AH; Desai, J; Johnson, J; Kotasek, D; McCoy, S; Price, T; Siu, LL; Sun, YN; Tebbutt, N; Welch, S, 2011)	0.37
" Optimal effects are obtained when these compounds are used in combination with chemotherapy, as shown in preclinical models and more recently in clinical trials."	( Docetaxel combined with targeted therapies in metastatic breast cancer. Cortes, J; Roché, H, 2012)	0.38
" In this study, we evaluated the cytotoxic effects of (ZEGFR:1907)2 in combination with external radiation and the possible inhibitory effects in the EGFR signalling pathways in the colon cancer cell lines HT-29 and HCT116."	( The effect of a dimeric Affibody molecule (ZEGFR:1907)2 targeting EGFR in combination with radiation in colon cancer cell lines. Glimelius, B; Häggblad Sahlberg, S; Lennartsson, J; Nygren, P; Spiegelberg, D; Stenerlöw, B, 2012)	0.38
" Patients were randomly assigned to receive erlotinib (150 mg orally once a day) in combination with either placebo, R1507 9 mg/kg weekly, or R1507 16 mg/kg intravenously once every 3 weeks."	( Randomized phase II study of erlotinib in combination with placebo or R1507, a monoclonal antibody to insulin-like growth factor-1 receptor, for advanced-stage non-small-cell lung cancer. Brownstein, CM; Chen, D; Crino, L; Eberhardt, WE; Engelman, JA; Habben, K; Jänne, PA; Liu, L; Novello, S; Ramalingam, SS; Reck, M; Schneider, CP; Spigel, DR; Steins, MB, 2011)	0.37
" There are currently insufficient safety data in human subjects, particularly when ascorbic acid is combined with chemotherapy."	( Phase I evaluation of intravenous ascorbic acid in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer. Bazzan, AJ; Deshmukh, S; Levine, M; Littman, S; Mitchell, E; Monti, DA; Newberg, AB; Pillai, MV; Yeo, CJ; Zabrecky, G, 2012)	0.38
" This, combined with the observed response to treatment, suggests the need for a phase II study of longer duration."	( Phase I evaluation of intravenous ascorbic acid in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer. Bazzan, AJ; Deshmukh, S; Levine, M; Littman, S; Mitchell, E; Monti, DA; Newberg, AB; Pillai, MV; Yeo, CJ; Zabrecky, G, 2012)	0.38
"This phase 1b dose-escalation study assessed safety, tolerability, and pharmacokinetics of ganitumab, a fully human monoclonal antibody against the insulin-like growth factor 1 (IGF1) receptor, combined with targeted agents or cytotoxic chemotherapy in patients with advanced solid tumors."	( Safety and pharmacokinetics of ganitumab (AMG 479) combined with sorafenib, panitumumab, erlotinib, or gemcitabine in patients with advanced solid tumors. Chan, E; Deng, H; Friberg, G; Gilbert, J; Hwang, YC; Mahalingam, D; McCaffery, I; Michael, SA; Mita, AC; Mita, MM; Mulay, M; Puzanov, I; Rosen, LS; Sarantopoulos, J; Shubhakar, P; Zhu, M, 2012)	0.38
" every 2 weeks) combined with either sorafenib 400 mg twice daily, panitumumab 6 mg/kg every 2 weeks, erlotinib 150 mg once daily, or gemcitabine 1,000 mg/m(2) on days 1, 8, and 15 of each 4-week cycle."	( Safety and pharmacokinetics of ganitumab (AMG 479) combined with sorafenib, panitumumab, erlotinib, or gemcitabine in patients with advanced solid tumors. Chan, E; Deng, H; Friberg, G; Gilbert, J; Hwang, YC; Mahalingam, D; McCaffery, I; Michael, SA; Mita, AC; Mita, MM; Mulay, M; Puzanov, I; Rosen, LS; Sarantopoulos, J; Shubhakar, P; Zhu, M, 2012)	0.38
"Ganitumab up to 12 mg/kg appeared well tolerated combined with sorafenib, panitumumab, erlotinib, or gemcitabine."	( Safety and pharmacokinetics of ganitumab (AMG 479) combined with sorafenib, panitumumab, erlotinib, or gemcitabine in patients with advanced solid tumors. Chan, E; Deng, H; Friberg, G; Gilbert, J; Hwang, YC; Mahalingam, D; McCaffery, I; Michael, SA; Mita, AC; Mita, MM; Mulay, M; Puzanov, I; Rosen, LS; Sarantopoulos, J; Shubhakar, P; Zhu, M, 2012)	0.38
"Ganitumab up to 12 mg/kg was well tolerated, without adverse effects on pharmacokinetics in combination with either sorafenib, panitumumab, erlotinib, or gemcitabine."	( Safety and pharmacokinetics of ganitumab (AMG 479) combined with sorafenib, panitumumab, erlotinib, or gemcitabine in patients with advanced solid tumors. Chan, E; Deng, H; Friberg, G; Gilbert, J; Hwang, YC; Mahalingam, D; McCaffery, I; Michael, SA; Mita, AC; Mita, MM; Mulay, M; Puzanov, I; Rosen, LS; Sarantopoulos, J; Shubhakar, P; Zhu, M, 2012)	0.38
"The aim of this study was to determine the safety and efficacy of metronomic chemotherapy combined with targeted drugs in patients with metastatic breast cancer (MBC)."	( Metronomic chemotherapy combined with bevacizumab and erlotinib in patients with metastatic HER2-negative breast cancer: clinical and biological activity. Bagnardi, V; Bertolini, F; Calleri, A; Cancello, G; Colleoni, M; Dellapasqua, S; Goldhirsch, A; Intra, M; Luini, A; Montagna, E; Pastrello, D; Perri, G; Rampinelli, C; Veronesi, P; Viale, G, 2012)	0.38
"The object of this study was to evaluate the safety and efficacy of metronomic chemotherapy in combination with bevacizumab and erlotinib in patients with HER2-negative (HER2(-)) metastatic breast cancer (MBC) and poor hormone receptor expression."	( Metronomic chemotherapy combined with bevacizumab and erlotinib in patients with metastatic HER2-negative breast cancer: clinical and biological activity. Bagnardi, V; Bertolini, F; Calleri, A; Cancello, G; Colleoni, M; Dellapasqua, S; Goldhirsch, A; Intra, M; Luini, A; Montagna, E; Pastrello, D; Perri, G; Rampinelli, C; Veronesi, P; Viale, G, 2012)	0.38
"Treatment with metronomic chemotherapy in combination with bevacizumab and erlotinib was effective in HER2(-), estrogen receptor (ER)- and progesterone receptor (PR)-poor advanced breast cancer."	( Metronomic chemotherapy combined with bevacizumab and erlotinib in patients with metastatic HER2-negative breast cancer: clinical and biological activity. Bagnardi, V; Bertolini, F; Calleri, A; Cancello, G; Colleoni, M; Dellapasqua, S; Goldhirsch, A; Intra, M; Luini, A; Montagna, E; Pastrello, D; Perri, G; Rampinelli, C; Veronesi, P; Viale, G, 2012)	0.38
"From September 2008 to October 2011, a total of 31 patients of NSCLC with multiple brain metastases (≥3) received selected incranial, bronchial and corresponding target arterial infusion chemotherapy combined with EGFR-TKIs."	( [Selected arterial infusion chemotherapy combined with target drugs for non-small cell lung cancer with multiple brain metastase]. Guo, Z; Li, J, 2012)	0.38
" This phase II study was designed to evaluate the efficacy and safety of erlotinib and enzastaurin in NSCLC, a combination with promise to overcome EGFR resistance based on preclinical models."	( A phase II study of enzastaurin in combination with erlotinib in patients with previously treated advanced non-small cell lung cancer. Bernstein, ED; Clément-Duchêne, C; Dudek, AZ; Jahan, T; Krupitskaya, Y; Latz, JE; Natale, RB; Osarogiagbon, R; Sanborn, RE; Shi, P; Wakelee, HA, 2012)	0.38
" This study will investigate onartuzumab (MetMAb) in combination with erlotinib compared with erlotinib alone, as second- or third-line treatment, in patients with advanced non-small-cell lung cancer (NSCLC) who are Met-positive by immunohistochemistry."	( Treatment Rationale Study Design for the MetLung Trial: A Randomized, Double-Blind Phase III Study of Onartuzumab (MetMAb) in Combination With Erlotinib Versus Erlotinib Alone in Patients Who Have Received Standard Chemotherapy for Stage IIIB or IV Met-Po Edelman, MJ; Mok, T; O'Byrne, K; Paz-Ares, L; Rittweger, K; Spigel, DR; Thurm, H; Yu, W, 2012)	0.38
"To determine the maximum tolerated dose (MTD) of OSI-930 that can be combined with erlotinib, and establish recommended phase 2 doses when both agents are administered daily in patients with advanced solid tumours."	( A phase 1 study of OSI-930 in combination with erlotinib in patients with advanced solid tumours. Brock, K; Evans, TR; Gedrich, R; Hopkins, CA; Macpherson, IR; Poondru, S; Simon, GR; Stephens, A; Stewart, K, 2013)	0.39
"The aim of this phase I trial was to define the maximum tolerated dose (MTD), the dose-limiting toxicity (DLT) and the recommended dose of erlotinib combined with capecitabine and gemcitabine in the treatment of advanced pancreatic cancer (APC)."	( Phase I trial of gemcitabine combined with capecitabine and erlotinib in advanced pancreatic cancer: a clinical and pharmacological study. Bennouna, J; Chamorey, E; Douillard, JY; Etienne-Grimaldi, MC; Follana, P; Francois, E; Mari, V; Michel, C; Milano, G; Renée, N; Senellart, H, 2012)	0.38
"Tyrosine kinase inhibitors (TKIs) have revolutionized the treatment of lung adenocarcinoma, and a theoretical basis exists for utilising whole brain radiotherapy (WBRT) combined with erlotinib for the treatment for brain metastases in patients with lung adenocarcinoma."	( The theoretical foundation and research progress for WBRT combined with erlotinib for the treatment of multiple brain metastases in patients with lung adenocarcinoma. Wang, J; Wang, P; Yuan, Z; Zhao, L; Zhuang, H, 2013)	0.39
" Here we report the first phase 2 study of erlotinib in combination with adjuvant chemoradiation and chemotherapy for resected PDAC."	( Phase 2 study of erlotinib combined with adjuvant chemoradiation and chemotherapy in patients with resectable pancreatic cancer. Blackford, AL; Cameron, JL; Choti, MA; De Jesus-Acosta, A; Donehower, RC; Edil, BH; Ellsworth, S; Fan, KY; Hacker-Prietz, A; Herman, JM; Hidalgo, M; Hruban, RH; Laheru, DA; Le, DT; Pawlik, TM; Schulick, RD; Wild, AT; Wolfgang, CL; Wood, LD; Zheng, L, 2013)	0.39
"Erlotinib can be safely administered with adjuvant IMRT-based CRT and chemotherapy."	( Phase 2 study of erlotinib combined with adjuvant chemoradiation and chemotherapy in patients with resectable pancreatic cancer. Blackford, AL; Cameron, JL; Choti, MA; De Jesus-Acosta, A; Donehower, RC; Edil, BH; Ellsworth, S; Fan, KY; Hacker-Prietz, A; Herman, JM; Hidalgo, M; Hruban, RH; Laheru, DA; Le, DT; Pawlik, TM; Schulick, RD; Wild, AT; Wolfgang, CL; Wood, LD; Zheng, L, 2013)	0.39
" Taken together, these data indicate that CH5164840 has potent antitumor activity and is highly effective in combination with erlotinib against NSCLC tumors with EGFR overexpression and mutations."	( Enhanced antitumor activity of erlotinib in combination with the Hsp90 inhibitor CH5164840 against non-small-cell lung cancer. Aoki, Y; Fujii, T; Ishii, N; Kondoh, O; Mio, T; Ono, N; Sakata, K; Suda, A; Tsukaguchi, T; Tsukuda, T; Yamazaki, T, 2013)	0.39
" The TASK study evaluated the efficacy and safety of the epidermal growth factor receptor tyrosine kinase inhibitor erlotinib in combination with the anti-angiogenic agent bevacizumab as first-line therapy in unselected, advanced non-squamous NSCLC patients."	( A phase II study of erlotinib in combination with bevacizumab versus chemotherapy plus bevacizumab in the first-line treatment of advanced non-squamous non-small cell lung cancer. Amoroso, D; Chao, TY; Chung, CY; Ciuleanu, T; Groen, HJ; Heo, DS; Klingelschmitt, G; Klughammer, B; Middleton, G; Milanowski, J; Szczesna, A; Thatcher, N; Tsai, CM; Tsao, CJ; Zeaiter, A, 2013)	0.39
" These results combined with the worse outcomes observed in MET-negative patients treated with onartuzumab highlight the importance of diagnostic testing in drug development."	( Randomized phase II trial of Onartuzumab in combination with erlotinib in patients with advanced non-small-cell lung cancer. Barlesi, F; Blumenschein, GR; Daniel, DB; Ervin, TJ; Godbert, B; Goldschmidt, JH; Govindan, R; Krzakowski, MJ; Orlov, SV; Patel, PH; Patel, T; Peterson, AC; Phan, SC; Ramlau, RA; Robinet, G; Spigel, DR; Wertheim, MS; Yauch, RL; Yu, W; Zha, J, 2013)	0.39
"The purpose of the current study was to assess a novel anti-cancer drug, MPT0B014, which is not a substrate for the P-glycoprotein (P-gp) transporter, alone and in combination with erlotinib, against human non-small cell lung cancer (NSCLC)."	( In vitro and in vivo anti-tumour effects of MPT0B014, a novel derivative aroylquinoline, and in combination with erlotinib in human non-small-cell lung cancer cells. Liou, JP; Pai, HC; Pan, SL; Teng, CM; Tsai, AC; Wang, CY; Wang, JC, 2014)	0.4
" B014 in combination with erlotinib caused significant tumour inhibition in vitro and in vivo."	( In vitro and in vivo anti-tumour effects of MPT0B014, a novel derivative aroylquinoline, and in combination with erlotinib in human non-small-cell lung cancer cells. Liou, JP; Pai, HC; Pan, SL; Teng, CM; Tsai, AC; Wang, CY; Wang, JC, 2014)	0.4
" Combined with the EGF receptor inhibitor, erlotinib, MPT0B014 exerted significant growth inhibition of A549 cells both in vitro and in vivo."	( In vitro and in vivo anti-tumour effects of MPT0B014, a novel derivative aroylquinoline, and in combination with erlotinib in human non-small-cell lung cancer cells. Liou, JP; Pai, HC; Pan, SL; Teng, CM; Tsai, AC; Wang, CY; Wang, JC, 2014)	0.4
"Japanese patients with advanced/metastatic NSCLC received tivantinib in combination with erlotinib to evaluate safety and pharmacokinetics."	( CYP2C19 genotype-based phase I studies of a c-Met inhibitor tivantinib in combination with erlotinib, in advanced/metastatic non-small cell lung cancer. Akinaga, S; Fujisaka, Y; Hayashi, H; Hirashima, T; Miyoshi, K; Murakami, H; Nakagawa, K; Satouchi, M; Takahashi, T; Takeda, K; Yamamoto, N, 2013)	0.39
"Tivantinib, when combined with erlotinib, was well tolerated up to 360 mg BID for EMs and 240 mg BID for PMs, respectively."	( CYP2C19 genotype-based phase I studies of a c-Met inhibitor tivantinib in combination with erlotinib, in advanced/metastatic non-small cell lung cancer. Akinaga, S; Fujisaka, Y; Hayashi, H; Hirashima, T; Miyoshi, K; Murakami, H; Nakagawa, K; Satouchi, M; Takahashi, T; Takeda, K; Yamamoto, N, 2013)	0.39
"Two doses of tivantinib in combination with erlotinib were recommended based on CYP2C19 genotype: 360 mg BID for EMs and 240 mg BID for PMs."	( CYP2C19 genotype-based phase I studies of a c-Met inhibitor tivantinib in combination with erlotinib, in advanced/metastatic non-small cell lung cancer. Akinaga, S; Fujisaka, Y; Hayashi, H; Hirashima, T; Miyoshi, K; Murakami, H; Nakagawa, K; Satouchi, M; Takahashi, T; Takeda, K; Yamamoto, N, 2013)	0.39
" A potential pharmacokinetic drug-drug interaction was also investigated."	( Phase I dose-escalation study of oral vinflunine in combination with erlotinib in pre-treated and unselected EGFR patients with locally advanced or metastatic non-small-cell lung cancer. Bennouna, J; Dansin, E; Favrel, S; Hiret, S; Kowalski, D; Krzakowski, M; Penel, N; Tourani, JM, 2014)	0.4
" This combination was highly active with a treatment response lasting for 9 months supporting the hypothesis that EGFR monoclonal antibodies in combination with chemotherapy may play a role in reversing EGFR-TKI resistance in EGFR mutation-positive NSCLC."	( Overcoming resistance to first generation EGFR TKIs with cetuximab in combination with chemotherapy in an EGFR mutated advanced stage NSCLC patient. Fiegl, M; Hilbe, W; Manzl, C; Pircher, A; Pirker, R; Popper, H, 2014)	0.4
"Panobinostat, a histone deacetylase (HDAC) inhibitor, enhances antiproliferative activity in non-small cell lung cancer (NSCLC) cell lines when combined with erlotinib."	( A phase I, pharmacokinetic, and pharmacodynamic study of panobinostat, an HDAC inhibitor, combined with erlotinib in patients with advanced aerodigestive tract tumors. Akar, A; Altiok, S; Bepler, G; Chiappori, A; Gray, JE; Haura, E; Kish, JA; Kreahling, J; Lush, R; Neuger, A; Pinder-Schenck, M; Schell, MJ; Tanvetyanon, T; Tetteh, L; Williams, CC; Zhao, X, 2014)	0.4
" Secondary objectives included evaluation of safety, toxicity and pharmacokinetics of LY2584702 in combination with erlotinib or everolimus."	( A phase Ib trial of LY2584702 tosylate, a p70 S6 inhibitor, in combination with erlotinib or everolimus in patients with solid tumours. Benhadji, KA; Brail, LH; Bumgardner, W; Cohen, EE; Hollebecque, A; Houédé, N; Italiano, A; Massard, C; Miller, J; Soria, JC; Westwood, P, 2014)	0.4
"Patients with advanced solid tumours were treated with a total daily dose of 50-200mg of LY2584702 in combination with erlotinib 150 mg once daily (Arm A) or everolimus 10mg once daily (Arm B)."	( A phase Ib trial of LY2584702 tosylate, a p70 S6 inhibitor, in combination with erlotinib or everolimus in patients with solid tumours. Benhadji, KA; Brail, LH; Bumgardner, W; Cohen, EE; Hollebecque, A; Houédé, N; Italiano, A; Massard, C; Miller, J; Soria, JC; Westwood, P, 2014)	0.4
" Exposure of erlotinib increased when administered in combination with LY2584702."	( A phase Ib trial of LY2584702 tosylate, a p70 S6 inhibitor, in combination with erlotinib or everolimus in patients with solid tumours. Benhadji, KA; Brail, LH; Bumgardner, W; Cohen, EE; Hollebecque, A; Houédé, N; Italiano, A; Massard, C; Miller, J; Soria, JC; Westwood, P, 2014)	0.4
"LY2584702 was not well tolerated when administered with erlotinib, therefore this combination is not feasible."	( A phase Ib trial of LY2584702 tosylate, a p70 S6 inhibitor, in combination with erlotinib or everolimus in patients with solid tumours. Benhadji, KA; Brail, LH; Bumgardner, W; Cohen, EE; Hollebecque, A; Houédé, N; Italiano, A; Massard, C; Miller, J; Soria, JC; Westwood, P, 2014)	0.4
"The primary objectives of this phase I study were to evaluate the safety and maximum tolerated dose (MTD) of SAR245409, a pan-class I phosphatidylinositol 3-kinase (PI3K)/mammalian target of rapamycin inhibitor, combined with erlotinib in patients with advanced solid tumors."	( Phase I safety and pharmacokinetic study of the PI3K/mTOR inhibitor SAR245409 (XL765) in combination with erlotinib in patients with advanced solid tumors. Cohen, RB; Engelman, JA; Felip, E; Jänne, PA; Laird, AD; Macé, S; Martinez, P; Rockich, K; Ruiz-Soto, R; Shapiro, GI; Xu, J, 2014)	0.4
" SAR245409 30, 50, 70, or 90 mg once daily (QD) or 20 or 30 mg twice daily (BID) was administered, in combination with erlotinib 100 mg QD, in 28-day cycles."	( Phase I safety and pharmacokinetic study of the PI3K/mTOR inhibitor SAR245409 (XL765) in combination with erlotinib in patients with advanced solid tumors. Cohen, RB; Engelman, JA; Felip, E; Jänne, PA; Laird, AD; Macé, S; Martinez, P; Rockich, K; Ruiz-Soto, R; Shapiro, GI; Xu, J, 2014)	0.4
"The MTDs of SAR245409, in combination with erlotinib 100 mg QD, were 70 mg QD and 20 mg BID."	( Phase I safety and pharmacokinetic study of the PI3K/mTOR inhibitor SAR245409 (XL765) in combination with erlotinib in patients with advanced solid tumors. Cohen, RB; Engelman, JA; Felip, E; Jänne, PA; Laird, AD; Macé, S; Martinez, P; Rockich, K; Ruiz-Soto, R; Shapiro, GI; Xu, J, 2014)	0.4
" Results of a previous phase 1 trial of the EGFR inhibitor erlotinib combined with cisplatin-based CRT (E + CRT) recommended a phase 2 erlotinib dose of 150 mg/day."	( Phase 2 trial of erlotinib combined with cisplatin and radiotherapy in patients with locally advanced cervical cancer. Alves, FV; Carmo, CC; Erlich, F; Ferreira, CG; Grazziotin, R; Mamede, M; Moralez, G; Nogueira-Rodrigues, A; Small, IA; Triginelli, SA; Viegas, C, 2014)	0.4
" Patients received erlotinib at a dose of 150 mg/day 1 week before and in combination with cisplatin (40 mg/m(2) administered weekly for 5 cycles) and radiotherapy (4500 centigrays in 25 fractions), followed by brachytherapy (4 fractions at a dose of 600 centigrays weekly)."	( Phase 2 trial of erlotinib combined with cisplatin and radiotherapy in patients with locally advanced cervical cancer. Alves, FV; Carmo, CC; Erlich, F; Ferreira, CG; Grazziotin, R; Mamede, M; Moralez, G; Nogueira-Rodrigues, A; Small, IA; Triginelli, SA; Viegas, C, 2014)	0.4
" Finally, this study demonstrated that MPT0B271 in combination with erlotinib significantly inhibits the growth of the human non-small cell lung cancer A549 cells as compared with erlotinib treatment alone, both in vitro and in vivo."	( Orally active microtubule-targeting agent, MPT0B271, for the treatment of human non-small cell lung cancer, alone and in combination with erlotinib. Chang, JY; Hsiao, CJ; Liou, JP; Pai, HC; Pan, SL; Teng, CM; Tsai, AC; Wang, CY; Wang, JC, 2014)	0.4
" This randomized phase 2 trial evaluated apricoxib, a novel COX-2 inhibitor, in combination with erlotinib in biomarker-selected patients."	( A randomized, placebo-controlled, multicenter, biomarker-selected, phase 2 study of apricoxib in combination with erlotinib in patients with advanced non-small-cell lung cancer. Bernstein, E; Burrows, F; Gitlitz, BJ; Milne, G; Otterson, GA; Santos, ES; Syto, M; Zaknoen, S, 2014)	0.4
" We investigated whether E7820 in combination with erlotinib, an EGFR-TKI, could overcome EGFR-TKI-resistance in the NSCLC cell lines A549 (KRAS; G12S), H1975 (EGFR; L858R/T790M), and H1650 (PTEN; loss, EGFR; exon 19 deletion), which are resistant to erlotinib."	( Enhanced anti-angiogenic effect of E7820 in combination with erlotinib in epidermal growth factor receptor-tyrosine kinase inhibitor-resistant non-small-cell lung cancer xenograft models. Asada, M; Funahashi, Y; Ito, K; Semba, T; Uenaka, T; Wakabayashi, T, 2014)	0.4
" Erlotinib combined with pemetrexed/cisplatin may be effective in the treatment of LM in EGFR mutation patients after gefitinib failure."	( Erlotinib in combination with pemetrexed/cisplatin for leptomeningeal metastases and cerebrospinal fluid drug concentrations in lung adenocarcinoma patients after gefitinib faliure. Deng, Q; He, J; Liu, X; Xu, X; Yang, H; Yang, X; Zhang, Y; Zhao, M, 2015)	0.42
"This phase I study evaluated the maximum tolerated dose (MTD), safety, pharmacokinetics (PK), and pharmacodynamics of pilaralisib (SAR245408), an oral pan-class I phosphoinositide 3-kinase (PI3K) inhibitor, in combination with erlotinib, an epidermal growth factor receptor (EGFR) inhibitor."	( Phase I dose-escalation study of pilaralisib (SAR245408, XL147), a pan-class I PI3K inhibitor, in combination with erlotinib in patients with solid tumors. Bahleda, R; Burris, H; Jiang, J; Lager, J; Liu, L; LoRusso, P; Macé, S; Martini, JF; Soria, JC, 2015)	0.42
" In this study, we investigated erlotinib in combination with shikonin and 14 shikonin derivatives in parental U87MG and transfected U87MG."	( Shikonin and its derivatives inhibit the epidermal growth factor receptor signaling and synergistically kill glioblastoma cells in combination with erlotinib. Bauer, R; Efferth, T; Kretschmer, N; Zhao, Q, 2015)	0.42
" This study evaluated the safety, tolerability, pharmacokinetics and efficacy of patritumab (U3-1287), a fully human anti-HER3 monoclonal antibody, in combination with erlotinib, an epidermal growth factor receptor-tyrosine kinase inhibitor in patients with previously treated advanced non-small cell lung cancer (NSCLC)."	( Phase I study of the HER3-targeted antibody patritumab (U3-1287) combined with erlotinib in Japanese patients with non-small cell lung cancer. Horiike, A; Horinouchi, H; Kaneda, H; Murakami, H; Nagashima, M; Nakagawa, K; Nishio, M; Sekiguchi, M; Tamura, T; Yamamoto, N, 2015)	0.42
"Patritumab in combination with erlotinib was well tolerated and the efficacy of the combination was encouraging, especially in patients where prior gefitinib treatment failed."	( Phase I study of the HER3-targeted antibody patritumab (U3-1287) combined with erlotinib in Japanese patients with non-small cell lung cancer. Horiike, A; Horinouchi, H; Kaneda, H; Murakami, H; Nagashima, M; Nakagawa, K; Nishio, M; Sekiguchi, M; Tamura, T; Yamamoto, N, 2015)	0.42
" We aimed to determine the benefit of survival and toxicity of Conformal Radiotherapy (CRT) combined with erlotinib-based multimodality therapy in newly diagnosed metastatic non-small-cell lung cancer (NSCLC)."	( A pilot study of conformal radiotherapy combined with erlotinib-based multimodality therapy in newly diagnosed metastatic non-small-cell lung cancer. Chen, LH; Chen, M; Dai, YM; Ding, Y; Guan, J; Li, L; Li, QS; Li, QY; Liu, LY; Xiao, NJ; Yang, M; Zhang, C; Zhang, Y; Zhang, YW, 2015)	0.42
"In this study, patients with newly diagnosed metastatic NSCLC had survival benefits when erlotinib was used combined with CRT."	( A pilot study of conformal radiotherapy combined with erlotinib-based multimodality therapy in newly diagnosed metastatic non-small-cell lung cancer. Chen, LH; Chen, M; Dai, YM; Ding, Y; Guan, J; Li, L; Li, QS; Li, QY; Liu, LY; Xiao, NJ; Yang, M; Zhang, C; Zhang, Y; Zhang, YW, 2015)	0.42
" Given the toxicity and the pharmacokinetic interaction, further investigation with this drug combination will not be pursued."	( Dovitinib and erlotinib in patients with metastatic non-small cell lung cancer: A drug-drug interaction. Das, M; Frymoyer, A; Neal, JW; Padda, SK; Riess, JW; Wakelee, HA; Zhou, L, 2015)	0.42
"We conducted a phase I trial of erlotinib, an epidermal growth factor receptor tyrosine kinase inhibitor, combined with amrubicin, a topoisomerase II inhibitor."	( Phase I and pharmacokinetic study of erlotinib administered in combination with amrubicin in patients with previously treated, advanced non-small cell lung cancer. Asakuma, M; Fukui, T; Hamada, A; Hayashi, N; Hiyoshi, Y; Igawa, S; Ishihara, M; Kasajima, M; Katagiri, M; Katono, K; Kimura, M; Kubota, M; Maki, S; Masuda, N; Mitsufuji, H; Otani, S; Ryuge, S; Saito, H; Sasaki, J; Takakura, A; Toyooka, I; Wada, M; Yamamoto, M; Yokoba, M, 2015)	0.42
" No drug-drug interactions between erlotinib and amrubicin were observed in this study."	( Phase I and pharmacokinetic study of erlotinib administered in combination with amrubicin in patients with previously treated, advanced non-small cell lung cancer. Asakuma, M; Fukui, T; Hamada, A; Hayashi, N; Hiyoshi, Y; Igawa, S; Ishihara, M; Kasajima, M; Katagiri, M; Katono, K; Kimura, M; Kubota, M; Maki, S; Masuda, N; Mitsufuji, H; Otani, S; Ryuge, S; Saito, H; Sasaki, J; Takakura, A; Toyooka, I; Wada, M; Yamamoto, M; Yokoba, M, 2015)	0.42
" This study aimed to evaluate the effect of metformin in combination with EGFR-TKI on the prognosis of non-small cell lung cancer (NSCLC) patients with diabetes mellitus type 2 (DM2)."	( Synergistic effects of metformin in combination with EGFR-TKI in the treatment of patients with advanced non-small cell lung cancer and type 2 diabetes. Cao, M; Chen, H; Chu, Q; Han, R; He, Y; Sun, J; Wang, D; Wang, Y; Yao, W, 2015)	0.42
" Bevacizumab (BEV), a humanized monoclonal antibody to vascular endothelial cell growth factor (VEGF), in combination with ERL (BEV+ERL) significantly extended progression-free survival in patients with EGFR-mutated NSCLC compared with ERL alone."	( Impact of bevacizumab in combination with erlotinib on EGFR-mutated non-small cell lung cancer xenograft models with T790M mutation or MET amplification. Fukumura, J; Furugaki, K; Harada, N; Iwai, T; Kurasawa, M; Mitsudomi, T; Mizuuchi, H; Moriya, Y; Suda, K; Yamamoto, K; Yanagisawa, M; Yorozu, K, 2016)	0.43
" The removal of AZD4547 from the optimized drug combination resulted in 80% of cell viability inhibition, while still maintaining the synergistic interaction."	( A streamlined search technology for identification of synergistic drug combinations. Berndsen, RH; Ding, X; Dyson, PJ; Griffioen, AW; Ho, CM; Nowak-Sliwinska, P; van den Bergh, H; Weiss, A, 2015)	0.42
" This phase I study (NCT01009073) evaluated the safety, pharmacokinetics, and preliminary antitumor activity of navitoclax combined with erlotinib in patients with advanced solid tumors."	( Safety, efficacy, and pharmacokinetics of navitoclax (ABT-263) in combination with erlotinib in patients with advanced solid tumors. Arzt, J; Busman, TA; Holen, KD; Kirschbrown, W; Lian, G; LoRusso, P; Rosen, LS; Rudersdorf, NS; Tolcher, AW; Vanderwal, CA, 2015)	0.42
"An open-label dose escalation study included an arm evaluating navitoclax combined with erlotinib, which included a dose escalation cohort and a planned safety expansion cohort."	( Safety, efficacy, and pharmacokinetics of navitoclax (ABT-263) in combination with erlotinib in patients with advanced solid tumors. Arzt, J; Busman, TA; Holen, KD; Kirschbrown, W; Lian, G; LoRusso, P; Rosen, LS; Rudersdorf, NS; Tolcher, AW; Vanderwal, CA, 2015)	0.42
"To determine the recommended dose for phase II trials of elisidepsin (PM02734, Irvalec®) in combination with erlotinib in patients with advanced malignant solid tumors."	( Phase I, dose-escalating study of elisidepsin (Irvalec(®)), a plasma membrane-disrupting marine antitumor agent, in combination with erlotinib in patients with advanced malignant solid tumors. Coronado, C; Dios, JL; Fernández-García, EM; Goel, S; Miguel-Lillo, B; Morán, T; Rosell, R; Viteri, S, 2016)	0.43
" Given their synergistic activity in combination, we conducted a phase II study to determine the clinical activity of sorafenib in combination with erlotinib in patients with advanced non-small cell lung cancer (NSCLC)."	( A multicenter phase II study of sorafenib in combination with erlotinib in patients with advanced non-small cell lung cancer (KCSG-0806). Cho, BC; Choi, JH; Choi, JR; Heo, DS; Jung, M; Kang, SY; Kim, DW; Kim, HT; Kim, JH; Kim, SW; Lee, DH; Lim, SM; Shim, HS, 2016)	0.43
"Sorafenib combined with erlotinib is well-tolerated with manageable toxicity and appears to be effective against advanced NSCLC with one or two prior line of systemic treatment (NCT00801385)."	( A multicenter phase II study of sorafenib in combination with erlotinib in patients with advanced non-small cell lung cancer (KCSG-0806). Cho, BC; Choi, JH; Choi, JR; Heo, DS; Jung, M; Kang, SY; Kim, DW; Kim, HT; Kim, JH; Kim, SW; Lee, DH; Lim, SM; Shim, HS, 2016)	0.43
" Treatment of EGFR TKI-resistant NSCLC cells with FAK inhibitor alone effectively inhibited cell viability in all cell lines tested; however, its use in combination with the EGFR TKI erlotinib was more effective at reducing cell viability than either treatment alone when tested in both 2- and 3-dimensional assays in vitro, with enhanced benefit seen in A549 cells."	( Focal Adhesion Kinase Inhibitors in Combination with Erlotinib Demonstrate Enhanced Anti-Tumor Activity in Non-Small Cell Lung Cancer. Addison, CL; Al-Zahrani, KN; Dimitroulakos, J; Goss, GD; Hasim, MS; Howe, GA; Sabourin, LA; Sekhon, HS; Villeneuve, J; Xiao, B; Zhao, H, 2016)	0.43
" Methods The study comprised a 3 + 3 dose-escalation part for LY2875358 monotherapy in patients with advanced malignancies (Part A) followed by an assessment of LY2875358 in combination with erlotinib or gefitinib in patients with non-small cell lung cancer (Part B)."	( A phase I dose-escalation study of LY2875358, a bivalent MET antibody, given as monotherapy or in combination with erlotinib or gefitinib in Japanese patients with advanced malignancies. Doi, T; Enatsu, S; Kojima, T; Nakamura, T; Ohmatsu, H; Takahashi, H; Turner, K; Uenaka, K; Wacheck, V; Yoh, K; Zenke, Y, 2016)	0.43
" A new combination with bevacizumab and erlotinib, a tyrosine kinase inhibitor of the epithelial growth factor receptor, has shown synergistic effects in preclinical tests and promising results in some clinical trials."	( Survival Benefit and Safety of Bevacizumab in Combination with Erlotinib as Maintenance Therapy in Patients with Metastatic Colorectal Cancer: A Meta-Analysis. Cao, C; Chen, J; Gong, Y; Kuang, M; Tang, C; Wu, P; Xu, W, 2017)	0.46
" Here, we investigated whether a frontline combination with an HSP90 inhibitor could delay the emergence of resistance to these inhibitors in preclinical lung cancer models."	( Emergence of resistance to tyrosine kinase inhibitors in non-small-cell lung cancer can be delayed by an upfront combination with the HSP90 inhibitor onalespib. Courtin, A; Hearn, K; Lyons, JF; Saini, HK; Smyth, T; Thompson, NT; Wallis, NG, 2016)	0.43
"The HSP90 inhibitor, onalespib, was combined with either crizotinib or erlotinib in ALK- or EGFR-activated xenograft models respectively (H2228, HCC827)."	( Emergence of resistance to tyrosine kinase inhibitors in non-small-cell lung cancer can be delayed by an upfront combination with the HSP90 inhibitor onalespib. Courtin, A; Hearn, K; Lyons, JF; Saini, HK; Smyth, T; Thompson, NT; Wallis, NG, 2016)	0.43
"Together, these preclinical data suggest that frontline combination with an HSP90 inhibitor may be a method for delaying the emergence of resistance to targeted therapies."	( Emergence of resistance to tyrosine kinase inhibitors in non-small-cell lung cancer can be delayed by an upfront combination with the HSP90 inhibitor onalespib. Courtin, A; Hearn, K; Lyons, JF; Saini, HK; Smyth, T; Thompson, NT; Wallis, NG, 2016)	0.43
" Concomitant use of erlotinib and the antiepileptic drug phenytoin, an inducer of CYP3A4, may result in a drug-drug interaction accompanied by changes in the blood concentrations of both drugs."	( Drug interaction between erlotinib and phenytoin for brain metastases in a patient with nonsmall cell lung cancer. Homma, M; Kaburagi, T; Kurosawa, A; Ohgami, M, 2016)	0.43
" We assessed the clinical relevance of this potential drug-drug interaction (DDI) in a retrospective cohort of EGFR-mutant NSCLC patients."	( EGFR kinase inhibitors and gastric acid suppressants in EGFR-mutant NSCLC: a retrospective database analysis of potential drug interaction. Asmat, A; Kumarakulasinghe, NB; Loy, EY; Pang, B; Soo, RA; Soon, YY; Syn, N; Zheng, H, 2016)	0.43
"Co-administration of antineoplastics with ART is challenging due to potential drug-drug interactions (DDIs)."	( Use of a physiologically based pharmacokinetic model to simulate drug-drug interactions between antineoplastic and antiretroviral drugs. Back, D; Clotet, B; Miranda, C; Moltó, J; Owen, A; Rajoli, R; Siccardi, M; Valle, M, 2017)	0.46
"This phase 1 study evaluated the safety, tolerability, pharmacokinetics and efficacy of patritumab (U3-1287) Process 2, a new formulation of fully human anti-HER3 monoclonal antibody in combination with erlotinib, an epidermal growth factor receptortyrosine kinase inhibitor (EGFR-TKI) in prior chemotherapy treated Japanese patients with advanced non-small cell lung cancer (NSCLC)."	( Phase 1 study of new formulation of patritumab (U3-1287) Process 2, a fully human anti-HER3 monoclonal antibody in combination with erlotinib in Japanese patients with advanced non-small cell lung cancer. Haratani, K; Hayashi, H; Iwasa, T; Kamiyama, E; Nakagawa, K; Ohwada, S; Shimizu, T; Yamada, H; Yonesaka, K, 2017)	0.46
"Patients received intravenous patritumab Process 2 formulation at 9 mg/kg every 3 weeks after initiation of 18 mg/kg loading dose combined with continuous daily dose of erlotinib (150 mg QD) until any of the withdrawal criteria are met."	( Phase 1 study of new formulation of patritumab (U3-1287) Process 2, a fully human anti-HER3 monoclonal antibody in combination with erlotinib in Japanese patients with advanced non-small cell lung cancer. Haratani, K; Hayashi, H; Iwasa, T; Kamiyama, E; Nakagawa, K; Ohwada, S; Shimizu, T; Yamada, H; Yonesaka, K, 2017)	0.46
"Total of six EGFR-mutant NSCLC patients including one EGFR-TKI naïve patient received patritumab Process 2 formulation combined with erlotinib."	( Phase 1 study of new formulation of patritumab (U3-1287) Process 2, a fully human anti-HER3 monoclonal antibody in combination with erlotinib in Japanese patients with advanced non-small cell lung cancer. Haratani, K; Hayashi, H; Iwasa, T; Kamiyama, E; Nakagawa, K; Ohwada, S; Shimizu, T; Yamada, H; Yonesaka, K, 2017)	0.46
"Patritumab Process 2 formulation in combination with erlotinib was well tolerated compatible with favorable PK profile in Japanese patients with advanced NSCLC."	( Phase 1 study of new formulation of patritumab (U3-1287) Process 2, a fully human anti-HER3 monoclonal antibody in combination with erlotinib in Japanese patients with advanced non-small cell lung cancer. Haratani, K; Hayashi, H; Iwasa, T; Kamiyama, E; Nakagawa, K; Ohwada, S; Shimizu, T; Yamada, H; Yonesaka, K, 2017)	0.46
" The erlotinib-less sensitive cell lines SK-MES-1 and A549 were treated with erlotinib or chelerythrine by themselves or in combination with each other."	( Additive effects of cherlerythrine chloride combination with erlotinib in human non-small cell lung cancer cells. He, M; Li, Y; Song, C; Yang, Z; Zhang, L; Zhang, X, 2017)	0.46
" We investigated the safety, tolerability, and pharmacokinetics (PK) of selumetinib in combination with molecularly targeted drugs erlotinib or temsirolimus in patients with advanced solid tumors."	( A phase I dose-escalation study of Selumetinib in combination with Erlotinib or Temsirolimus in patients with advanced solid tumors. Burris, HA; Clemett, D; Cohen, RB; Curt, G; Emeribe, U; Infante, JR; Kim, KB; LoRusso, PM; Tomkinson, HK, 2017)	0.46
"In this Phase II randomised trial, patients without progression following four cycles of first-line platinum-based chemotherapy (N=205) received continuous schedule maintenance oral linsitinib 150 mg or placebo BID combined with erlotinib 150 mg QD for 21-day cycles."	( Randomised Phase 2 study of maintenance linsitinib (OSI-906) in combination with erlotinib compared with placebo plus erlotinib after platinum-based chemotherapy in patients with advanced non-small cell lung cancer. Ahmed, S; Blackhall, F; Chen, J; Ciuleanu, TE; Kim, JH; Mezger, J; Park, K; Poondru, S; Thomas, M; VanTornout, JM; Whitcomb, D, 2017)	0.46
" No drug-drug interaction was implicated."	( Randomised Phase 2 study of maintenance linsitinib (OSI-906) in combination with erlotinib compared with placebo plus erlotinib after platinum-based chemotherapy in patients with advanced non-small cell lung cancer. Ahmed, S; Blackhall, F; Chen, J; Ciuleanu, TE; Kim, JH; Mezger, J; Park, K; Poondru, S; Thomas, M; VanTornout, JM; Whitcomb, D, 2017)	0.46
" An evaluation was undertaken with the ERBB3/Her3-specific antibody patritumab (P) either alone or with the ERBB1/epidermal growth factor receptor inhibitor erlotinib (E) in combination with standard cytotoxic agents, cisplatin, vincristine, and cyclophosphamide, in pediatric sarcoma xenograft models that express receptors and ligands targeted by these agents."	( Evaluation of patritumab with or without erlotinib in combination with standard cytotoxic agents against pediatric sarcoma xenograft models. Bandyopadhyay, A; Favours, E; Ghilu, S; Guttridge, D; Hirotani, K; Houghton, PJ; Kurmashev, D; Kurmasheva, RT; London, C; Michalek, J; Phelps, DA; Pozo, VD; Trevino, A; Zhang, L, 2018)	0.48
" Chloroquine (CQ) was used in combination with AP/ES to normalize tumor vessels for sufficient drug/gene delivery to overcome drug resistance in NSCLC cells."	( Chloroquine in combination with aptamer-modified nanocomplexes for tumor vessel normalization and efficient erlotinib/Survivin shRNA co-delivery to overcome drug resistance in EGFR-mutated non-small cell lung cancer. Chen, H; Gao, Y; Li, Z; Lv, T; Xu, L; Zhang, Y, 2018)	0.48
" However, the efficacy and safety of erlotinib in combination with bevacizumab compared with single agents remain unclear."	( Erlotinib in combination with bevacizumab has potential benefit in non-small cell lung cancer: A systematic review and meta-analysis of randomized clinical trials. Wei, Y; Xu, J; Yu, D; Zhang, W; Zhao, B, 2018)	0.48
" The MTD was reached at erlotinib 150 mg once daily combined with tipifarnib 300 mg twice daily."	( A phase I study of the farnesyltransferase inhibitor Tipifarnib in combination with the epidermal growth factor tyrosine kinase inhibitor Erlotinib in patients with advanced solid tumors. Adjei, A; Allred, J; Goetz, M; Jazieh, K; Kaufmann, SH; Lim, VS; Molina, J; Reid, J; Yin, J, 2019)	0.51
" Tyrosine kinase inhibitors (TKIs), including erlotinib and gefitinib, which block the action of the human epidermal growth factor receptor type 1 receptor, provide small increases in patient survival when administered with gemcitabine."	( Targeting retinoblastoma protein phosphorylation in combination with EGFR inhibition in pancreatic cancer cells. Abraham, RG; Dedi, B; Krucher, NA; Thomas, NA, 2019)	0.51
"The efficacy of bevacizumab combined with erlotinib (B + E) for the treatment of advanced hepatocellular carcinoma, especially for sorafenib-refractory patients, has been observed and evaluated in several trials."	( Efficacy of bevacizumab combined with erlotinib for advanced hepatocellular carcinoma: a single-arm meta-analysis based on prospective studies. Deng, H; Fan, X; He, L; Lei, J; Li, J; Wei, Y; Xu, J; Yi, F; Zhang, W, 2019)	0.51
"Bevacizumab combined with erlotinib is effective for treating hepatocellular carcinoma patients, especially sorafenib-refractory patients."	( Efficacy of bevacizumab combined with erlotinib for advanced hepatocellular carcinoma: a single-arm meta-analysis based on prospective studies. Deng, H; Fan, X; He, L; Lei, J; Li, J; Wei, Y; Xu, J; Yi, F; Zhang, W, 2019)	0.51
"A case of acute toxicity induced by erlotinib combined with cabozantinib is reported in this article."	( [Acute Myocardial Infarction and Purpuric Drug Eruption Caused by Erlotinib Combined with Cabozantinib:Report of One Case]. Hu, Y; Jia, LJ; Li, T; Zhang, J, 2019)	0.51
"This was a multicenter, single-arm phase I/II study to evaluate the efficacy of intermitted erlotinib in combination with docetaxel in patients with EGFR-negative NSCLC who failed one prior chemotherapy."	( Phase I/II study of intermitted erlotinib in combination with docetaxel in patients with recurrent non-small cell lung cancer (WJOG4708L). Asai, K; Chiba, Y; Hayashi, H; Kasai, T; Kawaguchi, T; Kijima, T; Kimura, T; Kogure, Y; Nakagawa, K; Nakanishi, Y; Niwa, T; Oguri, T; Ono, A; Tanaka, H; Watanabe, K; Yamamoto, N; Yano, S; Yoshimura, N; Yoshioka, H, 2019)	0.51
" It is known to interact with gastric acid suppressing medications(AS)."	( [A Survey on the Concurrent Administration of Erlotinib and Gastric Acid Suppressing Medications among Doctors:Concern for Drug Interaction]. Higuchi, M; Kodama, S; Koto, H; Matsuo, K; Miyazaki, M; Sasaki, Y; Wada, Y; Yamaguchi, R, 2019)	0.51
" The primary aim is to assess progression-free survival after EGFR-TKIs treatment combined with apatinib 250 mg once daily."	( Clinical study of apatinib combined with EGFR-TKI in the treatment of chronic progression after EGFR-TKI treatment in non-small cell lung cancer (ChiCTR1800019185). Chen, J; Li, X; Liu, H; Liu, M; Zhang, H, 2020)	0.56
"We reviewed randomized controlled trials on the use of erlotinib combined with bevacizumab in adult patients with NSCLC, including data on outcome measures of overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and adverse events."	( Efficacy and safety of erlotinib combined with bevacizumab in the treatment of non-small cell lung cancer: A systematic review and meta-analysis. Ding, L; Guo, W; Zhao, S; Zhou, K, 2020)	0.56
"This phase I study was conducted to evaluate the safety and pharmacokinetics of YM155, a potent, selective survivin inhibitor, in combination with erlotinib in patients with EGFR TKI refractory advanced non-small cell lung cancer (NSCLC)."	( Phase I safety and pharmacokinetic study of YM155, a potent selective survivin inhibitor, in combination with erlotinib in patients with EGFR TKI refractory advanced non-small cell lung cancer. Morishita, M; Nakagawa, K; Nishio, K; Okamoto, I; Okamoto, K; Sakai, K; Shimizu, T; Takeda, M, 2020)	0.56
" We conducted a retrospective cohort study using data from the claims database of Taipei Veterans General Hospital to perform direct comparisons of these three EGFR-TKIs (gefitinib, erlotinib, and afatinib) combined with co-medications (metformin, statins, antacids, and steroids)."	( The efficacy of first-line tyrosine kinase inhibitors combined with co-medications in Asian patients with EGFR mutation non-small cell lung cancer. Chang, YL; Chen, YM; Chou, YC; He, CH; Hsu, CC; Huang, TY; Su, VY; Yang, KY; Yen, JC, 2020)	0.56
" This report describes a Phase Ib clinical trial investigating PG-11047 in combination with cytotoxic and anti-angiogenic chemotherapeutic agents in patients with advanced refractory metastatic solid tumors or lymphoma."	( A Phase Ib multicenter, dose-escalation study of the polyamine analogue PG-11047 in combination with gemcitabine, docetaxel, bevacizumab, erlotinib, cisplatin, 5-fluorouracil, or sunitinib in patients with advanced solid tumors or lymphoma. Becerra, CHR; Boyd, TE; Casero, RA; Conkling, PR; Fitzgerald, M; Garbo, LE; Jotte, RM; Marton, LJ; Murray Stewart, T; Richards, DA; Smith, DA; Stephenson, JJ; Vogelzang, NJ; Von Hoff, D; Wu, HH, 2021)	0.62
"The maximum tolerated dose (MTD) of PG-11047 in combination with bevacizumab, erlotinib, cisplatin, and 5-FU was 590 mg."	( A Phase Ib multicenter, dose-escalation study of the polyamine analogue PG-11047 in combination with gemcitabine, docetaxel, bevacizumab, erlotinib, cisplatin, 5-fluorouracil, or sunitinib in patients with advanced solid tumors or lymphoma. Becerra, CHR; Boyd, TE; Casero, RA; Conkling, PR; Fitzgerald, M; Garbo, LE; Jotte, RM; Marton, LJ; Murray Stewart, T; Richards, DA; Smith, DA; Stephenson, JJ; Vogelzang, NJ; Von Hoff, D; Wu, HH, 2021)	0.62
"Results of this Phase Ib trial indicate that PG-11047 can be safely administered to patients in combination with bevacizumab, erlotinib, cisplatin, and 5-FU on the once weekly dosing schedule described and may provide therapeutic benefit."	( A Phase Ib multicenter, dose-escalation study of the polyamine analogue PG-11047 in combination with gemcitabine, docetaxel, bevacizumab, erlotinib, cisplatin, 5-fluorouracil, or sunitinib in patients with advanced solid tumors or lymphoma. Becerra, CHR; Boyd, TE; Casero, RA; Conkling, PR; Fitzgerald, M; Garbo, LE; Jotte, RM; Marton, LJ; Murray Stewart, T; Richards, DA; Smith, DA; Stephenson, JJ; Vogelzang, NJ; Von Hoff, D; Wu, HH, 2021)	0.62
"To determine the efficacy and safety of anti-angiogenic drugs combined with erlotinib in the treatment of advanced non-small cell lung cancer (NSCLC), we performed a meta-analysis of 10 randomized controlled trials (RCTs)."	( Efficacy and safety of anti-angiogenic drugs combined with erlotinib in the treatment of advanced non-small cell lung cancer: a meta-analysis of randomized clinical trials. Cao, P; Chen, Z; Jiang, S; Li, J; Li, X; Liu, L; Xin, Y; Zhang, J; Zhang, L, 2021)	0.62
" We collected and compared RCTs on antiangiogenic drugs combined with erlotinib (A + E) for NSCLC, and analyzed outcomes including overall survival (OS), objective response rate (ORR), progression-free survival (PFS), and incidence of severe adverse events (grade ≥3 AEs)."	( Efficacy and safety of anti-angiogenic drugs combined with erlotinib in the treatment of advanced non-small cell lung cancer: a meta-analysis of randomized clinical trials. Cao, P; Chen, Z; Jiang, S; Li, J; Li, X; Liu, L; Xin, Y; Zhang, J; Zhang, L, 2021)	0.62
"Anti-angiogenic drugs used in combination with erlotinib can significantly prolong PFS in patients with advanced NSCLC."	( Efficacy and safety of anti-angiogenic drugs combined with erlotinib in the treatment of advanced non-small cell lung cancer: a meta-analysis of randomized clinical trials. Cao, P; Chen, Z; Jiang, S; Li, J; Li, X; Liu, L; Xin, Y; Zhang, J; Zhang, L, 2021)	0.62
"The study was designed to investigate the safety of ramucirumab administered in combination with erlotinib or osimertinib for patients with untreated EGFR-mutated non-small cell lung cancer (NSCLC) and asymptomatic brain metastases, a patient subgroup in which these regimens have remained untested."	( Phase 1b study of ramucirumab in combination with erlotinib or osimertinib for untreated EGFR-mutated non-small cell lung cancer patients with asymptomatic brain metastases. Atagi, S; Daga, H; Izumi, M; Kaneda, H; Kawaguchi, T; Matsumoto, Y; Mitsuoka, S; Nakahama, K; Nakatani, Y; Ogawa, K; Okada, A; Okishio, K; Sawa, K; Tani, Y, 2021)	0.62
"Ramucirumab in combination with erlotinib or osimertinib showed safety for EGFR-mutated NSCLC with brain metastases."	( Phase 1b study of ramucirumab in combination with erlotinib or osimertinib for untreated EGFR-mutated non-small cell lung cancer patients with asymptomatic brain metastases. Atagi, S; Daga, H; Izumi, M; Kaneda, H; Kawaguchi, T; Matsumoto, Y; Mitsuoka, S; Nakahama, K; Nakatani, Y; Ogawa, K; Okada, A; Okishio, K; Sawa, K; Tani, Y, 2021)	0.62
"Pemetrexed (800 mg day 1), cis-platinum (40 mg day 1-3) combined with bevacizumab (400 mg day 1) every 3 weeks were administered to the patient."	( Erlotinib combined with bevacizumab and chemotherapy in first line osimertinib-resistant NSCLC patient with leptomeningeal metastasis: A case report. Li, M; Luo, N; Qi, Y; Wang, M; Zhu, F, 2021)	0.62
"To explore the application of evidence-based nursing intervention in the treatment of advanced squamous cell carcinoma of the lung by erlotinib combined with tegafur, gimeracil, and oteracil potassium (TS-1) and its influence on quality of life (QOL)."	( Application of Evidence-Based Nursing Intervention in the Treatment of Advanced Squamous Cell Carcinoma of the Lung by Erlotinib Combined with Tegafur, Gimeracil, and Oteracil Potassium and Its Influence on Quality of Life. Fu, F; Huang, X; Liu, S; Wang, H; Wen, J, 2021)	0.62
"Application of evidence-based nursing intervention in the treatment of advanced squamous cell carcinoma of the lung by erlotinib combined with TS-1 can help patients to relieve pain, improve their psychological state, reduce the incidence of adverse reactions, significantly improve the QOL, and also enhance the satisfaction of clinical nursing."	( Application of Evidence-Based Nursing Intervention in the Treatment of Advanced Squamous Cell Carcinoma of the Lung by Erlotinib Combined with Tegafur, Gimeracil, and Oteracil Potassium and Its Influence on Quality of Life. Fu, F; Huang, X; Liu, S; Wang, H; Wen, J, 2021)	0.62
" This study aimed to compare the anti-cancer efficacy of EGFR inhibitors (gefitinib and erlotinib) alone and in combination with nutritional supplements of Se/FO in treating lung cancer."	( Targeting EGFR in Combination with Nutritional Supplements on Antitumor Efficacy in a Lung Cancer Mouse Model. Chen, PC; Guo, CH; Hsia, S; Lee, SY; Li, WC; Peng, CL, 2022)	0.72
"We examined the antitumor activities and potential mechanisms of erlotinib in combination with berberine in vitro and in vivo using the MTT assay, immunoblotting, flow cytometry, and tumor xenograft models."	( Antitumor effects of erlotinib in combination with berberine in A431 cells. Cuan, X; Huang, Y; Luo, R; Sheng, J; Wang, X; Yang, X; Zhao, Y; Zhu, W, 2023)	0.91
"Our data supported use of BBR in combination with erlotinib as a novel strategy for treatment of patients with EGFR positive tumors."	( Antitumor effects of erlotinib in combination with berberine in A431 cells. Cuan, X; Huang, Y; Luo, R; Sheng, J; Wang, X; Yang, X; Zhao, Y; Zhu, W, 2023)	0.91

Excerpt	Reference	Relevance
"Clinical development of ZD1839 (Iressa; AstraZeneca Pharmaceuticals LP, Wilmington, DE) was initiated based on strong preclinical studies that showed antitumor responses in a variety of solid tumor types and established its oral bioavailability and tolerability."	( Phase I studies of ZD1839 in patients with common solid tumors. Lorusso, PM, 2003)	0.32
"A randomized, open-label, 2-period crossover study was conducted to evaluate the bioequivalence of 6 tablets of erlotinib 25 mg and 1 tablet of erlotinib 150 mg (arm A, n = 42) and the oral bioavailability of the 150-mg tablet versus a 25-mg intravenous infusion (arm B, n = 20) in healthy subjects."	( Evaluation of the absolute oral bioavailability and bioequivalence of erlotinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, in a randomized, crossover study in healthy subjects. Eppler, S; Frohna, P; Hamilton, M; Kenkare-Mitra, SR; Ling, J; Lu, J; Lum, BL; Rakhit, A; Wolf, J, 2006)	0.33
", Melville, NY) is a low molecular weight, orally bioavailable inhibitor of the EGFR that has been approved for both non-small cell lung cancer and pancreatic cancers."	( Inactivation of Akt by the epidermal growth factor receptor inhibitor erlotinib is mediated by HER-3 in pancreatic and colorectal tumor cell lines and contributes to erlotinib sensitivity. Buck, E; Cagnoni, P; Eyzaguirre, A; Gibson, NW; Haley, JD; Iwata, KK, 2006)	0.33
" EGFR inhibition may be achieved either by small-molecule orally bioavailable tyrosine kinase inhibitors, such as gefitinib or erlotinib, or else by large-molecule receptor antibodies, such as cetuximab or panitumumab."	( Tumor resensitization to erlotinib following brief substitution of cetuximab. Epstein, RJ; Leung, TW, 2008)	0.35
" This study illustrates the potential of BAS 100 to increase the low and variable oral bioavailability of erlotinib in cancer patients."	( Modulation of erlotinib pharmacokinetics in mice by a novel cytochrome P450 3A4 inhibitor, BAS 100. Baker, SD; Figg, WD; Gonzalez, FJ; Harris, JW; Smith, NF; Sparreboom, A, 2008)	0.35
" In the present study, we determined the effects of 3,3'-diindolylmethane (Bioresponse BR-DIM referred to as B-DIM), a formulated DIM with greater bioavailability on cell viability and apoptosis with erlotinib in vitro and in vivo using an orthotopic animal tumor model."	( Apoptosis-inducing effect of erlotinib is potentiated by 3,3'-diindolylmethane in vitro and in vivo using an orthotopic model of pancreatic cancer. Ahmad, A; Ali, S; Banerjee, S; El-Rayes, BF; Philip, PA; Sarkar, FH, 2008)	0.35
"01) as well as bioavailability of erlotinib after oral administration (5 mg/kg) were statistically significantly increased in Bcrp1/Mdr1a/1b(-/-) knockout mice (60."	( Effect of the ATP-binding cassette drug transporters ABCB1, ABCG2, and ABCC2 on erlotinib hydrochloride (Tarceva) disposition in in vitro and in vivo pharmacokinetic studies employing Bcrp1-/-/Mdr1a/1b-/- (triple-knockout) and wild-type mice. Beijnen, JH; Bolijn, MJ; Buckle, T; de Vries, NA; Marchetti, S; Mazzanti, R; Schellens, JH; van Eijndhoven, MA; van Tellingen, O, 2008)	0.57
" In vivo, absence of P-gp and Bcrp1 significantly affected the oral bioavailability of erlotinib."	( Effect of the ATP-binding cassette drug transporters ABCB1, ABCG2, and ABCC2 on erlotinib hydrochloride (Tarceva) disposition in in vitro and in vivo pharmacokinetic studies employing Bcrp1-/-/Mdr1a/1b-/- (triple-knockout) and wild-type mice. Beijnen, JH; Bolijn, MJ; Buckle, T; de Vries, NA; Marchetti, S; Mazzanti, R; Schellens, JH; van Eijndhoven, MA; van Tellingen, O, 2008)	0.57
"The epidermal growth factor receptor (EGFR), an N-glycosylated transmembrane protein, is the target of erlotinib, an orally bioavailable agent approved for treatment of patients with non-small cell lung cancer (NSCLC)."	( Activation of ER stress and inhibition of EGFR N-glycosylation by tunicamycin enhances susceptibility of human non-small cell lung cancer cells to erlotinib. Haigentz, M; Li, T; Ling, YH; Perez-Soler, R, 2009)	0.35
" Pharmacokinetic studies were conducted to assess the effect of pancreatic enzyme deficiency and intestinal malabsorption secondary to cystic fibrosis on the bioavailability of orally administered erlotinib, a lipophilic drug."	( Pharmacokinetics of erlotinib for the treatment of high-grade glioma in a pediatric patient with cystic fibrosis: case report and review of the literature. Broniscer, A; Christiansen, SR; Panetta, JC; Stewart, CF, 2009)	0.35
" This study sought to determine the maximum tolerated dose (MTD) of erlotinib administered as a single 30-min infusion in patients with advanced solid tumors and absolute bioavailability of erlotinib tablets at matched doses."	( A phase I dose-escalation and bioavailability study of oral and intravenous formulations of erlotinib (Tarceva, OSI-774) in patients with advanced solid tumors of epithelial origin. Dean, E; Hamilton, M; Judson, I; McCarthy, S; Ranson, M; Reid, A; Shaw, H; Wolf, J, 2010)	0.36
"This was a two-center, open label, Phase I, dose-escalation and bioavailability study of single dose IV and oral erlotinib."	( A phase I dose-escalation and bioavailability study of oral and intravenous formulations of erlotinib (Tarceva, OSI-774) in patients with advanced solid tumors of epithelial origin. Dean, E; Hamilton, M; Judson, I; McCarthy, S; Ranson, M; Reid, A; Shaw, H; Wolf, J, 2010)	0.36
" Median bioavailability of erlotinib tablets was 76%."	( A phase I dose-escalation and bioavailability study of oral and intravenous formulations of erlotinib (Tarceva, OSI-774) in patients with advanced solid tumors of epithelial origin. Dean, E; Hamilton, M; Judson, I; McCarthy, S; Ranson, M; Reid, A; Shaw, H; Wolf, J, 2010)	0.36
"A 100 mg single IV dose of erlotinib, given as a 30-min infusion, was well tolerated with only minor adverse events and the high level of bioavailability of oral erlotinib was confirmed."	( A phase I dose-escalation and bioavailability study of oral and intravenous formulations of erlotinib (Tarceva, OSI-774) in patients with advanced solid tumors of epithelial origin. Dean, E; Hamilton, M; Judson, I; McCarthy, S; Ranson, M; Reid, A; Shaw, H; Wolf, J, 2010)	0.36
" We report on a novel small molecule inhibitor of Hsp90, SNX-2112, and an orally bioavailable prodrug analog, SNX-5422."	( Targeting of multiple signaling pathways by the Hsp90 inhibitor SNX-2112 in EGFR resistance models as a single agent or in combination with erlotinib. Barabasz, A; Fadden, P; Foley, B; Hall, S; Huang, K; Rice, JW; Scott, A; Steed, P; Veal, JM, 2009)	0.35
" They are characterized by a moderate rate of absorption after oral administration with peak plasma concentrations at several hours post-dose."	( Clinical pharmacokinetics of tyrosine kinase inhibitors: focus on 4-anilinoquinazolines. Di Gion, P; Doroshyenko, O; Fuhr, U; Scheffler, M; Wolf, J, 2011)	0.37
" Friend Leukemia Virus Strain B (FVB) mice were used to determine the bioavailability of elacridar after a 10 mg/kg dose of elacridar in the microemulsion, intraperitoneally (i."	( Development and evaluation of a novel microemulsion formulation of elacridar to improve its bioavailability. Elmquist, WF; Mittapalli, RK; Sane, R, 2013)	0.39
"As the bioavailability of erlotinib is dependent on gastric pH, an increase in gastric pH via the concurrent use of gastric acid suppressive medications (AS) may reduce its bioavailability and efficacy."	( An evaluation of the possible interaction of gastric acid suppressing medication and the EGFR tyrosine kinase inhibitor erlotinib. Bradbury, PA; Hilton, JF; Seymour, L; Shepherd, FA; Tu, D, 2013)	0.39
" We evaluated the comparative bioavailability and tolerability of the test and reference formulations in healthy adult volunteers."	( Pharmacokinetic properties of two erlotinib 150 mg formulations with a genetic effect evaluation in healthy Korean subjects. Cho, SJ; Choi, HG; Im, YJ; Jeon, JY; Kim, MG; Kim, Y; Seo, YH; Song, EK, 2015)	0.42
" However, there was no clinically significant difference in bioavailability or toxicity between the two clinically used fed conditions at least in 14 days."	( Comparison of the pharmacokinetics of erlotinib administered in complete fasting and 2 h after a meal in patients with lung cancer. Fujiwara, Y; Goto, Y; Hamada, A; Horinouchi, H; Kanda, S; Katsuya, Y; Nokihara, H; Ohe, Y; Osawa, S; Sunami, K; Takashima, Y; Tamura, T; Utsumi, H; Yamamoto, N, 2015)	0.42
"To improve the solubility and oral bioavailability of erlotinib, a poorly water-soluble anticancer drug, solid self-emulsifying drug delivery system (SEDDS) was developed using solid inert carriers such as dextran 40 and Aerosil® 200 (colloidal silica)."	( Development of Solid Self-Emulsifying Formulation for Improving the Oral Bioavailability of Erlotinib. Choi, HG; Choi, JY; Kim, JO; Lee, HH; Moon, C; Ramasamy, T; Tran, TH; Truong, DH; Yong, CS, 2016)	0.43
"The present study was envisaged to evaluate the effect of erlotinib β-cyclodextrin nanosponge (ERL-NS) on the solubility, dissolution, in vitro cytotoxicity and oral bioavailability of erlotinib (ERL)."	( Potential of erlotinib cyclodextrin nanosponge complex to enhance solubility, dissolution rate, in vitro cytotoxicity and oral bioavailability. Devasari, N; Dora, CP; Jain, S; Kushwah, V; Singh, C; Suresh, S; Trotta, F, 2016)	0.43
" The effects of cola on erlotinib bioavailability in patients not treated with a PPI were also studied."	( Influence of the Acidic Beverage Cola on the Absorption of Erlotinib in Patients With Non-Small-Cell Lung Cancer. Aerts, JG; Codrington, H; de Bruijn, P; Hussaarts, KG; IJzerman, NS; Kienhuis, E; Kloover, JS; Mathijssen, RH; Peric, R; van der Holt, B; van der Leest, C; van Gelder, T; van Leeuwen, RW, 2016)	0.43
"Cola intake led to a clinically relevant and statistically significant increase in the bioavailability of erlotinib during esomeprazole treatment."	( Influence of the Acidic Beverage Cola on the Absorption of Erlotinib in Patients With Non-Small-Cell Lung Cancer. Aerts, JG; Codrington, H; de Bruijn, P; Hussaarts, KG; IJzerman, NS; Kienhuis, E; Kloover, JS; Mathijssen, RH; Peric, R; van der Holt, B; van der Leest, C; van Gelder, T; van Leeuwen, RW, 2016)	0.43
" There is an urgent need to obtain new solid forms of higher solubility to improve the bioavailability of the API (active pharmaceutical ingredient)."	( New multi-component solid forms of anti-cancer drug Erlotinib: role of auxiliary interactions in determining a preferred conformation. Desiraju, GR; Gopi, SP; Rajput, L; Sanphui, P, 2016)	0.43
" Simulations were performed in order to explore the influence of covariates on the apparent absorption rate constant."	( Levofloxacin effect on erlotinib absorption. Evaluation of the interaction in undernutrition situations through population pharmacokinetic analysis in rats. Guglieri-López, B; Merino, V; Merino-Sanjuan, M; Nacher, A; Pérez-Pitarch, A, 2017)	0.46
" The results revealed that a significant reduction in the oral bioavailability was recorded with both ERL and LAP following the ingestion of GTE particularly for short-term administration."	( UPLC-ESI-MS/MS study of the effect of green tea extract on the oral bioavailability of erlotinib and lapatinib in rats: Potential risk of pharmacokinetic interaction. Abahussain, AO; Alzoman, NZ; Maher, HM; Shehata, SM, 2017)	0.46
"Poor water solubility and low oral bioavailability limit the clinical application of Erlotinib as an anticancer."	( Development, In Vitro Characterization, Antitumor and Aerosol Performance Evaluation of Respirable Prepared by Self-nanoemulsification Method. Hamishehkar, H; Naseri, N; Pilehvar-Soltanahmadi, Y; Valizadeh, H; Zakeri-Milani, P, 2017)	0.46
"NUFS-Ert could improve poor bioavailability and reduce fed-fasted bioavailability variances of Ert."	( Nanoparticulation improves bioavailability of Erlotinib. Kim, DK; Kim, K; Kim, KS; Park, JW; Park, K; Shin, IC; Yang, KM, 2017)	0.46
" From the result of in vivo, it proved that erlotinib liposomes can significantly improve the drug targeting, rapidly distribute the drug in the body, prolong the drug circulation time and significantly increase the relative bioavailability of the drug."	( Novel therapeutic modalities and drug delivery - erlotinib liposomes modified with galactosylated lipid: in vitro and in vivo investigations. He, C; Jiang, J; Liu, Y; Ma, T; Xu, H, 2018)	0.48
" Pharmacokinetic results indicated that erlotinib-loaded PEGylation liposomes can significantly change the pharmacokinetic behavior of drugs and improve the drug bioavailability by nearly 2 times compared to ordinary liposomes."	( Development of a nanoliposomal formulation of erlotinib for lung cancer and in vitro/in vivo antitumoral evaluation. Shi, KH; Tao, H; Zhou, X, 2018)	0.48
" In this paper, we have investigated the cytotoxic interaction of ERL and valproic acid (VA) in ERL-resistant NSCLC cells and developed a liquisolid formulation of ERL-VA for improving oral bioavailability of ERL."	( Erlotinib-Valproic Acid Liquisolid Formulation: Evaluating Oral Bioavailability and Cytotoxicity in Erlotinib-Resistant Non-small Cell Lung Cancer Cells. Bagde, A; Doddapaneni, R; Patel, K; Patki, M; Sekar, V; Singh, M, 2019)	0.51
"We have investigated the effects of combination treatment involving ERL (erlotinib) with a glycyrrhetinic acid analog, CDODA-Me in overcoming ERL resistance, providing efforts to improve the oral bioavailability of this treatment using self-nanoemulsifying drug delivery systems (SNEDDS)."	( The Role of Self-Nanoemulsifying Drug Delivery Systems of CDODA-Me in Sensitizing Erlotinib-Resistant Non-Small Cell Lung Cancer. Mondal, A; Nottingham, E; Rishi, AK; Safe, S; Sekar, V; Singh, M, 2020)	0.56
" The poly(ester-thioether) microspheres significantly improved the bioavailability of both erlotinib and α-TOS in comparison to the free drug combination, realizing synergistic inhibition of A549 cells both in vitro and in vivo."	( Poly(ester-thioether) microspheres co-loaded with erlotinib and α-tocopheryl succinate for combinational therapy of non-small cell lung cancer. Cheng, F; He, B; Luo, K; Meng, G; Peng, X; Pu, Y, 2020)	0.56
" However, conventional ERL has important bioavailability problems resulting from oral administration, poor solubility and gastrointestinal degradation into inactive metabolites."	( Erlotinib entrapped in cholesterol-depleting cyclodextrin nanoparticles shows improved antitumoral efficacy in 3D spheroid tumors of the lung and the liver. Akkın, S; Benito, JM; Bilensoy, E; Demirtürk, N; Varan, G, 2021)	0.62
" However, poor water-solubility, low bioavailability and less drug accumulation of chemotherapeutic drugs restrict its antitumor activities in clinic."	( Designed DNA nanostructure grafted with erlotinib for non-small-cell lung cancer therapy. Cheng, J; Kong, XY; Liu, Y; Luo, T; Mo, F; Song, J; Wang, Y; Zhao, D; Zhong, YF, 2020)	0.56
" Such a change in AUC is expected to lower the bioavailability of ERL, a BCS II drug, in patients with a low RGFS."	( Profound effects of gastric secretion rate variations on the precipitation of erlotinib in duodenum - An in vitro investigation. Guo, Y; Sun, CC, 2022)	0.72
"The present investigation demonstrates the preparation of solid self nanoemulsfying drug delivery system (sSNEDDS) to enhance stability and bioavailability of Erlotinib (ERL) via the oral route."	( Enhanced stability and oral bioavailability of erlotinib by solid self nano emulsifying drug delivery systems. Dongare, K; Jain, S; Katiyar, SS; Kushwah, V; Nallamothu, B; Parkash Dora, C; Sharma, R, 2022)	0.72
"The present study was undertaken to synthesize PEGylated monomethoxy poly (ethylene glycol)-poly (ε-Caprolactone) (mPEG-PCL) block copolymer and formulate Erlotinib HCl-loaded mPEG-PCL nanoparticles for enhancing the bioavailability of the drug."	( PEGylated Erlotinib HCl Injectable Nanoformulation for Improved Bioavailability. Bhargave, H; Nijhawan, H; Yadav, KS, 2023)	0.91
"Molecular targeted therapy is one of the most pivotal strategies in the treatment of non-small cell lung cancer, yet its curative effect is severely compromised by the poor aqueous solubility, low bioavailability and inadequate tumor accumulation of targeted agents."	( Engineering of Amphiphilic Erlotinib Analogue as Novel Nanomedicine for Non-Small Cell Lung Cancer Therapy. Cong, M; Li, C; Li, F; Pang, H; Sun, H; Xie, G; Yang, S; Zhao, W, 2023)	0.91

Excerpt	Relevance	Reference
" Intermittent and continuous dosing schedules with ZD1839 were well tolerated by these patients for up to 6 months or more."	( Phase I studies of ZD1839 in patients with common solid tumors. Lorusso, PM, 2003)	0.32
" This includes defining dosing schedules and appropriate combination partners, identifying predictive markers of response, developing techniques to accurately assess antitumor activity, and determining whether it is possible to preselect patients before therapy."	( Challenges and opportunities for Erlotinib (Tarceva): what does the future hold? Hortobagyi, GN; Sauter, G, 2003)	0.32
" Ongoing investigation will help to determine optimal dosing and dose frequency of erlotinib in various cancers in the clinical setting."	( Erlotinib: preclinical investigations. Hidalgo, M, 2003)	0.32
" Dosing erlotinib at the maximum tolerated dose, which is associated with more frequent and more severe rash, may improve response rates and survival durations."	( Can rash associated with HER1/EGFR inhibition be used as a marker of treatment outcome? Pérez-Soler, R, 2003)	0.32
" Patient characteristics, lack of patient selection, dosing schedule, and trial design may all have played roles."	( HER1/EGFR targeting: refining the strategy. Pérez-Soler, R, 2004)	0.32
" Gefitinib, which can be given at doses below the maximum tolerated dose, is associated with slightly lower rates of adverse events than erlotinib, which is dosed at the maximum tolerated dose."	( Rationale and clinical validation of epidermal growth factor receptor as a target in the treatment of head and neck cancer. Caponigro, F, 2004)	0.32
" The anti-EGFR mAbs and TKIs have partially overlapping toxicity profiles, but distinct routes of administration, serum half-lives and therefore dosing schedules."	( Epidermal growth factor receptor inhibition strategies in oncology. Harari, PM, 2004)	0.32
" The major challenges on the clinical development of targeted therapy include the proper selection of patients, the identification of the optimal dosage and schedule of administration, the combinations with conventional treatments and the more appropriate therapeutic strategy."	( Therapy of breast cancer with molecular targeting agents. Gasparini, G; Longo, R; Morabito, A; Torino, F, 2005)	0.33
" The possibility that this skin toxicity correlates with anti-tumour activity offers the potential to titrate dosing on a case-by-case basis."	( The management of skin reactions in cancer patients receiving epidermal growth factor receptor targeted therapies. Chosidow, O; Dirschka, T; Elsner, J; Layton, A; Mancini, L; Maughan, T; Morere, JF; Santoro, A; Segaert, S; Sobrero, A; Tabernero, J; Van Cutsem, E, 2005)	0.33
"The long half-life of erlotinib supports the current once-daily dosing regimen at 150 mg/d."	( Clinical pharmacokinetics of erlotinib in patients with solid tumors and exposure-safety relationship in patients with non-small cell lung cancer. Bruno, R; Eppler, SM; Hamilton, M; Lu, JF; Lum, BL; Rakhit, A; Wolf, J, 2006)	0.33
" The actin remodeling effect was more prominent at lower dosage levels (1/8-1/4 of IC(50)), which was accompanied by an increased cell adhesion and decreased motility."	( Effect of an epidermal growth factor receptor tyrosine kinase inhibitor on actin remodeling in an in vitro bladder cancer carcinogenesis model. Belldegrun, A; Figlin, R; Iwata, KK; Jin, Y; Lieberman, R; Pantuck, A; Rao, J; Zhang, ZF, 2006)	0.33
" Although both classes of anti-EGFR agents target the same receptor, substantial distinctions regarding their mechanism significantly affect dosing requirements, toxicity profiles, and their use as combination agents."	( Clinical implications of the mechanism of epidermal growth factor receptor inhibitors. Marshall, J, 2006)	0.33
" In the escalating phase of the trial, patients were enrolled in sequential cohorts using 100 or 150 mg oral daily dosing of erlotinib."	( Erlotinib plus gemcitabine in patients with unresectable pancreatic cancer and other solid tumors: phase IB trial. Dragovich, T; Hage, G; Hamilton, M; Huberman, M; Nadler, P; Patnaik, A; Rowinsky, EK; Von Hoff, DD; Wolf, J; Wood, D, 2007)	0.34
" These EGFR mutations were associated with increased EGFR gene dosage and conferred anchorage-independent growth and tumorigenicity to NIH-3T3 cells."	( Epidermal growth factor receptor activation in glioblastoma through novel missense mutations in the extracellular domain. Beroukhim, R; Cloughesy, T; DeBiasi, RM; Feng, WL; Gabriel, S; Getz, G; Glatt, KA; Greulich, H; Huang, JH; Kawaguchi, T; Khan, H; King, JC; Leahy, DJ; Lee, JC; Levine, RL; Liau, LM; Linhart, DJ; Mellinghoff, IK; Meyerson, M; Mischel, P; Nelson, SF; Nghiemphu, P; O'Neill, K; Onofrio, R; Paez, JG; Peck, TC; Pieper, RO; Rao, PN; Sawyers, CL; Sellers, WR; Thomas, RK; Vivanco, I; Xu, Q; Yoshimoto, K; Yuza, Y; Ziaugra, L, 2006)	0.33
"Patients with measurable and nonmeasurable disease were treated with erlotinib 150 mg/d on days 1 through 28 of each 28-day dosing cycle."	( Phase II study of erlotinib in patients with malignant pleural mesothelioma: a Southwest Oncology Group Study. Altomare, DA; Borden, EC; Gandara, DR; Garland, LL; Klein-Szanto, AJ; Nagle, RB; Rankin, C; Rivkin, SE; Scott, KM; Testa, JR, 2007)	0.34
"The study design includes two different dosage arms and a placebo group with a total sample size of 150 patients and is powered to detect a modest reduction in the mean tumor size burden in the high-dose sorafenib arm compared with a slight increase in the placebo group."	( Design of phase II cancer trials using a continuous endpoint of change in tumor size: application to a study of sorafenib and erlotinib in non small-cell lung cancer. Karrison, TG; Maitland, ML; Ratain, MJ; Stadler, WM, 2007)	0.34
"These studies provide a rationale for intermittent dosing of EGFR TKIs with chemotherapy in order to enhance cytotoxicity."	( Schedule-dependent apoptosis in K-ras mutant non-small-cell lung cancer cell lines treated with docetaxel and erlotinib: rationale for pharmacodynamic separation. Davies, AM; Gandara, DR; Gumerlock, PH; Holland, W; Lara, PN; Mack, PC; Mahaffey, CM; Pryde, B, 2007)	0.34
" Three treatment cohorts were assessed, using different dosing regimens."	( Erlotinib in combination with capecitabine and docetaxel in patients with metastatic breast cancer: a dose-escalation study. Baselga, J; De Rosa, F; Fettner, S; Jones, R; Rakhit, A; Trigo, JM; Twelves, C; Wright, T, 2008)	0.35
"Although no maximum tolerated dose was reached in cycle 1 with 35 mg/m(2) docetaxel, repetitive dosing proved intolerable in a substantial number of patients; thus, the recommended phase II dose of weekly docetaxel is 30 mg/m(2) when combined with 150 mg of daily erlotinib."	( A phase I and pharmacokinetic trial of erlotinib in combination with weekly docetaxel in patients with taxane-naive malignancies. Al Omari, AS; Chiorean, EG; Fife, KL; Foster, AE; Jones, DR; Murry, DJ; Porter, JM; Strother, RM; Sweeney, CJ; Yoder, CA; Yu, M, 2008)	0.35
" Our findings suggest that HKI-272 treatment at maximally tolerated dosing may lead to the emergence of T790M-mediated resistance, whereas treatment with a more potent irreversible inhibitor could yield a resistance mutation at EGFR C797."	( The T790M "gatekeeper" mutation in EGFR mediates resistance to low concentrations of an irreversible EGFR inhibitor. Brannigan, BW; Godin-Heymann, N; Haber, DA; Lamb, J; Maheswaran, S; McDermott, U; Settleman, J; Ulkus, L, 2008)	0.35
" Multiplex ligation-dependent probe amplification and fluorescence in situ hybridization analysis revealed increased EGFR dosage in 28% of MPNSTs."	( EGFR and erbB2 in malignant peripheral nerve sheath tumors and implications for targeted therapy. Holtkamp, N; Malzer, E; Mautner, VF; Mawrin, C; Mucha, J; Okuducu, AF; Schildhaus, HU; von Deimling, A; Zietsch, J, 2008)	0.35
"Five dosage levels (70, 90, 120, 160, and 200 mg/m(2) per day) were planned in this phase I study."	( Phase I and pharmacokinetic studies of erlotinib administered concurrently with radiotherapy for children, adolescents, and young adults with high-grade glioma. Baker, SJ; Broniscer, A; Ellison, DW; Endersby, R; Gajjar, A; Kocak, M; Laningham, FH; Merchant, TE; Morris, EB; Schaiquevich, P; Stewart, CF, 2009)	0.35
" However, there was no relationship between erlotinib dosage and drug exposure."	( Phase I and pharmacokinetic studies of erlotinib administered concurrently with radiotherapy for children, adolescents, and young adults with high-grade glioma. Baker, SJ; Broniscer, A; Ellison, DW; Endersby, R; Gajjar, A; Kocak, M; Laningham, FH; Merchant, TE; Morris, EB; Schaiquevich, P; Stewart, CF, 2009)	0.35
"The clinical records were assessed for the patients who started treatment with erlotinib, on a compassionate-use basis, with an oral dosage of 150 mg/day until June 2008."	( [Effectiveness and safety of erlotinib in 2 patients with carcinoma of the cervix]. Albornoz López, R; Fernández García, I; Pérez Rodrigo, I; Soto Rojas, M; Torres Degayón, V, )	0.13
"This was a multicenter, open-label, single-arm trial evaluating the toxicity and efficacy of oral erlotinib at an initial dosage of 150 mg daily until progressive disease or adverse effects prohibited further therapy."	( A phase II trial of erlotinib in recurrent squamous cell carcinoma of the cervix: a Gynecologic Oncology Group Study. Lee, YC; Mannel, R; Schilder, RJ; Sill, MW, 2009)	0.35
", increasing the dosage until a rash appears) as a rational management strategy."	( Expert consensus on the management of erlotinib-associated cutaneous toxicity in the u.k. Dunlop, J; Eaby, B; Groves, RW; McPhelim, J; Nicolson, M; Nijjar, R; Steele, J; Thatcher, N; Ukachukwu, I, 2009)	0.35
" Individually, the selection and dosing of erlotinib for the treatment of lung cancer patients who continue to smoke is a clinical challenge."	( Using erlotinib to treat patients with non-small cell lung cancer who continue to smoke. Miller, AA; Petty, WJ; Waller, LL, 2010)	0.36
" This review summarizes the background, scientific rationale and early clinical data in support of intercalation of intermittent erlotinib dosing with pemetrexed as a means of achieving pharmacodynamic separation."	( Intercalation of erlotinib and pemetrexed in the treatment of non-small cell lung cancer. Gandara, DR; Lara, PN; Li, T; Mack, PC; Perez-Soler, R, 2010)	0.36
" Key aspects of erlotinib clinical pharmacology, dosing in special populations (e."	( A review of erlotinib--an oral, selective epidermal growth factor receptor tyrosine kinase inhibitor. Bharthuar, A; Iyer, R, 2010)	0.36
" The reader will also understand the pharmacologic bases for the recent change in dosing guidelines of erlotinib, and the current knowledge of clinical and laboratory correlates that can serve as surrogates of response."	( A review of erlotinib--an oral, selective epidermal growth factor receptor tyrosine kinase inhibitor. Bharthuar, A; Iyer, R, 2010)	0.36
" More studies to individualize therapy and optimize dosing are needed."	( A review of erlotinib--an oral, selective epidermal growth factor receptor tyrosine kinase inhibitor. Bharthuar, A; Iyer, R, 2010)	0.36
" The CSF concentration of EGFR-TKIs achieved by standard daily dosing may be insufficient for therapeutic effect."	( High dose weekly erlotinib achieves therapeutic concentrations in CSF and is effective in leptomeningeal metastases from epidermal growth factor receptor mutant lung cancer. Clarke, JL; Lassman, AB; Miller, VA; Pao, W; Wu, N, 2010)	0.36
" Dose-response curves were generated to determine sensitivity to lapatinib, erlotinib, and trastuzumab."	( Lapatinib, a dual EGFR and HER2 kinase inhibitor, selectively inhibits HER2-amplified human gastric cancer cells and is synergistic with trastuzumab in vitro and in vivo. Anghel, A; Ayala, R; Desai, AJ; Fejzo, MS; Finn, RS; Hecht, JR; Luo, T; Safran, B; Slamon, DJ; Wainberg, ZA, 2010)	0.36
" Wistar rats were orally administered with a daily dosage of 200 mg kg(-1) Erlotinib-HCl either as free drug or as Poly(D,L-lactic-co-glycolic acid) (PLGA) encapsulated nanoparticles."	( Poly(D,L-lactic-co-glycolic acid) nanoencapsulation reduces Erlotinib-induced subacute toxicity in rat. Franklin, G; Kalaichelvan, VK; Manavalan, R; Marslin, G; Reddy, PN; Sheeba, CJ, 2009)	0.35
"Given the marked toxicity in our patient population, the combination of vinflunine and erlotinib cannot be recommended for further study with these dosing schemas."	( A phase I evaluation of the combination of vinflunine and erlotinib in patients with refractory solid tumors. Buie, L; Chiu, WK; Davies, JM; Dees, EC; Irvin, W; Ivanova, A; Keller, K; O'Neil, BH; Sanoff, HK; Stinchcombe, TE; Walko, C, 2011)	0.37
" In 24 patients, the mean Cmax and AUC erlotinib values increased with dose and following cumulative dosing (days 7 and 8 vs."	( Phase I and pharmacokinetic study of erlotinib (OSI-774) in combination with docetaxel in squamous cell carcinoma of the head and neck (SSCHN). Agrawal, A; Aimiumu, J; Chan, KK; Chen, P; Cheng, H; Dancey, J; Grever, MR; Kraut, EH; Lang, J; Rhoades, C; Young, DC; Zhang, Y, 2011)	0.37
" Dosing for phase II trials was docetaxel 35 mg/m² and erlotinib 50 mg."	( Phase I and pharmacokinetic study of erlotinib (OSI-774) in combination with docetaxel in squamous cell carcinoma of the head and neck (SSCHN). Agrawal, A; Aimiumu, J; Chan, KK; Chen, P; Cheng, H; Dancey, J; Grever, MR; Kraut, EH; Lang, J; Rhoades, C; Young, DC; Zhang, Y, 2011)	0.37
" The synergy with docetaxel depended on the treatment sequence; a schedule of MK-2206 dosed before docetaxel was not effective."	( MK-2206, an allosteric Akt inhibitor, enhances antitumor efficacy by standard chemotherapeutic agents or molecular targeted drugs in vitro and in vivo. Hatch, H; Hirai, H; Kotani, H; Majumder, PK; Miyama, K; Nakatsuru, Y; Pan, BS; Sootome, H; Taguchi, S; Tsujioka, K; Ueno, Y, 2010)	0.36
" Patients were stratified by platinum sensitivity and were treated with erlotinib 150 mg daily on a continuous dosing schedule, and carboplatin at an AUC of 5 every 21 days."	( A phase II study of erlotinib (OSI-774) given in combination with carboplatin in patients with recurrent epithelial ovarian cancer (NCIC CTG IND.149). Ellard, SL; Fisher, B; Grimshaw, R; Hirte, H; Oza, A; Seymour, L; Swenerton, K; Tsao, M, 2010)	0.36
" Although some patients may benefit from the treatment, other dosing regimens and novel taxanes such as Nab-paclitaxel should be explored in this setting."	( Docetaxel second-line therapy in patients with advanced pancreatic cancer: a retrospective study. Kaley, K; Penney, R; Saif, MW; Syrigos, K, 2010)	0.36
" The patient's warfarin dosage was adjusted to reach a target INR of 2-3."	( Elevated international normalized ratio associated with concomitant warfarin and erlotinib. Amarshi, N; Billingsley, A; Nair, BA; Thomas, KS, 2010)	0.36
" Furthermore, we advise to monitor closely erlotinib plasma concentrations and adjust the erlotinib dose accordingly when a clinically relevant interaction is suspected and no proper dosing guidelines are available."	( Erlotinib and pantoprazole: a relevant interaction or not? Beijnen, JH; Fanggiday, JC; Lankheet, NA; Malingré, MM; Staaks, GH; Ter Heine, R; Van Der Westerlaken, MM, 2010)	0.36
" Treatment durations and dosing were derived from randomized controlled trials, FDA labeling, and National Comprehensive Cancer Network guidelines."	( Budget impact of erlotinib for maintenance therapy in advanced non-small cell lung cancer. Carlson, JJ; Reyes, C; Veenstra, DL; Wong, WB, 2011)	0.37
" Because both drugs were developed to target wild-type EGFR, we hypothesized that current dosing schedules were not optimized for mutant EGFR or to prevent resistance."	( Optimization of dosing for EGFR-mutant non-small cell lung cancer with evolutionary cancer modeling. Amato, KR; Arcila, M; Chmielecki, J; de Stanchina, E; Foo, J; Ginsberg, MS; Hutchinson, K; Inoue, A; Kris, MG; Ladanyi, M; Michor, F; Miller, VA; Ohashi, K; Oxnard, GR; Pao, W; Socci, ND; Somwar, R; Sos, ML; Thomas, RK; Viale, A; Wang, L, 2011)	0.37
"A total of 143 patients were randomly assigned to either erlotinib 150 mg daily orally until disease progression (PD) occurred or to chemotherapy with paclitaxel 200 mg/m(2) intravenously (IV) and carboplatin dosed by creatinine clearance (AUC 6) IV on day 1 intercalated with erlotinib 150 mg orally on days 2 through 15 every 3 weeks for four cycles followed by erlotinib 150 mg orally until PD occurred (CT + erlotinib)."	( A randomized, phase II, biomarker-selected study comparing erlotinib to erlotinib intercalated with chemotherapy in first-line therapy for advanced non-small-cell lung cancer. Bunn, PA; Camidge, DR; Camidge, R; Dziadziuszko, R; Eisen, T; Franklin, WA; Hirsch, FR; Kabbinavar, F; Martins, R; Richardson, F; Richardson, K; Rusk, J; Schnell, FM; Sternberg, DW; Varella-Garcia, M; Wacker, B, 2011)	0.37
"Erlotinib is effective for epidermal growth factor receptor (EGFR) mutant lung cancer, but CNS penetration at standard daily dosing is limited."	( "Pulsatile" high-dose weekly erlotinib for CNS metastases from EGFR mutant non-small cell lung cancer. Clarke, JL; Grommes, C; Holodny, AI; Kris, MG; Lassman, AB; Miller, VA; Oxnard, GR; Pao, W, 2011)	0.37
" Erlotinib was dosed at 150 mg daily, and 5-azacytidine was escalated by increasing the number of daily doses of 75 mg/m(2) per cycle."	( A phase I study of 5-azacytidine and erlotinib in advanced solid tumor malignancies. Bauman, J; Belinsky, S; Fekrazad, M; Jones, D; Lee, SJ; Muller, C; Ravindranathan, M; Rutledge, T; Verschraegen, C, 2012)	0.38
" Adequate monitoring and early intervention are recommended to prevent debilitating toxicity and suboptimal dosing of EGFRI."	( The risk of nail changes with epidermal growth factor receptor inhibitors: a systematic review of the literature and meta-analysis. Garden, BC; Lacouture, ME; Wu, S, 2012)	0.38
" was administered on days 1, 8, 15, and erlotinib 150 mg was dosed orally on days 2-7, 9-14, 16-28 of each 28-day cycle."	( Phase II trial of erlotinib and docetaxel in advanced and refractory hepatocellular and biliary cancers: Hoosier Oncology Group GI06-101. Bufill, JA; Chiorean, EG; Coleman, N; Currie, C; Johnston, EL; Loehrer, PJ; Picus, J; Ramasubbaiah, R; Tong, Y; Yu, M, 2012)	0.38
" Of 14 recruited subjects enrolled, nine completed the study (three in each dosage tier)."	( Phase I evaluation of intravenous ascorbic acid in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer. Bazzan, AJ; Deshmukh, S; Levine, M; Littman, S; Mitchell, E; Monti, DA; Newberg, AB; Pillai, MV; Yeo, CJ; Zabrecky, G, 2012)	0.38
"From May 2005 to August 2006, 15 patients received a 250 mg/day dosage of gefitinib after having disease progression while taking erlotinib at a dose of 150 mg/day."	( The administration of gefitinib in patients with advanced non-small-cell lung cancer after the failure of erlotinib. Barletta, G; Boldrini, L; Brianti, A; Cosso, M; Dal Bello, MG; Defferrari, C; Fontanini, G; Genova, C; Grossi, F; Murolo, C; Pronzato, P; Rijavec, E; Truini, M, 2012)	0.38
" We demonstrate that dasatinib plus erlotinib can be safely co-administered on a continuous, daily dosing schedule with erlotinib, and established the recommended dose level of this combination."	( Phase 1 trial of dasatinib plus erlotinib in adults with recurrent malignant glioma. Coan, A; Desjardins, A; Friedman, HS; Herndon, JE; McLendon, RE; McSherry, F; Peters, KB; Reardon, DA; Rich, JN; Sampson, JH; Sathornsumetee, S; Threatt, S; Vredenburgh, JJ; Zhang, S, 2012)	0.38
" This study aimed to establish the recommended dosing of the erlotinib and pertuzumab combination; assess safety, preliminary efficacy, and pharmacokinetics; and analyze biomarkers."	( A phase Ib, dose-finding study of erlotinib in combination with a fixed dose of pertuzumab in patients with advanced non-small-cell lung cancer. Brewster, M; Cedrés, S; Dean, E; Felip, E; Galdermans, D; Martínez, P; McNally, V; Ranson, M; Ross, G, 2012)	0.38
"A dosage of sunitinib 37."	( Sunitinib plus erlotinib for the treatment of advanced/metastatic non-small-cell lung cancer: a lead-in study. Blumenschein, GR; Chao, RC; Ciuleanu, T; Groen, HJ; Juhasz, E; Robert, F; Ruiz-Garcia, A; Tye, L; Usari, T, 2012)	0.38
" Assuming no dose limiting toxicities were observed, dosage was maintained at 150 mg BID for 10 more cycles."	( Phase I/II study of oral erlotinib for treatment of relapsed/refractory glioblastoma multiforme and anaplastic astrocytoma. Boockvar, JA; Christos, P; Kaplan, R; Kesavabhotla, K; Lavi, E; Mubita, L; Pannullo, SC; Scheff, R; Schlaff, CD; Shin, B; Tsiouris, AJ, 2012)	0.38
"We used mathematical modeling and available clinical trial data to predict how different pharmacokinetic parameters (fast versus slow metabolism) and dosing schedules (low dose versus high dose; missed doses with and without make-up doses) might affect the evolution of T790M-mediated resistance in mixed populations of tumor cells."	( Effects of pharmacokinetic processes and varied dosing schedules on the dynamics of acquired resistance to erlotinib in EGFR-mutant lung cancer. Chmielecki, J; Foo, J; Michor, F; Pao, W, 2012)	0.38
"For existing and new kinase inhibitors, this novel framework can be used to rationally and rapidly design optimal dosing strategies to minimize the development of acquired resistance."	( Effects of pharmacokinetic processes and varied dosing schedules on the dynamics of acquired resistance to erlotinib in EGFR-mutant lung cancer. Chmielecki, J; Foo, J; Michor, F; Pao, W, 2012)	0.38
"Patients with advanced solid tumors received three weekly AVE1642 dosed at 6 mg/kg, chosen following previous study, with 75 (cohort A) or 100 mg/m(2) (B) docetaxel, 1250 mg/m(2) gemcitabine/100 mg erlotinib (C1), or 60 mg/m(2) doxorubicin (D1)."	( Phase I study of humanized monoclonal antibody AVE1642 directed against the type 1 insulin-like growth factor receptor (IGF-1R), administered in combination with anticancer therapies to patients with advanced solid tumors. Bahleda, R; Blay, JY; Dieras, V; LoRusso, P; Macaulay, VM; Mery-Mignard, D; Middleton, MR; Protheroe, AS; Sessa, C; Soria, JC; Tolcher, A, 2013)	0.39
"To increase knowledge about lung tumor tissue levels of erlotinib and its primary active metabolite, and about erlotinib plasma levels in intercalated dosing schedules, a sensitive and accurate method for determination of erlotinib and O-desmethyl erlotinib (OSI-420) in human plasma and lung tumor tissue has been developed."	( Quantitative determination of erlotinib and O-desmethyl erlotinib in human EDTA plasma and lung tumor tissue. Beijnen, JH; Burgers, JA; Huitema, AD; Lankheet, NA; Rosing, H; Schaake, EE; Schellens, JH, 2012)	0.38
" However, these inhibitors have yet to prove clinically efficacious, and their toxicity in skin, reflecting activity against wild-type EGFR, may limit dosing required to effectively suppress EGFR T790M in vivo."	( Noncovalent wild-type-sparing inhibitors of EGFR T790M. Chan, E; Heffron, TP; La, H; Lee, HJ; Malek, S; Merchant, M; Pirazzoli, V; Politi, K; Schaefer, G; Settleman, J; Shao, L; Sideris, S; Ubhayakar, S; Yauch, RL; Ye, X, 2013)	0.39
" On detection of epidermal growth factor receptor(EGFR)mutations, we administered gefitinib, an EGFR tyrosine kinase inhibitor, at a dosage of 250 mg daily."	( [Efficacy of low-dose erlotinib against gefitinib-induced hepatotoxicity in a patient with lung adenocarcinoma harboring EGFR mutations]. Hokkoku, K; Igarashi, S; Kitade, H; Mori, M; Nakai, M; Sagawa, M; Shintaku, K; Yamada, T; Yano, S, 2013)	0.39
" Although daily dosing with erlotinib is effective, weekly dosing may reduce toxicity and have advantages, particularly for prevention."	( Effect of intermittent dosing regimens of erlotinib on methylnitrosourea-induced mammary carcinogenesis. Bode, A; Gill, SC; Grubbs, CJ; Iwata, KK; Juliana, MM; Lubet, RA; Nicastro, HL; Steele, VE; Szabo, E; Tucker, C, 2013)	0.39
"Based on the convenient oral dosing of erlotinib and the promising results of biologic therapy, we undertook a phase II study with 21 patients with locally advanced (T3-4) lesions combining radiation with intra-arterial (IA) cisplatin and oral daily erlotinib for a 7-week therapy."	( A phase II study of intra-arterial cisplatin with concurrent radiation and erlotinib for locally advanced head and neck cancer. Chalasani, P; Clausen, C; Dhiwakar, M; Kalapurakal, S; Malone, J; Rao, K; Robbins, KT; Robinson, K; Ronen, O; Shevlin, B, 2013)	0.39
" Despite the slightly faster clearance compared with typical bivalent mAbs, the PK of onartuzumab support dosing regimens of 15 mg/kg every 3 weeks or doses equivalent to achieve the target minimum tumoristatic concentration in patients."	( Population pharmacokinetic analysis from phase I and phase II studies of the humanized monovalent antibody, onartuzumab (MetMAb), in patients with advanced solid tumors. Bai, S; Bothos, J; Damico-Beyer, LA; Davis, JD; Eppler, S; Jin, D; Joshi, A; Kaur, S; Nijem, I; Patel, P; Peterson, A; Xin, Y, 2013)	0.39
"The pharmacokinetic/pharmacodynamic properties of erlotinib in a human tumor xenograft model were described by the indirect response model and integrated model, which will be helpful in understanding the detailed processes of erlotinib activity and determining an appropriate dosing regimen in clinical studies."	( Pharmacokinetic-pharmacodynamic modeling of the anticancer effect of erlotinib in a human non-small cell lung cancer xenograft mouse model. Deng, CH; Li, HQ; Li, L; Li, MY; Lu, W; Wu, Q; Zhou, TY, 2013)	0.39
"These findings suggest that the pharmacokinetics and metabolism of erlotinib are related to skin toxicity and may support further studies where erlotinib dosing is tailored according to pharmacokinetic parameters."	( Correlation between erlotinib pharmacokinetics, cutaneous toxicity and clinical outcomes in patients with advanced non-small cell lung cancer (NSCLC). Andreoli, R; Ardizzoni, A; Azzoni, C; Bartolotti, M; Bortesi, B; De Palma, G; Gelsomino, F; Goldoni, M; Mozzoni, P; Mutti, A; Silini, EM; Tiseo, M, 2014)	0.4
" Twelve phase I patients treated at the maximum tolerated dosage were included in the phase II cohort for analysis."	( Phase I/II study of erlotinib and temsirolimus for patients with recurrent malignant gliomas: North American Brain Tumor Consortium trial 04-02. Aldape, KD; Chang, SM; Cloughesy, TF; Dancey, J; Drappatz, J; Gilbert, MR; Groves, MD; Kuhn, JG; Lamborn, KR; Lieberman, FS; Ligon, AH; Ligon, KL; Mehta, MP; Norden, AD; Prados, MD; Robins, HI; Santagata, S; Wen, PY; Wright, JJ; Yung, WK, 2014)	0.4
"Because of increased toxicity, the maximum tolerated dosage of temsirolimus in combination with erlotinib proved lower than expected."	( Phase I/II study of erlotinib and temsirolimus for patients with recurrent malignant gliomas: North American Brain Tumor Consortium trial 04-02. Aldape, KD; Chang, SM; Cloughesy, TF; Dancey, J; Drappatz, J; Gilbert, MR; Groves, MD; Kuhn, JG; Lamborn, KR; Lieberman, FS; Ligon, AH; Ligon, KL; Mehta, MP; Norden, AD; Prados, MD; Robins, HI; Santagata, S; Wen, PY; Wright, JJ; Yung, WK, 2014)	0.4
"Erlotinib exposure (AUC0-∞ and C max) was reduced after pre- or concomitant dosing with rifampicin."	( The effect of rifampicin, a prototypical CYP3A4 inducer, on erlotinib pharmacokinetics in healthy subjects. Drolet, DW; Fettner, SH; Hamilton, M; Lum, BL; Rakhit, AK; Witt, K; Wolf, JL, 2014)	0.4
"Cigarette smoking dosage of ≥ 30 pack-years is an independent negative predictive factor of EGFR-TKI treatment outcome in lung adenocarcinoma patients with activating EGFR mutations."	( Impact of cigarette smoking on response to epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors in lung adenocarcinoma with activating EGFR mutations. Bae, MK; Cho, BC; Kang, DR; Kim, EY; Kim, HR; Kim, JH; Kim, MH; Lee, CY; Lee, JS, 2014)	0.4
" Low incidence of toxicity and low erlotinib exposure suggest standardized and maximum-allowable dosing may be suboptimal in African Americans."	( Erlotinib in African Americans with advanced non-small cell lung cancer: a prospective randomized study with genetic and pharmacokinetic analyses. Aimiuwu, J; Blachly, JS; Gao, Y; Hicks, WJ; Li, J; Otterson, GA; Papp, A; Phelps, MA; Poi, M; Schaaf, LJ; Socinski, MA; Starrett, SL; Stinchcombe, TE; Villalona-Calero, MA; Wang, D; Wei, L; Zhao, W, 2014)	0.4
"Erlotinib is currently marketed at fixed standard dosage against pancreatic cancer and non-small-cell lung carcinoma."	( Erlotinib: another candidate for the therapeutic drug monitoring of targeted therapy of cancer? A pharmacokinetic and pharmacodynamic systematic review of literature. Buclin, T; Decosterd, LA; Gairard-Dory, AC; Gourieux, B; Guidi, M; Petit-Jean, E; Quoix, E; Ubeaud-Séquier, G; Widmer, N, 2015)	0.42
"2% of the patients developed side effects resulting in dosage reductions."	( Chemotherapy for advanced pancreatic adenocarcinoma in elderly patients (≥70 years of age): a retrospective cohort study at the National Center for Tumor Diseases Heidelberg. Abel, U; Berger, AK; Harig, S; Jäger, D; Komander, C; Springfeld, C, )	0.13
" To investigate the antitumor effect of erlotinib at different dosing times and the underlying molecular mechanism via the PI3K/AKT pathway, we established a mouse model of Lewis lung cancer xenografts."	( Chronopharmacology and mechanism of antitumor effect of erlotinib in Lewis tumor-bearing mice. An, F; Li, M; Lin, P; Liu, J; Liu, L; Wang, P; Zhang, B; Zhao, L; Zhuang, X, 2014)	0.4
" Because tasisulam is highly albumin-bound, patients in the tumor-specific confirmation arms were dosed targeting specific albumin-corrected exposure ranges (AUCalb) identified during dose-escalation (3,500 hμg/mL [75th percentile] for docetaxel, temozolomide, and cisplatin; 4,000 hμg/mL for gemcitabine and erlotinib)."	( An innovative, multi-arm, complete phase 1b study of the novel anti-cancer agent tasisulam in patients with advanced solid tumors. Becerra, CR; Braiteh, F; Chen, J; Chow, KH; Conkling, PR; Garbo, L; Ilaria, R; Jotte, RM; Richards, DA; Robert-Vizcarrondo, F; Smith, DA; Stephenson, J; Tai, DF; Turner, PK; Von Hoff, DD, 2015)	0.42
"To determine the more effective dosing sequence of intermittent erlotinib and docetaxel for treating chemotherapy-naive patients with advanced Non-Small Cell Lung Cancer (NSCLC)."	( Docetaxel and intermittent erlotinib in patients with metastatic Non-Small Cell Lung Cancer; a phase II study from the Hellenic Cooperative Oncology Group. Boukovinas, I; Briasoulis, E; Dimopoulos, MA; Fountzilas, G; Kalogera-Fountzila, A; Karavasilis, V; Klouvas, G; Kosmidis, P; Kotoula, V; Mavropoulou, P; Papandreou, CN; Pectasides, D; Syrigos, KN, 2014)	0.4
"The purpose of this study was to assess whether an intercalated dosing schedule of erlotinib and docetaxel could avoid possible negative interactions and optimize the benefit obtained as second-line therapy in non-small-cell lung cancer (NSCLC) patients."	( Intercalated Dosing Schedule of Erlotinib and Docetaxel as a Therapeutic Strategy to Avoid Antagonism and Optimize Its Benefits in Advanced Non-Small-Cell Lung Cancer. A Randomized Phase II Clinical Trial. Aparisi, F; Esquerdo, G; García-Sánchez, J; Garde, J; Giner, V; Juan, Ó; López, A; Muñoz-Langa, J; Sánchez-Hernández, A, 2015)	0.42
" All of our results indicated that an intercalated dosing schedule of erlotinib and docetaxel could be more efficient than erlotinib treatment alone."	( Intercalated Dosing Schedule of Erlotinib and Docetaxel as a Therapeutic Strategy to Avoid Antagonism and Optimize Its Benefits in Advanced Non-Small-Cell Lung Cancer. A Randomized Phase II Clinical Trial. Aparisi, F; Esquerdo, G; García-Sánchez, J; Garde, J; Giner, V; Juan, Ó; López, A; Muñoz-Langa, J; Sánchez-Hernández, A, 2015)	0.42
" Our own data as well as data from the literature was used to calculate those R levels revealing that the formation of 5'-DFUR - the immediate precursor of 5-fluorouracil - was not affected by concomitant medication within the dosing range investigated."	( A simple method for comparing enzymatic capecitabine activation in various mono- and combination chemotherapies. Baroian, N; Buchner, P; Czejka, M; Dittrich, C; Sahmanovic, A; Schreiber, V, 2015)	0.42
" In the ranitidine study, on day 13, participants were randomized to either concomitant dosing (treatment B) or staggered administration (treatment C) of erlotinib and ranitidine and crossed over to the other treatment starting on day 27."	( Effect of gastric pH on erlotinib pharmacokinetics in healthy individuals: omeprazole and ranitidine. Abt, M; Ducray, PS; Giraudon, M; Hamilton, M; Kletzl, H; Lum, BL, 2015)	0.42
" To investigate the influence of dosing time on the ability of erlotinib to inhibit tumor growth and the underlying molecular mechanisms via the PI3K/AKT and ERK/MAPK pathway, we established nude mice HCC827 tumor xenografts models."	( Chronopharmacodynamics and mechanisms of antitumor effect induced by erlotinib in xenograft-bearing nude mice. An, F; Li, M; Lin, P; Liu, J; Liu, L; Liu, N; Wang, L; Wang, P; Xu, X; Zhao, L, 2015)	0.42
" Phase II studies were initiated with flat (nonweight-based) dosing at 1,100 mg q2w in SCCHN and colorectal cancer."	( Safety and Pharmacokinetics/Pharmacodynamics of the First-in-Class Dual Action HER3/EGFR Antibody MEHD7945A in Locally Advanced or Metastatic Epithelial Tumors. Amler, LC; Baselga, J; Blumenschein, GR; Bohórquez, SS; Calles, A; Cervantes, A; Dienstmann, R; Hidalgo, M; Jimeno, A; Juric, D; Kapp, AV; Leddy, C; Littman, C; Messersmith, W; Penuel, E; Pirzkall, A; Roda, D; Shames, DS; Tabernero, J; Wang, X, 2015)	0.42
"Based on the results, the EGF ointment is effective for ERSEs, regardless of gender, age, type of tumor, and dosage of erlotinib."	( Phase II trial of epidermal growth factor ointment for patients with Erlotinib-related skin effects. Hwang, IG; Jang, JS; Kang, JH; Kang, MH; Kim, CK; Kim, HG; Kim, HJ; Kim, SH; Lee, J; Lee, S; Oh, SY; Park, K; Park, MJ; Park, YS; Son, C; Song, KH; Sun, JM; Yi, SY, 2016)	0.43
"Escalating dose cohorts of daily erlotinib and dovitinib dosed 5 days on/2 days off, starting after a 2-week lead-in of erlotinib alone, were planned."	( Dovitinib and erlotinib in patients with metastatic non-small cell lung cancer: A drug-drug interaction. Das, M; Frymoyer, A; Neal, JW; Padda, SK; Riess, JW; Wakelee, HA; Zhou, L, 2015)	0.42
"The purpose of the current study was to investigate the effect of the dosing time on the pharmacokinetics of erlotinib and the circadian rhythms of the metabolism enzymes in tumor-bearing mice."	( Chronopharmacokinetics of Erlotinib and Circadian Rhythms of Related Metabolic Enzymes in Lewis Tumor-Bearing Mice. Ji, SG; Li, MC; Lin, PP; Liu, J; Liu, L; Liu, LK; Wang, CY; Wang, PP; Xu, X; Zhang, B; Zhao, LY, 2016)	0.43
" Model simulations predicted that the proposed pulsed regimen (1600 mg/week + 50 mg/day remaining week days) results in a maximum of 20% of the patients suffering from severe rash throughout the treatment course in comparison to 12% when treated with standard dosing (150 mg/day)."	( A Modeling and Simulation Framework for Adverse Events in Erlotinib-Treated Non-Small-Cell Lung Cancer Patients. Frechen, S; Fuhr, U; Jaehde, U; Kocher, M; Nogova, L; Scheffler, M; Suleiman, AA; Wolf, J; Zander, T, 2015)	0.42
" Navitoclax dosing remained at 150 mg/day because the maximum tolerated dose was exceeded at this starting dose."	( Safety, efficacy, and pharmacokinetics of navitoclax (ABT-263) in combination with erlotinib in patients with advanced solid tumors. Arzt, J; Busman, TA; Holen, KD; Kirschbrown, W; Lian, G; LoRusso, P; Rosen, LS; Rudersdorf, NS; Tolcher, AW; Vanderwal, CA, 2015)	0.42
" The FDA-approved dosing schedules for these drugs were not designed to optimally prevent the emergence of resistance."	( Dose-Dependent Mutation Rates Determine Optimum Erlotinib Dosing Strategies for EGFR Mutant Non-Small Cell Lung Cancer Patients. Li, F; Liu, LL; Michor, F; Pao, W, 2015)	0.42
"We used mathematical modeling, available clinical trial data, and different considerations of the relationship between mutation rate and drug concentration to predict the effectiveness of different dosing strategies."	( Dose-Dependent Mutation Rates Determine Optimum Erlotinib Dosing Strategies for EGFR Mutant Non-Small Cell Lung Cancer Patients. Li, F; Liu, LL; Michor, F; Pao, W, 2015)	0.42
"We designed several distinct measures to interrogate the effects of different treatment dosing strategies and found that a low-dose continuous strategy coupled with high-dose pulses leads to the maximal delay until clinically observable resistance."	( Dose-Dependent Mutation Rates Determine Optimum Erlotinib Dosing Strategies for EGFR Mutant Non-Small Cell Lung Cancer Patients. Li, F; Liu, LL; Michor, F; Pao, W, 2015)	0.42
" The metabolic ratio determined in serum may be used for therapeutic monitoring in erlotinib treatment and decisions on individual dosing to rash in rash-negative patients."	( Dosing to rash?--The role of erlotinib metabolic ratio from patient serum in the search of predictive biomarkers for EGFR inhibitor-mediated skin rash. Boeck, S; Heinemann, V; Hichert, V; Kächele, V; Paul, T; Reiser, B; Rüdiger, S; Scholl, C; Schumann, C; Seufferlein, T; Sörgel, F; Steffens, M; Stelzer, C; Stingl, J; von Mallek, D, 2016)	0.43
" The therapeutic window of erlotinib is narrow, and the recommended dosage is close to the maximum tolerable dosage."	( Evaluation of Three Small Molecular Drugs for Targeted Therapy to Treat Nonsmall Cell Lung Cancer. Ni, J; Zhang, L, 2016)	0.43
" On the basis of prior monotherapy data, S3 dosing at 150 mg twice daily/150 mg once daily was the recommended phase II dose for the expansion cohort."	( Phase I Dose-Escalation Study of Linsitinib (OSI-906) and Erlotinib in Patients with Advanced Solid Tumors. Eckhardt, SG; Gadgeel, SM; Gedrich, R; Gogov, S; Juergens, RA; Macaulay, VM; McCarthy, S; Middleton, MR; Poondru, S; Rudin, CM; Stephens, AW, 2016)	0.43
"The addition of erlotinib to gemcitabine and nab-paclitaxel is not tolerable at standard single-agent dosing of all drugs."	( A phase 1b study of erlotinib in combination with gemcitabine and nab-paclitaxel in patients with previously untreated advanced pancreatic cancer: an Academic Oncology GI Cancer Consortium study. Ames, P; Berlin, J; Catalano, PM; Cohen, SJ; Davies, A; Horan, J; Leichman, L; McKinley, M; O'Neil, BH; Weekes, CD, 2016)	0.43
"Purpose The approval history, pharmacology, pharmacokinetics, clinical trials, efficacy, dosing recommendations, drug interactions, safety, place in therapy, and economic considerations of gefitinib are reviewed."	( Flipped script for gefitinib: A reapproved tyrosine kinase inhibitor for first-line treatment of epidermal growth factor receptor mutation positive metastatic nonsmall cell lung cancer. Bogdanowicz, BS; Hartranft, ME; Hoch, MA, 2017)	0.46
" In order to expand the experience and to gain additional safety and pharmacokinetic data, two expansions cohorts using concurrent or alternating weekly dosing regimens at the RPTD were also evaluated."	( A phase I study of high-dose rosuvastatin with standard dose erlotinib in patients with advanced solid malignancies. Dimitroulakos, J; Goss, GD; Jonker, DJ; la Porte, C; Laurie, SA; Oza, AM; Spaans, JN; Weberpals, JI, 2016)	0.43
"This study aimed to evaluate the safety, tolerability and pharmacokinetics of the combination of oral vinorelbine with erlotinib using the conventional (CSV) and metronomic (MSV) dosing schedules in patients with advanced non-small cell lung cancer (NSCLC)."	( Phase I Study of Oral Vinorelbine in Combination with Erlotinib in Advanced Non-Small Cell Lung Cancer (NSCLC) Using Two Different Schedules. Ang, MK; Chowbay, B; Lim, WT; Ng, QS; Sutiman, N; Tan, EH; Tan, SW; Toh, CK; Zhang, Z, 2016)	0.43
" The model simulation predicted the tumor growth in different dosage regimens, and showed that the dose of SU played a decisive role in the combination treatment, and suggested that a lower dose of ER (≤5 mg·kg(-1)·d(-1)) and adjusting the dose of SU might yield a better dosage regimen for clinical research."	( Preclinical PK/PD model for combined administration of erlotinib and sunitinib in the treatment of A549 human NSCLC xenograft mice. Ji, SM; Li, JY; Li, L; Lu, W; Mou, ZZ; Ren, YP; Wang, LJ; Yuan, Y; Zhou, SP; Zhou, TY, 2016)	0.43
" The optimal dosage regimen determined by the PK/PD modeling and simulation can be used in future preclinical study and provide a reference for clinical application."	( Preclinical PK/PD model for combined administration of erlotinib and sunitinib in the treatment of A549 human NSCLC xenograft mice. Ji, SM; Li, JY; Li, L; Lu, W; Mou, ZZ; Ren, YP; Wang, LJ; Yuan, Y; Zhou, SP; Zhou, TY, 2016)	0.43
" The erlotinib prescribing information recommends staggering dosing with a histamine-2 receptor antagonist (H2RA) and avoiding concurrent use of a proton pump inhibitor (PPI)."	( Association of concurrent acid-suppression therapy with survival outcomes and adverse event incidence in oncology patients receiving erlotinib. Capparelli, EV; Kurzrock, R; Lam, LH, 2016)	0.43
"The stability of extemporaneously prepared erlotinib, lapatinib, and imatinib oral liquid dosage forms using two commercially available vehicles when stored at 4 and 25 °C was evaluated."	( Stability of extemporaneous erlotinib, lapatinib, and imatinib oral suspensions. Griffith, N; Kolli, S; Li, Q; Liu, Z; Poi, MJ; Wetz, K, 2016)	0.43
" Patients were stratified by performance status and line of therapy, and randomly assigned using permuted blocks within strata to receive open-label oral daily dosing of erlotinib (150 mg), cabozantinib (60 mg), or erlotinib (150 mg) and cabozantinib (40 mg)."	( Erlotinib, cabozantinib, or erlotinib plus cabozantinib as second-line or third-line treatment of patients with EGFR wild-type advanced non-small-cell lung cancer (ECOG-ACRIN 1512): a randomised, controlled, open-label, multicentre, phase 2 trial. Aisner, SC; Bowden, M; Carbone, DP; Dahlberg, SE; Gerstner, GJ; Huang, Y; Khalid, AA; Lerner, RE; Neal, JW; Owonikoko, TK; Ramalingam, SS; Rubin, JL; Steen, PD; Stella, PJ; Wakelee, HA, 2016)	0.43
" Based on our predictions, dose-adjustment strategies may consist of once-daily dosing erlotinib at 25 mg and gefitinib at 125 mg with darunavir/ritonavir; or erlotinib at 200 mg and gefitinib at 375 mg with etravirine."	( Use of a physiologically based pharmacokinetic model to simulate drug-drug interactions between antineoplastic and antiretroviral drugs. Back, D; Clotet, B; Miranda, C; Moltó, J; Owen, A; Rajoli, R; Siccardi, M; Valle, M, 2017)	0.46
" This evolutionary modeling-based dosing schedule was well-tolerated but did not improve progression-free survival or prevent emergence of EGFR T790M, likely due to insufficient peak serum concentrations of erlotinib."	( Phase 1 study of twice weekly pulse dose and daily low-dose erlotinib as initial treatment for patients with EGFR-mutant lung cancers. Cross, J; Feldman, D; Kris, MG; Liu, LL; Michor, F; Pao, W; Riely, GJ; Rudin, CM; Sima, C; Vaitheesvaran, B; Yu, HA, 2017)	0.46
" While the ETB is available as an oral dosage form, the local delivery of this TKI to the diseased cells of the lung may ameliorate its therapeutic impacts."	( Microparticles containing erlotinib-loaded solid lipid nanoparticles for treatment of non-small cell lung cancer. Aghanejad, A; Bakhtiary, Z; Barar, J; Ezzati Nazhad Dolatabadi, J; Nemati, E; Omidi, Y; Saei, AA, 2017)	0.46
" The average dosage of EGFR-TKI was 56±22% of the standard dosage."	( Effects of an Alkaline Diet on EGFR-TKI Therapy in EGFR Mutation-positive NSCLC. Hamaguchi, R; Hasegawa, M; Okamoto, T; Sato, M; Wada, H, 2017)	0.46
" We show that a higher dosage of the cytotoxic drug may delay a relapse, yet, when this happens, a more resistant trait emerges."	( Modeling the chemotherapy-induced selection of drug-resistant traits during tumor growth. Cho, H; Levy, D, 2018)	0.48
"A 72-year-old male with metastatic NSCLC developed conjunctivitis after accidentally taking erlotinib at a dosage of 300 mg/day for 4 days."	( Rapid onset of conjunctivitis associated with overdosing of erlotinib. Chen, P; Gao, X; He, Q; Li, S; Long, J; Sun, P, 2018)	0.48
" Increasing of erlotinib concentration led to dose-response sensorgrams of BSA."	( Bovine serum albumin binding study to erlotinib using surface plasmon resonance and molecular docking methods. Barzegar, A; Ezzati Nazhad Dolatabadi, J; Sharifi, M; Taghipour, P; Zakariazadeh, M, 2018)	0.48
" Erlotinib was dosed and administered corresponding to the terms of the marketing authorization at the time of recruitment."	( Erlotinib in routine clinical practice for first-line maintenance therapy in patients with advanced non-small cell lung cancer (NSCLC). Achenbach, J; Brugger, W; Faehling, M; Gaillard, VE; Staib, P; Steffen, U; Tessen, HW, 2018)	0.48
"Intermittent dosing of erlotinib plus docetaxel is clinically feasible in phase I part but did not significantly improve ORR in phase II part."	( Phase I/II study of intermitted erlotinib in combination with docetaxel in patients with recurrent non-small cell lung cancer (WJOG4708L). Asai, K; Chiba, Y; Hayashi, H; Kasai, T; Kawaguchi, T; Kijima, T; Kimura, T; Kogure, Y; Nakagawa, K; Nakanishi, Y; Niwa, T; Oguri, T; Ono, A; Tanaka, H; Watanabe, K; Yamamoto, N; Yano, S; Yoshimura, N; Yoshioka, H, 2019)	0.51
"76 μg/mL compared to the dosing of oral suspension (dose equivalent)."	( The Role of Self-Nanoemulsifying Drug Delivery Systems of CDODA-Me in Sensitizing Erlotinib-Resistant Non-Small Cell Lung Cancer. Mondal, A; Nottingham, E; Rishi, AK; Safe, S; Sekar, V; Singh, M, 2020)	0.56
"Although the efficacy of epidermal growth factor receptor tyrosine kinase inhibitors for EGFR gene mutation-positive non-small cell lung cancer is well established, optimal dosing remains to be established, especially in elderly or frail patients."	( Low-Dose Erlotinib Treatment in Elderly or Frail Patients With EGFR Mutation-Positive Non-Small Cell Lung Cancer: A Multicenter Phase 2 Trial. Aono, H; Azuma, K; Bessho, A; Fukamatsu, N; Hamada, A; Hosokawa, S; Hosomi, Y; Ishii, H; Ishii, M; Itani, H; Kikuchi, N; Kunitoh, H; Kusaka, K; Miyamoto, S; Mori, Y; Nakahara, Y; Okamoto, H; Tanaka, H; Yamada, K, 2020)	0.56
" Response to erlotinib in the context of KLF4 overexpression or silencing was assessed using cell number and dose-response curves."	( KLF4 defines the efficacy of the epidermal growth factor receptor inhibitor, erlotinib, in triple-negative breast cancer cells by repressing the EGFR gene. Anstine, LJ; Bryson, BL; Finke, VS; Keri, RA; Majmudar, PR; Roberts, MS; Seachrist, DD; Webb, BM; Weber-Bonk, KL, 2020)	0.56
" Simulations based on the final model allowed comparison of expected erlotinib concentrations under standard and alternative dosing regimens for smokers and for several age groups."	( Population Pharmacokinetics of Erlotinib in Patients With Non-small Cell Lung Cancer: Its Application for Individualized Dosing Regimens in Older Patients. Arrondeau, J; Blanchet, B; Csajka, C; Fabre, E; Guidi, M; Khoudour, N; Schneider, MP; Tlemsani, C; Vidal, M; Wagner, AD; Widmer, N, 2020)	0.56
" Concentration monitoring should be performed to individually adjust the erlotinib dosing regimen."	( Population Pharmacokinetics of Erlotinib in Patients With Non-small Cell Lung Cancer: Its Application for Individualized Dosing Regimens in Older Patients. Arrondeau, J; Blanchet, B; Csajka, C; Fabre, E; Guidi, M; Khoudour, N; Schneider, MP; Tlemsani, C; Vidal, M; Wagner, AD; Widmer, N, 2020)	0.56
" Unfortunately, the lesions recurred after reintroduction of the anti-EGFR, despite a dosage reduction, requiring up-titration of doxycycline to 200mg/day."	( [Erlotinib-induced scarring alopecia with a folliculitis decalvans-like presentation]. Acquitter, M; Chiappa, AM; Dervout, C; Fleuret, C; Plantin, P, 2020)	0.56
"Results of this Phase Ib trial indicate that PG-11047 can be safely administered to patients in combination with bevacizumab, erlotinib, cisplatin, and 5-FU on the once weekly dosing schedule described and may provide therapeutic benefit."	( A Phase Ib multicenter, dose-escalation study of the polyamine analogue PG-11047 in combination with gemcitabine, docetaxel, bevacizumab, erlotinib, cisplatin, 5-fluorouracil, or sunitinib in patients with advanced solid tumors or lymphoma. Becerra, CHR; Boyd, TE; Casero, RA; Conkling, PR; Fitzgerald, M; Garbo, LE; Jotte, RM; Marton, LJ; Murray Stewart, T; Richards, DA; Smith, DA; Stephenson, JJ; Vogelzang, NJ; Von Hoff, D; Wu, HH, 2021)	0.62
" Dosing strategies to reduce treatment costs are warranted."	( Ritonavir-Boosted Exposure of Kinase Inhibitors: an Open Label, Cross-over Pharmacokinetic Proof-of-Concept Trial with Erlotinib. Baas, P; Beijnen, JH; Boosman, RJ; Burgers, JA; de Gooijer, CJ; Groenland, SL; Huitema, ADR; Steeghs, N; van der Noort, V, 2022)	0.72
" Complete pharmacokinetic profiles at steady-state were taken up to 24 h after erlotinib intake for both dosing strategies."	( Ritonavir-Boosted Exposure of Kinase Inhibitors: an Open Label, Cross-over Pharmacokinetic Proof-of-Concept Trial with Erlotinib. Baas, P; Beijnen, JH; Boosman, RJ; Burgers, JA; de Gooijer, CJ; Groenland, SL; Huitema, ADR; Steeghs, N; van der Noort, V, 2022)	0.72
" Similar results regarding safety in both dosing strategies were observed, no grade 3 or higher adverse event was reported."	( Ritonavir-Boosted Exposure of Kinase Inhibitors: an Open Label, Cross-over Pharmacokinetic Proof-of-Concept Trial with Erlotinib. Baas, P; Beijnen, JH; Boosman, RJ; Burgers, JA; de Gooijer, CJ; Groenland, SL; Huitema, ADR; Steeghs, N; van der Noort, V, 2022)	0.72
"To evaluate if a once weekly dosing schedule for erlotinib intervention improves the AE profile, while still providing efficacy with respect to reduced polyp burden, in participants with FAP."	( Phase II trial of weekly erlotinib dosing to reduce duodenal polyp burden associated with familial adenomatous polyposis. Burke, CA; Buttar, N; Cruz-Correa, M; Das, R; Della'Zanna, G; Foster, N; Kanth, P; Limburg, PJ; Mankaney, G; McMurray, RP; Richmond, E; Rodriguez, LM; Samadder, NJ; Sossenheimer, M; Stoffel, E; Szabo, E; Thirumurthi, S; Turgeon, DK; Umar, A; Vilar, E; Westover, M; Zahrieh, D, 2023)	0.91

Role	Description
protein kinase inhibitor	An EC 2.7.* (P-containing group transferase) inhibitor that interferes with the action of protein kinases.
antineoplastic agent	A substance that inhibits or prevents the proliferation of neoplasms.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Class	Description
hydrochloride	A salt formally resulting from the reaction of hydrochloric acid with an organic base.
terminal acetylenic compound	An acetylenic compound which a carbon of the C#C moiety is attached to a hydrogen atom.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein	Taxonomy	Measurement	Average	Min (ref.)	Avg (ref.)	Max (ref.)	Bioassay(s)
Epidermal growth factor receptor	Homo sapiens (human)	IC50 (µMol)	0.1683	0.0000	0.5369	10.0000	AID1406661; AID472050; AID472051
Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)	IC50 (µMol)	1.7050	0.0001	0.5453	10.0000	AID472048; AID472049
Serine/threonine-protein kinase B-raf	Mus musculus (house mouse)	IC50 (µMol)	0.0400	0.0300	0.0650	0.1300	AID1406663
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Process	via Protein(s)	Taxonomy
cell surface receptor signaling pathway	Epidermal growth factor receptor	Homo sapiens (human)
epidermal growth factor receptor signaling pathway	Epidermal growth factor receptor	Homo sapiens (human)
positive regulation of cell population proliferation	Epidermal growth factor receptor	Homo sapiens (human)
MAPK cascade	Epidermal growth factor receptor	Homo sapiens (human)
ossification	Epidermal growth factor receptor	Homo sapiens (human)
embryonic placenta development	Epidermal growth factor receptor	Homo sapiens (human)
positive regulation of protein phosphorylation	Epidermal growth factor receptor	Homo sapiens (human)
hair follicle development	Epidermal growth factor receptor	Homo sapiens (human)
translation	Epidermal growth factor receptor	Homo sapiens (human)
signal transduction	Epidermal growth factor receptor	Homo sapiens (human)
epidermal growth factor receptor signaling pathway	Epidermal growth factor receptor	Homo sapiens (human)
activation of phospholipase C activity	Epidermal growth factor receptor	Homo sapiens (human)
salivary gland morphogenesis	Epidermal growth factor receptor	Homo sapiens (human)
midgut development	Epidermal growth factor receptor	Homo sapiens (human)
learning or memory	Epidermal growth factor receptor	Homo sapiens (human)
circadian rhythm	Epidermal growth factor receptor	Homo sapiens (human)
positive regulation of cell population proliferation	Epidermal growth factor receptor	Homo sapiens (human)
diterpenoid metabolic process	Epidermal growth factor receptor	Homo sapiens (human)
peptidyl-tyrosine phosphorylation	Epidermal growth factor receptor	Homo sapiens (human)
cerebral cortex cell migration	Epidermal growth factor receptor	Homo sapiens (human)
positive regulation of cell growth	Epidermal growth factor receptor	Homo sapiens (human)
lung development	Epidermal growth factor receptor	Homo sapiens (human)
positive regulation of cell migration	Epidermal growth factor receptor	Homo sapiens (human)
positive regulation of superoxide anion generation	Epidermal growth factor receptor	Homo sapiens (human)
positive regulation of peptidyl-serine phosphorylation	Epidermal growth factor receptor	Homo sapiens (human)
response to cobalamin	Epidermal growth factor receptor	Homo sapiens (human)
response to hydroxyisoflavone	Epidermal growth factor receptor	Homo sapiens (human)
cellular response to reactive oxygen species	Epidermal growth factor receptor	Homo sapiens (human)
peptidyl-tyrosine autophosphorylation	Epidermal growth factor receptor	Homo sapiens (human)
ERBB2-EGFR signaling pathway	Epidermal growth factor receptor	Homo sapiens (human)
negative regulation of epidermal growth factor receptor signaling pathway	Epidermal growth factor receptor	Homo sapiens (human)
negative regulation of protein catabolic process	Epidermal growth factor receptor	Homo sapiens (human)
vasodilation	Epidermal growth factor receptor	Homo sapiens (human)
positive regulation of phosphorylation	Epidermal growth factor receptor	Homo sapiens (human)
ovulation cycle	Epidermal growth factor receptor	Homo sapiens (human)
hydrogen peroxide metabolic process	Epidermal growth factor receptor	Homo sapiens (human)
negative regulation of apoptotic process	Epidermal growth factor receptor	Homo sapiens (human)
positive regulation of MAP kinase activity	Epidermal growth factor receptor	Homo sapiens (human)
tongue development	Epidermal growth factor receptor	Homo sapiens (human)
positive regulation of cyclin-dependent protein serine/threonine kinase activity	Epidermal growth factor receptor	Homo sapiens (human)
positive regulation of DNA repair	Epidermal growth factor receptor	Homo sapiens (human)
positive regulation of DNA replication	Epidermal growth factor receptor	Homo sapiens (human)
positive regulation of bone resorption	Epidermal growth factor receptor	Homo sapiens (human)
positive regulation of DNA-templated transcription	Epidermal growth factor receptor	Homo sapiens (human)
positive regulation of vasoconstriction	Epidermal growth factor receptor	Homo sapiens (human)
negative regulation of mitotic cell cycle	Epidermal growth factor receptor	Homo sapiens (human)
positive regulation of transcription by RNA polymerase II	Epidermal growth factor receptor	Homo sapiens (human)
regulation of JNK cascade	Epidermal growth factor receptor	Homo sapiens (human)
symbiont entry into host cell	Epidermal growth factor receptor	Homo sapiens (human)
protein autophosphorylation	Epidermal growth factor receptor	Homo sapiens (human)
astrocyte activation	Epidermal growth factor receptor	Homo sapiens (human)
positive regulation of fibroblast proliferation	Epidermal growth factor receptor	Homo sapiens (human)
digestive tract morphogenesis	Epidermal growth factor receptor	Homo sapiens (human)
positive regulation of smooth muscle cell proliferation	Epidermal growth factor receptor	Homo sapiens (human)
neuron projection morphogenesis	Epidermal growth factor receptor	Homo sapiens (human)
epithelial cell proliferation	Epidermal growth factor receptor	Homo sapiens (human)
positive regulation of epithelial cell proliferation	Epidermal growth factor receptor	Homo sapiens (human)
regulation of peptidyl-tyrosine phosphorylation	Epidermal growth factor receptor	Homo sapiens (human)
protein insertion into membrane	Epidermal growth factor receptor	Homo sapiens (human)
response to calcium ion	Epidermal growth factor receptor	Homo sapiens (human)
regulation of phosphatidylinositol 3-kinase/protein kinase B signal transduction	Epidermal growth factor receptor	Homo sapiens (human)
positive regulation of phosphatidylinositol 3-kinase/protein kinase B signal transduction	Epidermal growth factor receptor	Homo sapiens (human)
positive regulation of synaptic transmission, glutamatergic	Epidermal growth factor receptor	Homo sapiens (human)
positive regulation of glial cell proliferation	Epidermal growth factor receptor	Homo sapiens (human)
morphogenesis of an epithelial fold	Epidermal growth factor receptor	Homo sapiens (human)
eyelid development in camera-type eye	Epidermal growth factor receptor	Homo sapiens (human)
response to UV-A	Epidermal growth factor receptor	Homo sapiens (human)
positive regulation of mucus secretion	Epidermal growth factor receptor	Homo sapiens (human)
regulation of ERK1 and ERK2 cascade	Epidermal growth factor receptor	Homo sapiens (human)
positive regulation of ERK1 and ERK2 cascade	Epidermal growth factor receptor	Homo sapiens (human)
cellular response to amino acid stimulus	Epidermal growth factor receptor	Homo sapiens (human)
cellular response to mechanical stimulus	Epidermal growth factor receptor	Homo sapiens (human)
cellular response to cadmium ion	Epidermal growth factor receptor	Homo sapiens (human)
cellular response to epidermal growth factor stimulus	Epidermal growth factor receptor	Homo sapiens (human)
cellular response to estradiol stimulus	Epidermal growth factor receptor	Homo sapiens (human)
cellular response to xenobiotic stimulus	Epidermal growth factor receptor	Homo sapiens (human)
cellular response to dexamethasone stimulus	Epidermal growth factor receptor	Homo sapiens (human)
positive regulation of canonical Wnt signaling pathway	Epidermal growth factor receptor	Homo sapiens (human)
liver regeneration	Epidermal growth factor receptor	Homo sapiens (human)
cell-cell adhesion	Epidermal growth factor receptor	Homo sapiens (human)
positive regulation of protein kinase C activity	Epidermal growth factor receptor	Homo sapiens (human)
positive regulation of G1/S transition of mitotic cell cycle	Epidermal growth factor receptor	Homo sapiens (human)
positive regulation of non-canonical NF-kappaB signal transduction	Epidermal growth factor receptor	Homo sapiens (human)
positive regulation of prolactin secretion	Epidermal growth factor receptor	Homo sapiens (human)
positive regulation of miRNA transcription	Epidermal growth factor receptor	Homo sapiens (human)
positive regulation of protein localization to plasma membrane	Epidermal growth factor receptor	Homo sapiens (human)
negative regulation of cardiocyte differentiation	Epidermal growth factor receptor	Homo sapiens (human)
neurogenesis	Epidermal growth factor receptor	Homo sapiens (human)
multicellular organism development	Epidermal growth factor receptor	Homo sapiens (human)
positive regulation of kinase activity	Epidermal growth factor receptor	Homo sapiens (human)
cell surface receptor protein tyrosine kinase signaling pathway	Epidermal growth factor receptor	Homo sapiens (human)
cell surface receptor signaling pathway	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
positive regulation of protein phosphorylation	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
protein phosphorylation	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
signal transduction	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
enzyme-linked receptor protein signaling pathway	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
cell surface receptor protein tyrosine kinase signaling pathway	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
heart development	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
neuromuscular junction development	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
motor neuron axon guidance	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
Schwann cell development	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
peptidyl-tyrosine phosphorylation	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
positive regulation of cell growth	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
regulation of microtubule-based process	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
immature T cell proliferation in thymus	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
negative regulation of immature T cell proliferation in thymus	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
positive regulation of Rho protein signal transduction	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
intracellular signal transduction	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
ERBB2-ERBB3 signaling pathway	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
ERBB2-EGFR signaling pathway	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
ERBB2-ERBB4 signaling pathway	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
wound healing	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
myelination	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
positive regulation of MAP kinase activity	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
phosphatidylinositol 3-kinase/protein kinase B signal transduction	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
positive regulation of translation	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
regulation of angiogenesis	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
positive regulation of cell adhesion	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
positive regulation of transcription by RNA polymerase I	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
oligodendrocyte differentiation	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
positive regulation of epithelial cell proliferation	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
regulation of ERK1 and ERK2 cascade	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
cellular response to growth factor stimulus	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
cellular response to epidermal growth factor stimulus	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
semaphorin-plexin signaling pathway	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
positive regulation of protein targeting to membrane	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
neurotransmitter receptor localization to postsynaptic specialization membrane	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
neurogenesis	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
positive regulation of MAPK cascade	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
negative regulation of apoptotic process	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
positive regulation of kinase activity	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
multicellular organism development	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
positive regulation of cell population proliferation	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
neuron differentiation	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Process	via Protein(s)	Taxonomy
epidermal growth factor receptor activity	Epidermal growth factor receptor	Homo sapiens (human)
virus receptor activity	Epidermal growth factor receptor	Homo sapiens (human)
chromatin binding	Epidermal growth factor receptor	Homo sapiens (human)
double-stranded DNA binding	Epidermal growth factor receptor	Homo sapiens (human)
MAP kinase kinase kinase activity	Epidermal growth factor receptor	Homo sapiens (human)
protein tyrosine kinase activity	Epidermal growth factor receptor	Homo sapiens (human)
transmembrane receptor protein tyrosine kinase activity	Epidermal growth factor receptor	Homo sapiens (human)
transmembrane signaling receptor activity	Epidermal growth factor receptor	Homo sapiens (human)
epidermal growth factor receptor activity	Epidermal growth factor receptor	Homo sapiens (human)
integrin binding	Epidermal growth factor receptor	Homo sapiens (human)
protein binding	Epidermal growth factor receptor	Homo sapiens (human)
calmodulin binding	Epidermal growth factor receptor	Homo sapiens (human)
ATP binding	Epidermal growth factor receptor	Homo sapiens (human)
enzyme binding	Epidermal growth factor receptor	Homo sapiens (human)
kinase binding	Epidermal growth factor receptor	Homo sapiens (human)
protein kinase binding	Epidermal growth factor receptor	Homo sapiens (human)
protein phosphatase binding	Epidermal growth factor receptor	Homo sapiens (human)
protein tyrosine kinase activator activity	Epidermal growth factor receptor	Homo sapiens (human)
transmembrane receptor protein tyrosine kinase activator activity	Epidermal growth factor receptor	Homo sapiens (human)
ubiquitin protein ligase binding	Epidermal growth factor receptor	Homo sapiens (human)
identical protein binding	Epidermal growth factor receptor	Homo sapiens (human)
cadherin binding	Epidermal growth factor receptor	Homo sapiens (human)
actin filament binding	Epidermal growth factor receptor	Homo sapiens (human)
ATPase binding	Epidermal growth factor receptor	Homo sapiens (human)
epidermal growth factor binding	Epidermal growth factor receptor	Homo sapiens (human)
growth factor binding	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
RNA polymerase I core binding	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
protein tyrosine kinase activity	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
transmembrane receptor protein tyrosine kinase activity	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
transmembrane signaling receptor activity	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
signaling receptor binding	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
protein binding	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
ATP binding	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
coreceptor activity	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
receptor tyrosine kinase binding	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
identical protein binding	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
ErbB-3 class receptor binding	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
protein heterodimerization activity	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Process	via Protein(s)	Taxonomy
endosome	Epidermal growth factor receptor	Homo sapiens (human)
plasma membrane	Epidermal growth factor receptor	Homo sapiens (human)
ruffle membrane	Epidermal growth factor receptor	Homo sapiens (human)
Golgi membrane	Epidermal growth factor receptor	Homo sapiens (human)
extracellular space	Epidermal growth factor receptor	Homo sapiens (human)
nucleus	Epidermal growth factor receptor	Homo sapiens (human)
cytoplasm	Epidermal growth factor receptor	Homo sapiens (human)
endosome	Epidermal growth factor receptor	Homo sapiens (human)
endoplasmic reticulum membrane	Epidermal growth factor receptor	Homo sapiens (human)
plasma membrane	Epidermal growth factor receptor	Homo sapiens (human)
focal adhesion	Epidermal growth factor receptor	Homo sapiens (human)
cell surface	Epidermal growth factor receptor	Homo sapiens (human)
endosome membrane	Epidermal growth factor receptor	Homo sapiens (human)
membrane	Epidermal growth factor receptor	Homo sapiens (human)
basolateral plasma membrane	Epidermal growth factor receptor	Homo sapiens (human)
apical plasma membrane	Epidermal growth factor receptor	Homo sapiens (human)
cell junction	Epidermal growth factor receptor	Homo sapiens (human)
clathrin-coated endocytic vesicle membrane	Epidermal growth factor receptor	Homo sapiens (human)
early endosome membrane	Epidermal growth factor receptor	Homo sapiens (human)
nuclear membrane	Epidermal growth factor receptor	Homo sapiens (human)
membrane raft	Epidermal growth factor receptor	Homo sapiens (human)
perinuclear region of cytoplasm	Epidermal growth factor receptor	Homo sapiens (human)
multivesicular body, internal vesicle lumen	Epidermal growth factor receptor	Homo sapiens (human)
intracellular vesicle	Epidermal growth factor receptor	Homo sapiens (human)
protein-containing complex	Epidermal growth factor receptor	Homo sapiens (human)
receptor complex	Epidermal growth factor receptor	Homo sapiens (human)
Shc-EGFR complex	Epidermal growth factor receptor	Homo sapiens (human)
basal plasma membrane	Epidermal growth factor receptor	Homo sapiens (human)
semaphorin receptor complex	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
nucleus	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
nucleoplasm	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
early endosome	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
cytosol	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
plasma membrane	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
endosome membrane	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
membrane	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
basolateral plasma membrane	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
apical plasma membrane	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
neuromuscular junction	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
ruffle membrane	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
presynaptic membrane	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
myelin sheath	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
perinuclear region of cytoplasm	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
ERBB3:ERBB2 complex	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
receptor complex	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
plasma membrane	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
basal plasma membrane	Receptor tyrosine-protein kinase erbB-2	Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Assay ID	Title	Year	Journal	Article
AID1215784	Drug uptake at steady state in MDR1A/B/BCRP1 knock-out FVB mouse brain at 0.6 mg/h/kg, ip administered as infusion after 48 hrs by LC-MS/MS analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1	Function of the blood-brain barrier and restriction of drug delivery to invasive glioma cells: findings in an orthotopic rat xenograft model of glioma.
AID1215766	Ratio of drug level in tumor core to plasma in Rowett rat orthotopically xenografted with human U87 cells at 20 mg/kg/day, po for 5 days by LC-MS/MS analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1	Function of the blood-brain barrier and restriction of drug delivery to invasive glioma cells: findings in an orthotopic rat xenograft model of glioma.
AID1215762	Drug uptake in tumor rim of Rowett rat orthotopically xenografted with human U87 cells at 20 mg/kg/day, po for 5 days by LC-MS/MS analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1	Function of the blood-brain barrier and restriction of drug delivery to invasive glioma cells: findings in an orthotopic rat xenograft model of glioma.
AID1215780	Plasma concentration at steady state in MDR1A/B knock-out FVB mouse at 0.6 mg/h/kg, ip administered as infusion after 48 hrs by LC-MS/MS analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1	Function of the blood-brain barrier and restriction of drug delivery to invasive glioma cells: findings in an orthotopic rat xenograft model of glioma.
AID1215779	Plasma concentration at steady state in BCRP1 knock-out FVB mouse at 0.6 mg/h/kg, ip administered as infusion after 48 hrs by LC-MS/MS analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1	Function of the blood-brain barrier and restriction of drug delivery to invasive glioma cells: findings in an orthotopic rat xenograft model of glioma.
AID1215781	Plasma concentration at steady state in MDR1A/B/BCRP1 knock-out FVB mouse at 0.6 mg/h/kg, ip administered as infusion after 48 hrs by LC-MS/MS analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1	Function of the blood-brain barrier and restriction of drug delivery to invasive glioma cells: findings in an orthotopic rat xenograft model of glioma.
AID1215773	Drug uptake in tumor core of Rowett rat orthotopically xenografted with human U87 cells at 20 mg/kg/day for 3 days by LC-MS/MS analysis in presence of elacridar relative to elacridar non-treated control	2013	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1	Function of the blood-brain barrier and restriction of drug delivery to invasive glioma cells: findings in an orthotopic rat xenograft model of glioma.
AID1215771	Ratio of drug level in tumor rim to plasma in Rowett rat orthotopically xenografted with human U87 cells at 20 mg/kg/day for 3 days by LC-MS/MS analysis in presence of elacridar	2013	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1	Function of the blood-brain barrier and restriction of drug delivery to invasive glioma cells: findings in an orthotopic rat xenograft model of glioma.
AID1215764	Ratio of drug level in tumor core to tumor rim in Rowett rat orthotopically xenografted with human U87 cells at 20 mg/kg/day, po for 5 days by LC-MS/MS analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1	Function of the blood-brain barrier and restriction of drug delivery to invasive glioma cells: findings in an orthotopic rat xenograft model of glioma.
AID1529834	Cytotoxicity against human KB cells after 3 days by MTT assay	2018	Bioorganic & medicinal chemistry letters, 12-15, Volume: 28, Issue:23-24	Design, synthesis and evaluation of novel hybrids between 4-anilinoquinazolines and substituted triazoles as potent cytotoxic agents.
AID1215758	Ratio of steady state drug level in brain to plasma in MDR1A/B/BCRP1 FVB mouse at 0.6 mg/h/kg, ip administered as infusion after 48 hrs by LC-MS/MS analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1	Function of the blood-brain barrier and restriction of drug delivery to invasive glioma cells: findings in an orthotopic rat xenograft model of glioma.
AID1406663	Inhibition of mouse full length GST-tagged BRAF V600E mutant using recombinant human His6-tagged MEK1 as substrate preincubated for 1 hr followed by substrate addition measured after 25 mins by ELISA	2018	European journal of medicinal chemistry, Aug-05, Volume: 156	Synthesis, anticancer activity and molecular modeling studies of 1,2,4-triazole derivatives as EGFR inhibitors.
AID1215786	Ratio of steady state drug level in brain to plasma in BCRP1 FVB mouse at 0.6 mg/h/kg, ip administered as infusion after 48 hrs by LC-MS/MS analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1	Function of the blood-brain barrier and restriction of drug delivery to invasive glioma cells: findings in an orthotopic rat xenograft model of glioma.
AID1406661	Inhibition of His6-tagged recombinant EGFR cytoplasmic domain (645 to 1186 residues) (unknown origin) expressed in baculovirus infected Sf9 insect cells preincubated for 10 mins followed by ATP-MgCl2 addition and measured after 1 hr by DELFIA/time-resolve	2018	European journal of medicinal chemistry, Aug-05, Volume: 156	Synthesis, anticancer activity and molecular modeling studies of 1,2,4-triazole derivatives as EGFR inhibitors.
AID1215760	Drug uptake in brain of Rowett rat orthotopically xenografted with human U87 cells at 20 mg/kg/day for 3 days by LC-MS/MS analysis in presence of elacridar	2013	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1	Function of the blood-brain barrier and restriction of drug delivery to invasive glioma cells: findings in an orthotopic rat xenograft model of glioma.
AID1215778	Plasma concentration at steady state in wild-type FVB mouse at 0.6 mg/h/kg, ip administered as infusion after 48 hrs by LC-MS/MS analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1	Function of the blood-brain barrier and restriction of drug delivery to invasive glioma cells: findings in an orthotopic rat xenograft model of glioma.
AID1215761	Drug uptake in tumor core of Rowett rat orthotopically xenografted with human U87 cells at 20 mg/kg/day, po for 5 days by LC-MS/MS analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1	Function of the blood-brain barrier and restriction of drug delivery to invasive glioma cells: findings in an orthotopic rat xenograft model of glioma.
AID1215774	Drug uptake in tumor rim of Rowett rat orthotopically xenografted with human U87 cells at 20 mg/kg/day for 3 days by LC-MS/MS analysis in presence of elacridar relative to elacridar non-treated control	2013	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1	Function of the blood-brain barrier and restriction of drug delivery to invasive glioma cells: findings in an orthotopic rat xenograft model of glioma.
AID1215759	Drug uptake in tumor rim of Rowett rat orthotopically xenografted with human U87 cells at 20 mg/kg/day for 3 days by LC-MS/MS analysis in presence of elacridar	2013	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1	Function of the blood-brain barrier and restriction of drug delivery to invasive glioma cells: findings in an orthotopic rat xenograft model of glioma.
AID1215767	Ratio of drug level in tumor rim to plasma in Rowett rat orthotopically xenografted with human U87 cells at 20 mg/kg/day, po for 5 days by LC-MS/MS analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1	Function of the blood-brain barrier and restriction of drug delivery to invasive glioma cells: findings in an orthotopic rat xenograft model of glioma.
AID1215765	Ratio of drug level in tumor core to brain contralateral hemisphere in Rowett rat orthotopically xenografted with human U87 cells at 20 mg/kg/day, po for 5 days by LC-MS/MS analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1	Function of the blood-brain barrier and restriction of drug delivery to invasive glioma cells: findings in an orthotopic rat xenograft model of glioma.
AID1215763	Drug uptake in brain of Rowett rat orthotopically xenografted with human U87 cells at 20 mg/kg/day, po for 5 days by LC-MS/MS analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1	Function of the blood-brain barrier and restriction of drug delivery to invasive glioma cells: findings in an orthotopic rat xenograft model of glioma.
AID1215775	Drug uptake in brain of Rowett rat orthotopically xenografted with human U87 cells at 20 mg/kg/day for 3 days by LC-MS/MS analysis in presence of elacridar relative to elacridar non-treated control	2013	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1	Function of the blood-brain barrier and restriction of drug delivery to invasive glioma cells: findings in an orthotopic rat xenograft model of glioma.
AID1215776	Half life in mouse	2013	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1	Function of the blood-brain barrier and restriction of drug delivery to invasive glioma cells: findings in an orthotopic rat xenograft model of glioma.
AID1215785	Ratio of steady state drug level in brain to plasma in wild-type FVB mouse at 0.6 mg/h/kg, ip administered as infusion after 48 hrs by LC-MS/MS analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1	Function of the blood-brain barrier and restriction of drug delivery to invasive glioma cells: findings in an orthotopic rat xenograft model of glioma.
AID472049	Inhibition of HER2 by HTRF assay	2009	Bioorganic & medicinal chemistry letters, Nov-15, Volume: 19, Issue:22	Synthesis and biological evaluation of pyrrolopyridazine derivatives as novel HER-2 tyrosine kinase inhibitors.
AID472051	Inhibition of EGFR by HTRF assay	2009	Bioorganic & medicinal chemistry letters, Nov-15, Volume: 19, Issue:22	Synthesis and biological evaluation of pyrrolopyridazine derivatives as novel HER-2 tyrosine kinase inhibitors.
AID1215757	Ratio of steady state drug level in brain to plasma in MDR1A/B FVB mouse at 0.6 mg/h/kg, ip administered as infusion after 48 hrs by LC-MS/MS analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1	Function of the blood-brain barrier and restriction of drug delivery to invasive glioma cells: findings in an orthotopic rat xenograft model of glioma.
AID1215768	Ratio of drug level in brain contralateral hemisphere to plasma in Rowett rat orthotopically xenografted with human U87 cells at 20 mg/kg/day, po for 5 days by LC-MS/MS analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1	Function of the blood-brain barrier and restriction of drug delivery to invasive glioma cells: findings in an orthotopic rat xenograft model of glioma.
AID1215777	Drug uptake at steady state in wild-type FVB mouse brain at 0.6 mg/h/kg, ip administered as infusion after 48 hrs by LC-MS/MS analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1	Function of the blood-brain barrier and restriction of drug delivery to invasive glioma cells: findings in an orthotopic rat xenograft model of glioma.
AID1529836	Cytotoxicity against human SK-LU-1 cells after 3 days by MTT assay	2018	Bioorganic & medicinal chemistry letters, 12-15, Volume: 28, Issue:23-24	Design, synthesis and evaluation of novel hybrids between 4-anilinoquinazolines and substituted triazoles as potent cytotoxic agents.
AID1215782	Drug uptake at steady state in BCRP1 knock-out FVB mouse brain at 0.6 mg/h/kg, ip administered as infusion after 48 hrs by LC-MS/MS analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1	Function of the blood-brain barrier and restriction of drug delivery to invasive glioma cells: findings in an orthotopic rat xenograft model of glioma.
AID1529835	Cytotoxicity against human HepG2 cells after 3 days by MTT assay	2018	Bioorganic & medicinal chemistry letters, 12-15, Volume: 28, Issue:23-24	Design, synthesis and evaluation of novel hybrids between 4-anilinoquinazolines and substituted triazoles as potent cytotoxic agents.
AID1215772	Ratio of drug level in brain contralateral hemisphere to plasma in Rowett rat orthotopically xenografted with human U87 cells at 20 mg/kg/day for 3 days by LC-MS/MS analysis in presence of elacridar	2013	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1	Function of the blood-brain barrier and restriction of drug delivery to invasive glioma cells: findings in an orthotopic rat xenograft model of glioma.
AID472050	Inhibition of EGFR in human A431 cells by HTRF assay	2009	Bioorganic & medicinal chemistry letters, Nov-15, Volume: 19, Issue:22	Synthesis and biological evaluation of pyrrolopyridazine derivatives as novel HER-2 tyrosine kinase inhibitors.
AID1215769	Ratio of drug level in tumor core to plasma in Rowett rat orthotopically xenografted with human U87 cells at 20 mg/kg/day for 3 days by LC-MS/MS analysis in presence of elacridar	2013	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1	Function of the blood-brain barrier and restriction of drug delivery to invasive glioma cells: findings in an orthotopic rat xenograft model of glioma.
AID1215783	Drug uptake at steady state in MDR1A/B knock-out FVB mouse brain at 0.6 mg/h/kg, ip administered as infusion after 48 hrs by LC-MS/MS analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1	Function of the blood-brain barrier and restriction of drug delivery to invasive glioma cells: findings in an orthotopic rat xenograft model of glioma.
AID472048	Inhibition of HER2 in human SKBR3 cells by HTRF assay	2009	Bioorganic & medicinal chemistry letters, Nov-15, Volume: 19, Issue:22	Synthesis and biological evaluation of pyrrolopyridazine derivatives as novel HER-2 tyrosine kinase inhibitors.
AID1215770	Drug uptake in tumor core of Rowett rat orthotopically xenografted with human U87 cells at 20 mg/kg/day for 3 days by LC-MS/MS analysis in presence of elacridar	2013	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1	Function of the blood-brain barrier and restriction of drug delivery to invasive glioma cells: findings in an orthotopic rat xenograft model of glioma.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Timeframe	Studies, This Drug (%)	All Drugs %
pre-1990	0 (0.00)	18.7374
1990's	1 (0.02)	18.2507
2000's	962 (22.70)	29.6817
2010's	2783 (65.67)	24.3611
2020's	492 (11.61)	2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Publication Type	This drug (%)	All Drugs (%)
Trials	786 (18.06%)	5.53%
Reviews	611 (14.04%)	6.00%
Case Studies	565 (12.98%)	4.05%
Observational	25 (0.57%)	0.25%
Other	2,366 (54.35%)	84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (717)

Trial Overview

Trial	Phase	Enrollment	Study Type	Start Date	Status
Phase II Randomized Open-Label Trial of the EGFR Tyrosine Kinase Inhibitor OSI-774 (Tarceva™) in Combination With Paclitaxel and Carboplatin Prior to Surgery in Resectable Stage IIIA (N2) and IIIB (T4 N2) NSCLC: A Clinical Outcome and Biological Endpoint [NCT00063258]	Phase 2	5 participants (Actual)	Interventional	2003-06-30	Terminated(stopped due to Low accrual rate)
Phase III Study of Gemcitabine/Oxaliplatin (GEMOX) With or Without Erlotinib in Unresectable, Metastatic Biliary Tract Carcinoma [NCT01149122]	Phase 3	266 participants (Actual)	Interventional	2009-01-31	Completed
A Randomized, Phase III Trial of Prophylactic Cranial Irradiation (PCI) in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Who Are Effective on Erlotinib or Gefitinib(RT1001) [NCT01158170]	Phase 3	200 participants (Anticipated)	Interventional	2010-06-30	Recruiting
A Phase II Study of OSI-774 in Combination With Bevacizumab in Patients With Stage IV Breast Cancer [NCT00054132]	Phase 2	38 participants (Actual)	Interventional	2002-12-31	Completed
Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance [NCT01197170]	Phase 1	277 participants (Actual)	Interventional	2010-09-07	Completed
A Phase I Study of ARQ 197 in Combination With Erlotinib in Patients With Advanced/Recurrent Non-Small-Cell Lung Cancer [NCT01069757]	Phase 1	16 participants (Actual)	Interventional	2010-02-28	Completed
A Randomized, Open-label, Controlled, Multi-Center Phase II/III Study to Assess the Efficacy and Safety of AZD3759 vs. a Standard of Care EGFR TKI, as First Line Treatment to EGFR Mutation Positive Advanced NSCLC With CNS Metastases [NCT03653546]	Phase 2/Phase 3	492 participants (Actual)	Interventional	2018-10-29	Completed
Randomized Study of Erlotinib vs Observation in Patients With Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC) [NCT02193282]	Phase 3	450 participants (Anticipated)	Interventional	2015-02-11	Active, not recruiting
A Phase II-R and a Phase III Trial Evaluating Both Erlotinib (Ph II-R) and Chemoradiation (Ph III) as Adjuvant Treatment for Patients With Resected Head of Pancreas Adenocarcinoma [NCT01013649]	Phase 2/Phase 3	545 participants (Anticipated)	Interventional	2009-11-17	Active, not recruiting
Phase I Study of Chemoprevention With Green Tea Polyphenon E (PPE) and the Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor Erlotinib (OSI-774, Tarceva) in Patients With Premalignant Lesions of the Head and Neck [NCT01116336]	Phase 1	25 participants (Actual)	Interventional	2010-03-31	Completed
Tratamiento Individualizado en función de Las Mutaciones en EGFR y Del Nivel de expresión de BRCA1 en Pacientes Con Adenocarcinoma de pulmón Avanzado [NCT00883480]		153 participants (Actual)	Interventional	2005-06-30	Completed
A Phase 1 Study of LY2875358 in Patients With Advanced Cancer [NCT01287546]	Phase 1	117 participants (Anticipated)	Interventional	2010-04-13	Completed
A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study of ARQ 197 Plus Erlotinib Versus Placebo Plus Erlotinib in Previously Treated Subjects With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer With Wild-type Epidermal G [NCT01377376]	Phase 3	0 participants	Interventional	2011-07-31	Terminated
A Phase I Study of Preoperative Chemoradiation With Oxaliplatin, 5-Fluorouracil, Erlotinib and Radiation Followed by Resection and Consolidative Erlotinib for Patients With Locally Advanced Cancer of the Esophagus and Gastroesophageal Junction [NCT01561014]	Phase 1	9 participants (Actual)	Interventional	2007-04-30	Completed
A Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map) [NCT02154490]		1,864 participants (Actual)	Observational	2014-07-08	Completed
Phase II Study of Erlotinib Plus Carboplatin and Paclitaxel in Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma [NCT00059787]	Phase 2	56 participants (Actual)	Interventional	2003-04-30	Completed
A Phase II, Randomized, Placebo Controlled Study to Evaluate the Efficacy of the Combination of Gemcitabine, Erlotinib and Metformin in Patients With Locally Advanced and Metastatic Pancreatic Cancer [NCT01210911]	Phase 2	120 participants (Actual)	Interventional	2010-08-31	Completed
Bevacizumab, Pemetrexed and Cisplatin, or Erlotinib and Bevacizumab for Advanced Non-Squamous NSCLC Stratified by EGFR Mutation Status. A Multicenter Phase II Trial Including Biopsy at Progression (BIO-PRO Trial). [NCT01116219]	Phase 2	149 participants (Anticipated)	Interventional	2010-06-30	Completed
A Single Arm, One Center, Phase Ⅱ Study of Erlotinib as Neoadjuvent Treatment in Patients With Endobronchial Ultrasound Confirmed Stage ⅢA N2 NSCLC With EGFR Mutation in Exon 19 or 21 [NCT01217619]	Phase 2	25 participants (Actual)	Interventional	2011-03-02	Completed
Survival Analysis of A Chinese Randomized Crossover Study Comparing Erlotinib to Docetaxel/Cisplatin in Previously Untreated Stage IIIB/IV Lung Adenocarcinoma With EGFR Mutations [NCT01131429]	Phase 2	60 participants (Anticipated)	Interventional	2010-06-30	Not yet recruiting
A Phase II Trial of Erlotinib Plus Bevacizumab in Advanced Hepatocellular Carcinoma as a Second-line Therapy in Patients Who Have Received First-line Sorafenib Therapy (AVF4572) [NCT01180959]	Phase 2	45 participants (Actual)	Interventional	2011-04-14	Completed
A National, Multi Center, Randomized, Open-label, Phase II Trial of Tarceva Versus Combination of Gemcitabine Plus Cisplatin as Neoadjuvant Treatment in Stage IIIA-N1,N2 NSCLC With Activating EGFR Mutation in Exon 19 or 21 [NCT01297101]		0 participants	Expanded Access		Temporarily not available
Targeted Therapy Selection Based on Tumor Tissue Kinase Activity Profiles for Patients With Advanced Solid Malignancies, an Exploratory Study [NCT01190241]		45 participants (Actual)	Interventional	2010-08-31	Terminated
A Phase I Dose Escalation Study of the mTOR Inhibitor Everolimus (RAD001) and Erlotinib Concurrently With Radiation Therapy in the Re-Irradiation Setting for Head and Neck Cancer [NCT01332279]	Phase 1	0 participants (Actual)	Interventional	2011-04-30	Withdrawn(stopped due to Pharmaceutical co. withdrew support. Study was never activated and did not accrue any patients.)
Phase II Trial of Carboplatin/Paclitaxel and Cetuximab, Followed by Carboplatin/Paclitaxel/Cetuximab and Erlotinib, With Correlative Studies in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck. [NCT01316757]	Phase 2	24 participants (Actual)	Interventional	2011-02-16	Completed
A Phase 1/2 Study of LY3499446 Administered to Patients With Advanced Solid Tumors With KRAS G12C Mutation [NCT04165031]	Phase 1/Phase 2	5 participants (Actual)	Interventional	2019-11-28	Terminated(stopped due to The study was terminated due to an unexpected toxicity finding.)
Phase II, Open-label Study of Erlotinib (Tarceva®) Treatment in Patients With Locally Advanced, Metastatic or Recurrent Non-small Cell Lung Cancer Who Present Activating Mutations in the Tyrosine Kinase Domain of the Epidermal Growth Factor Receptor [NCT01372384]	Phase 2	6 participants (Actual)	Interventional	2012-01-31	Completed
Comparative Clinical Trial of Erlotinib and Pemetrexed for Maintenance Treatment in Lung Adenocarcinoma [NCT02399566]	Phase 4	300 participants (Anticipated)	Interventional	2015-05-31	Not yet recruiting
SAMSUNG MEDICAL CENTER [NCT03110484]	Phase 2	44 participants (Anticipated)	Interventional	2021-07-09	Recruiting
A Phase II/III Randomized Study of Rilotumumab Plus Erlotinib Versus Erlotinib as Second Line Therapy for C-Met Positive Patients With Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study) [NCT02926638]	Phase 2/Phase 3	9 participants (Actual)	Interventional	2014-06-16	Terminated(stopped due to Drug company decided to terminate all sponsored clinical studies involving rilotumumab.)
Phase II Trial of Weekly Erlotinib Dosing to Reduce Duodenal Polyp Burden Associated With Familial Adenomatous Polyposis [NCT02961374]	Phase 2	46 participants (Actual)	Interventional	2017-10-27	Completed
A Multicenter Phase II Trial of Carboplatin, Pemetrexed, and Bevacizumab Followed By Pemetrexed and Bevacizumab Maintenance Therapy in Patients With a Light or Never Smoking History [NCT01344824]	Phase 2	38 participants (Actual)	Interventional	2010-03-31	Completed
Pilot Study on the Determination of Tumor Concentrations of Protein Kinase Inhibitors in Patients With Newly Diagnosed High-grade Glioma [NCT02239952]		15 participants (Anticipated)	Interventional	2014-11-30	Recruiting
A Phase IIb Randomized Study to Evaluate the Efficacy of Gemcitabine-erlotinib Versus Gemcitabine-erlotinib-capecitabine in Patients With Metastatic Pancreatic Cancer [NCT01303029]	Phase 2	120 participants (Actual)	Interventional	2011-02-28	Completed
Real Life Experience of Erlotinib in Patients With Advanced Non-Small Cell Lung Cancer in the Middle Eastern Countries (REALME) [NCT01320501]	Phase 4	100 participants (Anticipated)	Interventional	2009-10-31	Suspended(stopped due to Difficulty in enrolling patients)
A Multi-center, Open-labeled Phase 2 Study of First Line Intermittent and Maintenance of Erlotinib in Combination With Pemetrexed/Carboplatin in ⅢB/IV Non Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation [NCT02066038]	Phase 2	60 participants (Anticipated)	Interventional	2014-01-31	Active, not recruiting
A Phase I, Single-center, Non-randomized, Open-label Study to Determine the Lowest Effective Theophylline Dose That Decreased Erlotinib's Diarrhea at the Standard Dose of 150 mg/Day and to Determine the Highest Erlotinib Dose in Combination With Theophyll [NCT02080078]	Phase 1	15 participants (Actual)	Interventional	2014-09-30	Terminated(stopped due to REB decision)
A Phase II Randomized Study of OSI-774 (Erlotinib) (NSC #718781) With or Without Carboplatin/Paclitaxel in Patients With Previously Untreated Adenocarcinoma of the Lung Who Never Smoked or Were Former Light Smokers [NCT00126581]	Phase 2	188 participants (Actual)	Interventional	2005-08-15	Completed
A Randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab (MetMAb) in Combination With Erlotinib as Second- or Third-Line Treatment for Patients With MET-Positive Incurable Stage IIIB/IV [NCT02031744]	Phase 3	530 participants (Anticipated)	Interventional	2014-01-22	Completed
Randomized Open Non Comparative Multicenter Phase II Study of Sequential Erlotinib With Docetaxel Versus Docetaxel Alone in Second Line of Treatment in Patients With Non Small Cell Lung Cancer After Failure of First Line Chemotherapy [NCT01350817]	Phase 2	156 participants (Actual)	Interventional	2011-05-31	Completed
Anlotinib-based Combination as First-line Treatment in Advanced Non-small Cell Lung Cancer: a Single Center, Three Arms and Exploratory Study [NCT03628521]	Phase 1	80 participants (Anticipated)	Interventional	2018-07-20	Recruiting
A Phase I/Pharmacokinetic Study of Erlotinib for Advanced Non-small Cell Lung Cancer in Persons With HIV Infection [NCT02134886]	Phase 1	48 participants (Actual)	Interventional	2014-07-31	Terminated(stopped due to No Accrual)
A Phase I/II Study of MK-3475 (SCH900475) in Combination With Chemotherapy or Immunotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma [NCT02039674]	Phase 1/Phase 2	267 participants (Actual)	Interventional	2014-02-21	Completed
Phase III, Multicenter, Open-label, Randomized Trial of Tarceva® vs Chemotherapy in Patients With Advanced NSCLC With Mutations in the TK Domain of the EGFR [NCT00446225]	Phase 3	174 participants (Actual)	Interventional	2007-02-28	Completed
A Phase II Study to Assess Efficacy of Combined Treatment With Erlotinib (Tarceva) and Silybin-phytosome (Siliphos) in Patients With EGFR(Epidermal Growth Factor Receptor) Mutant Lung Adenocarcinoma [NCT02146118]	Phase 2	42 participants (Anticipated)	Interventional	2014-04-30	Recruiting
A Phase I Study of ARQ 197 in Combination With Erlotinib in CYP2C19 Poor Metabolizer Patients With Advanced/Recurrent Non-Small-Cell Lung Cancer [NCT01251796]	Phase 1	9 participants (Actual)	Interventional	2010-12-31	Completed
Phase II Trial Evaluating the Combination of Gemcitabine, Trastuzumab and Erlotinib as First-line Chemotherapy in Patients With Metastatic Pancreatic Adenocarcinoma [NCT01204372]	Phase 2	63 participants (Actual)	Interventional	2010-06-30	Completed
Phase III Randomized, Controlled Trial of Erlotinib (Tarceva) as Maintenance Therapy in Patients With Squamous Cell Carcinoma of the Head and Neck Treated With Resection and Radiotherapy With or Without Concomitant Chemotherapy With Curative Aim [NCT00412217]	Phase 3	94 participants (Actual)	Interventional	2006-11-30	Terminated(stopped due to The study was terminated because recruitment was too slow.)
Phase II Open-Label Trial of Erlotinib (Tarceva) and Bevacizumab in Women With Advanced Ovarian Cancer [NCT00130520]	Phase 2	40 participants (Actual)	Interventional	2005-06-30	Completed
A Phase III, Multicenter, Placebo-Controlled, Double-Blind, Randomized Clinical Trial to Evaluate the Efficacy of Bevacizumab in Combination With Tarceva (Erlotinib) Compared With Tarceva Alone for Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) [NCT00130728]	Phase 3	636 participants (Actual)	Interventional	2005-06-08	Completed
Phase I/II Study of OSI-774 (Erlotinib) and CCI-779 (Temsirolimus) in Patients With Recurrent Malignant Glioma [NCT00112736]	Phase 1/Phase 2	69 participants (Actual)	Interventional	2005-04-30	Completed
Erlotinib Prevention of Oral Cancer (EPOC) [NCT00402779]	Phase 3	303 participants (Actual)	Interventional	2006-11-03	Completed
A Randomized Phase II Study of Bevacizumab (NSC# 704865) and Gemcitabine in Combination With Either Cetuximab (NSC# 714692) or OSI-774 (NSC# 718781) in Patients With Advanced Pancreatic Cancer [NCT00091026]	Phase 2	143 participants (Actual)	Interventional	2004-07-31	Completed
A Phase II Study of Erlotinib Combined With Radiotherapy in Patients With Non-resectable Locally Advanced Non-small Cell Lung Cancer [NCT01091376]	Phase 2	75 participants (Anticipated)	Interventional	2010-01-31	Recruiting
A Phase III, Double-blind, Randomised Study to Assess the Safety and Efficacy of AZD9291 Versus a Standard of Care Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor as First Line Treatment in Patients With Epidermal Growth Factor Receptor Mutatio [NCT02296125]	Phase 3	674 participants (Actual)	Interventional	2014-12-03	Active, not recruiting
Clinical Pilot to Evaluate the Accuracy of FDG-/FLT-PET and DCE-MRI for Early Prediction of Non-Progression in Patients With Advanced Non Squamous Cell Non Small Cell Lung Cancer (NSCLC) Treated With Erlotinib and Bevacizumab and to Associate Imaging Find [NCT01047059]	Phase 2	40 participants (Actual)	Interventional	2010-01-31	Completed
Phase I-II Trial of Erlotinib in Higher Risk Myelodysplastic Syndrome [NCT01085838]	Phase 1/Phase 2	30 participants (Actual)	Interventional	2010-07-31	Completed
A Phase I/II Trial of OSI-774 in Patients With Recurrent Malignant Gliomas and Malignant Gliomas Post Radiation Therapy [NCT00045110]	Phase 1/Phase 2	136 participants (Actual)	Interventional	2002-08-31	Completed
A Phase 1 Study of Gemcitabine, Dasatinib and Erlotinib in Patients With Advanced Pancreatic Carcinoma [NCT01660971]	Phase 1	19 participants (Actual)	Interventional	2012-07-30	Active, not recruiting
Phase I Trial of OSI-774 and CPT-11 in Patients With Advanced Solid Tumors [NCT00045201]	Phase 1	60 participants (Actual)	Interventional	2002-06-13	Active, not recruiting
A Randomized Open-label Phase 3 Trial Comparing Bevacizumab + Erlotinib vs Erlotinib Alone as First Line Treatment of Patients With EGFR Mutated Advanced Non Squamous Non Small Cell Lung Cancer [NCT02633189]	Phase 3	200 participants (Anticipated)	Interventional	2016-04-30	Active, not recruiting
Phase II, Open-label Study of Erlotinib (Tarceva®) Treatment in Patients With Locally Advanced or Metastatic Non-small-cell Lung Cancer Who Present Activating Mutations in the Tyrosine Kinase Domain of the Epidermal Growth Factor Receptor (EGFR) - (TRIGGE [NCT01378962]	Phase 2	50 participants (Actual)	Interventional	2011-03-31	Completed
An Open Label Study to Evaluate the Effect of First Line Treatment With Tarceva in Combination With Gemcitabine on Disease Progression in Patients With Unresectable Advanced and/or Metastatic Non-small Cell Lung Cancer [NCT00701558]	Phase 2	20 participants (Actual)	Interventional	2008-08-31	Completed
A Randomized Phase 2 Study of Erlotinib Plus ARQ 197 Versus Erlotinib Plus Placebo in Previously Treated Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) [NCT00777309]	Phase 2	167 participants (Actual)	Interventional	2008-09-30	Completed
A Phase 2 Study Comparing Sequential Satraplatin and Erlotinib to Single-Agent Erlotinib in Patients ≥ 70 Years of Age With Unresectable Stage 3 OR 4 Non-Small Cell Lung Cancer as 1st-Line Therapy [NCT00370383]	Phase 2	100 participants (Actual)	Interventional	2006-07-31	Completed
A Phase IIIb Study of Tarceva (Erlotinib) in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer [NCT02694536]	Phase 3	80 participants (Actual)	Interventional	2006-08-01	Completed
An Open-label, Multicenter Extension Study of Onartuzumab in Patients With Solid Tumors on Study Treatment Previously Enrolled in an F.Hoffmann-la Roche- and/or Genentech- Sponsored Study [NCT02488330]	Phase 3	12 participants (Actual)	Interventional	2015-08-27	Completed
A Phase II Study to Evaluate Foretinib in Genomic Subpopulations of Subjects With Non-Small-Cell Lung Cancer (NSCLC) [NCT02034097]	Phase 2	0 participants (Actual)	Interventional	2014-04-30	Withdrawn(stopped due to GSK has decided to terminate the Product Development of foretinib and conclude our Development Agreement with Exelixis)
A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABBV-399, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors [NCT02099058]	Phase 1	237 participants (Actual)	Interventional	2014-01-15	Active, not recruiting
A Phase II Trial of Preoperative Concurrent Chemotherapy/Radiation Therapy Plus Bevacizumab/Erlotinib in the Treatment of Localized Esophageal Cancer [NCT00393068]	Phase 2	62 participants (Actual)	Interventional	2007-02-28	Completed
Intercalated Combination of Chemotherapy and Erlotinib in 1st Line Setting for Patients Advanced Stage Non-small-cell Lung Cancer With Low Abundant Activating EGFR Mutation(INNOVATE) [NCT02095782]	Phase 2	10 participants (Actual)	Interventional	2014-03-31	Terminated(stopped due to Because of the very slow enrollment, this study was stopped.)
A Randomized, Controlled Phase 2 Study Evaluating LY2875358 Plus Erlotinib Versus Erlotinib as First-Line Treatment in Metastatic Non-Small Cell Lung Cancer Patients With Activating EGFR Mutations Who Have Disease Control After an 8-Week Lead-In Treatment [NCT01897480]	Phase 2	150 participants (Anticipated)	Interventional	2013-08-28	Active, not recruiting
A Multicenter, Open-label, Randomized Phase III Study to Evaluate the Efficacy and Safety of Erlotinib (Tarceva®) Versus Gemcitabine/Cisplatin as the First-line Treatment for Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) Patients With Mutations in the [NCT01342965]	Phase 3	217 participants (Actual)	Interventional	2011-03-31	Completed
Pilot Study of EGFR Inhibition With Erlotinib in Cirrhosis to Inhibit Fibrogenesis and Prevent Hepatocellular Carcinoma [NCT02273362]	Phase 1/Phase 2	25 participants (Actual)	Interventional	2014-11-24	Active, not recruiting
A Phase I Study of Ixazomib and Erlotinib in Advanced Solid Tumor Patients [NCT02942095]	Phase 1	9 participants (Actual)	Interventional	2017-03-06	Completed
A Phase II Trial of Adjuvant Bevacizumab and Erlotinib in Patients at High Risk for Early Relapse Following Radical Prostatectomy for Prostate Cancer [NCT00203424]	Phase 2	23 participants (Actual)	Interventional	2006-01-31	Completed
A Phase II Study Of The Weekly Administration Of Docetaxel In Combination With The Epidermal Growth Factor Receptor Inhibitor OSI-774 In Recurrent And/Or Metastatic Breast Cancer [NCT00054275]	Phase 2	39 participants (Actual)	Interventional	2002-12-31	Completed
A Double-Blind, Randomized, Parallel Two-Arm Phase II Trial of BMS-690514 Versus Erlotinib in Previously Treated NSCLC Patients [NCT00743938]	Phase 2	141 participants (Actual)	Interventional	2009-03-31	Completed
A Randomized, Open-label, Phase III Study of Single Agent Nazartinib Versus Investigator's Choice (Erlotinib or Gefitinib) as First-Line Treatment in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Activating Mutatio [NCT03529084]	Phase 3	0 participants (Actual)	Interventional	2018-07-24	Withdrawn(stopped due to Decision by Sponsor not to continue with the trial.)
The Continuation of Erlotinib Treatment in Non-small Cell Lung Cancer Patients Whose Brain Lesion is the Only Site of Progression : Pilot Study [NCT01130779]	Phase 2	23 participants (Anticipated)	Interventional	2009-08-31	Enrolling by invitation
Development of an Integrated Molecular Biomarker ofEarly Prediction of Therapeutic Response to Targeted Therapy in Stage IIIB/IV or Recurrent Lung Cancer Patients Using Imaging Assessments and Genomic Modeling [NCT00708448]	Phase 1	26 participants (Actual)	Interventional	2008-03-28	Completed
A Phase I Single Arm Open Label Study of Erlotinib and 13-cis-Retinoic Acid (CRA) in Patients With Recurrent Malignant Gliomas [NCT01103375]	Phase 1	5 participants (Actual)	Interventional	2010-05-31	Terminated(stopped due to Slow accrual)
An Multicenter,Phase II Trial of EGFR-TKIs Combine With Anlotinib as First-line Treatment for Patients With Advanced EGFR Mutation-positive NSCLC [NCT03720873]	Phase 2	90 participants (Anticipated)	Interventional	2018-10-31	Recruiting
Addition of the Gamma-Secretase Inhibitor RO4929097 to Erlotinib in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) [NCT01193881]	Phase 1	16 participants (Actual)	Interventional	2010-08-31	Terminated
An Open-Label, Phase I/Ib Dose Escalation Study to Assess the Safety and Tolerability of GSK1120212 in Combination With Docetaxel, Erlotinib, Pemetrexed, Pemetrexed + Carboplatin, Pemetrexed + Cisplatin, or Nab-Paclitaxel in Subjects With Advanced Solid T [NCT01192165]	Phase 1	169 participants (Actual)	Interventional	2010-09-14	Completed
A Phase II Trial of Neoadjuvant Erlotinib (Tarceva®) Followed by Surgery for Selected Patients With Stage IIIA, N2-positive Non-Small Cell Lung Cancer [NCT01130753]	Phase 2	43 participants (Anticipated)	Interventional	2007-01-31	Completed
Randomized Multicenter Study to Compare the Effectiveness and Safety of Erlotinib and Pemetrexed as Maintenance Therapy of Advanced Non-Squamous Non-Small Cell Lung Cancer [NCT03460678]	Phase 4	9 participants (Actual)	Interventional	2018-02-28	Terminated(stopped due to Difficulty recruiting)
[NCT01229813]	Phase 3	233 participants (Actual)	Interventional	2010-10-31	Completed
β-elemene Combine With EGFR-TKI for Advanced EGFR-TKI-resistant Non-Small Cell Lung Cancer [NCT03123484]	Phase 2	80 participants (Anticipated)	Interventional	2017-04-30	Not yet recruiting
A Clinical Phase I / II Trial of Belinostat in Combination With Erlotinib in Patients With Non-small Cell Lung Cancer [NCT01188707]	Phase 1/Phase 2	5 participants (Actual)	Interventional	2010-10-01	Terminated(stopped due to Dose over MTD reached)
Phase Ⅱ Study of Induction Erlotinib Therapy in Stage III A(N2) Non-small Cell Lung Cancer Proceeding to Mediastinoscopy/PET and Thoracotomy/Radiotherapy [NCT00600587]	Phase 2	24 participants (Actual)	Interventional	2007-09-30	Completed
CCCWFU 60307 - Pilot Study to Evaluate the Anti-tumor Effect of Erlotnib Administered Befor Surgery in Operable Patients With Squamous Cell Carcinoma of the Head and Neck (HNSCC) [NCT00601913]	Early Phase 1	24 participants (Actual)	Interventional	2008-03-31	Completed
Phase II Study of Sorafenib (NSC-724772) and Erlotinib (NSC-718781) in Patients With Advanced Gallbladder Carcinoma or Cholangiocarcinoma [NCT01093222]	Phase 2	40 participants (Actual)	Interventional	2010-04-30	Completed
Phase II Trial of Erlotinib in Patients With JAK-2 V617F Positive Polycythemia Vera [NCT01038856]	Phase 2	5 participants (Actual)	Interventional	2009-12-31	Terminated(stopped due to The study was terminated by the sponsor)
A Randomized, Phase 2 Study of Single-agent Erlotinib Versus Oral Etoposide in Patients With Recurrent or Refractory Pediatric Ependymoma [NCT01032070]	Phase 2	25 participants (Actual)	Interventional	2010-09-27	Terminated(stopped due to In a pre-planned interim analysis, OSI-774-205 met futility for efficacy with no safety concerns. As a result, it has been stopped.)
A Phase I/II Trial of AMG 102 and Erlotinib in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer [NCT01233687]	Phase 1/Phase 2	49 participants (Actual)	Interventional	2011-08-31	Completed
A Phase II Trial of Endocrine Therapy in Combination With OSI-906 (an IGF-1R Inhibitor) and Erlotinib (Tarceva®, an EGFR Inhibitor) in Patients With Hormone-sensitive Metastatic Breast Cancer [NCT01205685]	Phase 2	11 participants (Actual)	Interventional	2010-05-31	Terminated(stopped due to PI closed study early, all patients experienced severe toxicities and progressed)
A Phase II Study of Erlotinib and Radiation Therapy in Patients With Locally Advanced Squamous Cell Cancer of the Head and Neck [NCT01192815]	Phase 2	2 participants (Actual)	Interventional	2011-01-31	Terminated(stopped due to Funding unavailable)
First-Line Erlotinib Therapy and the Subsequent Development of Mechanisms of Secondary Resistance in Patients With Non-Small Cell Lung Cancer and Known Sensitizing EGFR Mutations [NCT00997334]	Phase 2	60 participants (Actual)	Interventional	2010-02-28	Completed
Phase I Study of LBH589 in Combination With Erlotinib for Advanced Aerodigestive Tract Cancers (CLBH5889CUS11T) [NCT00738751]	Phase 1	44 participants (Actual)	Interventional	2008-11-30	Completed
A Phase I Dose-escalation Study of OSI-906 and Erlotinib (Tarceva®) in Patients With Advanced Solid Tumors [NCT00739453]	Phase 1	95 participants (Actual)	Interventional	2008-10-23	Completed
Phase I/II Dose Escalation Trial of Induction and Concomitant Erlotinib and Celecoxib With Radiation Therapy for Treatment of Poor Prognosis Head and Neck Cancer, Including Reirradiation [NCT00970502]	Phase 1/Phase 2	15 participants (Actual)	Interventional	2007-02-28	Completed
Combined Targeted Therapies for Triple Negative Advanced Breast Cancer - A Phase II Trial of Weekly Nab-Paclitaxel and Bevacizumab Followed by Maintenance Targeted Therapy With Bevacizumab and Erlotinib [NCT00733408]	Phase 2	59 participants (Actual)	Interventional	2008-04-23	Completed
An Expanded Access Program of Tarceva (Erlotinib) in Patients With Advanced Stage IIIB/IV Non-Small Cell Lung Cancer [NCT00949910]	Phase 4	6,586 participants (Actual)	Interventional	2004-11-30	Completed
A Phase 1 Dose Escalation Study of Daily Oral OSI-930 and Erlotinib (Tarceva) in Patients With Advanced Solid Tumors [NCT00603356]	Phase 1	60 participants (Anticipated)	Interventional	2007-11-30	Completed
A Randomized Phase II Study of Dual Epidermal Growth Factor Receptor Inhibition With Erlotinib and Panitumumab With or Without Irinotecan as Second Line Therapy in Patients With Metastatic Colorectal Cancer [NCT00940316]	Phase 2	28 participants (Actual)	Interventional	2010-01-18	Completed
Phase II Clinical Trial of the Combination of RAD001 and Erlotinib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck [NCT00942734]	Phase 2	49 participants (Actual)	Interventional	2009-07-31	Completed
Phase I Study of Erlotinib and Temsirolimus in Resistant Solid Malignancies [NCT00770263]	Phase 1	46 participants (Actual)	Interventional	2009-05-31	Completed
A Randomized Open-Label Multi-Institution Phase II Study of the Combination of Bevacizumab and Erlotinib Compared to Sorafenib in the First-Line Treatment of Patients With Advanced Hepatocellular Carcinoma (HCC) [NCT00881751]	Phase 2	95 participants (Actual)	Interventional	2009-03-31	Completed
Comparison of Biomarker Modulation by Inhibition of EGFR and/or Src Family Kinases Using Erlotinib and Dasatinib in Head and Neck Lung Cancers [NCT00779389]	Phase 1	58 participants (Actual)	Interventional	2009-01-31	Completed
A Phase II Single-Arm Trial Assessing the Use of an Ex Vivo Sensitivity Assay to Predict Response of Relapsed Metastatic Non-Small Cell Lung Cancer Patients to Erlotinib [NCT00673569]	Phase 2	40 participants (Anticipated)	Interventional	2006-09-30	Completed
A Multicenter, Open-label, Phase II Study of Sorafenib in Combination With Erlotinib in Non-small Cell Lung Cancer (NSCLC) Refractory to One or Two Prior Chemotherapy Regimens [NCT00801385]	Phase 2	47 participants (Anticipated)	Interventional	2008-09-30	Recruiting
A Phase II Study of Combination Therapy of Carboplatin -Gemcitabine Plus Bevacizumab Beyond Progression in Patients With Locally Advanced and/or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Not Received Prior Systemic Therapy [NCT00702975]	Phase 2	35 participants (Actual)	Interventional	2008-09-30	Completed
University of Alabama at Birmingham(UAB 0808), A Phase II Study of Short-course Preoperative Erlotinib Followed by Post-operative Erlotinib-gemcitabine in Patients With Resectable Pancreatic Adenocarcinoma [NCT00841035]	Phase 2	6 participants (Actual)	Interventional	2009-02-28	Terminated(stopped due to Sponsor stopped due to slow enrollment)
Phase Ib Study To Evaluate The Safety Of Combining IGF-1R Antagonist R1507 With Multiple Standard Chemotherapy Drug Treatments In Patients With Advanced Malignancies [NCT00811993]	Phase 1	104 participants (Actual)	Interventional	2009-02-28	Terminated
Optimization of Erlotinib for the Treatment of Patients With Advanced Non Small Cell Lung Cancer: an Italian Randomized Trial [NCT00637910]	Phase 3	850 participants (Anticipated)	Interventional	2007-11-30	Recruiting
[NCT00830245]	Phase 2	20 participants (Anticipated)	Interventional	2009-01-31	Terminated(stopped due to low accrual rate)
A Randomized Phase II Study of Erlotinib Compared to Single Agent Chemotherapy-erlotinib Combination in Pretreated Patients With Advanced NSCLC (NVALT10 Study) [NCT00835471]	Phase 2	195 participants (Actual)	Interventional	2009-03-31	Completed
A Randomized, Open-Label, Phase 2 Study to Evaluate OBI-833/OBI-821 in Combination With First-Line Erlotinib in Patients With EGFR-Mutated, Globo H-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer [NCT05442060]	Phase 2	60 participants (Anticipated)	Interventional	2022-07-27	Recruiting
A Phase I/II Study of Foretinib in Patients With Previously Treated Non-Small Cell Lung Cancer Receiving Standard Erlotinib Therapy [NCT01068587]	Phase 1/Phase 2	31 participants (Actual)	Interventional	2010-01-21	Completed
A Phase I Study of Adjuvant OSI-774 (Tarceva®) in Patients Following Combined Chemo-Radiotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck [NCT00079053]	Phase 1	19 participants (Actual)	Interventional	2004-03-02	Completed
A Randomized, Double-Blind, Placebo-controlled Phase 2 Study of Maintenance OSI-906 Plus Erlotinib (Tarceva®), or Erlotinib Plus Placebo in Patients With Nonprogression Following Four Cycles of 1st-line Platinum-based Chemotherapy for Advanced NSCLC [NCT01186861]	Phase 2	205 participants (Actual)	Interventional	2011-03-04	Completed
A Phase I, Open-label, Dose Escalation Study of Gemcitabine and Pulse Dose Erlotinib in Second Line Treatment of Advanced Pancreatic Cancer [NCT02154737]	Phase 1	24 participants (Anticipated)	Interventional	2013-07-31	Completed
An Open-label, Randomized, Phase II Study of Erlotinib Monotherapy Versus Docetaxel and Cisplatin as Neoadjuvant Therapy in Patients of Stage IIIA Lung Adenocarcinoma With Epidermal Growth Factor Receptor Gene Mutation. [NCT02036359]	Phase 2	76 participants (Anticipated)	Interventional	2012-05-31	Recruiting
Chemotherapy in Combination With Erlotinib, or Sequential Chemotherapy for Erlotinib for Treatment, EGFR - TKI Resistance of EGFR Mutations in Patients With NSCLC Randomized Controlled Phase II Clinical Study [NCT02037997]	Phase 2	80 participants (Anticipated)	Interventional	2013-12-31	Recruiting
A Phase Ib/II, Open-label, Multicenter Trial With Oral cMET Inhibitor INC280 Alone and in Combination With Erlotinib Versus Platinum With Pemetrexed in Adult Patients With EGFR Mutated, cMET-amplified, Locally Advanced/Metastatic Non-small Cell Lung Cance [NCT02468661]	Phase 1	23 participants (Actual)	Interventional	2015-09-23	Terminated(stopped due to Major challenge for enrollment of participants.)
Intercalated Combination of Erlotinib and Radiotherapy for Patients With EGFR-mutant, Unresectable, Locally Advanced Non-small-cell Lung Cancer [NCT03074864]	Phase 2/Phase 3	90 participants (Anticipated)	Interventional	2017-02-27	Active, not recruiting
Phase 3 Study of Erlotinib 100mg or 150mg in Treating EGFR Mutated Patients With Non-small Cell Lung Cancer [NCT02140333]	Phase 3	220 participants (Anticipated)	Interventional	2013-08-31	Recruiting
Erlotinib Treatment Beyond Progression in EGFR Mutant or Patients Who Have Responded EGFR TKI in Stage IIIB/IV NSCLC [NCT02064491]	Phase 2	18 participants (Actual)	Interventional	2014-02-28	Completed
Multicentre Perspective Non-interventional Study of Survival Benefits of iCAGES-guided Therapy in Contrast to Standard Therapy or IHC-guided Therapy for Advanced Cancers [NCT03192501]		250 participants (Anticipated)	Observational	2017-07-01	Recruiting
A Multicenter Randomized Phase III Study Comparing Second-line Treatment With Chemotherapy Associated or Not to Erlotinib in NSCLC Patients With Secondary Resistance to TKI-EGFR [NCT02178397]	Phase 3	6 participants (Actual)	Interventional	2014-06-30	Terminated(stopped due to lack of recruitment)
A Phase I Clinical Study of Erlotinib (Tarceva) and Bexarotene (Targretin) Oral Capsules in Advanced Cancers of the Aerodigestive Tract [NCT01116622]	Phase 1	24 participants (Actual)	Interventional	2003-04-30	Completed
A Randomized, Placebo-Controlled, Phase 2 Study of Docetaxel and Cisplatin/Carboplatin With or Without Erlotinib in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck [NCT01064479]	Phase 2	123 participants (Actual)	Interventional	2010-02-05	Completed
Phase II Study of Erlotinib and RAD001 (Everolimus) in Patients With Previously Treated Advanced Pancreatic Cancer [NCT00640978]	Phase 2	16 participants (Actual)	Interventional	2008-03-31	Terminated(stopped due to Significant Adverse Effects - Futility)
Phase II Study of Erlotinib (Tarceva®) and Radiotherapy for Elderly Patients With Esophageal Carcinoma [NCT00524121]	Phase 2	22 participants (Actual)	Interventional	2006-03-31	Completed
A Phase II Clinical Study of Erlotinib (Tarceva) and Bexarotene (Targretin) Oral Capsules in Patients With Advanced Non-small Cell Lung Cancer [NCT00125359]	Phase 2	42 participants (Actual)	Interventional	2005-08-31	Completed
A Phase I/II Trial of a New Tyrosine Kinase Inhibitor (Tarceva; Erlotinib Hydrochloride; OSI-774) During and After Radiotherapy in the Treatment of Patients With Newly Diagnosed High Grade Glioma and Unfavorable Low-Grade Glioma [NCT00124657]	Phase 1/Phase 2	62 participants (Actual)	Interventional	2005-03-31	Completed
A Phase II Study of Erlotinib and Sorafenib in Patients With Locally Advanced and/or Metastatic (Stage IIIb or IV) Non Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy [NCT00722969]	Phase 2	48 participants (Anticipated)	Interventional	2007-11-30	Active, not recruiting
Phase II, Multicenter, Randomized, Open Label Study of a Sequential Treatment of Intermittent Erlotinib and Docetaxel Versus Erlotinib in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer After Failure of a Prior Chemotherapy Regimen [NCT00908336]	Phase 2	70 participants (Anticipated)	Interventional	2009-03-31	Recruiting
An Umbrella Protocol for Histology-Independent, Phase I Modular Study Based on Epidermal Growth Factor Receptor (EGFR) Mutation Status: Using Erlotinib Alone or in Combination With Cetuximab, Bortezomib, or Dasatinib to Overcome Resistance [NCT00903734]	Phase 1	16 participants (Actual)	Interventional	2009-04-30	Completed
A Phase III Trial Comparing Whole Brain Radiation and Stereotactic Radiosurgery Alone Versus With Temozolomide or Erlotinib in Patients With Non-Small Cell Lung Cancer and 1-3 Brain Metastases [NCT00096265]	Phase 3	126 participants (Actual)	Interventional	2004-10-06	Terminated
A Pilot Study of the Effect of Erlotinib (Tarceva®) on Biomarkers in Estrogen Receptor Negative Breast Cancer Expressing the Epidermal Growth Factor Receptor and Interleukin 1α [NCT00503841]		44 participants (Actual)	Interventional	2007-12-31	Terminated(stopped due to All enrolled participants were screen failures, no data were collected for outcome measures.)
Phase I Study of Erlotinib (Tarceva) in Combination With AT-101 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) [NCT00934076]	Phase 1	0 participants (Actual)	Interventional	2010-02-28	Withdrawn(stopped due to Study was never activated)
A Phase I Open-Label, Dose-Finding Study to Evaluate the Safety and Efficacy of Concurrent Radiosurgery and Erlotinib Administration in Non-Small Cell Lung Cancer Patients With Brain Metastases [NCT00738335]	Phase 1	0 participants (Actual)	Interventional	2009-01-31	Withdrawn
Combination of Erlotinib (Tarceva®) and Bevacizumab (Avastin®) as Second-line Treatment in Locally Advanced / Metastatic, Non-squamous, Non-small Cell Lung Cancer (NSCLC) Patients: A Phase II Study [NCT00749567]	Phase 2	13 participants (Actual)	Interventional	2008-07-31	Terminated(stopped due to Poor accrual)
KOrean Precision Medicine Networking Group Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II [NCT05525858]		1,000 participants (Anticipated)	Observational	2022-09-28	Recruiting
A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of GDC-0941 in Combination With Erlotinib in Patients With Advanced Solid Tumors [NCT00975182]	Phase 1	58 participants (Actual)	Interventional	2009-09-30	Completed
A Phase II Study on the Safety and Efficacy of Radiation Therapy and Concurrent Erlotinib in Locally Advanced Non-small-cell Lung Cancer [NCT00973310]	Phase 2	50 participants (Anticipated)	Interventional	2009-10-31	Recruiting
Randomized, Open Label, Phase 3 Trial Of Erlotinib Alone Or In Combination With CP-751,871 In Patients With Advanced Non Small Cell Lung Cancer Of Non Adenocarcinoma Histology [NCT00673049]	Phase 3	583 participants (Actual)	Interventional	2008-05-31	Terminated(stopped due to See termination reason in detailed description.)
Randomized Proteomic Stratified Phase III Study of Second-Line Erlotinib Versus Chemotherapy in Patients With Inoperable Non Small Cell Lung Cancer [NCT00989690]	Phase 3	275 participants (Anticipated)	Interventional	2008-02-29	Recruiting
IMRT Combined With Erlotinib Compared With Whole-brain Radiotherapy for EGFR Wild Type Non-small Cell Lung Cancer With 4-10 Brain Metastases [NCT02556593]	Phase 2	12 participants (Actual)	Interventional	2015-09-30	Terminated
Dual Inhibition of EGFR Signalling Using the Combination of Cetuximab (Erbitux) and Erlotinib (Tarceva) in Patients With Chemotherapy-refractory Colorectal Cancer [NCT00784667]	Phase 2	50 participants (Anticipated)	Interventional	2008-10-31	Active, not recruiting
Phase I Study of Combined Temsirolimus, Erlotinib and Cisplatin in Advanced Solid Tumors [NCT00998036]	Phase 1	9 participants (Actual)	Interventional	2009-09-30	Completed
A Phase II Selection Design of Pharmacodynamic Separation of Carboplatin/Paclitaxel/OSI-774 (Erlotinib; NSC-718781) or OSI-774 Alone in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients With Performance Status 2 (PS-2) [NCT00661193]	Phase 2	59 participants (Actual)	Interventional	2008-12-31	Completed
A Phase II Trial Assessing Metronidazol Actavis 1% Topical Cream in the Prevention and Treatment of Erlotinib Associated Rash [NCT00642473]	Phase 2	34 participants (Actual)	Interventional	2008-02-29	Completed
A Phase 2 Study of Pemetrexed Versus Pemetrexed Plus Erlotinib in Second-Line Treatment in Patients With Nonsquamous NSCLC [NCT00447057]	Phase 2	204 participants (Actual)	Interventional	2007-03-31	Completed
A Randomized, Controlled Phase III Trial to Evaluate the Efficacy of Elortinib vs Gefitinib in Advanced Non-small-cell Lung Cancer With EGFR Exon 19 or 21 Mutations [NCT01024413]	Phase 3	256 participants (Actual)	Interventional	2009-07-31	Completed
A Randomized, Open-label Study Comparing the Anti-tumor Effect of Treatment With Tarceva Plus Avastin Versus Chemotherapy Plus Avastin in Patients With Advanced Non-small Cell Lung Cancer [NCT00531960]	Phase 2	124 participants (Actual)	Interventional	2008-01-31	Completed
A Phase 1b Dose Escalation/Phase 2 Randomized, Non-Comparative, Multiple Center, Open Label Study Of CP 751,871 In Combination With Paclitaxel And Carboplatin And Of Paclitaxel And Carboplatin Alone As First Line Treatment For Advanced Non-Small Cell Lung [NCT00147537]	Phase 1/Phase 2	282 participants (Actual)	Interventional	2005-02-28	Completed
Phase I/II Study Of Herceptin Combined With OSI-774 In The First-Line Treatment Of Metastatic Breast Cancer Associated With HER2/Neu Overexpression [NCT00033514]	Phase 1/Phase 2	27 participants (Actual)	Interventional	2001-08-31	Completed
A Phase 1b Study of Erlotinib and Momelotinib for the Treatment of Epidermal Growth Factor Receptor (EGFR) Mutated EGFR Tyrosine Kinase Inhibitor (TKI) Naïve Metastatic Non-Small Cell Lung Cancer (NSCLC) [NCT02206763]	Phase 1	11 participants (Actual)	Interventional	2014-10-16	Terminated
A Randomized Phase III Study of Docetaxel Versus Intercalated Erlotinib Docetaxel Combination Therapy in Patients With Relapsed EGFR (Epidermal Growth Factor Receptor) Wild Type, ALK(Anaplastic Lymphoma Kinase) Negative Non Squamous Cell Carcinoma. (NVALT [NCT02775006]	Phase 3	45 participants (Actual)	Interventional	2016-10-14	Terminated(stopped due to accrual to slow, target not achievable)
Phase I Multicenter, Open-label, Dose-escalating Clinical and Pharmacokinetic Trial of PM02734 Administered in Combination With Erlotinib in Patients With Advanced Malignant Solid Tumors [NCT00884845]	Phase 1	35 participants (Actual)	Interventional	2009-01-31	Completed
A Phase I Dose-Escalation Study of Erlotinib in Combination With Bortezomib in Subjects With Advanced Cancer. Companion Study to Umbrella Protocol 2007-0638. [NCT00895687]	Phase 1	24 participants (Actual)	Interventional	2009-04-30	Completed
Phase 1 Study of Tarceva and Rapamycin For Recurrent Low-Grad Gliomas in Children With or Without Neurofibromatosis Type 1 (NF1) [NCT00901849]	Phase 1	21 participants (Actual)	Interventional	2007-05-31	Completed
Phase II Study of TARCEVA (Erlotinib) as Adjuvant Treatment for Locally Advanced Head and Neck Squamous Cell Carcinoma With Evaluation of Neoadjuvant Biomarker Modulation With TARCEVA vs. TARCEVA Plus Sulindac [NCT01515137]	Phase 1	47 participants (Actual)	Interventional	2005-11-30	Completed
An Open Label Study to Evaluate the Safety and Effect on Disease Progression of Triple Combination Treatment With Erlotinib (Tarceva), Bevacizumab (Avastin), and Capecitabine (Xeloda) in Patients With Locally Advanced and/or Metastatic Pancreatic Cancer ( [NCT00925769]	Phase 1	32 participants (Actual)	Interventional	2009-01-31	Completed
A Randomized, Placebo-controlled, Double-blind Phase III Study of the Effect of First-line Treatment With Intercalated Tarceva Versus Placebo in Combination With Gemcitabine/Platinum on Progression-free Survival in Patients With Stage IIIB/IV Non-small Ce [NCT00883779]	Phase 3	451 participants (Actual)	Interventional	2009-04-30	Completed
ERLOTINIB, A TYROSINE KINASE INHIBITOR OF EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) AS FIRST LINE TREATMENT, IN PATIENTS WITH LOCALLY ADVANCED/METASTATIC NON SMALL CELL LUNG CANCER (NSCLC). A PHASE II STUDY [NCT00615758]	Phase 2	50 participants (Anticipated)	Interventional	2006-10-31	Completed
A Phase I Study of Pazopanib in Combination With Either Erlotinib or Pemetrexed in Patients With Advanced Solid Tumors [NCT00619424]	Phase 1	58 participants (Actual)	Interventional	2007-11-15	Completed
A Phase III Randomized, Placebo Controlled, Double Blind Trial of Sorafenib Plus Erlotinib vs. Sorafenib Plus Placebo as First Line Systemic Treatment for Hepatocellular Carcinoma (HCC) [NCT00901901]	Phase 3	732 participants (Actual)	Interventional	2009-05-21	Completed
A Randomized, Placebo-controlled, Double-blind, Multicenter Phase 2 Study With a Lead in Phase of Erlotinib With or Without SNDX-275 in Patients With NSCLC After Failure In Up to Two Prior Chemotherapeutic Regimens for Advanced Disease [NCT00602030]	Phase 1/Phase 2	141 participants (Actual)	Interventional	2008-01-08	Completed
A Phase II Study to Determine the Efficacy of Tarceva® (Erlotinib Hydrochloride) With Concurrent Whole Brain Radiation Therapy in Patients With Brain Metastases From Non-Small Cell Lung Cancer (NSCLC) [NCT00871923]	Phase 2	44 participants (Actual)	Interventional	2009-03-26	Completed
A Phase II, Open Label, Multicenter Study of Bevacizumab in Combination With Erlotinib Versus Erlotinib Alone in Patients With EGFR Mutant Non-small Cell Lung Cancer Who Have Brain Metastases [NCT02655536]	Phase 2	109 participants (Anticipated)	Interventional	2017-08-01	Recruiting
A Phase II Study of the Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor, Erlotinib, in Combination With Docetaxel and Radiation in Locally Advanced Squamous Cell Cancer of the Head and Neck [NCT00720304]	Phase 2	37 participants (Actual)	Interventional	2007-11-30	Completed
Efficacy and Safety of Afatinib in Patients With EGFR-mutated Metastatic Non-small-cell Lung Cancer Previously Responsive to First-generation Tyrosine-kinase Inhibitors and Chemotherapy [NCT02625168]	Phase 2	25 participants (Actual)	Interventional	2013-01-31	Completed
A Phase II Open-Label Study Designed to Evaluate the Efficacy and Safety, of Erlotinib in Combination With Docetaxel in Selected Non Small Cell Lung Cancer Patients Eligible for First Line Treatment [NCT00840125]	Phase 2	4 participants (Actual)	Interventional	2009-02-28	Completed
An Open Non-randomized Multicenter Phase II Trial to Evaluate the Efficacy and Safety of Tarceva in Combination With Capecitabine in Patients With Advanced Pancreatic Cancer [NCT00873353]	Phase 2	32 participants (Actual)	Interventional	2008-03-31	Completed
Randomized, Placebo-Controlled, Phase 2 Study Of Induction Chemotherapy With Cisplatin/Carboplatin, And Docetaxel With Or Without Erlotinib In Patients With Head And Neck Squamous Cell Carcinomas Amenable For Surgical Resection [NCT01927744]	Phase 2	105 participants (Anticipated)	Interventional	2013-12-16	Recruiting
Pilot Study of Erlotinib for the Treatment of Patients With de Novo Acute Myeloid Leukemia [NCT01174043]	Phase 2	11 participants (Actual)	Interventional	2010-07-31	Completed
Phase Ib Study of Erlotinib Prior to Surgery in Patients With Head and Neck Cancer [NCT00954226]	Phase 1	48 participants (Actual)	Interventional	2009-08-05	Active, not recruiting
Neoadjuvant Chemotherapy With Docetaxel, Cisplatin Followed by Maintenance Therapy With the EGFR Inhibitor Erlotinib (Tarceva) in Patients With Stage I, II and III Non-Small Cell Lung Cancer Following Definitive Surgical Resection [NCT00254384]	Phase 1	50 participants (Actual)	Interventional	2005-10-05	Active, not recruiting
Phase I/II Studies of BAY 43-9006 (Sorafenib) in Combination With OSI-774 (Erlotinib), R115777 (Tipifarnib) or CCI-779 (Temsirolimus) in Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma [NCT00335764]	Phase 1/Phase 2	92 participants (Actual)	Interventional	2006-04-30	Completed
A Phase II Trial of Adjuvant Erlotinib in Patients With Resected, Early Stage Non-Small Cell Lung Cancer (NSCLC) With Confirmed Mutations in the Epidermal Growth Factor Receptor (EGFR) [NCT00567359]	Phase 2	100 participants (Actual)	Interventional	2007-12-31	Completed
A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Single-agent Tarceva® (Erlotinib) Following Complete Tumor Resection With or Without Adjuvant Chemotherapy in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma Who Have [NCT00373425]	Phase 3	1,252 participants (Actual)	Interventional	2006-09-30	Completed
Effect of COX-2 (Cyclooxygenase-2) and EGFR (Epidermal Growth Factor Receptor) Suppression on Molecular Markers of Angiogenesis and Proliferation in Squamous Cell Carcinoma of Oral Cavity - Prospective Randomized Study. [NCT02748707]	Phase 2	64 participants (Actual)	Interventional	2015-08-18	Active, not recruiting
A Phase I/II Study of MGCD265 in Combination With Erlotinib or Docetaxel in Subjects With Advanced Malignancies and in Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC) [NCT00975767]	Phase 1	126 participants (Actual)	Interventional	2009-08-31	Terminated(stopped due to The study was terminated due to a need for a reformulation of the study drug. Phase 1 completed, no patients enrolled in Phase 2.)
Phase II Study Investigating the Efficacy and Activity of Single Agent Erlotinib in Chemotherapy-Naive Androgen Independent Prostate Cancer [NCT00272038]	Phase 2	29 participants (Actual)	Interventional	2005-12-31	Completed
A Multicenter, Randomized, Double-Blind, Controlled Phase 3, Efficacy And Safety Study Of Sunitinib (SU011248) In Patients With Advanced/Metastatic Non-Small Cell Lung Cancer Treated With Erlotinib [NCT00457392]	Phase 3	960 participants (Actual)	Interventional	2007-07-31	Completed
A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (RHUMAB VEGF; NSC 704865) in Never-Smokers With Stage IIIB and IV Primary NSCLC Adenocarcinomas [NCT00445848]	Phase 2	89 participants (Actual)	Interventional	2007-07-31	Completed
Phase I/II Trial of Induction Carboplatin/Paclitaxel With Bevacizumab Followed by Concurrent Thoracic Conformal Radiation Therapy With Carboplatin/Paclitaxel, Bevacizumab and Erlotinib in Stage IIIA/B Non-Small Cell Lung Cancer [NCT00280150]	Phase 1/Phase 2	46 participants (Actual)	Interventional	2006-01-31	Completed
A Phase II Trial of Bevacizumab and Erlotinib in Patients With Advanced Biliary Tumors [NCT00356889]	Phase 2	56 participants (Actual)	Interventional	2006-05-31	Completed
MERIT - A Phase II Marker Identification Trial for Tarceva in Second Line NSCLC Patients [NCT02774278]	Phase 2	264 participants (Actual)	Interventional	2005-07-31	Completed
A Phase II Trial of Cabozantinib and Erlotinib for Patients With EGFR and c-Met Co-expressing Metastatic Pancreatic Adenocarcinoma [NCT03213626]	Phase 2	7 participants (Actual)	Interventional	2017-10-13	Terminated(stopped due to There were no objective responses by patient 7.)
Concurrent Chemoradiotherapy Containing Paclitaxel and Cisplatin With/Without Tarceva in Locally Advanced Esophageal Carcinoma: a Randomized Phase III Multi-center Trial. [NCT00686114]	Phase 3	344 participants (Anticipated)	Interventional	2008-05-31	Recruiting
A Phase II Trial of Tarceva (Erlotinib) and Avastin (Bevacizumab) in the Treatment of Patients With Metastatic Melanoma [NCT00466687]	Phase 2	34 participants (Actual)	Interventional	2004-09-30	Completed
Phase II Trial Evaluating Addition of Fulvestrant to Erlotinib in Patients With Stage IIIB/IV NSCLC Who Are Stable on Erlotinib and Exhibit Positivity for Estrogen or Progesterone Receptor [NCT00592007]	Phase 2	7 participants (Actual)	Interventional	2007-09-30	Terminated(stopped due to Study was terminated due to slow subject accrual)
A Randomized, Placebo Controlled Study to Determine the Effect of Two Dose Schedules of R1507 or Placebo, Both in Combination With Erlotinib (Tarceva®), on Progression-free Survival in Patients With Advanced Non-small Cell Lung Cancer With Disease Progres [NCT00760929]	Phase 2	171 participants (Actual)	Interventional	2008-11-10	Terminated(stopped due to The study was terminated due to the termination of the clinical development program.)
A Phase I Dose Escalation Study of MK-2206 in Combination With Standard Doses of Selected Chemotherapies or Targeted Agents in Patients With Locally Advanced or Metastatic Solid Tumors [NCT00848718]	Phase 1	77 participants (Actual)	Interventional	2009-03-17	Completed
A Phase II Exploratory Study of Pre-Operative Treatment With Erlotinib (Tarceva) in Muscle Invasive or Recurrent Transitional Cell Carcinoma Requiring Cystectomy [NCT00749892]	Phase 2	34 participants (Actual)	Interventional	2008-06-10	Completed
A Phase II Study of Erlotinib in Benefitted Patients With Asymptomatic Brain Metastases Advanced Non-Small Cell Lung Cancer By Chemotherapy. [NCT00663689]	Phase 2	45 participants (Anticipated)	Interventional	2008-03-31	Active, not recruiting
A Phase II Trial of Erlotinib in Combination With Gemcitabine and Cisplatin in Metastatic Pancreatic Cancer [NCT00922896]	Phase 2	22 participants (Actual)	Interventional	2009-06-30	Completed
Pharmacokinetic Trial of Sorafenib and Erlotinib in Patients With Refractory Solid Tumors [NCT00759928]	Phase 1	48 participants (Actual)	Interventional	2008-10-31	Completed
A Phase II Study of Preoperative Gemcitabine and Erlotinib Plus Pancreatectomy and Postoperative Gemcitabine and Erlotinib for Patients With Operable Pancreatic Adenocarcinoma [NCT00733746]	Phase 2	123 participants (Actual)	Interventional	2009-04-30	Completed
Phase II Trial to Assess Target Oral Therapy as Adjuvant Chemoprevention in High-Risk Head and Neck Cancer [NCT00570232]	Phase 2	31 participants (Actual)	Interventional	2007-12-31	Completed
A Phase 1/2 Trial of Enzastaurin and Erlotinib in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer (NSCLC) After Prior Chemotherapy [NCT00452413]	Phase 1/Phase 2	65 participants (Actual)	Interventional	2007-05-31	Completed
Phase 1 Study of Oral Vinorelbine in Combination With Erlotinib in Advanced Non-Small Cell Lung Cancer (NSCLC) Using Two Different Schedules [NCT00702182]	Phase 1	30 participants (Actual)	Interventional	2008-04-30	Completed
Phase I/II Study of Polyphenon E in Addition to Erlotinib in Advanced Non Small Cell Lung Cancer [NCT00707252]	Phase 1	11 participants (Actual)	Interventional	2008-01-31	Terminated(stopped due to Phase II not initiated due to cancellation of supply of Poly E by collaborator.)
A Randomized, Open-label, Dose-escalation to Rash Study to Assess the Effect of Tarceva in Combination With Gemcitabine on Overall Survival in Patients With Metastatic Pancreatic Cancer. [NCT00652366]	Phase 2	467 participants (Actual)	Interventional	2008-05-31	Completed
A Phase II Study of Erlotinib and Chemotherapy for Patients With Stage IB-IIIA NSCLC With EGFR Mutations (ECON) [NCT00577707]	Phase 2	9 participants (Actual)	Interventional	2007-11-30	Completed
An Open Label Study to Assess the Effect of Avastin (Bevacizumab) Combined With First Line Paclitaxel-carboplatin or Second Line Tarceva (Erlotinib) on Progression-free Survival in Non-squamous Non-small Cell Lung Cancer Patients With Asymptomatic Untreat [NCT00800202]	Phase 2	91 participants (Actual)	Interventional	2009-04-30	Completed
"A Phase I/II Trial of Cetuximab in Patients With Lung Adenocarcinoma Receiving Erlotinib That Have Developed Acquired Resistance to Erlotinib" [NCT00716456]	Phase 1/Phase 2	21 participants (Actual)	Interventional	2008-07-31	Completed
A Phase II Study of Erlotinib in Combination With Capecitabine as First-line Treatment in Elderly Patients With Stage IIIB/IV Adenocarcinoma Non-small Cell Lung Cancer (NSCLC) [NCT00816868]	Phase 2	62 participants (Actual)	Interventional	2009-01-31	Completed
A Phase II Biomarker Identification Trial for Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Carcinoma [NCT00674973]	Phase 2	207 participants (Actual)	Interventional	2008-06-30	Completed
Docetaxel Combined With Pulsatile Erlotinib (Tarceva®) In Patients With Metastatic Non Small Cell Lung Cancer (NSCLC) (DOPERLO) [NCT00783471]	Phase 2	51 participants (Actual)	Interventional	2008-11-30	Terminated(stopped due to The low accrual rate of the study (30% of the expected accrual rate)/Low efficacy in both treatment arms.)
Randomized Double-Blind Placebo Controlled Phase II Trial Evaluating Erlotinib in Non-Smoking Patients With (Bevacizumab-Eligible and Ineligible) Advanced Non-Small Cell Lung Cancer (NSCLC) [NCT00976677]	Phase 2	10 participants (Actual)	Interventional	2010-01-31	Terminated
A Multi-Center, Phase 3, Double-Blind, Randomized, and Controlled Trial of KD019 vs Erlotinib in Subjects With Stage IIIB/IV Non-Small Cell Lung Cancer Who Have Progressed After First- or Second-Line Chemotherapy [NCT01487174]	Phase 3	8 participants (Actual)	Interventional	2011-12-14	Terminated(stopped due to Kadmon has made a business decision to terminate the study due to slow enrollment. Note the decision to terminate the study was not related to safety issues)
A Phase 1 Study of AV-299 (Formerly SCH 900105) Administered by IV Infusion as Monotherapy in Advanced Solid Tumors, Lymphomas, or Multiple Myeloma or in Combination With Erlotinib in Advanced Solid Tumors [NCT00725634]	Phase 1	41 participants (Actual)	Interventional	2008-09-30	Completed
Phase II Study Of Neoadjuvant Chemotherapy With Gemcitabine, Oxaliplatin And Erlotinib (Gemoxt) In Borderline Resectable Pancreatic Adenocarcinoma [NCT00728000]	Phase 2	0 participants (Actual)	Interventional	2008-08-31	Withdrawn(stopped due to study withdrawn due to lack of enrollment)
A Randomized Phase 2 Study of SCH 727965 in Subjects With Advanced Breast and Non Small Cell Lung (NSCLC) Cancers [NCT00732810]	Phase 2	97 participants (Actual)	Interventional	2008-07-31	Completed
A Phase 2 Study of Pertuzumab and Erlotinib for Refractory Pancreatic Adenocarcinoma [NCT01108458]	Phase 2	1 participants (Actual)	Interventional	2010-07-31	Terminated(stopped due to Extreme toxicity of Pertuzumab and Erlotinib combination)
A Phase II Study of Gemcitabine and Erlotinib Plus Sorafenib (GES) in Metastatic Pancreatic Cancer [NCT00696696]	Phase 2	45 participants (Actual)	Interventional	2007-09-30	Completed
A Randomized, Phase 2b, Multi-center Study of Pralatrexate Versus Erlotinib in Patients With Stage IIIB/IV Non-small Cell Lung Cancer After Failure of at Least 1 Prior Platinum-based Treatment [NCT00606502]	Phase 2	201 participants (Actual)	Interventional	2008-01-31	Completed
A Single Arm, Open Label Study of First Line Treatment With Tarceva Plus Avastin on Progression-free Survival in Patients With Advanced or Metastatic Liver Cancer [NCT00605722]	Phase 2	51 participants (Actual)	Interventional	2008-03-31	Completed
[NCT02795884]	Phase 3	0 participants (Actual)	Interventional	2016-06-30	Withdrawn(stopped due to Because of reconsideration of using erlotinib(EGFR Tyrosine kinase inhibitor) as adjuvant aim)
Phase I/II Study of Erlotinib (TARCEVA) and Cetuximab (ERBITUX) in Advanced Solid Tumors, With Emphasis on Non Small Cell Lung Cancer (NSCLC) [NCT00408499]	Phase 1/Phase 2	64 participants (Actual)	Interventional	2006-08-31	Completed
Tailored Second Line Treatment by EGFR Mutation in Patients With Advanced Lung Adenocarcinoma [NCT00903292]		52 participants (Anticipated)	Interventional	2009-03-31	Recruiting
Phase II Study of Erlotinib, An Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor, in the Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Skin [NCT01198028]	Phase 2	42 participants (Actual)	Interventional	2011-03-10	Completed
A Phase II Randomized Trial of Erlotinib or Vinorelbine in Chemo-naive, Advanced, Non-Small-Cell Lung Cancer Patients Aged 70 Years or Older in Taiwan [NCT01196078]	Phase 4	114 participants (Actual)	Interventional	2007-02-28	Completed
A Randomized, Open-label Study of the Effect of First Line Treatment With Tarceva in Sequential Combination With Gemcitabine, Compared to Gemcitabine Monotherapy, on Progression-free Survival in Elderly or ECOG PS of 2 Patients With Advanced Non-small Cel [NCT00940875]	Phase 2	54 participants (Actual)	Interventional	2009-06-30	Terminated(stopped due to Study was stopped due to slower than expected recruitment.)
Randomized, Open-label, Controlled Multicenter Study to Compare Bevacizumab in Combination With Erlotinib Versus Erlotinib Alone in Chinese NSCLC Patients Harbouring Activating EGFR Mutations(Artemis) [NCT02759614]	Phase 3	311 participants (Actual)	Interventional	2016-04-01	Active, not recruiting
Randomized Study of Bevacizumab/Tarceva and Tarceva/Sulindac in Squamous Cell Carcinoma of the Head and Neck [NCT00392665]	Phase 2	36 participants (Actual)	Interventional	2006-10-31	Terminated(stopped due to slow accrual)
Phase II Study of Gemcitabine, Bevacizumab and Erlotinib in Locally Advanced and Metastatic Pancreatic Cancer [NCT00366457]	Phase 2	32 participants (Actual)	Interventional	2006-08-31	Completed
A Phase I/II Study of Combination Therapy of CG200745 PPA With Gemcitabine and Erlotinib to Determine the Maximum Tolerated Dose (MTD) and Evaluate the Safety and Efficacy for Locally Advanced Unresectable, or Metastatic Pancreatic Cancer [NCT02737228]	Phase 1/Phase 2	24 participants (Anticipated)	Interventional	2016-03-31	Active, not recruiting
Concomitant Radiotherapy and Erlotinib in Advanced Lung Cancer [NCT02714530]	Phase 2	118 participants (Actual)	Interventional	2014-04-01	Terminated(stopped due to Slow accrual)
A Phase 2 Study of Pemetrexed and Erlotinib for Metastatic Colorectal Cancer Refractory to Standard Chemotherapy [NCT02723578]	Phase 2	50 participants (Actual)	Interventional	2015-12-01	Completed
Phase I Study of Dasatinib Plus Erlotinib in Recurrent Malignant Glioma [NCT00609999]	Phase 1	47 participants (Actual)	Interventional	2008-01-31	Completed
Phase 2 Clinical Trial Treating Relapsed/Recurrent/Refractory Pediatric Solid Tumors With the Genomically-Targeted Agent Erlotinib in Combination With Temozolomide [NCT02689336]	Phase 2	0 participants (Actual)	Interventional	2016-08-06	Withdrawn(stopped due to Could not recruit any participants)
A Phase III, International, Randomised, Double Blind, Parallel-Group Study to Assess the Efficacy of Zactima™ Versus Tarceva® in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Failure of at Least One Prior Chemotherapy [NCT00364351]	Phase 3	1,574 participants (Actual)	Interventional	2006-08-31	Completed
A Phase 2 Trial of Erlotinib Re-Challenge for Recurrent EGFR-mutant Lung Cancer in Patients Who Previously Received Adjuvant Erlotinib or Gefitinib [NCT01189435]	Phase 2	2 participants (Actual)	Interventional	2010-08-31	Terminated(stopped due to Lack of accrual)
A Phase 1, Open Label Study of ABT-869 in Combination With Tarceva in Subjects With Advanced Non-hematologic Malignancy [NCT00754104]	Phase 1	0 participants (Actual)	Interventional	2008-09-30	Withdrawn
Phase II Study Open, Not Randomized to Evaluate the Efficacy and Safety of Neoadjuvant Treatment With Gemcitabine and Erlotinib Followed by Gemcitabine, Erlotinib and Radiotherapy in Patients With Resectable Pancreatic Adenocarcinoma [NCT01389440]	Phase 2	24 participants (Actual)	Interventional	2011-05-31	Completed
A Randomized, Open-label, Multi-center Phase III Study of Erlotinib Versus Gemcitabine/Carboplatin in Chemo-naive Stage IIIB/IV Non-Small Cell Lung Cancer Patients With EGFR Exon 19 or 21 Mutation (Optimal) [NCT00874419]	Phase 3	165 participants (Actual)	Interventional	2008-08-31	Completed
A Phase II Trial of Letrozole Plus OSI-774 (Tarceva) in Post-menopausal Women With ER and/or PR-Positive Metastatic Breast Cancer [NCT00611715]	Phase 2	48 participants (Actual)	Interventional	2003-11-30	Terminated(stopped due to low accrual)
A Randomized Double-Blind Placebo-Controlled Phase II Trial of Sorafenib and Erlotinib or Erlotinib Alone in Previously Treated Advanced Non-Small Cell Lung Cancer [NCT00600015]	Phase 2	166 participants (Actual)	Interventional	2008-02-29	Completed
A Phase II Trial of Erlotinib Versus Combination of Vinorelbine Plus Cisplatin as Adjuvant Treatment in Stage IIIA Non-small-cell Lung Cancer After Complete Resection With Sensitizing EGFR Mutation in Exon 19 or 21 and Wild-type K-ras [NCT01410214]	Phase 2	80 participants (Anticipated)	Interventional	2011-05-31	Recruiting
A Phase I, Dose Finding Study of the Combination of High-dose Statin Agent (Rosuvastatin) With Erlotinib in Patients With Advanced Solid Malignancies, With a Focus on Squamous Cell Carcinomas and NSCLC. [NCT00966472]	Phase 1	24 participants (Actual)	Interventional	2009-03-31	Completed
A Phase II Study of TARCEVA (Erlotinib) in Combination With Chemoradiation in Patients With Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC) [NCT00563784]	Phase 2	68 participants (Actual)	Interventional	2007-11-30	Completed
Phase I Trial of Cetuximab and Erlotinib (EGFR Inhibitors) and SIR-Spheres (Yttrium Microspheres) in Patients With Advanced Malignancies and Liver Metastases [NCT01432119]	Phase 1	0 participants (Actual)	Interventional	2012-12-31	Withdrawn
Phase Ib Trial of Gemcitabine and Oxaliplatin (GEMOX) With Erlotinib in Patients With Advanced Biliary Tract Cancer. [NCT00987766]	Phase 1	28 participants (Actual)	Interventional	2009-11-30	Completed
A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Activity of MetMAb, a Monovalent Antagonist Antibody to the Receptor Met, Administered to Patients With Advanced Non-Small Cell Lung Cancer, in Combinati [NCT00854308]	Phase 2	137 participants (Actual)	Interventional	2009-04-30	Completed
Phase II Trial of Gemcitabine and Cisplatin/Carboplatin (GC) Plus Erlotinib in Patients With Recurrent and/or Metastatic Nasopharyngeal Cancer [NCT00603915]	Phase 2	20 participants (Actual)	Interventional	2006-06-30	Completed
Dose-finding, Safety, Pharmacokinetic and Pharmacodynamic Study of AVE1642, an Anti-Insulin-like Growth Factor-1 Receptor (IGF-1R/CD221) Monoclonal Antibody, Administered as Single Agent and in Combination With Other Anti Cancer Therapies (Sorafenib or Er [NCT00791544]	Phase 1/Phase 2	13 participants (Actual)	Interventional	2008-11-30	Terminated(stopped due to Company decision to discontinue the AVE1642 development program, not due to any safety or efficacy concerns)
An Open-label Study to Determine the Effect of R1507 Plus Tarceva (Erlotinib) on Progression-free Survival in Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) With Progressive Disease After Clinical Benefit to Second or Third Line Tarceva Mo [NCT00773383]	Phase 2	35 participants (Actual)	Interventional	2008-11-30	Terminated
A Phase I/ Randomized Phase II Study of Gemcitabine Plus Erlotinib Plus MK-0646; Gemcitabine Plus MK-0646 and Gemcitabine Plus Erlotinib for Patients With Advanced Pancreatic Cancer (IISP#33337) [NCT00769483]	Phase 1/Phase 2	81 participants (Actual)	Interventional	2008-11-13	Completed
Randomized Phase II Trial, Comparing Standard of Care Chemotherapy (Pemetrexed or Docetaxel) Plus Erlotinib to Standard of Care Chemotherapy (Pemetrexed or Docetaxel) Alone in EGFR TKI-Responsive Non-Small Cell Lung Cancer [NCT00660816]	Phase 2	46 participants (Actual)	Interventional	2008-01-31	Completed
Randomized Multicenter Phase III Study in Patients With Locally Advanced Adenocarcinoma of the Pancreas: Gemcitabine With or Without Chemoradiotherapy and With or Without Erlotinib. Intergroup Study [NCT00634725]	Phase 3	820 participants (Anticipated)	Interventional	2008-02-29	Completed
An Open Label, Randomized Phase I/IIa Trial Evaluating MK-0646 in Combination With Erlotinib (TARCEVA™) for Patients With Recurrent Non-Small Cell Lung Cancer [NCT00654420]	Phase 2	95 participants (Actual)	Interventional	2008-03-19	Completed
A Randomized Phase 2 Trial Of Pf-00299804 Versus Erlotinib For The Treatment Of Advanced Non-small Cell Lung Cancer After Failure Of At Least One Prior Chemotherapy Regimen [NCT00769067]	Phase 2	188 participants (Actual)	Interventional	2008-11-30	Completed
Study of Erlotinib, Small Molecule Targeting Epidermal Growth Factor Receptor (EGFR) in Treatment of Patients w/EGFR-overexpressing 'Triple Receptor-negative' Metastatic Carcinoma of Breast That Progressed on Anthracyclines and Taxanes [NCT00739063]	Phase 2	11 participants (Actual)	Interventional	2008-07-31	Terminated(stopped due to Poor Accrual)
Phase II Randomized, Double-blind, Placebo-controlled, Two-arm Study to Evaluate the Safety and Efficacy of Erlotinib in the Treatment of Moderate to Severe Psoriasis [NCT01006096]	Phase 2	0 participants (Actual)	Interventional		Withdrawn(stopped due to IND not obtained)
Tarceva With or Without Apatinib in the First-line Therapy of Advanced Lung Adenocarcinoma With Mutant EGFR:a Phase II Study. [NCT02704767]	Phase 2	60 participants (Anticipated)	Interventional	2016-06-30	Not yet recruiting
Imaging With 11C-erlotinib PET/CT to Identify Responders to Erlotinib Treatment in NSCLC [NCT01889212]		4 participants (Actual)	Interventional	2013-04-30	Terminated(stopped due to Due to technical problems)
Phase I Study of INC280 Plus Erlotinib in Patients With C-Met Expressing Non-Small Cell Lung Cancer [NCT01911507]	Phase 1	35 participants (Actual)	Interventional	2013-08-27	Completed
Phase I, Open Label, Dose Escalating Study of Intravenous Ascorbic Acid in Combination With Gemcitabine and Erlotinib in the Treatment of Metastatic Pancreatic Cancer [NCT00954525]	Phase 1	14 participants (Actual)	Interventional	2009-07-31	Completed
A Randomized, Open Label Study to Evaluate the Effect of Doxycycline on Tarceva-induced Skin Rash in Patients With Non-small Cell Lung Cancer After Failure of First Line Chemotherapy [NCT00531934]	Phase 2	147 participants (Actual)	Interventional	2007-10-31	Completed
An Open Label Pilot Trial of Erlotinib (Tarceva) in Primary Sclerosing Cholangitis With Trisomy 7 [NCT00955149]	Phase 1	6 participants (Actual)	Interventional	2009-08-31	Completed
A Randomized, Phase III Trial of Prophylactic Cranial Irradiation (PCI) in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Who Are Nonprogressive on Gefitinib or Erlotinib [NCT00955695]	Phase 3	242 participants (Anticipated)	Interventional	2009-05-31	Not yet recruiting
A Phase II Study of Bevacizumab and Erlotinib in Subjects With Advanced Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) or Sporadic Papillary Renal Cell Cancer [NCT01130519]	Phase 2	83 participants (Actual)	Interventional	2010-05-06	Active, not recruiting
Phase I/II Trial Using a Biomarker-Integrated Approach of Targeted Therapy for Lung Cancer Elimination Plus External Beam Radiation Therapy (BATTLE-XRT) [NCT02044601]	Phase 1/Phase 2	0 participants (Actual)	Interventional	2014-06-30	Withdrawn
Phase I/II Study of Two Different Schedules of Pemetrexed (ALIMTA) and Erlotinib (TARCEVA) in Advanced Solid Tumors, With Emphasis on Non-Small Cell Lung Cancer (NSCLC) [NCT00387322]	Phase 1/Phase 2	42 participants (Actual)	Interventional	2005-03-31	Completed
A Randomized Phase II Study of Erlotinib Alone Versus Erlotinib Plus Bevacizumab for Advanced Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor Activating Mutations [NCT03126799]	Phase 2	128 participants (Anticipated)	Interventional	2016-11-01	Active, not recruiting
Safety and Efficacy of Anlotinib Hydrochloride Combined With Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR TKIs) in Treating Advanced Non-small-cell Lung Cancer (NSCLC) Patients With Acquired Resistance to EGFR TKIs [NCT04007835]		120 participants (Anticipated)	Interventional	2019-07-31	Not yet recruiting
MARVEL: Marker Validation of Erlotinib in Lung Cancer- A Phase III Biomarker Validation Study of Second-Line Therapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Randomized to Pemetrexed Versus Erlotinib [NCT00738881]	Phase 3	23 participants (Actual)	Interventional	2008-10-31	Terminated(stopped due to Slow accrual)
Safety and Dose Finding Study of Oral MP470, a Multi-targeted Tyrosine Kinase Inhibitor, in Combination With Standard-of-Care Chemotherapy Regimens [NCT00881166]	Phase 1	101 participants (Actual)	Interventional	2007-11-30	Completed
APRiCOT-L (Apricoxib in Combination Oncology Treatment - Lung) A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Erlotinib in Non-Small Cell Lung Cancer Patients [NCT00652340]	Phase 2	120 participants (Actual)	Interventional	2008-04-30	Completed
Phase II Study of Erlotinib in Patients With Non-Metastatic Prostate Cancer With a Rising PSA on Hormone Therapy [NCT00148772]	Phase 2	29 participants (Anticipated)	Interventional	2005-08-31	Completed
Phase II Study of Erlotinib (Tarceva) Alternating With Chemotherapy for Second-line Treatment of Metastatic Colorectal Cancer With Molecular Correlates for p53 Pathway [NCT00642746]	Phase 2	16 participants (Actual)	Interventional	2008-03-31	Terminated(stopped due to Terminated due to poor enrollment and grade 3 toxicities noted during an interim analysis.)
A Phase I Dose-Escalation Study of Erlotinib in Combination With Dasatinib in Subjects With Advanced Cancer. Companion Study to Umbrella Protocol 2007-0638. [NCT00895128]	Phase 1	65 participants (Actual)	Interventional	2009-04-30	Completed
A Phase I Dose-Escalation Study of Erlotinib in Combination With Cetuximab in Subjects With Advanced Cancer. Companion Study to Umbrella Protocol 2007-0638. [NCT00895362]	Phase 1	65 participants (Actual)	Interventional	2009-04-30	Completed
A Randomized Phase 2 Study of Gemcitabine ± Erlotinib and DN-101 Versus Gemcitabine ± Erlotinib and Placebo in Subjects With Advanced Pancreatic Adenocarcinoma [NCT00536770]	Phase 2	132 participants (Anticipated)	Interventional	2007-09-30	Suspended(stopped due to DSMB)
A Phase 2 Study of Tarceva for Untreated, Good Prognosis Patients With Advanced Non-Small Cell Lung Cancer [NCT00585533]	Phase 2	40 participants (Actual)	Interventional	2004-06-30	Completed
A Phase 1 Protocol of 5-Azacytidine and Erlotinib in Advanced Solid Tumor Malignancies [NCT00996515]	Phase 1	30 participants (Actual)	Interventional	2008-06-30	Completed
A Phase II Trial of the Combination of OSI-774 (ERLOTINIB; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) and Adenocarcinoma With BAC Features (ADENOBAC) [NCT00436332]	Phase 2	84 participants (Actual)	Interventional	2007-07-31	Completed
A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-263 in Combination With Erlotinib and ABT-263 in Combination With Irinotecan, and Evaluating the Safety of ABT-263 Monotherapy in Subjects With Cancer [NCT01009073]	Phase 1	51 participants (Actual)	Interventional	2009-10-31	Completed
Pilot Study of Changes in FDG- and FLT-PET Imaging in Patients With Non-Small Cell Lung Cancer Following Treatment With Erlotinib [NCT00453362]	Phase 1/Phase 2	88 participants (Actual)	Interventional	2006-12-31	Completed
An Open Label Study of Tarceva in Combination With Gemcitabine in Unresectable and/or Metastatic Cancer of the Pancreas : Relationship Between Skin Rash and Survival [NCT00461708]	Phase 2	153 participants (Actual)	Interventional	2007-05-31	Completed
Phase-2 Study of Tarceva in Patients With Recurrent EGFR Positive and Phosphatase and Tensin Homolog (PTEN) Wild Type Glioblastoma Multiforme and Gliosarcoma [NCT00387894]	Phase 2	6 participants (Actual)	Interventional	2007-01-31	Terminated(stopped due to Insufficient accrual of population likely to benefit; progression in 6 patients)
A Randomized, Double-Blind, Placebo-Controlled, Phase IIIb Trial Comparing Bevacizumab Therapy With or Without Erlotinib After Completion of Chemotherapy With Bevacizumab for the First-Line Treatment of Locally Advanced, Recurrent, or Metastatic Non-Small [NCT00257608]	Phase 3	1,145 participants (Actual)	Interventional	2006-01-31	Completed
A Phase 2, Exploratory Study of Erlotinib and SNDX-275 in Patients With Non-small Cell Lung Carcinoma Who Are Progressing on Erlotinib [NCT00750698]	Phase 2	8 participants (Actual)	Interventional	2008-08-31	Terminated(stopped due to Due to business reasons, enrollment on the study was halted and the study terminated. The decision to close enrollment was not due to any safety concern.)
A Phase II Study of Erlotinib (Tarceva) in Combination With Bexarotene (Targretin) in Chemorefractory Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) [NCT00411632]	Phase 2	37 participants (Actual)	Interventional	2006-11-29	Completed
Phase II Study of Tarceva Plus Temodar During and Following Radiation Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme and Gliosarcoma [NCT00187486]	Phase 2	66 participants (Actual)	Interventional	2004-08-31	Completed
Randomized, Double-Blind, Phase 2 Study Of Erlotinib With Or Without SU011248 In The Treatment Of Metastatic Non-Small Cell Lung Cancer [NCT00265317]	Phase 2	162 participants (Actual)	Interventional	2006-06-30	Completed
A Phase I/II Clinical Trial of Oral Vorinostat (MK0683) in Combination With Erlotinib in Patients With Relapsed/Refractory Non-Small-Cell Lung Cancer [NCT00251589]	Phase 1/Phase 2	23 participants (Actual)	Interventional	2006-01-31	Terminated(stopped due to This trial is being closed based on lack of substantive efficacy, slow accrual and overall tolerance in patients treated to date.)
INST 0601C: A Non-Randomized Phase II Protocol of Erlotinib for Patients With Newly Diagnosed, Advanced Non-Small Cell Carcinoma of the Lung [NCT00391586]	Phase 2	45 participants (Actual)	Interventional	2006-07-31	Terminated(stopped due to PI left institution.)
A Randomized Phase II Trial of Avastin (A) or Avastin and Erlotinib (AE) as First Line Consolidation Chemotherapy After Carboplatin, Paclitaxel, and Avastin (CTA) Induction Therapy for Newly Diagnosed Advanced Ovarian, Fallopian Tube, Primary Peritoneal C [NCT00520013]	Phase 2	60 participants (Actual)	Interventional	2007-08-31	Completed
A Phase Ib Study of Erlotinib in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Previously Untreated Advanced Pancreatic Cancer [NCT01010945]	Phase 1	19 participants (Actual)	Interventional	2010-02-03	Completed
A Phase I Study of Erlotinib in Patients With Premalignant Lesions of the Lung [NCT01013831]	Phase 1	60 participants (Actual)	Interventional	2009-10-31	Terminated
Phase I/II Study of Chemoprevention With Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor Erlotinib (OSI-774, Tarceva) and Cyclooxygenase-2 (COX-2) Inhibitor (Celecoxib) in Premalignant Lesions of Head and Neck of Former Smokers [NCT00314262]	Phase 1/Phase 2	17 participants (Actual)	Interventional	2006-10-31	Completed
Phase II Study of RADPLAT and Tarceva in Locally Advanced Head and Neck Squamous Cell Carcinoma (SCCA) [NCT00304278]	Phase 2	21 participants (Actual)	Interventional	2006-03-31	Completed
A Phase I/II Study of Bevacizumab, Erlotinib and 5-fluorouracil With Concurrent External Beam Radiation Therapy in Locally Advanced Rectal Cancer [NCT00307736]	Phase 1/Phase 2	32 participants (Actual)	Interventional	2006-05-31	Completed
A Phase 2 Randomized Study of Tarceva (Erlotinib) as a Single Agent or Intercalated With Combination Chemotherapy in Patients With Newly Diagnosed Advanced Non-small Cell Lung Cancer Who Have Tumors With EGFR Protein Overexpression and/or Increased EGFR G [NCT00294762]	Phase 2	143 participants (Actual)	Interventional	2006-01-31	Completed
[NCT01066884]	Phase 4	5 participants (Actual)	Interventional	2009-04-30	Completed
A Phase I/II Trial of Neoadjuvant Paclitaxel, Carboplatin and OSI-774 (Tarceva) With Concurrent Accelerated Hyperfractionation Radiation Followed by Maintenance Therapy With OSI-774 for Stage III Non-Small Cell Lung Cancer [NCT00278148]	Phase 1/Phase 2	32 participants (Actual)	Interventional	2005-10-31	Completed
A Feasibility Study for Individualized Treatment of Patients With Advanced Pancreatic Cancer [NCT00276744]	Phase 2	249 participants (Actual)	Interventional	2005-10-31	Terminated(stopped due to Because there was no longer an active laboratory component to this study.)
Randomized Phase II Study of First-Line Treatment With Gemcitabine vs. Erlotinib vs. Gemcitabine and Erlotinib in Elderly Patients With Stage IIIB/IV Non-Small Cell Lung Cancer [NCT00283244]	Phase 2	147 participants (Actual)	Interventional	2006-03-31	Completed
A Phase II Trial of Bevacizumab and Erlotinib in the Treatment of Patients With Carcinoma of Unknown Primary Site [NCT00193622]	Phase 2	50 participants	Interventional	2004-04-30	Completed
A Phase II Study of OSI-774 (Tarceva) in Combination With Capecitabine in Previously Treated Patients With Metastatic Pancreatic Cancer [NCT00125021]	Phase 2	32 participants (Actual)	Interventional	2003-10-31	Completed
[NCT01887795]	Phase 3	224 participants (Actual)	Interventional	2013-08-31	Completed
A Phase I/Phase II Study of Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer Patients [NCT06071013]	Phase 1/Phase 2	20 participants (Anticipated)	Interventional	2023-09-28	Not yet recruiting
A Phase I Study of Cetuximab in Combination With Erlotinib in Patients With Advanced Solid Malignancies [NCT00207077]	Phase 1	33 participants (Anticipated)	Interventional	2005-08-31	Completed
A Phase I-II Study of OSI-774 (Tarceva, Erlotinib) With Docetaxel/Carboplatin Followed by Maintenance Therapy With Tarceva as Treatment for Newly Diagnosed Stage III/IV Epithelial Ovarian Cancer, Primary Peritoneal or Fallopian Tube Cancer [NCT00217529]	Phase 1/Phase 2	0 participants	Interventional	2004-06-30	Completed
UpSwinG: Real World Study on TKI Activity in Uncommon Mutations and Sequencing Giotrif® [NCT04179890]		462 participants (Actual)	Observational	2019-12-17	Completed
Pilot Study of EGFR Inhibition Using High Dose Administration of Erlotinib Weekly for Recurrent Malignant Gliomas With EGFR Variant III Mutation [NCT01257594]	Phase 1	22 participants (Actual)	Interventional	2011-01-07	Completed
A Randomized, Open-label Phase II Trial of Erlotinib 100mg Daily Versus Gefitinib 250mg Daily in Patients With Advanced Non-small Cell Lung Cancer Who Harbor EGFR Mutations. [NCT01955421]	Phase 2	224 participants (Anticipated)	Interventional	2013-07-31	Recruiting
An Open,Multi Center Trial to Evaluate the Efficacy and Safety of High-Dose,Pulsatile Erlotinib/Gefitinib for Advanced Non-Small Cell Lung Cancer Patients After Failure of Standard Dose EGFR-TKIs [NCT01965275]	Phase 2	20 participants (Anticipated)	Interventional	2013-10-31	Recruiting
A Phase 1 Trial of Low Dose Daily Erlotinib in Combination With High Dose Twice Weekly Erlotinib in Patients With EGFR-Mutant Lung Cancer [NCT01967095]	Phase 1	53 participants (Actual)	Interventional	2013-10-15	Completed
A Phase I Study of BAY 43-9006 (Sorafenib) in Combination With OSI-774 (Erlotinib; Tarceva) in Advanced Solid Tumors [NCT00126620]	Phase 1	17 participants (Actual)	Interventional	2005-09-30	Completed
Chemoprevention Trial Using Erlotinib in Barrett's Esophagus With High-Grade Dysplasia [NCT00566800]	Phase 1	25 participants (Anticipated)	Interventional	2007-07-31	Recruiting
Evaluation of Combination Checkpoint Inhibitor Plus Targeted Inhibitor (Erlotinib or Crizotinib) for EGFR or ALK Mutated Stage IV Non-small Cell Lung Cancer: Phase Ib With Expansion Cohorts [NCT01998126]	Phase 1	14 participants (Actual)	Interventional	2013-12-02	Completed
A Randomized, Open-label Phase III Study of First-line Treatment With Erlotinib Intercalated With Gemcitabine/ Cisplatin or Carboplatin Therapy Versus Erlotinib in Stage IIIB/IV NSCLC Patients With EGFR Mutation [NCT02001896]	Phase 3	60 participants (Anticipated)	Interventional	2013-12-31	Not yet recruiting
A Phase II, Open, Single Arm Trial to Evaluate Erlotinib Efficacy and Safety as the 2nd/3rd Line Treatment in Advanced or Recurrent NSCLC With EGFR Wild Type and Without C-met Expression [NCT02006043]	Phase 2	54 participants (Anticipated)	Interventional	2013-12-31	Recruiting
A Phase I/II Trial of an Oral MTOR Protein Kinase Inhibitor (Everolimus, RAD001) in Combination With an Oral EGFR Tyrosine Kinase Inhibitor (Erlotinib, Tarceva™) In Patients With Metastatic Breast Cancer [NCT00574366]	Phase 1	14 participants (Actual)	Interventional	2005-12-31	Completed
Genetic Events Leading to APC-Dependent Colon Cancer in High-Risk Families; a Clinical Trial of COX and EGFR Inhibition in Familial Polyposis Patients [NCT01187901]	Phase 2	92 participants (Actual)	Interventional	2010-04-30	Completed
EGFR-TKIs Combine Chemotherapy as First-line Therapy for Patients With Advanced EGFR Mutation-positive NSCLC [NCT02886195]	Phase 3	120 participants (Anticipated)	Interventional	2016-07-31	Enrolling by invitation
Phase 1/2, Open Label, Randomized Study Of The Safety, Efficacy, And Pharmacokinetics Of Erlotinib With Or Without Pf 02341066 In Patients With Advanced Non Small Cell Adenocarcinoma Of The Lung. [NCT00965731]	Phase 1	27 participants (Actual)	Interventional	2010-01-31	Completed
A Phase 1b Study of the Safety and Pharmacology of Atezolizumab (Anti-PD-L1 Antibody) Administered With Erlotinib or Alectinib in Patients With Advanced Non-Small Cell Lung Cancer [NCT02013219]	Phase 1	52 participants (Actual)	Interventional	2014-04-03	Completed
A Pilot Study of Genomic Sequencing Guided Individualized Therapy in Gastrointestinal Cancers [NCT02013089]		50 participants (Anticipated)	Interventional	2013-12-31	Recruiting
The Feasibility of Selecting Patient-Specific Biologically Targeted Therapy With Sorafenib, Everolimus, Erlotinib or Dasatinib for Pediatric Patients With Refractory Or Recurrent Brain Tumors [NCT02015728]		20 participants (Anticipated)	Interventional	2013-12-31	Active, not recruiting
A Two-Stage Phase 1 Dose Escalation Pharmacokinetic Study of Tarceva® (Erlotinib) in Patients With Stage IIIB/IV Non-small Cell Lung Cancer Who Continue To Smoke After Failure of One or Two Prior Chemotherapy Regimens [NCT00294736]	Phase 1	57 participants (Actual)	Interventional	2005-11-30	Completed
Phase 1 Umbrella Trial of Erlotinib In Combination With Select Tyrosine Kinase Inhibitors In Adult Patients With Advanced Solid Tumors [NCT06161558]	Phase 1	70 participants (Anticipated)	Interventional	2024-01-03	Not yet recruiting
Phase II Study of Gemcitabine Plus Erlotinib Versus Erlotinib Plus Gemcitabine Plus Oxaliplatin, in Patients With Locally Advanced or Metastatic Pancreatic Cancer [NCT00564720]	Phase 2	140 participants (Actual)	Interventional	2006-12-31	Terminated(stopped due to Due to poor accrual of the study)
Biomarkers Impact on the Response to Treatment With Erlotinib in First Line Non-small Cell Lung Cancer With EGFR Activating Mutations - BIOTEC [NCT01153984]	Phase 2	23 participants (Actual)	Interventional	2011-06-30	Completed
Phase II of Erlotinib an Epidermal Growth Factor Receptor Inhibitor in the Treatment of Myelodysplastic Syndrome [NCT00570375]	Phase 2	0 participants (Actual)	Interventional	2007-11-30	Withdrawn(stopped due to PI left institution)
Phase I Study of Combination of Capecitabine and Erlotinib Concurrent With Radiotherapy in Patients With Non-Operable Locally Advanced Pancreatic Cancer [NCT00565487]	Phase 1	15 participants (Actual)	Interventional	2007-12-31	Completed
A Phase-II Clinical Trial to Evaluate the Accuracy of FDG-/FLT-PET for Early Prediction of Non-progression in Patients With Advanced NSCLC Treated With Erlotinib and to Associate PET Findings With Molecular Markers [NCT00568841]	Phase 2	40 participants (Anticipated)	Interventional	2007-10-31	Active, not recruiting
An Open-label Study of the Effect of First-line Treatment With Avastin+Xelox, Followed by Avastin+Tarceva, on Progression-free Survival in Patients With Metastatic Colorectal Cancer [NCT01135498]	Phase 2	90 participants (Actual)	Interventional	2006-11-30	Completed
Phase II Study of Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Adenocarcinoma [NCT00470535]	Phase 2	18 participants (Actual)	Interventional	2007-01-31	Terminated(stopped due to This study was terminated earlier due to a phase III study that showed this drug inferior to sorafenib)
Phase I Study of Indibulin in Combination With Erlotinib in Advanced Solid Tumors [NCT00591383]	Phase 1	10 participants (Actual)	Interventional	2008-01-31	Active, not recruiting
Phase I Study of Erlotinib and Sunitinib in Non-small Cell Lung Cancer [NCT00581789]	Phase 1	11 participants (Actual)	Interventional	2007-08-31	Completed
Phase 1b Study of CS-7017 in Combination With Erlotinib in Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) Who Failed First-line Therapy [NCT01199068]	Phase 1	15 participants (Actual)	Interventional	2010-06-30	Completed
A Randomized Phase II Study of Preoperative Chemotherapy (Gemcitabine and Erlotinib) With or Without Radiation Therapy for Patients With Resectable Adenocarcinoma of the Pancreas [NCT00766636]	Phase 2	5 participants (Actual)	Interventional	2008-09-30	Terminated(stopped due to Slow Accrual)
Tyrosine-kinase Inhibitor （TKI） With or Without SBRT in Newly Diagnosed EGFRm Advanced Staged Lung Adenocarcinoma [NCT02893332]	Phase 3	200 participants (Anticipated)	Interventional	2016-01-15	Terminated(stopped due to After interim analysis, IRB recommend termination.)
A Phase 1b/2 Study of XL184 With or Without Erlotinib in Subjects With Non-Small Cell Lung Cancer [NCT00596648]	Phase 1/Phase 2	92 participants (Actual)	Interventional	2007-12-31	Completed
A Phase II Open-Label Trial to Evaluate the Efficacy and Toxicity of Tarceva (Erlotinib) in Women With Metastatic, Hormone Receptor Negative and Her2-Negative Breast Cancer [NCT00597597]	Phase 2	11 participants (Actual)	Interventional	2007-04-30	Terminated(stopped due to not enough patients enrolled)
An Open-Label Multicenter Study of Erlotinib (Tarceva®) as First Line Therapy Until and Beyond RECIST Progression in NSCLC Patients Who Harbour EGFR Mutations [NCT01310036]	Phase 2	208 participants (Actual)	Interventional	2011-04-30	Completed
Phase 2 Study of CS-7017 and Erlotinib in Subjects With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy [NCT01101334]	Phase 2	90 participants (Actual)	Interventional	2010-03-31	Completed
A Phase II Study of Bevacizumab and Erlotinib After Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma Without MGMT Promoter Methylation [NCT00720356]	Phase 2	115 participants (Actual)	Interventional	2009-07-07	Completed
A Phase 1 Dose-Escalation Study of XL765 in Combination With Erlotinib in Subjects With Solid Tumors [NCT00777699]	Phase 1	80 participants (Actual)	Interventional	2008-08-31	Completed
Second Line Erlitinib Combination With Gemcitabine Cisplatinum in Non-small Cell Lung Cancer Patients Who Harbored EGFR Sensitive Mutation Developed Resistance After First Line TKI Treatment [NCT02098954]	Phase 2	40 participants (Anticipated)	Interventional	2014-07-01	Recruiting
Phase I Study of Gemcitabine, Capecitabine, and Erlotinib Together in Advanced Pancreatic Cancers [NCT00885066]	Phase 1	30 participants (Actual)	Interventional	2008-05-31	Completed
A Phase 1 Dose-Escalation Study of XL147 (SAR245408) in Combination With Erlotinib in Subjects With Solid Tumors [NCT00692640]	Phase 1	35 participants (Actual)	Interventional	2008-05-31	Completed
Phase II Trial of Erlotinib in Combination With Docetaxel in Advanced Hepatocellular and Biliary Tract Carcinomas: Hoosier Oncology Group GI06-101 [NCT00532441]	Phase 2	25 participants (Actual)	Interventional	2007-09-30	Terminated(stopped due to Terminated due to funding issues.)
A Phase 1b, Multicenter Trial to Evaluate Molecular Determinants of Response to Erlotinib and MK0646 in Advanced Non-Small-Cell Lung Cancer [NCT00729742]	Phase 1	49 participants (Actual)	Interventional	2009-02-28	Completed
Phase I-II Study of Dasatinib and Erlotinib in Non-Small Cell Lung Cancer [NCT00826449]	Phase 1/Phase 2	53 participants (Actual)	Interventional	2009-02-28	Completed
A Randomized, Open Label Study Comparing the Effect of First-line Therapy With Tarceva + Gemcitabine Versus Gemcitabine Monotherapy on Treatment Response in Treatment-naïve Patients With Advanced Non-small Cell Lung Cancer [NCT00518011]	Phase 2	17 participants (Actual)	Interventional	2007-08-31	Completed
Phase I/II Clinical Trial Combining TUSC2-nanoparticles and Erlotinib in Stage IV Lung Cancer [NCT01455389]	Phase 1/Phase 2	25 participants (Actual)	Interventional	2014-02-28	Terminated(stopped due to Trial terminated by sponsor after decision to evaluate combination of quaratusugene ozeplasmid and osimertinib instead of further evaluating quaratusugene ozeplasmid and erlotinib.)
An Open-label Phase II Multicenter Study of the Safety and Activity (as Measured by FDG-PET Imaging Changes) of the Combination of Erlotinib and Pertuzumab in Patients With Relapsed Non-small Cell Lung Cancer [NCT00855894]	Phase 2	41 participants (Actual)	Interventional	2009-03-31	Completed
Thoracic Radiotherapy Combined With EGFR-TKI for Wild-type Non-small Cell Lung Cancer [NCT02738983]	Phase 2	22 participants (Anticipated)	Interventional	2012-01-31	Recruiting
A Phase II Study of Temsirolimus (Torisel®) and Erlotinib (Tarceva®) in Platinum-Refractory or -Ineligible, Advanced, Squamous Cell Carcinoma of the Head and Neck [NCT01009203]	Phase 2	13 participants (Actual)	Interventional	2009-12-31	Terminated(stopped due to High patient withdrawal rate)
Phase I Trial of Preoperative Radiotherapy With Concurrent Bevacizumab, Erlotinib and Capecitabine for Locally Advanced Pancreatic Cancer [NCT00614653]	Phase 1	17 participants (Actual)	Interventional	2008-01-31	Completed
Randomized, Placebo-controlled, Double-blind Phase 1b/2 Study of U3-1287 (AMG 888) in Combination With Erlotinib in EGFR Treatment Naïve Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Progressed on at Least One Prior Chemotherapy [NCT01211483]	Phase 1/Phase 2	222 participants (Actual)	Interventional	2010-09-30	Completed
A Randomized Phase II Trial of Erlotinib or Intermittent Dosing of Erlotinib and Docetaxel in Male Former-smokers With Locally Advanced or Metastatic Squamous NSCLC in Second-line Setting After Failure on Chemotherapy [NCT01204697]	Phase 2	74 participants (Actual)	Interventional	2010-11-30	Completed
A Randomized Phase II Study of Induction Chemotherapy Followed by Concurrent Chemoradiation Therapy According to EGFR Mutation Status in Patients With Unresectable Stage III NSCLC [NCT00620269]	Phase 2	212 participants (Anticipated)	Interventional	2008-02-29	Recruiting
An Open Label Study to Evaluate the Effect of First Line Treatment With Tarceva in Combination With Gemcitabine on Overall Survival and Disease Progression in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer [NCT00642733]	Phase 4	6 participants (Actual)	Interventional	2007-08-31	Terminated(stopped due to poor recruitment)
"A Non-interventional Study to Follow and Evaluate Patients With Advanced NSCLC Who Are Treated in Second Line Setting With Tarceva (Erlotinib) in a Real Life Clinical Setting" [NCT01161173]		347 participants (Actual)	Observational	2008-04-30	Completed
Phase II Trial of Molecularly Determined Treatment of Children and Young Adults With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas [NCT01182350]	Phase 2	53 participants (Actual)	Interventional	2011-09-30	Terminated(stopped due to Per design: Stop if fewer than 3 cohorts by molecular classification were with 10 participants or only 1 cohort enrolled at least 15 participants of 50.)
Phase II Study Evaluating the Role of Erlotinib an Epidermal Growth Factor Receptor (EGFR) Inhibitor in the Treatment of Myelodysplastic Syndrome [NCT00977548]	Phase 2	39 participants (Actual)	Interventional	2009-09-30	Completed
Phase II Study of Erlotinib With or Without Hydroxychloroquine in Patients With Previously Untreated Advanced NSCLC and EGFR Mutations [NCT00977470]	Phase 2	76 participants (Actual)	Interventional	2009-10-31	Active, not recruiting
Comparing Whole Brain Radiation With Hypofractionated Stereotactic RadioSurgery (HFSRS) in Patients With NSCL Brain Metastases [NCT02882984]	Phase 3	325 participants (Anticipated)	Interventional	2015-03-31	Recruiting
Multicentre Randomised Phase II Trial of Erlotinib Versus Carboplatin/Vinorelbine in Elderly Patients (=/> 70 Years) With Advanced Non-Small Cell Lung Cancer [NCT00678964]	Phase 2	260 participants (Anticipated)	Interventional	2006-06-30	Recruiting
A Prospective, Double-blind Randomized Phase III Study of 300 mg Versus 150 mg Erlotinib in Current Smokers With Locally Advanced or Metastatic NSCLC in Second-line Setting After Failure on Chemotherapy (CURRENTS) [NCT01183858]	Phase 3	315 participants (Actual)	Interventional	2010-10-31	Completed
A Multi-centre, Open-label, Phase IV, Interventional Study to Evaluate the Efficacy of Erlotinib (Tarceva®) Following 4 Cycles of Platinum-based Chemotherapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Not E [NCT01230710]	Phase 4	51 participants (Actual)	Interventional	2011-03-31	Completed
Randomized Phase II Study of AZD6244 MEK-Inhibitor With Erlotinib in KRAS Wild Type and KRAS Mutant Advanced Non-Small Cell Lung Cancer [NCT01229150]	Phase 2	89 participants (Actual)	Interventional	2010-10-26	Completed
A Randomised Phase II Double Blind Placebo Controlled Trial of Whole Brain Radiotherapy (WBRT) and Tarceva (OSI-774, Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With Multiple Brain Metastases [TACTIC] [NCT00554775]	Phase 2	80 participants (Actual)	Interventional	2008-01-31	Terminated(stopped due to IDMC made a recommendation to stop the trial as the target for continuing to the 2nd phase was not met.)
Phase I/II Trial of Preoperative Radiotherapy With Concurrent Bevacizumab, Erlotinib and Capecitabine for Locally Advanced Rectal Cancer [NCT00543842]	Phase 1	19 participants (Actual)	Interventional	2007-12-31	Completed
Cytochrom p450 3A4 and 1A2 Phenotyping for the Individualization of Treatment With Sunitinib or Erlotinib in Cancer Patients [NCT01402089]	Phase 4	54 participants (Actual)	Interventional	2012-01-31	Completed
A National, Multi Center, Randomized, Open-label, Phase II Trial of Erlotinib Versus Combination of GC as (Neo)Adjuvant Treatment in Stage IIIA-N2 NSCLC With Sensitizing EGFR Mutation in Exon 19 or 21(EMERGING) [NCT01407822]	Phase 2/Phase 3	72 participants (Actual)	Interventional	2011-12-05	Active, not recruiting
Pilot Trial of Molecular Profiling and Targeted Therapy for Advanced Non-Small Cell Lung Cancer, Small Cell Lung Cancer, and Thymic Malignancies [NCT01306045]	Phase 2	647 participants (Actual)	Interventional	2011-02-08	Active, not recruiting
Phase II Trial of OSI-774 (NSC-718781) in Patients With Advanced Non-Small Cell Lung Cancer and a Performance Status of 2 [NCT00087412]	Phase 2	65 participants (Actual)	Interventional	2004-09-30	Completed
A Multicenter, Open-Label, Phase IIIb Trial of Tarceva (Erlotinib Hydrochloride) in Patients With Advanced Non-Small Cell Lung Cancer [NCT00091663]	Phase 3	5,000 participants	Interventional	2004-08-31	Completed
A Phase II Open-label Rollover Study for Subjects That Have Participated in an Astellas Sponsored Linsitinib Trial [NCT02057380]	Phase 2	13 participants (Actual)	Interventional	2014-04-16	Completed
A Randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab in Combination With Erlotinib as First-Line Treatment for Patients With MET-Positive Unresectable Stage IIIb or IV Non-Small Cel [NCT01887886]	Phase 3	10 participants (Actual)	Interventional	2013-12-31	Completed
A Phase II Trial of Endocrine Therapy in Combination With OSI-906 (an IGF-1R Inhibitor) With or Without Erlotinib (Tarceva, an EGFR Inhibitor) in Patients With Hormone-sensitive Metastatic Breast Cancer. [NCT01013506]	Phase 2	0 participants (Actual)	Interventional	2009-08-31	Withdrawn(stopped due to Study was abandoned before opening to accrual. Replaced by another study.)
A Phase I and Randomized Phase II Trial of Gemcitabine + Erlotinib (NSC-718781) + IMC-A12 (NSC-742460) vs. Gemcitabine + Erlotinib as First-Line Treatment in Patients With Metastatic Pancreatic Cancer [NCT00617708]	Phase 1/Phase 2	134 participants (Actual)	Interventional	2008-03-31	Completed
A Phase II Study of Erlotinib (OSI-774); Tarceva in Women With Previously Untreated Advance Adenocarcinoma of the Lung [NCT00137839]	Phase 2	84 participants (Actual)	Interventional	2004-11-30	Completed
A Randomized, Open Label Study to Compare the Use of the Dermatological Creams Verutex, Eritex and Fisiogel in the Management of Skin Rash Associated With Tarceva Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer. [NCT00718315]	Phase 3	201 participants (Actual)	Interventional	2009-04-30	Completed
A Phase I/II, Dual-Center, Open-Label Trial of the Safety and Efficacy of Tarceva™ (Erlotinib Hydrochloride) Plus Sirolimus in Patients With Recurrent Malignant Glioma Not on P450-Inducing Anti-Epileptics [NCT00509431]	Phase 1	19 participants (Actual)	Interventional	2006-08-31	Completed
Bevacizumab Plus EGFR Tyrosine Kinase Inhibitors in Chinese Patients With Stage IIIB-IV EGFR-mutant Non-small Cell Lung Cancer: a Prospective,Multicenter, Non-interventional,Real-world Study [NCT04575415]		272 participants (Anticipated)	Observational	2020-10-07	Recruiting
Prospective Evaluation of Small Molecule EGFR-1 Tyrosine Kinase Inhibition as a First-Line Treatment in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Harbouring a Mutant EGFR Gene [NCT00339586]	Phase 2	40 participants	Interventional	2006-01-31	Recruiting
A Phase II Trial of Tarceva (Erlotinib) in Women With Squamous Cell Carcinoma of the Vulvar [NCT00476476]	Phase 2	41 participants (Actual)	Interventional	2006-12-31	Completed
A Phase II Study of OSI-774 (Tarceva) in Combination With Oxaliplatin and Capecitabine in Previously Treated Patients With Stage IV Colorectal Cancer [NCT00123851]	Phase 2	32 participants	Interventional	2003-03-31	Completed
A Phase II Study of Erlotinib (Tarceva) and Hypofractionated Thoracic Radiotherapy for Patients With Advanced or Inoperable Non-Small-Cell Lung Cancer [NCT00983307]	Phase 2	17 participants (Actual)	Interventional	2009-08-27	Completed
Randomized, Double Blind Multicenter Phase II Study of Time to Progression on Fulvestrant in Combination With Erlotinib or Placebo in Hormone Receptor-Positive Metastatic Breast Cancer (MBC) Subjects Who Progressed on First Line Hormonal Therapy [NCT00570258]	Phase 2	27 participants (Actual)	Interventional	2006-09-30	Terminated(stopped due to FDA approved higher dose of study drug. Dose used in protocol lower than SOC - enrollment stopped, those on treatment were given option to opt out.)
A Phase III, Open Label, Randomised, Multi-centre, International Study of MEDI4736, Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non-Small C [NCT02352948]	Phase 3	597 participants (Actual)	Interventional	2015-01-13	Completed
A Phase I/II Trial to Assess Safety and Tolerability of an Oral Aurora Kinase A Inhibitor, MLN8237, In Combination With Erlotinib In Patients With Recurrent or Metastatic Non-Small Cell Lung Cancer [NCT01471964]	Phase 1/Phase 2	22 participants (Actual)	Interventional	2011-10-20	Terminated(stopped due to Phase I portion completed. Phase II will open pending amendment approval.)
A Multi-Center, Phase 1/1b, Open-Label, Dose Escalation Study of ABT-700, a Monoclonal Antibody in Subjects With Advanced Solid Tumors [NCT01472016]	Phase 1	74 participants (Actual)	Interventional	2011-10-06	Completed
A Phase II Study of Erlotinib and Bevacizumab in Patients With Advanced Upper Gastrointestinal Carcinomas, Refractory or Intolerable to Standard Systemic Therapy [NCT00350753]	Phase 2	126 participants (Anticipated)	Interventional	2006-06-30	Completed
Phase II Trial of Tarceva Following Concurrent Chemo-Radiotherapy as First Line Therapy in Patients With Unresectable Non-Small Cell Lung Cancer [NCT00466284]	Phase 2	46 participants	Interventional	2006-01-31	Recruiting
A Multicenter Randomized Phase III Study of Pemetrexed Versus Erlotinib in Patients With Pretreated Advanced Non-Small-Cell Lung Cancer (NSCLC) [NCT00440414]	Phase 3	320 participants (Anticipated)	Interventional	2006-04-30	Completed
Phase I/II Trial of Erlotinib, Radiation Therapy, and Cisplatin in Patients With Complete Resected Squamous Cell Carcinoma of the Head and Neck [NCT00442455]	Phase 3	53 participants (Actual)	Interventional	2006-01-31	Completed
A Combined Phase 1 and 2 Study Investigating the Combination of RAD001 and Erlotinib in Patients With Advanced NSCLC Previously Treated Only With Chemotherapy [NCT00456833]	Phase 1	248 participants (Actual)	Interventional	2005-06-30	Completed
Phase I Trial Evaluating the Epidermal Growth Factor Receptor Inhibitor Erlotinib in Combination With the SRC Kinase Inhibitor Dasatinib for Patients With Recurrent Non-small Cell Lung Cancer (NSCLC) [NCT00444015]	Phase 1	34 participants (Actual)	Interventional	2007-03-31	Completed
Surgery for Early Lung Cancer With Preoperative Erlotinib (Tarceva): A Clinical Phase II Trial [NCT00462995]	Phase 2	25 participants (Actual)	Interventional	2006-05-31	Completed
A Phase I Trial of GemCap-T, Capecitabine in Combination With Gemcitabine and Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Adenocarcinoma [NCT00480584]	Phase 1	20 participants (Actual)	Interventional	2007-04-30	Completed
A Study of Pegylated Alfa Interferon, Sunitinib and Tarceva in Patients With Metastatic Renal Cell Carcinoma [NCT00522249]	Phase 1/Phase 2	10 participants (Actual)	Interventional	2007-05-31	Terminated(stopped due to PI decision)
A Study of Erlotinib (Tarceva®) Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Present Activating Mutations in the Tyrosine Kinase Domain of the Epidermal Growth Factor Receptor [NCT01287754]	Phase 4	24 participants (Actual)	Interventional	2011-10-31	Completed
Phase II, Open-Label Study of Erlotinib (Tarceva®) Treatment in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Present Activating Mutations in the Tyrosine Kinase Domain of the Epidermal Growth Factor Receptor [NCT01260181]	Phase 2	30 participants (Actual)	Interventional	2011-03-31	Completed
Avastin and Chemotherapy Followed by Avastin Alone or in Combination With Tarceva for the Treatment of Metastatic Colorectal Cancer. [NCT00598156]	Phase 3	249 participants (Actual)	Interventional	2007-06-30	Completed
A Phase I Study of Radiotherapy Concurrent With Erlotinib (Tarceva®) in the Treatment of Brain Metastases From Non-Small Cell Lung Cancer (NSCLC) [NCT00536861]	Phase 1	11 participants (Actual)	Interventional	2006-05-31	Completed
Inoperable Non-Squamous NSCLC Stage III/IV: A Randomised Phase II Study With Bevacizumab Plus Erlotinib Or Gemcitabin/Cisplatin Plus Bevacizumab [NCT00536640]	Phase 2	224 participants (Actual)	Interventional	2007-11-30	Completed
"A Phase I/II Trial of Hsp 90 Inhibitor AUY-922 in Patients With Lung Adenocarcinoma With Acquired Resistance to EGFR Tyrosine Kinase Inhibitors" [NCT01259089]	Phase 1/Phase 2	38 participants (Actual)	Interventional	2011-04-27	Completed
Assess the Incidence of Mutations in the Tyrosine Kinase Domain of the Endothelial Growth Factor Receptor in UK Patients With Newly Diagnosed Metastatic or Recurrent Non-small Cell Lung Cancer and to Investigate the Quality of Life of These Patients Under [NCT01250119]	Phase 2	688 participants (Actual)	Interventional	2011-03-31	Completed
A Phase 1/2 Trial of Erlotinib and Onalespib Lactate in EGFR-Mutant Non-Small Cell Lung Cancer [NCT02535338]	Phase 1/Phase 2	11 participants (Actual)	Interventional	2016-01-21	Active, not recruiting
A Phase 1 Study of Bevacizumab in Combination With 1) Sunitinib, 2) Sorafenib, 3) Erlotinib and Cetuximab, 4) Trastuzumab and Lapatinib [NCT00543504]	Phase 1	343 participants (Actual)	Interventional	2007-10-10	Completed
Phase IIa Single-arm Clinical Trial of Hepatocellular Carcinoma Chemoprevention With Low-dose Erlotinib in Patients With Liver Cirrhosis [NCT04172779]	Phase 2	30 participants (Anticipated)	Interventional	2024-07-31	Not yet recruiting
A Phase I Study to Assess the Food Effect on the Pharmacokinetics of Entinostat in Postmenopausal Women With Locally Recurrent or Metastatic ER+ Breast Cancer and Men and Women With Progressive Non-Small Cell Lung Cancer [NCT01594398]	Phase 1	14 participants (Actual)	Interventional	2012-05-31	Completed
A Phase II Study to Evaluate the Safety and Efficacy of RAD001 Plus Erlotinib in Patients With Well- to Moderately-Differentiated Neuroendocrine Tumors [NCT00843531]	Phase 2	17 participants (Actual)	Interventional	2009-06-25	Terminated(stopped due to Low Accrual)
A Non Interventional Trial of Tarceva Metastatic Non Small Lung Cancer. [NCT02595450]		299 participants (Actual)	Observational	2008-09-30	Completed
Archer 1009:a Randomized, Double Blind Phase 3 Efficacy And Safety Study Of Pf-00299804 (Dacomitinib) Versus Erlotinib For The Treatment Of Advanced Non-small Cell Lung Cancer Following Progression After, Or Intolerance To, At Least One Prior Chemotherapy [NCT01360554]	Phase 3	878 participants (Actual)	Interventional	2011-06-16	Completed
Multicenter Phase II Trial of OSI-774 (Erlotinib, Tarceva) In Patients With Advanced Bronchioloalveolar Cell Lung Cancer [NCT00590902]	Phase 2	81 participants (Actual)	Interventional	2002-03-31	Completed
A Phase II Study of OSI-774 in Combination With Cisplatin and Docetaxel in Metastatic or Recurrent Head and Neck Squamous Cell Cancer [NCT00076310]	Phase 2	50 participants (Actual)	Interventional	2004-01-28	Active, not recruiting
Phase II Quality of Life Study of Stereotactic RadioSurgery, Temozolomide and Erlotinib Chemotherapy for the Treatment of 1-3 Brain Metastases in Non-small Cell Lung Cancer [NCT00385398]	Phase 2	0 participants (Actual)	Interventional	2008-07-31	Withdrawn(stopped due to lack of funding and drug supply)
Randomized Phase II Trial of Panitumumab, Erlotinib and Gemcitabine vs. Erlotinib and Gemcitabine in Patients With Untreated, Metastatic Pancreatic Adenocarcinoma [NCT00550836]	Phase 2	104 participants (Actual)	Interventional	2009-03-31	Completed
Phase Ia/Ib, Open-Label, Multicenter, Dose-Escalation Study Followed by an Extension Phase to Evaluate the Safety, Pharmacokinetics and Activity of RO5479599, A Glycoengineered Antibody Against HER3, Administered Either Alone (Part A) or in Combination Wi [NCT01482377]	Phase 1	145 participants (Actual)	Interventional	2011-12-31	Completed
A Phase I Study of OSI-774 in Combination With Gemcitabine and Radiation in Locally Advanced, Non-Operable Pancreatic Cancer [NCT00063947]	Phase 1	28 participants (Actual)	Interventional	2003-05-31	Completed
A Randomized, Open-Label Phase II Clinical Trial of Combination Erlotinib (Tarceva®) and Fulvestrant (Faslodex®) Versus Erlotinib (Tarceva®) Alone in Advanced Non-Small Cell Lung Cancer Patients [NCT00100854]	Phase 2	108 participants (Actual)	Interventional	2004-10-28	Completed
A Phase III Trial Comparing Whole Brain Radiation (WBRT) and Stereotactic Radiosurgery (SRS) Alone Versus With Temozolomide or Erlotinib in Patients With Non-Small Cell Lung Cancer and 1-3 Brain Metastases [NCT00268684]	Phase 3	381 participants	Interventional	2005-05-31	Recruiting
Multicenter Phase II Trial of OSI-774 (Erlotinib, Tarceva) in Patients With Advanced Bronchioalveolar Cell Lung Cancer. [NCT00416650]	Phase 2	16 participants (Actual)	Interventional	2002-07-31	Completed
Genotypic-Based Pharmacodynamic Evaluation of Erlotinib (Erlotinib (Tarceva™, OSI Pharmaceuticals, Uniondale, NY) in Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN) [NCT00281866]	Phase 2	37 participants (Anticipated)	Interventional	2005-07-31	Completed
A Randomized Phase III Trial Assessing in Patients With Advanced Non-small Cell Lung Cancer Not Progressing on First Line Cisplatin-gemcitabine Chemotherapy Maintenance Chemotherapy With Gemcitabine or Sequential Treatment With Erlotinib [NCT00300586]	Phase 3	842 participants (Actual)	Interventional	2006-06-30	Completed
Phase I Studies of TarcevaTM (Erlotinib Hydrochloride, OSI-774) as Single Agent in Children With Refractory and Relapsed Malignant Brain Tumors and in Combination With Irradiation in Newly Diagnosed Brain Stem Glioma [NCT00418327]	Phase 1	48 participants (Anticipated)	Interventional	2005-06-30	Completed
A Phase II, Multicenter, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Tarceva (Erlotinib Hydrochloride) in Combination With Avastin (Bevacizumab) Versus Avastin Alone for Treatment of Metastatic Renal Cell Carcinoma [NCT00081614]	Phase 2	100 participants	Interventional	2004-03-31	Completed
Phase I Study of Erlotinib and Celecoxib in Former Smokers With Advanced Non-Small Cell Lung Cancer [NCT00088959]	Phase 1	45 participants (Actual)	Interventional	2003-12-31	Completed
A Pilot Study to Determine if Downstream Markers of EGFR Linked Signaling Pathways Predict Response to OSI-774 (Erlotinib) in the First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer [NCT00085280]		129 participants (Actual)	Interventional	2004-09-30	Completed
Phase I Trial of R115777 and OSI-774 in Patients With Advanced Solid Tumors [NCT00085553]	Phase 1	29 participants (Actual)	Interventional	2004-05-20	Completed
Randomized Phase II of TARCEVA™ (Erlotinib) Versus Temozolomide Or BCNU in Patients With Recurrent Glioblastoma Multiforme [NCT00086879]	Phase 2	110 participants (Actual)	Interventional	2004-05-31	Completed
Phase II Trial Of TAXOTERE + TARCEVA™ To Treat HRPC In Men ≥ 65 Years Of Age [NCT00087035]	Phase 2	1 participants (Actual)	Interventional	2004-05-31	Completed
Phase II Study to Evaluate the Tumor Biochemical Effects of the EGFR Tyrosine Kinase Inhibitor OSI-774 (Erlotinib) Administered Prior to Surgical Resection in Patients With Early Stage Non-Small Cell Lung Cancer [NCT00087269]	Phase 2	110 participants (Actual)	Interventional	2004-12-31	Terminated
Parallel, Randomized, Double-Blind, Placebo Controlled Phase II Adjuvant Studies of Erlotinib and Polyphenon E to Prevent the Recurrence and Progression of Tobacco-Related, Superficial Bladder Cancer [NCT00088946]	Phase 2	17 participants (Actual)	Interventional	2004-05-31	Completed
Erlotinib in Combination With Cisplatin as Radiosensitizing Agents in Women Receiving Radiation Therapy for Locally Advanced Squamous Cell Carcinoma of the Cervix; A Phase I Trial [NCT00428194]	Phase 1	0 participants (Actual)	Interventional	2007-01-31	Withdrawn(stopped due to Withdrawn due to lack of accrual)
A Phase II, Multicenter, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy (Docetaxel or Pemetrexed) or Tarceva (Erlotinib) Compared With Chemotherapy (Docetaxel or Pemetrexed) Alone for Treatmen [NCT00095225]	Phase 2	122 participants (Actual)	Interventional	2004-07-31	Completed
A Phase I, and Biologic Correlative Study of Erlotinib, in Combination With Cetuximab and Bevacizumab in Patients With Metastatic Renal Cell Carcinoma [NCT00101348]	Phase 1/Phase 2	66 participants (Actual)	Interventional	2005-01-31	Completed
Phase II Study of Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Malignant Mesothelioma [NCT00137826]	Phase 2	37 participants (Actual)	Interventional	2004-02-29	Completed
Randomized Phase III Trial With Capecitabine/Erlotinib Followed of Gemcitabine Versus Gemcitabine/Erlotinib Followed of Capecitabine in Patients With Advanced Pancreatic Cancer [NCT00440167]	Phase 3	280 participants (Anticipated)	Interventional	2006-06-30	Active, not recruiting
A Phase II, Multicenter, Open-Label Clinical Trial to Evaluate the Efficacy and Safety of OSI-774 in Patients With Advanced or Metastatic Breast Cancer and Disease Progression During or Following Chemotherapy [NCT00109265]	Phase 2	0 participants	Interventional	2001-05-31	Completed
An International Randomized Phase III Study of First-line Erlotinib Followed by Second-line Cisplatin + Gemcitabine Versus First-line Cisplatin + Gemcitabine Followed by Second-line Erlotinib in Advanced Non Small Cell Lung Cancer [NCT00349219]	Phase 3	760 participants (Actual)	Interventional	2006-12-31	Completed
Erlotinib (Tarceva) Given Intermittently During First Line Standard Platinum Containing Chemotherapy for Advanced Squamous Cell Carcinoma of the Head and Neck [NCT00448240]	Phase 2/Phase 3	6 participants (Actual)	Interventional	2007-02-28	Terminated(stopped due to Low Accrual, Funding)
Phase II Trial of OSI-774 (Erlotinib, Tarceva™,) and Capecitabine for Patients With Previously Untreated Metastatic Colorectal Cancer [NCT00459901]	Phase 2	13 participants (Actual)	Interventional	2004-06-30	Terminated(stopped due to Study halted by drug manufacturer)
A Phase II Trial of Bevacizumab (NSC# 704865) and OSI-774 (NSC# 718781) In Recurrent Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Carcinoma [NCT00126542]	Phase 2	35 participants (Actual)	Interventional	2005-04-30	Completed
A Phase I Study of the Combination of Chemoradiotherapy With Biologic Therapy for Advanced Head and Neck Cancer [NCT00405405]	Phase 1	13 participants (Actual)	Interventional	2006-12-31	Completed
Phase II Trial of Erlotinib in Advanced Pancreatic Cancer [NCT00497224]	Phase 2	51 participants (Actual)	Interventional	2006-11-30	Completed
Sequential Phase I/II Trial of Oral Vorinostat in Combination With Erlotinib in Non-small-cell Lung Cancer Patients With Mutations at Epidermal Growth Factor Receptor With Disease Progression After Erlotinib Treatment [NCT00503971]	Phase 1/Phase 2	50 participants (Actual)	Interventional	2007-12-31	Terminated
An Open-Label Study to Characterize the Pharmacokinetic Parameters of Erlotinib (Tarceva®, OSI-774) in Cancer Patients With Advanced Solid Tumors, With Adequate and Moderately Impaired Hepatic Function [NCT00139620]	Phase 1	39 participants (Actual)	Interventional	2005-08-22	Completed
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of ARQ197 Plus Erlotinib Versus Placebo Plus Erlotinib in Previously Treated Subjects With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer (NSCLC) [NCT01244191]	Phase 3	1,048 participants (Actual)	Interventional	2011-01-11	Terminated(stopped due to Sponsor decision due to the protocol-defined stopping boundary for futility was met based on the interim OS data.)
BATTLE-2 Program: A Biomarker-Integrated Targeted Therapy Study in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer [NCT01248247]	Phase 2	334 participants (Actual)	Interventional	2011-06-02	Completed
Real World Study to Evaluate the Efficacy and Resistant Mechanism of Erlotinib/Gefitinib Combined With Bevacizumab in First Line EGFR Mutation Positive Advanced Non-aquamous Non-small Cell Lung Cancer [NCT03647592]		30 participants (Anticipated)	Observational	2018-06-01	Recruiting
A Phase I, Open-Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6244 (ARRY-142886) When Given in Combination With Standard Doses of Selected Chemotherapies to Patients With Advanced Solid Tumors [NCT00600496]	Phase 1	140 participants (Actual)	Interventional	2007-12-14	Active, not recruiting
Multicenter Randomized Phase II Study of Erlotinib, Cisplatin and Radiotherapy Versus Cisplatin and Radiotherapy in Patients With Stage III and IV Squamous Cell Carcinoma of the Head and Neck [NCT00410826]	Phase 2	204 participants (Actual)	Interventional	2006-06-30	Completed
Randomized Phase II Trial of Sorafenib and Erlotinib or Sorafenib Alone in Patients With Advanced Non-Small Cell Lung Cancer Progressing on Erlotinib [NCT00609804]	Phase 2	53 participants (Actual)	Interventional	2008-03-31	Completed
A Phase 1b Trial of LY2584702 in Combination With Erlotinib or Everolimus in Patients With Solid Tumors [NCT01115803]	Phase 1	29 participants (Actual)	Interventional	2010-03-31	Terminated(stopped due to Primary objective has been met; safety and pharmacokinetics have been characterized.)
Phase II Trial of Bevacizumab Plus Erlotinib for Patients With Recurrent Malignant Glioma [NCT00671970]	Phase 2	57 participants (Actual)	Interventional	2007-02-28	Completed
A Phase I/II Trial of Radiation, Avastin and Tarceva for Resectable or Locally Advanced Pancreatic Adenocarcinoma [NCT00735306]	Phase 1	12 participants (Actual)	Interventional	2008-07-31	Completed
A Phase IIa Randomized, Double-Blind Trial of Erlotinib in Inhibiting EGF Receptor Signaling in Aberrant Crypt Foci of the Colon [NCT00754494]	Phase 2	45 participants (Actual)	Interventional	2008-07-31	Completed
Phase I/II Study of Bendamustine and Erlotinib for Metastatic or Locally Advanced Triple Negative Breast Cancer [NCT00834678]	Phase 1/Phase 2	11 participants (Actual)	Interventional	2009-04-30	Completed
Continuous Infusion Topotecan With Erlotinib for Topotecan Pretreated Ovarian Cancer: Tumor Features and Phase II/Pharmacokinetic Evaluation [NCT01003938]	Phase 2	6 participants (Actual)	Interventional	2009-08-31	Terminated(stopped due to due to administrative issue and financial sponsor decision to suspend ovarian cancer studies)
Phase I / II Adaptive Randomized Trial of Vorinostat, Erlotinib and Temozolomide in Adults With Recurrent Glioblastoma Multiforme [NCT01110876]	Phase 1/Phase 2	21 participants (Actual)	Interventional	2011-06-30	Terminated(stopped due to Unanticipated Toxicities)
A Randomized Phase II Trial of Erlotinib Versus Pemetrexed as Second-Line Therapy in Treating Patients With Advanced EGFR Wild-Type and EGFR FISH-Positive Lung Adenocarcinoma [NCT01565538]	Phase 2	123 participants (Actual)	Interventional	2008-12-31	Completed
A Phase II Trial of Tarceva (OSI-774) and Avastin (Bevacizumab) in the Treatment of Patients With Metastatic Renal Cell Carcinoma [NCT00193154]	Phase 2	63 participants (Actual)	Interventional	2003-02-28	Completed
A Multi-Center Study Investigating the Correlation Between TARCEVA ®-Induced Rash and Efficacy Among EGFR-mutated NSCLC Patients Receiving First-line Therapy [NCT01174563]	Phase 2	60 participants (Actual)	Interventional	2011-05-23	Completed
Study of Chinese Medicine Plus Targeted Therapy Maintenance Versus Targeted Therapy Maintenance in Advanced Pulmonary Adenocarcinoma: A Randomized Double-blind Controlled Clinical Trial [NCT02889692]	Phase 3	23 participants (Actual)	Interventional	2013-03-31	Completed
A Phase II, Multicenter, Open-Label Trial of the Safety and Efficacy of Tarceva (Erlotinib Hydrochloride) in Patients With First Relapse of Grade IV Glioma (Glioblastoma Multiforme) [NCT00337883]	Phase 2	110 participants	Interventional	2003-07-31	Completed
Phase II Randomized Trial of 3D Radiotherapy Versus the Combination of 3D Radiotherapy and Erlotinib (Tarceva®) in Patients With Localized-Unresectable Non-Small Cell Lung Cancer Non Susceptible for Chemotherapy Treatment. [NCT00466089]	Phase 2	90 participants (Anticipated)	Interventional	2006-03-31	Recruiting
Phase II Trial of Neoadjuvant Erlotinib Plus Chemotherapy for Treatment of ER Negative, PgR Negative and HER-2 Negative Primary Breast Cancer [NCT00491816]	Phase 2	32 participants (Actual)	Interventional	2007-07-31	Active, not recruiting
A Multi-Arm Complete Phase 1 Trial of Valproic Acid-Based 2-Agent Oral Regimens for Patients With Advanced Solid Tumor [NCT00495872]	Phase 1	204 participants (Actual)	Interventional	2007-06-30	Completed
Open-label Phase 2 Study of Single-agent Erlotinib for Patients With Pediatric Ependymoma Previously Treated With Oral Etoposide in Protocol OSI-774-205 [NCT01247922]	Phase 2	4 participants (Actual)	Interventional	2011-05-23	Terminated(stopped due to In a pre-planned interim analysis, OSI-774-205 met futility for efficacy with no safety concerns. As a result, the companion trial, OSI-774-206 has been stopped)
A Phase I-II, Multicenter, Open-label Trial of Co-administered CHR-2797 and Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer [NCT00522938]	Phase 1/Phase 2	2 participants (Actual)	Interventional	2007-12-31	Terminated(stopped due to Very poor recruitment of patients to the study)
A Phase I Study of Erlotinib and Dovitinib (TKI258) in Advanced Non-small Cell Lung Cancer [NCT01515969]	Phase 1	9 participants (Actual)	Interventional	2012-07-31	Terminated(stopped due to Patient safety - Unacceptable toxicity)
Whole Brain Radiation With or Without Erlotinib for Brain Metastases From Non-Small Cell Lung Cancer [NCT01518621]	Phase 2	25 participants (Actual)	Interventional	2012-05-31	Terminated(stopped due to Slow accrual)
Phase II Study of Neoadjuvant Treatment With Gemcitabine, Tarceva and Oxaliplatin Followed by Chemotherapy With Tarceva and Gemcitabine in Patients With Pancreas Adenocarcinoma With Borderline Resectability. [NCT01531712]	Phase 2	6 participants (Actual)	Interventional	2011-02-10	Terminated(stopped due to Due to a low recruitment rate since start of recruitment period.)
A Phase I Dose-Escalation Study of Erlotinib in Combination With Pralatrexate in Subjects With Advanced Cancer [NCT01532011]	Phase 1	72 participants (Actual)	Interventional	2012-03-31	Completed
A PHASE 1B, MULTI-CENTER, OPEN-LABEL STUDY OF THE MTOR KINASE INHIBITOR CC-223 IN COMBINATION WITH ERLOTINIB OR ORAL AZACITIDINE IN ADVANCED NON-SMALL CELL LUNG CANCER [NCT01545947]	Phase 1	76 participants (Actual)	Interventional	2012-05-01	Completed
Phase II Randomised Clinical Trial Evaluating an EGFR Tyrosine Kinase Inhibitor (EGFR-TKI) Versus an EGFR-TKI Combined With an Anti-oestrogen Treatment (Fulvestrant) in Women With Advanced Stage Non-squamous Lung Cancer [NCT01556191]	Phase 2	379 participants (Actual)	Interventional	2012-05-15	Completed
Phase I Evaluation of Erlotinib and Docetaxel With Concomitant Boost Radiation for Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck [NCT00113347]	Phase 1	10 participants (Actual)	Interventional	2005-04-30	Completed
A Phase II Study of Bevacizumab (Avastin™) and Erlotinib (Tarceva™) in Combination With FOLFOX for Patients With Untreated Metastatic Colorectal Cancer [NCT00116506]	Phase 2	35 participants	Interventional	2005-01-31	Completed
A Phase IB Study in Patients With Metastatic Colorectal Cancer to Evaluate Pharmacodynamic Effects of Erlotinib and Safety and Efficacy of Erlotinib in Combination With Modified FOLFOX6 (mFOLFOX6) and Bevacizumab [NCT00118261]	Phase 1	17 participants (Actual)	Interventional	2005-03-31	Completed
A Phase II Trial of Erlotinib and Concurrent Palliative Thoracic Radiation Therapy for Patients With Non-small Cell Carcinoma of the Lung. (PEARL Trial) [NCT00391248]	Phase 2	40 participants (Actual)	Interventional	2006-11-30	Completed
A Randomized Placebo Controlled Study Of OSI-774 (TARCEVA) Plus Gemcitabine In Patients With Locally Advanced, Unresectable Or Metastatic Pancreatic Cancer [NCT00026338]	Phase 3	569 participants (Actual)	Interventional	2001-10-29	Completed
A Phase II Evaluation Of OSI-774 (NSC #718781) In The Treatment Of Persistent or Recurrent Squamous Cell Carcinoma Of The Cervix [NCT00031993]	Phase 2	51 participants (Actual)	Interventional	2002-03-31	Completed
A Phase II Study of OSI-774 in Metastatic Colorectal Cancer [NCT00032110]	Phase 2	30 participants (Actual)	Interventional	2002-01-31	Completed
A Phase Ib Multicenter Trial To Determine The Safety, Tolerance And Preliminary Antineoplastic Activity Of Gemcitabine Administered In Combination With Escalating Oral Doses Of OSI-774 To Patient Cohorts With Recently Diagnosed, Gemcitabine-Naive, Advance [NCT00033241]	Phase 1	0 participants	Interventional	2001-07-23	Completed
A Randomized Placebo Controlled Study of OSI-774 (Tarceva (TM)) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer [NCT00040183]	Phase 3	569 participants (Actual)	Interventional	2001-11-29	Completed
A Phase I Study Of OSI-774 (NSC #718781)-Based Multimodality Therapy For Inoperable Stage III Non Small Cell Lung Cancer [NCT00042835]	Phase 1	48 participants (Actual)	Interventional	2002-05-31	Terminated(stopped due to Administratively complete.)
A Phase I Clinical and Biological Evaluation of Combined EGFR Blockade With Erlotinib and Cetuximab in Patients With Advanced Cancer [NCT00397384]	Phase 1	43 participants (Actual)	Interventional	2007-01-31	Completed
Phase II Study Of OSI-774 In Advanced Esophageal Cancer [NCT00045526]	Phase 2	48 participants (Anticipated)	Interventional	2002-06-30	Completed
Phase II Study Trial Of Tarceva In Patients With Recurrent/Progressive Glioblastoma Multiforme [NCT00054496]	Phase 2	73 participants (Anticipated)	Interventional	2002-08-31	Recruiting
A Phase II Study of OSI-774 (NSC-718781) in Patients With Locally Advanced or Metastatic Papillary Histology Renal Cell Cancer [NCT00060307]	Phase 2	40 participants (Anticipated)	Interventional	2003-05-31	Completed
A Phase II Study of OSI 774 (IND Number 63383) in Combination With Celecoxib (Celebrex, Pharmacia) as Second-Line Therapy in Advanced Non-Small Cell Lung Cancer [NCT00062101]	Phase 2	80 participants (Actual)	Interventional	2004-01-31	Completed
A Pharmacogenetic and Pharmacodynamic Study of Erlotinib (OSI-774) Toxicity in Patients With Advanced Solid Tumors [NCT00063895]	Phase 1/Phase 2	80 participants (Anticipated)	Interventional	2003-04-30	Completed
A Phase II, Open-label, Intra-patient Dose-escalation Study of Erlotinib in Patients With Advanced Non-small Cell Lung Cancer Who Have Failed Prior Chemotherapy [NCT00072631]	Phase 2	43 participants (Actual)	Interventional	2003-11-05	Completed
A Phase II Study of OSI-774 (Tarceva) in Elderly Subjects With Previously Untreated Advanced Non-Small Cell Lung Cancer (NSCLC) [NCT00137800]	Phase 2	82 participants (Actual)	Interventional	2003-02-28	Completed
Phase I/II Study of Postoperative Adjuvant Chemoradiation for cSCCHN [NCT01465815]	Phase 1/Phase 2	0 participants (Actual)	Interventional	2011-12-31	Withdrawn(stopped due to Drug manufacturer, Astellas Pharma, informed us that safety and efficacy of Erlotinib and OSI-906 in other oncology studies was determined to be unfavorable.)
A Phase II Study of Neo-adjuvant Erlotinib for Operable Stage IIB or IIIA Non-small Cell Lunc Cancer With Epidermal Growth Factor Receptor Activation Mutations [NCT01470716]	Phase 2	26 participants (Anticipated)	Interventional	2012-01-31	Active, not recruiting
Phase I Study of OSI-774 (NSC 718781) for Solid Tumors in Patients With Hepatic or Renal Dysfunction [NCT00030498]	Phase 1	75 participants (Actual)	Interventional	2001-12-31	Completed
A Pilot Study to Evaluate Epidermal Growth Factor Receptor Signaling After Treatment With Oral OSI-774 in Patients With Locally Advanced or Metastatic Breast Cancer [NCT00030537]	Phase 2	0 participants	Interventional	2001-11-30	Completed
A Phase I/II Study Of OSI-774 In Combination With Cisplatin In Patients With Recurrent Or Metastatic Squamous Cell Cancer Of The Head And Neck [NCT00030576]	Phase 1/Phase 2	51 participants (Actual)	Interventional	2001-11-30	Completed
A Phase II Trial of OSI-774 in Patients With Hepatocellular or Biliary Carcinoma [NCT00033462]	Phase 2	78 participants (Anticipated)	Interventional	2002-03-31	Completed
Phase I Study of Bevacizumab in Combination With Everolimus and Erlotinib in Advanced Cancer [NCT00276575]	Phase 1	65 participants (Actual)	Interventional	2005-03-31	Completed
A Randomised, Placebo-Controlled Trial of Erlotinib in Patients With Advanced NSCLC Unsuitable for Chemotherapy [NCT00275132]	Phase 3	670 participants (Actual)	Interventional	2005-04-30	Completed
A Phase I/II Study Of OSI-774 In Combination With Oxaliplatin, And 5-Fluourouracil In Patients With Metastatic Colorectal Carcinoma [NCT00049101]	Phase 1/Phase 2	0 participants	Interventional	2002-08-31	Completed
A Phase I and Phase II Study of OSI-774 in Combination With Docetaxel in Squamous Cell Carcinoma of the Head and Neck [NCT00055770]	Phase 1/Phase 2	45 participants (Anticipated)	Interventional	2002-10-31	Completed
A Phase II Study Of OSI-774 (NSC 718781) Given In Combination With Carboplatin In Patients With Recurrent Epithelial Ovarian Cancer [NCT00030446]	Phase 2	50 participants (Actual)	Interventional	2002-01-10	Completed
A Phase II Study of OSI-774 (NSC 718781) in Patients With Locally Advanced and/or Metastatic Carcinoma of the Endometrium [NCT00030485]	Phase 2	0 participants	Interventional	2002-01-31	Completed
A Phase II Study Of OSI-774 (NSC 718781) In Unresectable Or Metastatic Adenocarcinoma Of The Stomach And Gastroesophageal Junction [NCT00032123]	Phase 2	0 participants	Interventional	2002-06-30	Completed
A Phase I, Pharmacological, and Biological Study of OSI-774 in Combination With FOLFOX 4 (5-FU, Leucovorin, and Oxaliplatin) and Bevacizumab (Avastin) in Patients With Advanced Colorectal Cancer [NCT00060411]	Phase 1	24 participants (Actual)	Interventional	2003-06-30	Completed
A Randomized Placebo Controlled Study of OSI-774 (Erlotinib HCl, Tarceva[TM]) in Patients With Incurable Stage IIIB/IV Non-small Cell Lung Cancer Who Have Failed Standard Therapy for Advanced or Metastatic Disease [NCT00036647]	Phase 3	731 participants (Actual)	Interventional	2001-11-01	Completed
Pilot Study, Without Direct Individual Benefice, of Biological Effect of Tarceva (OSI-774) at Posology of 150 mg by Day for Patients Stricken by ENT Epidermoid Carcinoma Waiting for First Surgical Picking up. [NCT00144976]		43 participants (Actual)	Interventional	2003-10-31	Completed
A Phase I Trial Of A COX-2 Inhibitor (Celecoxib) In Combination With An EGFR Inhibitor (OSI-774) In Metastatic Non-Small Cell Lung Cancer [NCT00072072]	Phase 1	0 participants	Interventional	2003-08-31	Completed
A Phase II Study of Oral EGFR Tyrosine Kinase Inhibitor OSI-774 (NSC-718781) in Patients With Malignant Pleural Mesothelioma [NCT00039182]	Phase 2	55 participants (Actual)	Interventional	2002-05-31	Completed
A Pilot and Phase II Study of OSI-774 and Temozolomide in Combination With Radiation Therapy in Glioblastoma Multiforme [NCT00039494]	Phase 2	171 participants (Anticipated)	Interventional	2002-12-31	Completed
A Phase I Study of Single Agent OSI-774 (Tarceva) (NSC# 718781, IND# 63383) Followed by OSI-774 With Temozolomide for Patients With Selected Recurrent/Refractory Solid Tumors, Including Brain Tumors [NCT00077454]	Phase 1	95 participants (Actual)	Interventional	2004-02-29	Completed
Phase I Study To Determine The Safety, Tolerance And Preliminary Antineoplastic Activity Of Combined EGFR (erbB1) And HER2 (erbB2) Blockade, With OSI-774 And Trastuzumab, In Combination With Weekly Paclitaxel [NCT00042809]	Phase 1	40 participants (Actual)	Interventional	2002-05-31	Completed
Safety and Efficacy of Recombinant Humanized Monoclonal Anti-VEGF Antibody rhuMAb VEGF and EGFR Tyrosine Kinase Inhibitor OSI-774 for Locally Advanced or Metastatic Non-Squamous Cell NSCLC in Patients Who Have Been Previously Treated [NCT00043823]	Phase 1/Phase 2	41 participants (Actual)	Interventional	2002-08-01	Completed
A Phase 2 Open-Label Study Of OSI-774 (NSC 718781) In Unresectable Hepatocellular Carcinoma [NCT00047333]	Phase 2	80 participants (Actual)	Interventional	2002-08-31	Terminated(stopped due to Administratively complete.)
Open-Label, Multicenter, Dose-Escalation Study in Subjects w/Advanced Colorectal Cancer to Evaluate the Safety, Efficacy, and Pharmacokinetics of Tarceva in Combination w/5-Fluorouracil, Leucovorin, and Irinotecan and of Bevacizumab in Combination w/Tarce [NCT00047762]	Phase 1	0 participants	Interventional	2002-10-31	Completed
A Phase I Study of OSI-774 in Combination With Standard Fractionation Radiation Therapy in Patients With Oral Cavity or Oropharyngeal Cancer Stage II or III and in Combination With Standard Fractionation Radiation Therapy and Low Dose Daily Cisplatin in P [NCT00049166]	Phase 1	48 participants (Actual)	Interventional	2002-10-31	Completed
A Phase I Study of the Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor, OSI-774, in Combination With Docetaxel and Radiation in Locally Advanced Squamous Cell Cancer of the Head and Neck [NCT00049283]	Phase 1	30 participants (Actual)	Interventional	2002-09-30	Completed
Gemcitabine and Cisplatin With Erlotinib in Hepatocellular Carcinoma (HCC) and Biliary Tree Cancer (BTC) (Intra- and Extra-hepatic Cholangiocarcinoma, Bile Duct Cancer, Adenocarcinoma of the Ampulla of Vater and Gallbladder Carcinoma) [NCT00832637]	Phase 2	33 participants (Actual)	Interventional	2007-08-31	Terminated(stopped due to Low accrual)
A Phase I/II Study Of Bevacizumab (rhuMAb VEGF) In Combination With OSI-774 For Patients With Recurrent Or Metastatic Cancer Of The Head And Neck [NCT00055913]	Phase 1/Phase 2	58 participants (Actual)	Interventional	2003-03-31	Completed
A Dose-Finding, Safety, And Pharmacokinetic Study Of The Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor OSI-774 (NSC 718781) In Patients With Unresectable Hepatocellular Carcinoma And Moderate Hepatic Dysfunction [NCT00047346]	Phase 1	24 participants (Actual)	Interventional	2002-08-31	Completed
A Phase II Study of OSI-774 (Tarceva) and Gemcitabine for Patients With Metastatic Breast Cancer [NCT00059852]	Phase 2	61 participants (Actual)	Interventional	2003-06-30	Completed
A Phase III, Randomized, Double Blind, Multicenter Trial of Tarceva (Erlotinib) Plus Chemotherapy (Carboplatin and Paclitaxel) Versus Chemotherapy Alone in Patients With Advanced (Stage IIIb or IV) Non-Small Cell Lung Cancer Who Have Not Received Prior Ch [NCT00047736]	Phase 3	0 participants	Interventional	2001-07-31	Completed
Phase II Study of OSI-774 (Erlotinib, Tarceva) in Elderly Patients With Advanced Stage or Inoperable Non Small Cell Lung Cancer (NSCLC) [NCT00200395]	Phase 2	30 participants (Actual)	Interventional	2003-07-02	Completed
Phase I Study of Secondary Primary Tumor Prevention With Epidermal Growth Factor Receptor (EGFR), Tyrosine Kinase Inhibitor Erlotinib (OSI-774, Tarceva™), and Cyclooxygenase-2 (COX-2) Inhibitor (Celecoxib) in Early Stage (Stage I/II) Squamous Cell Carcino [NCT00400374]	Phase 1	10 participants (Actual)	Interventional	2007-08-31	Completed
Phase I Study of Erlotinib Administered Every 72 Hours in Patients With Glioblastoma Multiforme With Pharmacokinetic/Pharmacodynamic Correlates [NCT00227032]	Phase 1	10 participants (Actual)	Interventional	2005-09-30	Terminated(stopped due to Loss of funding)
A Randomized Phase 2 Study Comparing Erlotinib-Pemetrexed, Pemetrexed Alone, and Erlotinib Alone, as Second-Line Treatment for Non-Smoker Patients With Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer [NCT00550173]	Phase 2	247 participants (Actual)	Interventional	2007-11-30	Completed
A Phase II, Open Label Study of Erlotinib (Tarceva) in Previously Treated Subjects With Advanced Non-Small Cell Lung Cancer [NCT00410059]	Phase 2	59 participants (Actual)	Interventional	2006-11-30	Completed
A Phase II Study of Erlotinib (Tarceva®) in Patients With Muscle-Invasive Bladder Cancer Undergoing Radical Cystectomy [NCT00380029]	Phase 2	27 participants (Actual)	Interventional	2006-05-31	Completed
A Phase II Study of Erlotinib With Bevacizumab in Chemotherapy Naïve Performance Status (PS) 2 Patients With Advanced Non-Small Cell Lung Cancer [NCT00367601]	Phase 2	25 participants (Actual)	Interventional	2006-08-31	Completed
A Phase II Trial of Erlotinib and Avastin in Previously Treated Patients With Cancer of the Esophagus or Gastroesophageal Junction [NCT00442507]	Phase 2	6 participants (Actual)	Interventional	2007-03-31	Terminated(stopped due to Slow accrual)
A Phase 2 Randomized Open-label Study of Erlotinib Plus Tivantinib (ARQ 197) Versus Single Agent Chemotherapy in Previously Treated KRAS Mutation Positive Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer [NCT01395758]	Phase 2	96 participants (Actual)	Interventional	2011-07-31	Completed
A Phase II Trial of Erlotinib (Tarceva®) in Combination With Stereotactic Body Radiation Therapy (SBRT) for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) [NCT00547105]	Phase 2	24 participants (Actual)	Interventional	2007-06-25	Completed
A Single-Dose,ComparativeBioavailability Study ofTwo Formulations ofErlotinib150mgTabletsunderFastingConditions [NCT04145570]	Phase 4	24 participants (Actual)	Interventional	2008-10-23	Completed
A Randomized, Placebo-Controlled Phase II Clinical Trial of Combination Erlotinib (Tarceva) and Celecoxib (Celebrex) Versus Erlotinib (Tarceva)/Placebo in Advanced Non-Small Cell Lung Cancer Patients [NCT00499655]	Phase 2	107 participants (Actual)	Interventional	2007-11-30	Completed
Randomized Phase II Trial of Adjuvant Carboplatin, Docetaxel, Bevacizumab, and Erlotinib Versus Chemotherapy Alone in Patients With Resected Non-Small Cell Lung Cancer [NCT00621049]	Phase 2	112 participants (Actual)	Interventional	2007-12-31	Completed
Phase I/II Clinical Trial of Combined Pre-Irradiation With Pemetrexed and Erlotinib Followed by Maintenance Erlotinib for Recurrent and Second Primary Squamous Cell Carcinoma of the Head and Neck [NCT00573989]	Phase 1/Phase 2	27 participants (Actual)	Interventional	2008-03-31	Terminated(stopped due to Drug Supply Issue)
AVF4236s: Bevacizumab (Avastin®) + Erlotinib as First-line Therapy for Stage IIIB/IV or Recurrent, Non-squamous Cell Lung Cancer [NCT00585377]	Phase 2	50 participants (Actual)	Interventional	2007-08-31	Completed
A Phase II Study of Chemotherapy Treatment Based on Molecular Profiling Diagnosis for Patients With Carcinoma of Unknown Primary Site [NCT00737243]	Phase 2	289 participants (Actual)	Interventional	2008-08-31	Completed
Phase I Study of Low-Dose Fractionated Radiotherapy as a Chemosensitizer for Gemcitabine and Erlotinib in Patients With Locally Advanced or Limited Metastatic Pancreatic Cancer [NCT00761345]	Phase 1	27 participants (Actual)	Interventional	2008-09-30	Completed
A Phase II Study of Erlotinib and Modified FOLFOX-6 (5-Fluorouracil, Leucovorin and Oxaliplatin) in Previously Untreated Patients With Unresectable or Metastatic Adenocarcinoma of the Esophagus and Gastric Cardia [NCT00591123]	Phase 2	38 participants (Actual)	Interventional	2007-12-31	Completed
Phase II Study of Gemcitabine and Intermittent Erlotinib in Advanced Pancreatic Cancer [NCT00810719]	Phase 2	30 participants (Actual)	Interventional	2009-04-30	Completed
Concomitant Tarceva® and Irradiation in Patients in Local-regionally Advanced Non-small Cell Lung Cancer. A Phase II Study [NCT00888511]	Phase 2	15 participants (Actual)	Interventional	2009-05-31	Completed
A Phase I Study of Erlotinib in Combination With Quinacrine in Patients With Advanced Non-Small-Cell Lung Cancer [NCT01839955]	Phase 1	12 participants (Actual)	Interventional	2013-09-30	Completed
[NCT01727869]	Phase 1	56 participants (Actual)	Interventional	2012-10-31	Completed
A Phase I/II Study of Tivozanib and Erlotinib as Initial Treatment for Metastatic Non-small Cell Lung Cancer Assigned by VeriStrat® Serum Proteomic Evaluation [NCT01728181]	Phase 1/Phase 2	0 participants (Actual)	Interventional	2013-11-30	Withdrawn(stopped due to Stopped before approval due to ineffective drug)
Phase II Study of Bevacizumab and Erlotinib in Elderly Patients With Advanced Non-Small Lung Cancer [NCT00553800]	Phase 2	32 participants (Actual)	Interventional	2007-07-05	Completed
Rapid Plasma Genotyping For Early Initiation Of Erlotinib In EGFR Mutant Lung Cancer [NCT02770014]	Phase 2	43 participants (Actual)	Interventional	2016-06-30	Terminated(stopped due to Terminated due to Osimertinib approval)
Personalized Adaptive Radiation Therapy With Individualized Systemic Targeted Therapy (PARTIST) for Locally Advanced, Non-small Cell Lung Cancer With Genomic Driver Mutations [NCT02277457]	Early Phase 1	0 participants (Actual)	Interventional	2015-09-30	Withdrawn
Phase III Study of an Optimized Chemotherapy Followed by Maintenance With Bevacizumab Strategy With or Without Erlotinib in Unresectable Metastatic Colorectal Cancer. DREAM OPTIMOX 3. C04-2 [NCT00265824]	Phase 3	700 participants (Actual)	Interventional	2005-05-31	Completed
A Two-Part Phase I Study of the Addition of Oxaliplatin to Gemcitabine, and Then Erlotinib Plus Oxaliplatin to Gemcitabine as Radiosensitizers for Pancreatic and Biliary Adenocarcinoma [NCT00266097]	Phase 1	23 participants (Actual)	Interventional	2004-08-31	Completed
A Phase I-II Dose Finding and Early Efficacy Study of Combination Therapy With Erlotinib (Tarceva), Gemcitabine, Bevacizumab (Avastin), and Capecitabine in Advanced Pancreatic Cancer [NCT00260364]	Phase 1/Phase 2	44 participants (Actual)	Interventional	2005-11-30	Completed
Pilot Study Using Neoadjuvant Chemo-Radiotherapy and EGFR-tyrosine Kinase Inhibitor for Potentially Resectable Pancreatic Cancer [NCT00243854]	Phase 1	8 participants (Actual)	Interventional	2005-11-30	Completed
A Phase II Trial of Erlotinib With Temozolomide and Concurrent Radiation Therapy Post-Operatively in Patients With Newly Diagnosed Glioblastoma Multiforme [NCT00274833]	Phase 2	27 participants (Actual)	Interventional	2005-10-31	Completed
Phase II Open-Label Study of Volociximab (M200) in Combination With Erlotinib (Tarceva™) in Previously Treated Patients With Locally Advanced (Stage IIIb) or Metastatic (Stage IV) Non-Small Cell Lung Cancer [NCT00278187]	Phase 2	0 participants	Interventional	2005-07-31	Active, not recruiting
A Prospective, Open-labelled, Randomized, Multicenter Phase II Study to Evaluate Efficacy and Safety of Erlotinib vs NP Chemotherapy as Adjuvant Therapy in Post Radical Operation NSCLC Patients With EGFR19 or 21 Exon Mutation [NCT01683175]	Phase 2	94 participants (Actual)	Interventional	2012-08-31	Active, not recruiting
Phase I/II Trial of OSI-906 in Combination With Gemcitabine and Erlotinib in Patients With Metastatic Ductal Adenocarcinoma of the Pancreas [NCT01600807]	Phase 1/Phase 2	0 participants (Actual)	Interventional		Withdrawn(stopped due to Study was pending major changes and was on hold, pending activation; administratively withdrawn; will be submitted as a new protocol if study is revised.)
The Role of Epidermal Growth Factor Receptor (EGFR) Mutations in Pancreatic Cancer Patients Receiving Gemcitabine With or Without Erlotinib [NCT01608841]	Phase 2	88 participants (Anticipated)	Interventional	2005-07-31	Recruiting
A Phase 1 Study of LY2875358 in Japanese Patients With Advanced Malignancies [NCT01602289]	Phase 1	17 participants (Actual)	Interventional	2012-06-30	Completed
A Phase I/II Study of Celecoxib and Erlotinib Hydrochloride as Adjuvant Therapy for High Risk Patients With a History of Hepatocellular Carcinoma [NCT00293436]	Phase 1/Phase 2	0 participants (Actual)	Interventional	2005-01-31	Withdrawn
A Randomized, Multicenter, Phase III Study of Erlotinib Versus Observation in Patients With no Evidence of Disease Progression After First Line, Platinum-Based Chemotherapy For High-Risk Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer [NCT00263822]	Phase 3	835 participants (Actual)	Interventional	2005-09-30	Completed
A Multicenter Randomized Phase II Trial in NSCLC Stage IV and IIIB (T4 With Pleural Effusion) in Elderly Independent Patients the Schedule Docetaxel / Gemcitabine First Line Following by Erlotinib When Progression Versus Erlotinib First Line Following by/ [NCT00418704]		100 participants (Actual)	Observational	2006-05-31	Completed
A Randomized, Non-comparative, Multicenter, Open-Label, Phase 2 Study of Tarceva™ (Erlotinib) Alone and of Tarceva Plus VELCADE* (Bortezomib) for Injection in Patients With Relapsed or Refractory, Locally Advanced or Metastatic Non-Small Cell Lung Cancer [NCT00283634]	Phase 2	0 participants	Interventional	2005-08-31	Terminated(stopped due to insufficient efficacy)
A Two Arm Phase I Dose Escalation Trial of Vinflunine With Erlotinib or Pemetrexed in Refractory Solid Tumors [NCT00320073]	Phase 1	41 participants (Actual)	Interventional	2006-08-31	Completed
A Phase I Study of Hydroxychloroquine With or Without Erlotinib in Advanced NSCLC [NCT01026844]	Phase 1	27 participants (Actual)	Interventional	2007-07-31	Terminated(stopped due to slow enrollment)
Pemetrexed Plus Tarceva as Salvage Treatment in EGFR Overexpressed Metastatic Colorectal Cancer Patients Who Were Failed After Standard Chemotherapy: A Phase II Single Arm Prospective Study [NCT03086538]	Phase 2	29 participants (Actual)	Interventional	2017-05-30	Completed
Phase III Study of Monotherapy by Gemcitabine or Vinorelbine Comparing to Doublet by Carboplatin and Paclitaxel Among Elderly Patients With Stage IIIB/IV NSCLC (Obligatory Second-line by Erlotinib) [NCT00298415]	Phase 3	451 participants (Actual)	Interventional	2006-03-31	Completed
A Phase II Study of Erlotinib and Predictive Markers as First-line Treatment of Advanced Non-small Cell Lung Cancer for Patients Unfit for Chemotherapy [NCT00452075]	Phase 2	24 participants (Actual)	Interventional	2007-03-31	Terminated(stopped due to Poor recruitment)
A Multicenter Randomized Phase II Trial in NSCLC Stage IV et IIIB in Elderly Dependent Patients With Evaluation of the Sequence Gemcitabine First Line Followed by Erlotinib When Progression Versus Erlotinib First Line Followed by Gemcitabine When Progress [NCT00419042]		100 participants (Actual)	Observational	2006-07-31	Completed
Phase 2 Study of GEMOX-T in Previously Untreated Patients With Advanced Pancreatic Cancer [NCT01505413]	Phase 2	33 participants (Actual)	Interventional	2011-01-31	Completed
Pilot Study on the Determination of Intratumoral Concentrations of Kinase Inhibitors in Patients With Advanced Solid Malignancies. [NCT01636908]		43 participants (Actual)	Interventional	2011-08-31	Completed
Phase II Study of Bevacizumab Plus Erlotinib in Patients With Advanced Hepatocellular Cancer (HCC) [NCT00365391]	Phase 2	27 participants (Actual)	Interventional	2006-08-31	Completed
Phase I Study of Erlotinib and Metformin in Triple Negative Breast Cancer [NCT01650506]	Phase 1	8 participants (Actual)	Interventional	2012-07-31	Completed
A Phase II Trial of Erlotinib and Radiotherapy in Patients With Stage III Cutaneous Squamous Cell Carcinomas [NCT00369512]	Phase 2	15 participants (Actual)	Interventional	2006-08-31	Completed
A Phase II Study of S-1 in Combination With Gemcitabine and Erlotinib in Patients With Advanced or Metastatic Pancreatic Cancer [NCT01693419]	Phase 2	37 participants (Actual)	Interventional	2011-08-31	Completed
Phase II Individualized Therapies Selection Study for Patients With Metastatic Colorectal Carcinoma According to the Genomic Expression Profile in Tumor Samples. [NCT01703910]	Phase 2	29 participants (Actual)	Interventional	2012-11-30	Completed
A Multicenter, Randomized, Open-label, Phase II Study to Evaluate the Efficacy and Safety of Erlotinib Versus Etoposide Plus Cisplatin With Concurrent Radiotherapy in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) With Activating Mutation of Ep [NCT01714908]	Phase 2	100 participants (Anticipated)	Interventional	2012-12-14	Active, not recruiting
[NCT01717807]		30 participants (Anticipated)	Observational	2013-04-30	Not yet recruiting
A Randomized Phase III Study: Paclitaxel Plus Radiation Therapy With or Without Erlotinib in Treating Patients With Esophageal Squamous Carcinoma [NCT01752205]	Phase 3	120 participants (Anticipated)	Interventional	2012-11-30	Recruiting
Erlotinib With Concurrent Brain Radiotherapy and Secondary Brain Radiotherapy After Recurrence With Erlotinib in NSCLC Non-increased-intracranial-pressure Symptomatic Brain Metastases: A Prospective Multicenter Trial(TRACTS) [NCT01763385]	Phase 2	210 participants (Anticipated)	Interventional	2012-11-30	Recruiting
Detection of Resistance Genes From Serially Collected Plasma DNA in Non-small Cell Lung Cancer Patients Harboring EGFR Activating Mutation Who Are Being Treated With EGFR TKIs [NCT01776684]		200 participants (Anticipated)	Interventional	2012-06-30	Recruiting
A Phase II Trial of Gemcitabine and Erlotinib (GE) Plus Proton-chemotherapy (PCT) and Capox for Locally Advanced Pancreatic Cancer (LAPC) [NCT01683422]		9 participants (Actual)	Interventional	2013-01-02	Terminated(stopped due to Updated chemotherapy regimens currently evaluated in clinical trials due to lack of progress in treating this condition; analysis continues in the realm of patterns of failure and increasing quality of life)
Phase II Trial of XL184 (Cabozantinib) Plus Erlotinib in Patients With Advanced EGFR-Mutant Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy [NCT01866410]	Phase 2	37 participants (Actual)	Interventional	2013-05-20	Completed
A Randomized, Double-blind Study to Evaluate the Effect of Tarceva or Placebo Following Platinum-based CT on Overall Survival and Disease Progression in Patients With Advanced, Recurrent or Metastatic NSCLS Who Have Not Experienced Disease Progression or [NCT00556712]	Phase 3	889 participants (Actual)	Interventional	2006-01-31	Completed
An Open-label, Randomized Study to Evaluate the Effect of Tarceva, Compared With Alimta (Pemetrexed) or Taxotere (Docetaxel),on Survival in Patients With Advanced, Recurrent or Metastatic Non-small Cell Lung Cancer Who Have Experienced Disease Progression [NCT00556322]	Phase 3	424 participants (Actual)	Interventional	2006-03-31	Completed
Phase II Study of Maintenance of Tarceva (Erlotinib) in Patients With Locally Advanced Head and Neck Cancer [NCT00750555]	Phase 2	4 participants (Actual)	Interventional	2008-09-30	Terminated(stopped due to PI Law left Geisinger-study terminated prematurely - 4 patients enrolled)
Evaluation of Costs and Outcomes of the Implementation of Treatment Protocol Based on Rational Utilization of Anti-PD1 Agents in Patients With Non-small-cell Lung Cancer in the Brazilian Public Health System [NCT05081674]	Phase 2	154 participants (Actual)	Interventional	2020-01-01	Completed
A Phase 1-2 Trial of MM-121 in Combination With Erlotinib in Three Groups of Patients With Non-Small Cell Lung Cancer [NCT00994123]	Phase 1/Phase 2	162 participants (Actual)	Interventional	2010-02-28	Completed
Ensayo Fase II de selección Individualizada Del Tratamiento de Quimioterapia en Pacientes Con Carcinoma de páncreas Avanzado en función de la determinación de Dianas terapéuticas en el Tejido Tumoral [NCT01454180]	Phase 2	31 participants (Actual)	Interventional	2011-10-31	Completed
A Phase 2, Multicenter, Randomized, Double-blind Study of Ficlatuzumab Plus Erlotinib Versus Placebo Plus Erlotinib in Subjects Who Have Previously Untreated Metastatic, EGFR-mutated Non-small Cell Lung Cancer (NSCLC) and BDX004 Positive Label [NCT02318368]	Phase 2	10 participants (Actual)	Interventional	2014-11-30	Terminated(stopped due to Sponsor's decision)
A Phase I/II Study of Bevacizumab and Erlotinib in Combination With Docetaxel and Prednisone for Patients With Hormone Refractory Prostate Cancer [NCT00996502]	Phase 1/Phase 2	4 participants (Actual)	Interventional	2006-07-31	Terminated(stopped due to Poor enrollment; PI left the institution)
Phase II Trial of Erlotinib, a Small Molecule Tyrosine Kinase Inhibitor of EGFR, Prior to Surgery or Radiation in Patients With Aggressive Squamous Cell Cancers (SCC) of the Skin [NCT01059305]	Phase 2	10 participants (Actual)	Interventional	2011-02-28	Terminated(stopped due to Lack of primary outcome efficacy.)
Effect of an Early Therapeutic Permutation on the Tumoral Control of Patients Receiving in First Line a Specific Inhibitor of Tyrosin Kinase of EGFR (Erlotinib) or a Taxan-based Chemotherapy for the Treatment of Not Resecable Adenocarcinoma With Bronchiol [NCT00384826]	Phase 2	133 participants (Actual)	Interventional	2006-09-30	Completed
A Clinical and Pharmacologic Study of the Combination of Erlotinib and Bexarotene in Resectable Clinical Stage I-II Non-Small Cell Lung Cancer [NCT00125372]		12 participants (Actual)	Interventional	2005-12-31	Completed
Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma [NCT00602667]	Phase 2	293 participants (Actual)	Interventional	2007-12-17	Active, not recruiting
A Phase 2 Study of AZD6244 Plus Erlotinib for the Second-Line Treatment of Advanced Pancreatic Adenocarcinoma [NCT01222689]	Phase 2	46 participants (Actual)	Interventional	2010-11-30	Completed
A Phase II Trial of Erlotinib and AT-101 in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients With EGFR Activating Mutations [NCT00988169]	Phase 2	6 participants (Actual)	Interventional	2009-09-30	Terminated
A Phase II Clinical Trial of Bevacizumab Plus eRlotinIb in patientS With Advanced Cancer Having Genetic Alterations in Krebs Cycle (BRISK, KCSG AL22-16) [NCT05904457]	Phase 2	32 participants (Anticipated)	Interventional	2023-01-02	Recruiting
A Randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Onartuzumab (Metmab) in Combination With Tarceva (Erlotinib) in Patients With Met Diagnostic-Positive Non-Small Cell Lung Cancer Who Have Receiv [NCT01456325]	Phase 3	494 participants (Actual)	Interventional	2012-01-31	Completed
A Multi-Center Open-Label Phase I/2 Study of BGB324(Bemcentinib) in Combination With Erlotinib in Patients With Stage IIIb or Stage IV Non-Small Cell Lung Cancer [NCT02424617]	Phase 1/Phase 2	40 participants (Actual)	Interventional	2015-03-31	Completed
A Multi-arm Phase I Safety Study of Nivolumab in Combination With Gemcitabine/Cisplatin, Pemetrexed/Cisplatin, Carboplatin/Paclitaxel, Bevacizumab Maintenance, Erlotinib, Ipilimumab or as Monotherapy in Subjects With Stage IIIB/IV Non-small Cell Lung Canc [NCT01454102]	Phase 1	472 participants (Actual)	Interventional	2011-12-16	Completed
Phase IIIb, Open-Label Study of Erlotinib (Tarceva®) Treatment in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Present Activating Mutations in the Tyrosine Kinase Domain of the Epidermal Growth Factor Receptor [NCT01667562]	Phase 3	375 participants (Actual)	Interventional	2012-01-20	Completed
A National Web-Based Randomized Phase III Study of Erlotinib or Placebo Following Concurrent Docetaxel, Carboplatin, and Thoracic Radiotherapy in Patients With Inoperable Stage III Non-Small Cell Lung Cancer (D0410). [NCT00153803]	Phase 3	245 participants (Actual)	Interventional	2005-05-31	Completed
A Phase II, Pharmacokinetic And Biologic Correlative Study of OSI-774, An EGFR Tyrosine Kinase Inhibitor, In Patients With Advanced Renal Cell Carcinoma [NCT00045487]	Phase 2	41 participants (Actual)	Interventional	2002-06-30	Completed
A Phase I Study of IRX4204 in Combination With Erlotinib in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer [NCT02991651]	Phase 1	12 participants (Anticipated)	Interventional	2016-05-31	Suspended(stopped due to Limited IRX4204 Study Drug Supply)
Phase II Trial of Second Line Erlotinib + Digoxin in Patients With Non-Small Cell Lung Cancer [NCT00281021]	Phase 2	26 participants (Actual)	Interventional	2006-02-28	Terminated(stopped due to Interim analysis revealed that only 1 patient had a partial response.)
A Randomized Phase II Trial Comparing Two Doses of Pulsed Erlotinib Prechemotherapy (PEP-C) in Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer [NCT00287989]	Phase 2	86 participants (Actual)	Interventional	2004-11-30	Completed
An Open-label, Randomized Phase 3 Efficacy Study of ASP8273 vs Erlotinib or Gefitinib in First-line Treatment of Patients With Stage IIIB/IV Non-small Cell Lung Cancer Tumors With EGFR Activating Mutations [NCT02588261]	Phase 3	530 participants (Actual)	Interventional	2016-02-11	Terminated(stopped due to Following recommendation by SOLAR Study IDMC, Astellas closed enrollment in ASP8273 studies)
A Randomized Phase III Trial of Erlotinib Versus Docetaxel in Patients With Advanced Squamous Cell Non-small Cell Lung Cancer Who Failed First Line Platinum Based Doublet Chemotherapy Stratified by VeriStrat Good vs VeriStrat Poor [NCT01652469]	Phase 3	81 participants (Actual)	Interventional	2012-08-31	Completed
Prospective, Open-label, Multicenter, National, Non-interventional Phase IV Trial of the Effectiveness, Safety and Tolerability of Tarceva as Second-line Treatment of Patients With Advanced Non-small Cell Lung Cancer (NSCLC), After Failure of First-line T [NCT01664533]		57 participants (Actual)	Observational	2011-09-30	Completed
A Phase 1/2 Trial of Ruxolitinib and Erlotinib in Patients With EGFR-mutant Lung Adenocarcinoma With Acquired Resistance to Erlotinib [NCT02155465]	Phase 1/Phase 2	22 participants (Actual)	Interventional	2014-06-30	Completed
A Prospective Phase I Clinical Trial of Carbon Ion Radiation Therapy for Locally Advanced, Unresectable Pancreatic Cancer [NCT03403049]	Phase 1	14 participants (Actual)	Interventional	2016-04-01	Completed
A Phase II Study of Pertuzumab and Erlotinib for Metastatic or Unresectable Neuroendocrine Tumors [NCT00947167]	Phase 2	4 participants (Actual)	Interventional	2009-03-31	Terminated(stopped due to Extreme toxicity of Pertuzumab and Erlotinib combination)
A Randomized Phase II Study of Schedule-Modulated Concomitant Pemetrexed (Alimta) and Erlotinib (Tarceva) vs Single Agent Pemetrexed (Alimta®) in Patients With Progressive or Recurrent Non-small Cell Lung Cancer (NSCLC) [NCT00950365]	Phase 2	79 participants (Actual)	Interventional	2006-04-30	Completed
Phase 2 Study of Erlotinib Plus Pemetrexed/Cisplatin Treating Lung Adenocarcinoma With Brain Metastases [NCT01578668]	Phase 2	69 participants (Actual)	Interventional	2012-01-31	Completed
A Phase I/IB Trial of MEK162 in Combination With Erlotinib in Non-Small Cell Lung Cancer (NSCLC) Harboring KRAS or EGFR Mutation [NCT01859026]	Phase 1	43 participants (Actual)	Interventional	2013-12-30	Completed
Phase II Trial of OSI-774 (Tarceva), a Human Epidermal Growth Factor (HER) (erbB, Also Known as Epidermal Growth Factor Receptor, EGFR) Tyrosine Kinase Inhibitor, in Treatment-Naïve Operable Breast Cancer [NCT00633750]	Phase 2	50 participants (Actual)	Interventional	2002-08-31	Completed
A Randomized Open-Label Phase II Trial of Pemetrexed and a Platinum (Carboplatin or Cisplatin) With or Without Erlotinib in Patients With Non-Small Cell Lung Cancer Harboring Activating Epidermal Growth Factor Receptor Mutations and Acquired Resistance to [NCT01928160]	Phase 2	0 participants (Actual)	Interventional	2014-06-30	Withdrawn(stopped due to study not accruing)
A Phase II Study of the Combination of Bevacizumab and Erlotinib in Patients With Unresectable Hepatocellular Carcinoma [NCT00242502]	Phase 2	62 participants (Actual)	Interventional	2005-10-31	Completed
Concurrent Angiogenic and EGFR Blockade in Conjunction With Curative Intent Chemoradiation for Locally Advanced Head and Neck Cancer [NCT00140556]	Early Phase 1	28 participants (Actual)	Interventional	2005-08-31	Completed
A Phase II Study of Paclitaxel/Carboplatin Plus Bevacizumab/Erlotinib in the First Line Treatment of Patients With Carcinoma of Unknown Primary Site [NCT00360360]	Phase 2	60 participants (Actual)	Interventional	2006-07-31	Completed
Phase II Study of Erlotinib (TarcevaTM) Combined With Chemoradiation and Adjuvant Chemotherapy in Patients With Resectable Pancreatic Cancer [NCT00313560]	Phase 2	48 participants (Actual)	Interventional	2006-03-16	Completed
Almonertinib Vs. Erlotinib/Chemotherapy for Neo-adjuVant Treatment of Stage IIIA-N2 EGFR-mutated NSCLC: a Multicenter, Open-label, Phase II Randomized Controlled Trial [NCT04455594]	Phase 2	168 participants (Anticipated)	Interventional	2020-10-31	Not yet recruiting
A Phase Ia/Ib Dose-Escalation and Dose-Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-6036 as a Single Agent and in Combination With Other Anti-cancer Therapies in Patients With Advanced or Metastatic Solid Tumors With a KRAS [NCT04449874]	Phase 1	498 participants (Anticipated)	Interventional	2020-07-29	Recruiting
Bevacizumab and Erlotinib First-Line Therapy in Advanced Non-Squamous Non-Small-Cell Lung Cancer (Stage IIIB/IV) Followed by Platinum-Based Chemotherapy at Disease Progression. A Multicenter Phase II Trial [NCT00354549]	Phase 2	104 participants (Actual)	Interventional	2006-01-31	Completed
Phase II Trial of the Akt Inhibitor MK-2206 Plus Erlotinib (OSI-774) in Patients With Advanced Non-small Cell Lung Cancer Who Have Progressed After Previous Response (Including Stable Disease) With Erlotinib Therapy [NCT01294306]	Phase 2	80 participants (Actual)	Interventional	2011-02-28	Completed
A Phase I/II Study of Erlotinib and Romidepsin in Advanced Non-Small Cell Lung Cancer [NCT01302808]	Phase 1	17 participants (Actual)	Interventional	2009-09-30	Completed
A Single-Arm, Phase II Study of Tarceva Plus FOLFOX6 in Patients With Unresectable or Metastatic Cancer of Esophagus or Gastroesophageal Junction [NCT00539617]	Phase 2	7 participants (Actual)	Interventional	2007-10-05	Terminated(stopped due to For slow accrual)
A Phase 1b/2 Study of ASP2215 in Combination With Erlotinib in Subjects With EGFR Activating Mutation-Positive (EGFRm+) Advanced NSCLC Who Have Acquired Resistance to an EGFR Tyrosine Kinase Inhibitor (TKI) [NCT02495233]	Phase 1/Phase 2	10 participants (Actual)	Interventional	2015-09-08	Terminated(stopped due to Study terminated due to adverse events related to the combination therapy)
TIGER 1: A Randomized, Open-Label, Phase 2/3 Study of CO-1686 or Erlotinib as First-Line Treatment of Patients With EGFR-Mutant Advanced/Metastatic NSCLC [NCT02186301]	Phase 2/Phase 3	100 participants (Actual)	Interventional	2014-11-30	Terminated(stopped due to Sponsor discontinued development of CO-1686 for NSCLC)
Phase Ib, Open-label, Multi-center Study of the Combination of Pertuzumab and Erlotinib in Patients With Locally Advanced or Metastatic (Stage IIIb/IV) NSCLC After Failure of at Least One Prior Chemotherapy Regimen. [NCT02507375]	Phase 1	17 participants (Actual)	Interventional	2006-09-30	Completed
An Open-label Study of the Effect of Tarceva Monotherapy on Treatment Response in Patients With Advanced Non-small Cell Lung Cancer for Whom Tarceva Monotherapy is Considered the Best Option [NCT01996332]	Phase 2	1,805 participants (Actual)	Interventional	2004-04-30	Completed
Pilot Study of Local Therapies for Oligometastatic Non-Small Cell Lung Cancer Harboring Sensitizing EGFR Mutations [NCT02450591]		4 participants (Actual)	Interventional	2015-05-14	Completed
An Open-label, Randomized, Phase IIIb Trial Evaluating the Efficacy and Safety of Standard of Care +/- Continuous Bevacizumab Treatment Beyond Progression of Disease (PD) in Patients With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC) After Firs [NCT01351415]	Phase 3	485 participants (Actual)	Interventional	2011-06-25	Completed
Efficacy and Safety of Erlotinib (Tarceva® ) Therapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) , Subtype Adenocarcinoma, Who Have Good Performance Status (PS 0-1) - ELEMENT [NCT01836133]		70 participants (Actual)	Observational	2013-05-31	Completed
A Feasibility Study Investigating Translational Science in Chemotherapy-Naive Patients With Stage IIIb or IV Non-Small Cell Lung Cancer (NSCLC) Treated With the EGFR-TKI, Erlotinib [NCT00550537]	Phase 2	116 participants (Actual)	Interventional	2007-10-31	Completed
Phase I Studies of TARCEVA™ (ERLOTINIB HYDROCHLORIDE, OSI-774) as Single Agent in Children With Refractory and Relapsed Malignant Brain Tumors and in Combination With Irradiation in Newly Diagnosed Brain Stem Glioma [NCT00360854]	Phase 1	48 participants (Anticipated)	Interventional	2005-05-31	Active, not recruiting
A Phase II Study of Erlotinib Plus Bevacizumab in the Treatment of Advanced Thymoma and Thymic Carcinoma [NCT00369889]	Phase 2	18 participants (Actual)	Interventional	2006-08-31	Completed
LUX-Lung 8: A Randomized, Open-label Phase III Trial of Afatinib Versus Erlotinib in Patients With Advanced Squamous Cell Carcinoma of the Lung as Second-line Therapy Following First-line Platinum-based Chemotherapy [NCT01523587]	Phase 3	795 participants (Actual)	Interventional	2012-03-05	Completed
Phase I/II Trial of Bevacizumab, Pemetrexed and Erlotinib in the First-Line Treatment of Elderly Patients With Advanced (Stage IIIB(With Malignant Pleural Effusion) or IV) Non-Squamous Non-Small Cell Lung Cancer (NSCLC) [NCT00351039]	Phase 1/Phase 2	8 participants (Actual)	Interventional	2006-07-31	Terminated(stopped due to slow accrual)
A Phase II Single Arm Clinical Trial to Evaluate the Efficacy and Safety of the Combination of Tarceva™ (Erlotinib Hydrochloride) and Rapamune™ (Sirolimus) in the Treatment of Metastatic Renal Cell Carcinoma. [NCT00353301]	Phase 2	25 participants (Actual)	Interventional	2006-07-31	Completed
Phase I/II Study of Docetaxel and OSI-774 (Erlotinib) in Solid Tumor Patients With an Emphasis on NSCLC Using Molecular Correlates as Potential Markers of Response [NCT00390429]	Phase 1/Phase 2	81 participants (Actual)	Interventional	2002-07-31	Completed
A Randomized Phase II Trial of Erlotinib, Cabozantinib, or Erlotinib Plus Cabozantinib as 2nd or 3rd Line Therapy in Patients With EGFR Wild-Type NSCLC [NCT01708954]	Phase 2	125 participants (Actual)	Interventional	2013-02-13	Active, not recruiting
Phase IIA Trial Testing Erlotinib as an Intervention Against Intraductal Pancreatic Mucinous Neoplasms [NCT00482625]	Phase 2	6 participants (Actual)	Interventional	2007-06-30	Terminated(stopped due to The protocol has been completed prematurely (e.g., due to poor accrual, insufficient drug supply, IND closure).)
An Adaptive Randomized Trial Comparing Multiple Treatments for Ebola Virus (EBOV) Infected Children and Adults [NCT02380625]	Phase 1/Phase 2	150 participants (Anticipated)	Interventional	2015-04-30	Not yet recruiting
A Randomized, Double-blind Phase 2 Study of Itacitinib in Combination With Erlotinib Versus Erlotinib Alone in Subjects With Stage IIIB/ IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) Whose Tumors Have Epidermal Growth Factor Receptor (EGFR) Activatin [NCT02355431]	Phase 2	0 participants (Actual)	Interventional	2014-12-31	Withdrawn(stopped due to Study withdrawn before enrolling first patient)
A Phase I/II Study of Pacritinib in Patients With EGFR Mutant NSCLC After EGFR TKI [NCT02342353]	Phase 1	8 participants (Actual)	Interventional	2015-05-18	Terminated(stopped due to Drug shortage)
The Purpose of This Study is to Investigate Two Different Dose Regimens of Eribulin Mesylate in Combination With Intermittent Erlotinib in Patients With Previously Treated, Advanced Non-small Cell Lung Cancer [NCT01104155]	Phase 2	123 participants (Actual)	Interventional	2010-02-22	Completed
Randomised, Controlled Study Comparing Chemotherapy Plus Intercalated EGFR-Tyrosine Kinase Inhibitors Combination Therapy With EGFR-Tyrosine Kinase Inhibitors Alone Therapy as First-line Treatment for Patients With Non-Small-Cell Lung Cancer [NCT02031601]	Phase 4	250 participants (Anticipated)	Interventional	2014-01-31	Recruiting
A Phase II Study of Bevacizumab Plus Temodar and Tarceva After Radiation Therapy and Temodar in Patients With Newly Diagnosed Glioblastoma or Gliosarcoma Who Are Stable Following Radiation [NCT00525525]	Phase 2	74 participants (Actual)	Interventional	2007-09-30	Completed
Phase II Trial of Erlotinib Plus Sirolimus for Patients With Recurrent Malignant Glioma Multiforme [NCT00672243]	Phase 2	32 participants (Actual)	Interventional	2007-04-30	Completed
Bevacizumab and Erlotinib in Inoperable and Metastatic Hepatocellular Carcinoma [NCT00287222]	Phase 2	21 participants (Actual)	Interventional	2006-02-28	Completed
A Phase II Randomized Study of OSI-774 in African American Patients With Advanced and Previously Treated Non-Small Cell Lung Cancer (NSCLC) [NCT00230126]	Phase 2	57 participants (Actual)	Interventional	2005-10-31	Completed
Phase I/II Trial of Oral Erlotinib (Tarceva, OSI-774) for Treatment of Relapsed/Refractory Glioblastoma Multiforme and Anaplastic Astrocytoma [NCT00301418]	Phase 1/Phase 2	11 participants (Actual)	Interventional	2006-03-31	Completed
Phase II Study of Sequential Dose-Dense Chemotherapy and Dose-Intense Erlotinib for the Initial Treatment of Advanced Non-Small Cell Lung Cancer [NCT01557959]	Phase 2	45 participants (Actual)	Interventional	2007-07-31	Completed
A Pilot Phase II Study of Erlotinib for the Treatment of Patients With Refractory/Relapsed AML [NCT01664897]	Phase 2	29 participants (Actual)	Interventional	2013-05-16	Completed
A Randomized Phase II Double-Blind Trial of Erlotinib and Pazopanib, or Erlotinib and Placebo in Patients With Previously Treated Advanced Non-Small-Cell Lung Cancer (NSCLC) [NCT01027598]	Phase 2	202 participants (Actual)	Interventional	2010-01-31	Completed
My Pathway: An Open-Label Phase IIa Study Evaluating Trastuzumab/Pertuzumab, Erlotinib, Vemurafenib/Cobimetinib, Vismodegib, Alectinib, and Atezolizumab in Patients Who Have Advanced Solid Tumors With Mutations or Gene Expression Abnormalities Predictive [NCT02091141]	Phase 2	670 participants (Actual)	Interventional	2014-04-14	Completed
A Randomized Phase II Study of Individualized Combined Modality Therapy for Stage III Non-small Cell Lung Cancer (NSCLC) [NCT01822496]	Phase 2	59 participants (Actual)	Interventional	2013-11-04	Terminated
Parallel (Randomized) Phase II Evaluation of ARQ 197 and ARQ 197 in Combination With Erlotinib in Papillary Renal Cell Carcinoma [NCT01688973]	Phase 2	55 participants (Actual)	Interventional	2012-08-20	Completed
A Phase II Trial of Bevacizumab Plus Erlotinib for Patients With Metastatic Gemcitabine-Refractory Pancreatic Cancer [NCT00365144]	Phase 2	36 participants (Actual)	Interventional	2006-02-28	Completed
Phase II Trial of Erlotinib and BKM120 in Patients With Advanced Non Small Cell Lung Cancer Previously Sensitive to Erlotinib [NCT01487265]	Phase 2	37 participants (Actual)	Interventional	2014-03-31	Completed
A Phase I/II Trial of Bevacizumab (Avastin), Erlotinib (Tarceva), and Imatinib (Gleevec) in the Treatment of Patients With Advanced Renal Cell Carcinoma [NCT00193258]	Phase 1/Phase 2	94 participants (Actual)	Interventional	2004-06-30	Completed
A Phase II Study of Gemcitabine and Erlotinib As Adjuvant Therapy In Patients With Resected Pancreatic Cancer [NCT00336700]	Phase 2	25 participants (Actual)	Interventional	2006-06-30	Terminated(stopped due to Study published November 2010 and no further work will be done)
A Phase II Trial of Neoadjuvant Chemotherapy Plus Bevacizumab Followed By Concurrent Chemotherapy/Bevacizumab/Erlotinib/Radiation Therapy in the Treatment of Locally Advanced Squamous Carcinoma of the Head and Neck [NCT00392704]	Phase 2	60 participants (Actual)	Interventional	2006-12-31	Completed
A Dose Escalation Phase II Study of Sunitinib Plus Erlotinib in Advanced Renal Carcinoma [NCT00425386]	Phase 2	60 participants (Actual)	Interventional	2006-08-31	Completed
Phase II Trial of Novasoy®, Gemcitabine, and Erlotinib in Locally Advanced or Metastatic Pancreatic Cancer [NCT00376948]	Phase 2	20 participants (Actual)	Interventional	2005-05-31	Completed
A Phase II Trial of Erlotinib (OSI-774) and Sorafenib (BAY 43-9006) for Patients With Progression or Recurrent Glioblastoma Multiforme [NCT00445588]	Phase 2	56 participants (Actual)	Interventional	2007-01-31	Completed
A Pilot Study of Preoperative Tarceva (Erlotinib) Monotherapy in Patients With Early Stage (I/II) Non-Small Cell Lung Cancer [NCT00385996]	Phase 2	22 participants (Actual)	Interventional	2006-10-31	Completed
EValuation of Erlotinib as a Neoadjuvant Therapy in Stage III NSCLC Patients With EGFR Mutations (EVENT Trial) [NCT01857271]	Phase 2	3 participants (Actual)	Interventional	2013-11-30	Terminated(stopped due to low accrual)
A Phase I Open Label, Multicenter, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Dose Limiting Toxicity, Safety and Pharmacokinetics of CGC-11047 When Used in Individual Combinations With 1) Gemcitabine or 2) Docetaxel or 3) Bevacizumab o [NCT00705874]	Phase 1	172 participants (Actual)	Interventional	2006-05-31	Completed
An Open-Label, Non-Randomized, Multicenter Phase I/II Trial of RO5424802 Given Orally to Non-Small Cell Lung Cancer Patients Who Have ALK Mutation and Who Have Failed Crizotinib Treatment [NCT01801111]	Phase 1/Phase 2	138 participants (Actual)	Interventional	2013-06-20	Completed
Open Label Study of Erlotinib (Tarceva®) as Single Agent First Line Treatment of Patients With Locally Advanced or Metastatic Lung Adenocarcinoma With Activating Epidermal Growth Factor Receptor (EGFR) Mutations [NCT01609543]	Phase 4	62 participants (Actual)	Interventional	2012-05-31	Completed
Ensure Extension Study to Assess the PFS of First-Line Erlotinib (Tarceva®) and Erlotinib After the Time of Disease Progression in Chinese Population Enrolled in the Ensure Trial [NCT02000531]	Phase 4	45 participants (Actual)	Interventional	2014-01-31	Completed
Phase II Study of Erlotinib for Patients With Malignant Peritoneal Mesothelioma (MPeM) Exhibiting EGFR Mutations [NCT01592383]	Phase 2	2 participants (Actual)	Interventional	2012-06-30	Completed
JUNIPER: A Randomized Phase 3 Study of Abemaciclib Plus Best Supportive Care Versus Erlotinib Plus Best Supportive Care in Patients With Stage IV NSCLC With a Detectable KRAS Mutation Who Have Progressed After Platinum-Based Chemotherapy [NCT02152631]	Phase 3	453 participants (Actual)	Interventional	2014-10-03	Active, not recruiting
Dose Finding and Early Efficacy Study of Erlotinib in Treatment of Chronic Hepatitis C Virus infection_proof of Concept Study [NCT01835938]	Phase 1/Phase 2	12 participants (Anticipated)	Interventional	2013-05-31	Not yet recruiting
The Survival of Non-Small Cell Lung Carcinoma EGFR Non-mutated (Wild Type) Patients Treated With Erlotinib (TARceva) After the Failure of at Least One Chemotherapy Regimen [NCT01990261]		33 participants (Actual)	Observational	2013-05-31	Terminated
A Study of Apatinib Combine With EGFR-TKI for Advanced EGFR-TKI-resistant Non-Small Cell Lung Cancer [NCT03050411]	Phase 1	30 participants (Anticipated)	Interventional	2016-05-31	Recruiting
Maintenance Systemic Therapy Versus Local Consolidative Therapy (LCT) Plus Maintenance Systemic Therapy for Limited Metastatic Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II/III Trial [NCT03137771]	Phase 2	218 participants (Actual)	Interventional	2017-04-07	Active, not recruiting
The Value of Radiotherapy in the Oligometastatic Non-squamous Non-small Cell Lung Cancer With Clinical Benefits From Erlotinib as Second-line Treatment: a Randomized Controlled Phase II Clinical Trial [NCT01796288]	Phase 2	200 participants (Anticipated)	Interventional	2012-10-31	Recruiting
A Randomized Phase II Trial of Erlotinib Alone or in Combination With Bevacizumab in Patients With Non-Small Cell Lung Cancer and Activating Epidermal Growth Factor Receptor Mutations [NCT01532089]	Phase 2	88 participants (Actual)	Interventional	2012-03-16	Completed
A Phase I, Dosage-finding and Pharmacokinetic Study of Intravenous Topotecan and Oral Erlotinib in Adults With Refractory Solid Tumors [NCT00611468]	Phase 1	29 participants (Actual)	Interventional	2006-06-30	Completed
A Phase 1 Multicenter, Dose-escalation Study of LY573636-sodium in Combination With 1) Gemcitabine HCl or 2) Docetaxel or 3) Temozolomide or 4) Cisplatin, or 5) Erlotinib in Patients With Advanced Solid Tumors [NCT01284335]	Phase 1	234 participants (Actual)	Interventional	2008-07-31	Terminated(stopped due to Study was terminated due to the termination of tasisulam development.)
APRiCOT-P (Apricoxib in Combination Oncology Treatment - Pancreas): Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Gemcitabine and Erlotinib in the Treatment of Patients With Advanced Pancreatic Cancer [NCT00709826]	Phase 2	109 participants (Actual)	Interventional	2008-08-31	Completed
A Randomised, Placebo-controlled, Double-blind Phase II of Sequential Administration of Tarceva (Erlotinib) or Placebo in Combination With Gemcitabine/Platinum as First-line Treatment in Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC). [NCT01998919]	Phase 2	154 participants (Actual)	Interventional	2006-08-31	Completed
A Phase II Study of Sirolimus and Erlotinib in Recurrent/Refractory Germ Cell Tumors [NCT01962896]	Phase 2	4 participants (Actual)	Interventional	2014-01-08	Terminated(stopped due to Low accrual)
A Randomized, Open-Label Phase 2 Study Evaluating LY2875358 Plus Erlotinib and LY2875358 Monotherapy in MET Diagnostic Positive NSCLC Patients With Acquired Resistance to Erlotinib [NCT01900652]	Phase 2	111 participants (Actual)	Interventional	2013-08-31	Completed
Phase II Study of Stereotactic Radiosurgery or Other Local Ablation Followed by Erlotinib for Patients With Epidermal Growth Factor Receptor(EGFR) Mutation Who Have Previously Progressed on an Epidermal Growth Factor Receptor-tyrosine Kinase Inhibitor (EG [NCT01573702]	Phase 2	32 participants (Actual)	Interventional	2012-12-11	Completed
MEK114375: A Rollover Study to Provide Continued Treatment With GSK1120212 to Subjects With Solid Tumors or Leukemia [NCT01376310]	Phase 2	159 participants (Actual)	Interventional	2010-11-02	Terminated(stopped due to Company Decision)
A Phase II Study of Induction Chemotherapy Followed by Thoracic Radiotherapy and Erlotinib in Poor-Risk Stage III Non-Small Cell Lung Cancer [NCT00553462]	Phase 2	78 participants (Actual)	Interventional	2008-03-31	Completed
Impact on Survival of Cutaneous Reactions in Erlotinib Plus Gemcitabine Treated Patients With Metastatic Pancreatic Cancer Under Conditions of Daily Routine Practice [NCT01782690]		338 participants (Actual)	Observational	2012-03-31	Completed
An Open-label Phase II Trial of Erlotinib and Bevacizumab in Patients With Advanced Non-small Cell Lung Cancer and Activating EGFR Mutations [NCT01562028]	Phase 2	109 participants (Actual)	Interventional	2012-06-30	Completed
A Phase 1/2 Trial of Trametinib and Erlotinib in Patients With EGFR-Mutant Lung Adenocarcinomas and Acquired Resistance to Erlotinib [NCT03076164]	Phase 1/Phase 2	24 participants (Actual)	Interventional	2017-03-01	Completed
Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication [NCT02233049]	Phase 2	250 participants (Anticipated)	Interventional	2014-10-31	Recruiting
A Phase 1 Open-label Prospective Cohort Trial of Curcumin Plus Tyrosine Kinase Inhibitors for Epidermal Growth Factor Receptor (EGFR)-Mutant Advanced Non-small Cell Lung Cancer [NCT02321293]	Phase 1	20 participants (Anticipated)	Interventional	2015-08-31	Recruiting
A Randomized, Double-Blind, Phase 2 Study of Erlotinib (Tarceva®) in Combination With OSI-906 or Placebo in Chemonaive Patients With Advanced NSCLC With Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene [NCT01221077]	Phase 2	88 participants (Actual)	Interventional	2011-04-08	Completed
A Randomized Phase 2 Trial Of Erlotinib With Or Without PF-3512676 For The Treatment Of Patients With Advanced EGFR-Positive Non-Small Cell Lung Cancer After Failure Of At Least One Prior Chemotherapy Regimen [NCT00321815]	Phase 2	43 participants (Actual)	Interventional	2006-08-31	Completed
A Randomized, Double-Blind, Placebo-Controlled Phase III Study of First-Line Maintenance Tarceva Versus Tarceva at the Time of Disease Progression in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following 4 Cycles of P [NCT01328951]	Phase 3	643 participants (Actual)	Interventional	2011-09-30	Completed
Phase I Trial of the Combination of Vismodegib GDC-0449 and Erlotinib +/- Gemcitabine [NCT00878163]	Phase 1	55 participants (Actual)	Interventional	2009-03-31	Active, not recruiting
A Phase I/Randomized Phase II Study of the Anti-IGF-1R Monoclonal Antibody IMC-A12 in Combination With Erlotinib Compared With Erlotinib Alone in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) [NCT00778167]	Phase 1/Phase 2	18 participants (Actual)	Interventional	2008-10-31	Completed
A Phase 2, Multicenter, Randomized Study to Evaluate the Safety and Efficacy of Viagenpumatucel-L (HS-110) in Combination With Low Dose (Metronomic) Cyclophosphamide Versus Chemotherapy Alone in Patients With Non-Small Cell Lung Adenocarcinoma After Failu [NCT02117024]	Phase 2	66 participants (Actual)	Interventional	2014-07-31	Terminated(stopped due to Sponsor Decision; strategic - based on changing treatment landscape)
A Multicenter, Randomized, Double-Blind Study of Erlotinib in Combination With Ramucirumab or Placebo in Previously Untreated Patients With EGFR Mutation-Positive Metastatic Non-Small Cell Lung Cancer [NCT02411448]	Phase 3	545 participants (Actual)	Interventional	2015-05-06	Active, not recruiting
An Parallel Phase II Study of Tarceva (Erlotinib) in Patients With Advanced Non-small Cell Lung Cancer (Stage IIIB/IV) Not Pre-treated by Chemotherapy Including Dose Escalation to Toxicity in Current and Former Smokers [NCT02013206]	Phase 2	52 participants (Actual)	Interventional	2006-09-30	Completed
U.S./Canada Sarcoma Intergroup Study of OSI-774 in Malignant Peripheral Nerve Sheath Tumors, Phase II [NCT00068367]	Phase 2	24 participants (Actual)	Interventional	2003-12-31	Completed
A Randomized Phase II Study of Single Agent Erlotinib [Tarceva (TM), OSI-774] Versus Standard Chemotherapy in Patients With Previously Untreated Advanced NSCLC and a Poor Performance Status [NCT00085839]	Phase 2	103 participants (Actual)	Interventional	2004-02-29	Completed
Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multi-Center, Two-Part Study of Patritumab (U3-1287) In Combination With Erlotinib in EGFR Wild-type Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Who Have Progressed [NCT02134015]	Phase 3	145 participants (Actual)	Interventional	2014-03-31	Terminated(stopped due to Pre-defined criteria for continuation were not reached)
Phase II Clinical Chemoprevention Trial of Weekly Erlotinib Before Bladder Cancer Surgery [NCT02169284]	Phase 2	50 participants (Actual)	Interventional	2014-10-01	Terminated
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Trial	Outcome
NCT00033514 (5) [back to overview]	Duration of Objective Response
NCT00033514 (5) [back to overview]	Serum Concentration of Herceptin at Specified Time-points.
NCT00033514 (5) [back to overview]	Incidence of Adverse Events
NCT00033514 (5) [back to overview]	Recommended Dose for Phase II
NCT00033514 (5) [back to overview]	The Objective Response Rate as Defined as Stable Disease or the Rate of Complete and Partial Responses Determined on Two Consecutive Occasions Greater Than or Equal to 4 Weeks Apart.
NCT00045110 (18) [back to overview]	Overall Survival Newly Diagnosed GBM Post RT
NCT00045110 (18) [back to overview]	6 Months Progression-free Survival in Recurrent Malignant Gliomas (Phase II)
NCT00045110 (18) [back to overview]	Number of Dose Limiting Toxicity (DLT) Each Dose Level Phase I
NCT00045110 (18) [back to overview]	Response Rate (Complete or Partial Response) Graded Using Modified RECIST Criteria Phase II
NCT00045110 (18) [back to overview]	1 Year Survival - Phase II Newly Diagnosed GBM Post RT
NCT00045110 (18) [back to overview]	Estimation of the Area Under the Curve Per Dose Level Phase I (on Anticonvulsants) -
NCT00045110 (18) [back to overview]	Define Maximum Tolerated Dose (MTD) of Erlotinib by Phase 1 Cohorts
NCT00045110 (18) [back to overview]	Estimation of Area Under the Curve for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg-
NCT00045110 (18) [back to overview]	Pharmacokinetics (Tissue) Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs
NCT00045110 (18) [back to overview]	Trough Level Per Dose Level Phase I (on Anticonvulsants) -
NCT00045110 (18) [back to overview]	Trough Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg -
NCT00045110 (18) [back to overview]	Peak Plasma Concentration Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg -
NCT00045110 (18) [back to overview]	Peak Plasma Concentration Per Dose Level Phase I (on Anticonvulsants) -
NCT00045110 (18) [back to overview]	Percent of Participants With a Grade 3 or 4 Adverse Events Phase 1
NCT00045110 (18) [back to overview]	Percent of Patients With One or More Grade 3-5 Toxicity Described Based on the CTC Severity Grading Phase II
NCT00045110 (18) [back to overview]	Pharmacokinetics (Plasma) Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs
NCT00045110 (18) [back to overview]	Time of Peak Plasma Concentration Per Dose Level Phase I (on Anticonvulsants) -
NCT00045110 (18) [back to overview]	Time to Peak Plasma Concentration for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg -
NCT00045487 (1) [back to overview]	Number of Patients With Ani-tumor Activity After Taking OSI-774.
NCT00054132 (6) [back to overview]	Duration of Response
NCT00054132 (6) [back to overview]	Number of Patients Evaluated for Toxicity
NCT00054132 (6) [back to overview]	Participants With Duration of Stable Disease Greater Than or Equal to 6 Months
NCT00054132 (6) [back to overview]	Time to Progression
NCT00054132 (6) [back to overview]	Level of EGFR Expression
NCT00054132 (6) [back to overview]	Response Rate, Defined as Complete Response (CR) + Partial Response (PR), Using the Response Evaluation Criteria in Solid Tumors
NCT00054275 (3) [back to overview]	Progression Free Survival(PFS)
NCT00054275 (3) [back to overview]	Overall Survival as of 2008
NCT00054275 (3) [back to overview]	Disease Response (Tumor Measurements)Per RECIST Criteria v. 2000
NCT00059787 (5) [back to overview]	Pathologic Complete Response Rates
NCT00059787 (5) [back to overview]	To Measure EGFR Gene Amplification in Tumor Specimens
NCT00059787 (5) [back to overview]	To Determine the Tolerability of Twelve Months of Maintenance Treatment
NCT00059787 (5) [back to overview]	To Determine Progession Free Survival With the Addition of OSI-774 (Tarceva) to the Combination of Paclitaxel and Carboplatin
NCT00059787 (5) [back to overview]	The Percentage of Participants Experiencing Toxicty (Grade 2 and Grade 3/4) Associated With the Combined Regimen
NCT00063258 (1) [back to overview]	Number of Patients With Response
NCT00068367 (2) [back to overview]	Patients With Response (Confirmed Complete, and Partial) With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor When Treated With Erlotinib.
NCT00068367 (2) [back to overview]	Toxicity
NCT00085839 (3) [back to overview]	Progression-free Survival
NCT00085839 (3) [back to overview]	Overall Survival
NCT00085839 (3) [back to overview]	Best Tumor Response
NCT00091026 (3) [back to overview]	Progression-free Survival
NCT00091026 (3) [back to overview]	Overall Survival
NCT00091026 (3) [back to overview]	Objective Response Rate (Complete or Partial Response) Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST)
NCT00096265 (6) [back to overview]	Quality-adjusted Survival as Measured by EuroQol 5-dimension Instrument
NCT00096265 (6) [back to overview]	Rate of CNS Progression (One Year)
NCT00096265 (6) [back to overview]	Overall Survival
NCT00096265 (6) [back to overview]	Change in Steroid Dependence at Six Months
NCT00096265 (6) [back to overview]	Change in Performance Status at Six Months
NCT00096265 (6) [back to overview]	Change in Functional Assessment of Cancer Therapy-Brain (FACT-Br) Score at 3 Months
NCT00112736 (5) [back to overview]	Efficacy - Response Phase 1
NCT00112736 (5) [back to overview]	Maximum Tolerated Dose (Phase I)
NCT00112736 (5) [back to overview]	Pharmacokinetics (Phase I)
NCT00112736 (5) [back to overview]	Progression-free Survival at 6 Months (Phase II)
NCT00112736 (5) [back to overview]	Safety/Dose Limiting Toxities Phase I
NCT00124657 (8) [back to overview]	Erlotinib Tmax
NCT00124657 (8) [back to overview]	Cmax of Erlotinib and Its Metabolite OSI-420
NCT00124657 (8) [back to overview]	AUC Time 0-infinite (AUCinf) of Erlotinib and Its Metabolite OSI-420
NCT00124657 (8) [back to overview]	Number of Participants With Dose-limiting Toxicity (DLT)
NCT00124657 (8) [back to overview]	Maximum Tolerated Dose (MTD) of Erlotinib
NCT00124657 (8) [back to overview]	Progression Free Survival (PFS)
NCT00124657 (8) [back to overview]	Number of Positive Mutations of EGFR and Downstream Pathways
NCT00124657 (8) [back to overview]	Number of Participants Experiencing Grade 3 or 4 Toxicity Events
NCT00125359 (3) [back to overview]	Radiographic Response Rates
NCT00125359 (3) [back to overview]	Progression-free Survival and Overall Survival
NCT00125359 (3) [back to overview]	Correlation of Early PET Responses With Objective Radiographic Responses.
NCT00125372 (1) [back to overview]	Number of Participants With EGFR Mutations and Correlation of EGFR Mutations With Response
NCT00126581 (8) [back to overview]	Overall Response Rate
NCT00126581 (8) [back to overview]	Number of Participants With Grade 3, 4 or 5 Adverse Event at Least Possibly Related to Treatment.
NCT00126581 (8) [back to overview]	18 Weeks Progression Free Survival (PFS) Rate
NCT00126581 (8) [back to overview]	Progression Free Survival With KRAS Mutation Status
NCT00126581 (8) [back to overview]	Progression Free Survival (PFS) by Epidermal Growth Factor Receptor (EGFR) Mutation Status
NCT00126581 (8) [back to overview]	Overall Response Rate by EGFR Mutation Status
NCT00126581 (8) [back to overview]	Overall Survival
NCT00126581 (8) [back to overview]	Overall Response Rate With KRAS Mutational Status
NCT00130520 (3) [back to overview]	Progression Free Survival(PFS)
NCT00130520 (3) [back to overview]	Objective Response (Complete Partial, Stable and Progression)
NCT00130520 (3) [back to overview]	Median Response Duration (Weeks)
NCT00130728 (4) [back to overview]	Overall Survival (OS) Among All Randomized Patients
NCT00130728 (4) [back to overview]	Percentage of Participants With Objective Response
NCT00130728 (4) [back to overview]	Progression-free Survival (PFS)
NCT00130728 (4) [back to overview]	Duration of Objective Response
NCT00137839 (4) [back to overview]	Overall Response Rate (ORR)
NCT00137839 (4) [back to overview]	Overall Survival (OS)
NCT00137839 (4) [back to overview]	Overall Survival by EGFR Mutation Status
NCT00137839 (4) [back to overview]	Overall Response Rate (ORR) by EGFR Mutation Status
NCT00140556 (1) [back to overview]	Tumor Resolution
NCT00147537 (22) [back to overview]	Progression-Free Survival (PFS): Phase 2
NCT00147537 (22) [back to overview]	Area Under the Curve From Time Zero to 504 Hours [AUC (0-504)] Post Infusion of CP-751,871 for Cycle 4 in Phase 1b
NCT00147537 (22) [back to overview]	Plasma Concentration of CP-751,871 at the End of Infusion (Cendinf) for Cycle 1 in Phase 1b
NCT00147537 (22) [back to overview]	Area Under the Curve From Time Zero to Last Quantifiable Concentration of CP-751,871 (AUClast) for Cycle 4 in Phase 1b
NCT00147537 (22) [back to overview]	Area Under the Curve From Time Zero to Last Quantifiable Concentration of CP-751,871(AUClast) for Cycle 1 in Phase 1b
NCT00147537 (22) [back to overview]	Number of Participants With Positive Human Anti-human Antibody (HAHA) Values: Phase 1b
NCT00147537 (22) [back to overview]	Area Under the Curve From Time Zero to 504 Hours [AUC (0-504)] Post Infusion of CP-751,871 for Cycle 1 in Phase 1b
NCT00147537 (22) [back to overview]	Area Under the Curve From Time Zero Extrapolated to Infinite Time [AUCinf] for CP-751,871 for Cycle 1 in Phase 1b
NCT00147537 (22) [back to overview]	Accumulation of CP-751,871 Ratio (Cycle 4 AUC504 / Cycle 1 AUC504) (Rac) in Phase 1b
NCT00147537 (22) [back to overview]	CP-751,871 Concentration at 504 Hours Post Dose (C504) for Cycle 1 (End of the 21-day Cycle) in Phase 1b
NCT00147537 (22) [back to overview]	Maximum Observed Plasma CP-751,871 Concentration (Cmax) for Cycle 1 in Phase 1b
NCT00147537 (22) [back to overview]	Maximum Observed Plasma CP-751,871 Concentration (Cmax) for Cycle 4 in Phase 1b
NCT00147537 (22) [back to overview]	Maximum Tolerated Dose (MTD)of CP-751,871 in Combination With Paclitaxel and Carboplatin: Phase 1b
NCT00147537 (22) [back to overview]	CP-751,871 Concentration at 504 Hours Post Dose(C504) for Cycle 4 (End of the 21-day Cycle) in Phase 1b
NCT00147537 (22) [back to overview]	Number of Participants With Positive Human Anti-human Antibody (HAHA) Values: Phase 2
NCT00147537 (22) [back to overview]	Objective Response Rate in Non-Adenocarcinoma Participants: Phase 2
NCT00147537 (22) [back to overview]	Objective Response Rate: Phase 1b
NCT00147537 (22) [back to overview]	Objective Response Rate: Phase 2
NCT00147537 (22) [back to overview]	Recommended Phase 2 Dose (RP2D): Phase 1b
NCT00147537 (22) [back to overview]	Plasma Concentration of CP-751,871 at the End of Infusion (Cendinf) for Cycle 4 in Phase 1b
NCT00147537 (22) [back to overview]	Plasma Decay Half-Life (t1/2) of CP-751,871 for Cycle 1 in Phase 1b
NCT00147537 (22) [back to overview]	Plasma Decay Half-Life (t1/2) of CP-751,871 for Cycle 4 in Phase 1b
NCT00153803 (5) [back to overview]	Percent of Participants Surviving 3 Years
NCT00153803 (5) [back to overview]	Overall Survival
NCT00153803 (5) [back to overview]	Progression Free Survival
NCT00153803 (5) [back to overview]	Serious Adverse Event Profile Relating to Death, Disability, Life-threatening, Hospitalization, and Impairment/Damage for Concurrent Chemoradiation
NCT00153803 (5) [back to overview]	Serious Adverse Event Profile Relating to Death, Disability, Life-threatening, Hospitalization, and Impairment/Damage for Erlotinib and Placebo
NCT00187486 (2) [back to overview]	Progression Free Survival
NCT00187486 (2) [back to overview]	Overall Survival
NCT00193258 (3) [back to overview]	Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
NCT00193258 (3) [back to overview]	Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease
NCT00193258 (3) [back to overview]	Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
NCT00203424 (4) [back to overview]	To Evaluate the Efficacy of Bevacizumab Plus Erlotinib
NCT00203424 (4) [back to overview]	Overall Survival
NCT00203424 (4) [back to overview]	Time to Tumor Progression.
NCT00203424 (4) [back to overview]	Time to Tumor Recurrence
NCT00230126 (3) [back to overview]	Disease Control Rate at 12 Weeks
NCT00230126 (3) [back to overview]	1-year Survival Rate
NCT00230126 (3) [back to overview]	Time to Progression
NCT00242502 (1) [back to overview]	Progression-free Survival (PFS) Rate
NCT00251589 (8) [back to overview]	Progressive Disease (PD) as Best Response Based on Response Criteria in Solid Tumors (RECIST)
NCT00251589 (8) [back to overview]	Progression-free Survival
NCT00251589 (8) [back to overview]	Unconfirmed Partial Response (UPR) Based on Response Criteria in Solid Tumors (RECIST)
NCT00251589 (8) [back to overview]	Dose Limiting Toxicity Occurring in Cycles 2 and Beyond of the Phase II Portion of the Study
NCT00251589 (8) [back to overview]	Dose Limiting Toxicity (DLT) Occurring in Cycle 1 of the Phase I Portion of the Study
NCT00251589 (8) [back to overview]	Disease Progression After Week 8 Based on Response Criteria in Solid Tumors (RECIST)
NCT00251589 (8) [back to overview]	Stable Disease (SD) as Best Response Based on Response Criteria in Solid Tumors (RECIST)
NCT00251589 (8) [back to overview]	Dose Limiting Toxicity Occurring in Cycle 1 of the Phase II Portion of the Study
NCT00257608 (7) [back to overview]	Incidence of Study Treatment Discontinuation
NCT00257608 (7) [back to overview]	Progression-free Survival (PFS)
NCT00257608 (7) [back to overview]	Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Post-Chemotherapy Phase
NCT00257608 (7) [back to overview]	Overall Survival
NCT00257608 (7) [back to overview]	Number of Participants With Any Adverse Events During Post-Chemotherapy Phase
NCT00257608 (7) [back to overview]	Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Chemotherapy Phase
NCT00257608 (7) [back to overview]	Incidence of Study Treatment Discontinuation for Reasons Other Than Disease Progression in Chemotherapy Phase
NCT00265317 (57) [back to overview]	Percentage of Participants With KRAS (V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog) Gene Mutations
NCT00265317 (57) [back to overview]	PFS in Subgroups That Were Defined by EGFR Expression (Using 0% Cutoff)
NCT00265317 (57) [back to overview]	PFS in Subgroups That Were Defined by EGFR Expression (Using 10% Cutoff)
NCT00265317 (57) [back to overview]	PFS in Subgroups That Were Defined by EGFR Gene Amplification
NCT00265317 (57) [back to overview]	PFS in Subgroups That Were Defined by EGFR Gene Copy Number Increase
NCT00265317 (57) [back to overview]	PFS in Subgroups That Were Defined by EGFR Gene Mutation
NCT00265317 (57) [back to overview]	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms
NCT00265317 (57) [back to overview]	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms
NCT00265317 (57) [back to overview]	PFS in Subgroups That Were Defined by KRAS Gene Mutation
NCT00265317 (57) [back to overview]	PFS in Subgroups That Were Defined by RNA Expression Profile
NCT00265317 (57) [back to overview]	sKIT Ratio to Baseline at Each Timepoint
NCT00265317 (57) [back to overview]	Time to Reach Maximum Observed Plasma Concentration (Tmax) for Erlotinib
NCT00265317 (57) [back to overview]	Tmax for SU-012662 (Metabolite of Sunitinib)
NCT00265317 (57) [back to overview]	Tmax for Sunitinib
NCT00265317 (57) [back to overview]	Tmax for Total Drug (Sunitinib + SU-012662)
NCT00265317 (57) [back to overview]	VEGF-C Ratio to Baseline at Each Timepoint
NCT00265317 (57) [back to overview]	VEGFR-2 Ratio to Baseline at Each Timepoint
NCT00265317 (57) [back to overview]	VEGFR-3 Ratio to Baseline at Each Timepoint
NCT00265317 (57) [back to overview]	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score
NCT00265317 (57) [back to overview]	Erlotinib Clearance at Steady State After Oral Administration (CL/F)
NCT00265317 (57) [back to overview]	Number of Participants With Blood Pressure (BP) Greater Than 150/100 Millimeters of Mercury (mmHg)
NCT00265317 (57) [back to overview]	Number of Participants With BP Greater Than 200/110 mmHg
NCT00265317 (57) [back to overview]	Overall Survival (OS)
NCT00265317 (57) [back to overview]	Percentage of Participants Surviving at 1 Year
NCT00265317 (57) [back to overview]	Percentage of Participants With Objective Response
NCT00265317 (57) [back to overview]	Plasma Concentration of Soluble KIT (sKIT) at Baseline
NCT00265317 (57) [back to overview]	Plasma Concentration of Soluble VEGFR-2 at Baseline
NCT00265317 (57) [back to overview]	Plasma Concentration of Soluble VEGFR-3 at Baseline
NCT00265317 (57) [back to overview]	Plasma Concentration of VEGF-C at Baseline
NCT00265317 (57) [back to overview]	Progression-Free Survival (PFS)
NCT00265317 (57) [back to overview]	Sunitinib Clearance at Steady State After Oral Administration (CL/F)
NCT00265317 (57) [back to overview]	Time to Tumor Progression (TTP)
NCT00265317 (57) [back to overview]	Area Under the Curve From Time Zero to 24 Hours [AUC(0-24)] of Erlotinib
NCT00265317 (57) [back to overview]	AUC(0-24) of SU-012662 (Metabolite of Sunitinib)
NCT00265317 (57) [back to overview]	AUC(0-24) of Sunitinib
NCT00265317 (57) [back to overview]	AUC(0-24) of Total Drug (Sunitinib + SU-012662)
NCT00265317 (57) [back to overview]	Cmax of SU-012662 (Metabolite of Sunitinib)
NCT00265317 (57) [back to overview]	Cmax of Sunitinib
NCT00265317 (57) [back to overview]	Cmax of Total Drug (Sunitinib + SU-012662)
NCT00265317 (57) [back to overview]	Dose-Corrected Ctrough for Erlotinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)
NCT00265317 (57) [back to overview]	Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)
NCT00265317 (57) [back to overview]	Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)
NCT00265317 (57) [back to overview]	Dose-Corrected Ctrough for Sunitinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)
NCT00265317 (57) [back to overview]	Dose-Corrected Ctrough for Sunitinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)
NCT00265317 (57) [back to overview]	Dose-Corrected Observed Plasma Trough Concentrations (Ctrough) for Erlotinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)
NCT00265317 (57) [back to overview]	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score
NCT00265317 (57) [back to overview]	Maximum Observed Plasma Concentration (Cmax) of Erlotinib
NCT00265317 (57) [back to overview]	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms
NCT00265317 (57) [back to overview]	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms
NCT00265317 (57) [back to overview]	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile
NCT00265317 (57) [back to overview]	Percentage of Participants With EGFR Expression by IHC (Using 10% Cutoff)
NCT00265317 (57) [back to overview]	Percentage of Participants With EGFR Gene Amplification
NCT00265317 (57) [back to overview]	Percentage of Participants With EGFR Gene Copy Number Increase
NCT00265317 (57) [back to overview]	Percentage of Participants With EGFR Gene Mutation
NCT00265317 (57) [back to overview]	Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Expression by Immunohistochemistry (IHC) Using 0 Percent [%] Cutoff
NCT00265317 (57) [back to overview]	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms
NCT00265317 (57) [back to overview]	Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms
NCT00272038 (3) [back to overview]	Time to Disease Progression
NCT00272038 (3) [back to overview]	Overall Clinical Benefit of Tarceva in CRPC.
NCT00272038 (3) [back to overview]	Overall Survival
NCT00276744 (1) [back to overview]	6-month Overall Survival
NCT00278148 (4) [back to overview]	Pathological Complete Response Rate
NCT00278148 (4) [back to overview]	Progression Free Survival (PFS)
NCT00278148 (4) [back to overview]	Overall Survival
NCT00278148 (4) [back to overview]	Maximum Tolerated Dose of Erlotinib Hydrochloride (Phase I)
NCT00280150 (6) [back to overview]	Progression-free Survival (PFS)
NCT00280150 (6) [back to overview]	Feasibility and Tolerability of Administering Consolidation Therapy
NCT00280150 (6) [back to overview]	Maximum Dose of Erlotinib When Given Together With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy (Phase I [Closed to Accrual as of 1/3/2008])
NCT00280150 (6) [back to overview]	Response Rate to Induction Therapy (Phase I [Closed to Accrual as of 1/3/2008] and II)
NCT00280150 (6) [back to overview]	Overall Response Rate and Survival Profile
NCT00280150 (6) [back to overview]	Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy
NCT00281021 (1) [back to overview]	Therapeutic Response, Evaluated by Computed Tomography (CT) Scans of Chest & Abdomen.
NCT00283244 (5) [back to overview]	Toxicity
NCT00283244 (5) [back to overview]	Quality of Life (QOL)- Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) Trial Outcome Index-L (TOI-L)
NCT00283244 (5) [back to overview]	Response Rate
NCT00283244 (5) [back to overview]	Progression-free Survival
NCT00283244 (5) [back to overview]	Overall Survival
NCT00287222 (1) [back to overview]	Number of Participants Who Remained Free of Progression at the 27th Week.
NCT00287989 (2) [back to overview]	Overall Response Rate
NCT00287989 (2) [back to overview]	Time to Progression
NCT00294762 (6) [back to overview]	Progression-free Survival
NCT00294762 (6) [back to overview]	Overall Survival at 12 Months
NCT00294762 (6) [back to overview]	6-month Progression-free Survival
NCT00294762 (6) [back to overview]	Duration of Tumor Response
NCT00294762 (6) [back to overview]	Overall Survival
NCT00294762 (6) [back to overview]	Best Tumor Response
NCT00301418 (3) [back to overview]	Safety of Twice a Day Oral 150 mg Erlotinib Dosing
NCT00301418 (3) [back to overview]	Overall Survival (OS)
NCT00301418 (3) [back to overview]	6-month Progression Free Survival (PFS)
NCT00304278 (1) [back to overview]	Survival Post Treatment
NCT00307736 (5) [back to overview]	Summary of Grade 3 or Greater Toxicity
NCT00307736 (5) [back to overview]	Maximum Tolerated Dose (MTD) of Erlotinib When Administered in Combination With 5-fluorouracil (5-FU), Bevacizumab, and External Beam Radiation Therapy
NCT00307736 (5) [back to overview]	Pathologic Complete Response
NCT00307736 (5) [back to overview]	Percentage of Participants With Disease-free Survival
NCT00307736 (5) [back to overview]	Post-operative Complications After Resection of Rectal Cancers Following Preoperative 5-FU, Bevacizumab, Erlotinib, and External Beam Radiation Therapy.
NCT00313560 (5) [back to overview]	Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
NCT00313560 (5) [back to overview]	Change in QoL as Assessed by QLQ-PAN 26
NCT00313560 (5) [back to overview]	Time to Death as Assessed by Median Overall Survival (Months)
NCT00313560 (5) [back to overview]	Recurrence Free Survival
NCT00313560 (5) [back to overview]	Number of Participants Experiencing Adverse Events
NCT00314262 (3) [back to overview]	Clinical Outcome: Documented Progression
NCT00314262 (3) [back to overview]	Dose Escalation and Toxicity: Toxicities Including Grades 1 to 4
NCT00314262 (3) [back to overview]	Clinical Outcome: Progression to a Higher-grade Dysplasia or Carcinoma
NCT00335764 (14) [back to overview]	Plasma Time Curve (AUC) of Group 2 Sorafenib and Temsirolimus (Phase I)
NCT00335764 (14) [back to overview]	Pharmacokinetic Max Concentration (Cmax) of Group 2 Sorafenib and Temsirolimus (Phase I)
NCT00335764 (14) [back to overview]	Plasma Time Curve (AUC) of Group 3 Phase I Sorafenib and Tipifarnib 100mg QD (Level -1)
NCT00335764 (14) [back to overview]	Pharmacokinetic Cpmax Group 3 Sorafenib and Tipifarnib (Phase I) 100 mg QD (Level -1)
NCT00335764 (14) [back to overview]	Plasma Time Curve (AUC) of Group 3 Phase I Sorafenib and Tipifarnib 100mg BID (Level 1)
NCT00335764 (14) [back to overview]	Trough Concentration Group 2 Sorafenib and Temsirolimus (Phase I)
NCT00335764 (14) [back to overview]	Pharmacokinetic cMax Group 1 Sorafenib and Erlotinib (Phase I)
NCT00335764 (14) [back to overview]	Pharmacokinetic AUC 0-12 Group 1 Sorafenib and Erlotinib (Phase I)
NCT00335764 (14) [back to overview]	Pharmacokinetic CpMax Concentration of Group 3 Sorafenib and Tipifarnib (Phase I) 100mg BID
NCT00335764 (14) [back to overview]	Objective Response Rate in Patients With Measurable Disease (Phase II)
NCT00335764 (14) [back to overview]	Number of High Grade (3 and 4) Related Adverse Events of Each Combination Agent Combined With BAY 43-9006 (Phase I)
NCT00335764 (14) [back to overview]	Number of High Grade (3 and 4) Related Adverse Events of Each Combination Agent Combined With BAY 43-9006 (Phase 2)
NCT00335764 (14) [back to overview]	Progression-free Survival at 6 Months (Phase II)
NCT00335764 (14) [back to overview]	Maximum Tolerated Dose (MTD) of the Each Combination Agent Combined With a Fixed Dose of BAY 43-9006 Determined by Dose-limiting Toxicities (DLT) (Phase I)
NCT00336700 (6) [back to overview]	1-year Recurrence Free Survival (RFS)
NCT00336700 (6) [back to overview]	2-year Recurrence Free Survival (RFS)
NCT00336700 (6) [back to overview]	KRAS Mutational Status
NCT00336700 (6) [back to overview]	Recurrence Free Survival (RFS)
NCT00336700 (6) [back to overview]	Estimated 1&2 Year Overall Survival (OS)
NCT00336700 (6) [back to overview]	Percentage of Participants With Expression of Epidermal Growth Factor Receptor (EGFR)
NCT00351039 (1) [back to overview]	Number of Participants With Grade 3 and Grade 4 Adverse Events
NCT00353301 (2) [back to overview]	Progression-free Survival
NCT00353301 (2) [back to overview]	Overall Survival
NCT00356889 (4) [back to overview]	Time to Disease Progression
NCT00356889 (4) [back to overview]	Survival Time
NCT00356889 (4) [back to overview]	Duration of Response
NCT00356889 (4) [back to overview]	Number of Confirmed Tumor Responses.
NCT00360360 (2) [back to overview]	Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
NCT00360360 (2) [back to overview]	Progression-free Survival
NCT00364351 (7) [back to overview]	Progression-Free Survival (PFS)
NCT00364351 (7) [back to overview]	Overall Survival (OS)
NCT00364351 (7) [back to overview]	Objective Response Rate (ORR)
NCT00364351 (7) [back to overview]	Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Cough
NCT00364351 (7) [back to overview]	Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Dyspnoea
NCT00364351 (7) [back to overview]	Disease Control Rate (DCR)
NCT00364351 (7) [back to overview]	Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Pain
NCT00365144 (5) [back to overview]	Time to Tumor Progression
NCT00365144 (5) [back to overview]	Proportion of Patients With ≥ 25% Decline in Serum CA19-9 Biomarker
NCT00365144 (5) [back to overview]	Overall Survival Rate at 6 Months
NCT00365144 (5) [back to overview]	Objective Response as Measured by RECIST Criteria
NCT00365144 (5) [back to overview]	Safety and Toxicity
NCT00365391 (4) [back to overview]	Survival Time
NCT00365391 (4) [back to overview]	Time to Treatment Failure
NCT00365391 (4) [back to overview]	Time to Disease Progression
NCT00365391 (4) [back to overview]	Number of Patients With Confirmed Tumor Response Defined to be Either a Complete Response (CR) or Partial Response (PR).
NCT00366457 (3) [back to overview]	Toxicity Profile
NCT00366457 (3) [back to overview]	Time to Tumor Progression
NCT00366457 (3) [back to overview]	Overall Survival
NCT00367601 (3) [back to overview]	Overall Survival
NCT00367601 (3) [back to overview]	Time to Progression
NCT00367601 (3) [back to overview]	To Establish Rate of Non-progressive Disease at 4 Months in Patients With Advanced NSCLC Who Have Been Designated PS2 by Their Treating Physician
NCT00369512 (3) [back to overview]	Median Time to Cancer Recurrence
NCT00369512 (3) [back to overview]	Number of Patients With Recurrence at 2 Years
NCT00369512 (3) [back to overview]	Toxicities Associated With Combined Radiotherapy and Erlotinib Treatments.
NCT00373425 (9) [back to overview]	Overall Survival in Participants With EGFR Mutation - Positive Tumors
NCT00373425 (9) [back to overview]	Overall Survival in Participants With EGFR Mutation - Positive Tumors
NCT00373425 (9) [back to overview]	Overall Survival (OS)
NCT00373425 (9) [back to overview]	Disease-free Survival in Participants With EGFR Mutation - Positive Tumors
NCT00373425 (9) [back to overview]	Disease-free Survival in Participants With EGFR Mutation - Positive Tumors
NCT00373425 (9) [back to overview]	Overall Survival (OS)
NCT00373425 (9) [back to overview]	Disease Free Survival (DFS)
NCT00373425 (9) [back to overview]	Disease Free Survival (DFS)
NCT00373425 (9) [back to overview]	Number of Participants With Adverse Events (AEs)
NCT00376948 (7) [back to overview]	Median Overall Survival Estimate
NCT00376948 (7) [back to overview]	Grade 3 or Higher Toxicity Evaluation
NCT00376948 (7) [back to overview]	Time to Treatment Failure
NCT00376948 (7) [back to overview]	Time to Progression
NCT00376948 (7) [back to overview]	Response Duration
NCT00376948 (7) [back to overview]	Patients Alive
NCT00376948 (7) [back to overview]	Overall Objective Response Rate (Complete and Partial Response)
NCT00380029 (5) [back to overview]	Pathological Complete Response Rate
NCT00380029 (5) [back to overview]	Number of Subjects Experiencing Adverse Events
NCT00380029 (5) [back to overview]	Overall Survival Rate
NCT00380029 (5) [back to overview]	Disease Recurrence and Progression Rates After Cystectomy
NCT00380029 (5) [back to overview]	EGFR Activation Signal (AKT2) Expression to Predict Sensitivity to Erlotinib
NCT00385996 (4) [back to overview]	Time-to-progression (TTP)
NCT00385996 (4) [back to overview]	Response Rate Defined as the Percentage of Subjects Achieving at Least 50% Tumor Volume Reduction.
NCT00385996 (4) [back to overview]	Number of Participants With Grade 3, 4, or 5 Treatment Related Adverse Events as Assessed by CTCAE v3.0.
NCT00385996 (4) [back to overview]	Disease-free Survival (DFS)
NCT00387894 (2) [back to overview]	Duration of Progress-free Survival (PFS)
NCT00387894 (2) [back to overview]	Disease Response Measured Objectively by MRI of Brain
NCT00390429 (7) [back to overview]	Safety and Toxicity of Erlotinib Hydrochloride and Docetaxel as Measured by NCI CTC v3.0 on Day 8 of Course 1 and on Day 1 of Every Subsequent Course (Phase I [Completed as of 12/01/2004])
NCT00390429 (7) [back to overview]	Response Rate (Phase II)
NCT00390429 (7) [back to overview]	Overall Survival (Phase II)
NCT00390429 (7) [back to overview]	Comparison of Toxicity of Two Different Schedules of Erlotinib Hydrochloride and Docetaxel (Phase I [Completed as of 12/01/2004])
NCT00390429 (7) [back to overview]	Progression-free Survival (Phase II)
NCT00390429 (7) [back to overview]	Frequency and Severity of Toxicities (Phase II)
NCT00390429 (7) [back to overview]	Maximum Tolerated Dose of Two Different Schedules of Erlotinib Hydrochloride and Docetaxel (Phase I [Completed as of 12/01/2004])
NCT00391586 (1) [back to overview]	Toxicity Profile
NCT00392665 (4) [back to overview]	Number of Participants With Toxicities According to Severity
NCT00392665 (4) [back to overview]	Duration of Overall Survival
NCT00392665 (4) [back to overview]	Efficacy of Erlotinib Plus Bevacizumab (Arm A) or Erlotinib Plus Sulindac (Arm B) as Measured by Progression-free Survival.
NCT00392665 (4) [back to overview]	Overall Response Rate (ORR)
NCT00392704 (2) [back to overview]	Overall Survival (OS)Probability, the Percentage of Patients Estimated to be Alive Two Years After Beginning Protocol Treatment
NCT00392704 (2) [back to overview]	Two-Year Progression Free Survival (PFS) Probability, the Percentage of Patients Estimated to be Alive Without Worsening of Their Disease Two Years After Beginning Protocol Treatment
NCT00393068 (3) [back to overview]	Progression-Free Survival
NCT00393068 (3) [back to overview]	Pathologic Complete Response (pCR) Rate
NCT00393068 (3) [back to overview]	Overall Survival
NCT00402779 (1) [back to overview]	Oral Cancer-free Survival in Participants Receiving Erlotinib as Compared With the Control Arm or Placebo Group.
NCT00408499 (1) [back to overview]	Number of Patients Experiencing a DLT
NCT00410059 (1) [back to overview]	8 Week Progression-Free Survival Rate (i.e. Disease Control Rate)
NCT00410826 (2) [back to overview]	Comparison of the Percentage of Participants With a Complete Response in Each Treatment Arm
NCT00410826 (2) [back to overview]	Progression Free Survival of Patients With Locally Advanced Head and Neck Cancer Treated With Cisplatin and Radiotherapy, With and Without Erlotinib Hydrochloride
NCT00411632 (1) [back to overview]	Number of Participants With 8-week Progression-Free Survival (i.e. Disease Control Rate) Stratified by Cancer Mutation Type
NCT00412217 (4) [back to overview]	Number of Participants With Disease Progression
NCT00412217 (4) [back to overview]	Number of Participants Who Died
NCT00412217 (4) [back to overview]	Time to Progression (TTP)
NCT00412217 (4) [back to overview]	Overall Survival (OS)
NCT00425386 (6) [back to overview]	To Determine the Safety of Sunitinib in Combination With Erlotinib
NCT00425386 (6) [back to overview]	Proportion of Patients Whose Best Overall Response is Complete Response, Partial Response, Stable Disease, or Progressive Disease
NCT00425386 (6) [back to overview]	Maximum Tolerated Dose (MTD) of Erlotinib Hydrochloride When Used in Combination With Sunitinib.
NCT00425386 (6) [back to overview]	Progression-free Survival at 8 Months
NCT00425386 (6) [back to overview]	Median Time to Progression
NCT00425386 (6) [back to overview]	Maximum Percent Change in Tumor Measurement
NCT00436332 (3) [back to overview]	Progression-free Survival
NCT00436332 (3) [back to overview]	Overall Survival
NCT00436332 (3) [back to overview]	Frequency and Severity of Toxicities
NCT00442507 (4) [back to overview]	Time to Progression (TTP)
NCT00442507 (4) [back to overview]	Overall Survival Rate (OS)
NCT00442507 (4) [back to overview]	Incidence and Severity of Toxicities
NCT00442507 (4) [back to overview]	Response Rate (Complete Response (CR), Partial Response (PR), and CR+PR)
NCT00445588 (2) [back to overview]	Overall Survival
NCT00445588 (2) [back to overview]	6months -Progression-free Survival Rate
NCT00445848 (4) [back to overview]	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
NCT00445848 (4) [back to overview]	Progression-free Survival
NCT00445848 (4) [back to overview]	Overall Survival
NCT00445848 (4) [back to overview]	Response Rate (Complete and Partial)
NCT00447057 (7) [back to overview]	Percentage of Participants Surviving at 1 Year
NCT00447057 (7) [back to overview]	Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR) (Response Rate)
NCT00447057 (7) [back to overview]	Percentage of Participants With Best Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR) (Disease Control Rate)
NCT00447057 (7) [back to overview]	Progression Free Survival (PFS)
NCT00447057 (7) [back to overview]	Time to Treatment Failure (TTTF)
NCT00447057 (7) [back to overview]	Number of Participants With Adverse Events (AEs)
NCT00447057 (7) [back to overview]	Overall Survival (OS)
NCT00452413 (10) [back to overview]	Phase 2: Overall Survival (OS)
NCT00452413 (10) [back to overview]	Recommended Phase 2 Dose for Enzastaurin Plus Erlotinib Combination Therapy (Assess the Tolerated Dose of the Combination Erlotinib and Enzastaurin)
NCT00452413 (10) [back to overview]	Phase 2: Progression-Free Survival (PFS) With the Enzastaurin Plus Erlotinib Combination Regimen
NCT00452413 (10) [back to overview]	Phase I: Pharmacokinetic (PK) Interactions Between Enzastaurin and Erlotinib: Apparent Oral Clearance of Erlotinib Under Steady State Conditions During Multiple Dosing (CLss/F)
NCT00452413 (10) [back to overview]	Phase 2: Percentage of Participants With Tumor Response
NCT00452413 (10) [back to overview]	Phase 2: Number of Participants Who Experienced TEAEs (Safety and AE Profile)
NCT00452413 (10) [back to overview]	Phase I: PK Interactions Between Enzastaurin and Erlotinib: Maximum Observed Plasma Concentration at Steady State (Cmax,ss)
NCT00452413 (10) [back to overview]	Phase I: Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) (Safety and AE Profile for Enzastaurin/Erlotinib Combination)
NCT00452413 (10) [back to overview]	Phase I: PK Interactions Between Enzastaurin and Erlotinib: Area Under the Plasma Concentration Time Curve at Steady State [AUC(Tau,ss)]
NCT00452413 (10) [back to overview]	Phase 2: Duration of Response
NCT00453362 (13) [back to overview]	Progression Free Survival (PFS) of Groups by FDG Response at Day 56
NCT00453362 (13) [back to overview]	Progression Free Survival of Groups by FLT Response at Day 56
NCT00453362 (13) [back to overview]	Progression Free Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56
NCT00453362 (13) [back to overview]	FDG Response in Subgroups by CT Response at Day 56
NCT00453362 (13) [back to overview]	FLT Response in Subgroups by CT Response at Day 56
NCT00453362 (13) [back to overview]	Percentage of Patients With FLT-PET Responses
NCT00453362 (13) [back to overview]	PFS of Patients With FDG-PET Complete Response (CR)/Partial Response (PR) Versus FDG-PET Progressive Disease (PD) in Patients With Computed Tomography (CT) Stable Disease (SD) at Day 56
NCT00453362 (13) [back to overview]	Number of Participants With Adverse Events Due to FLT-PET Imaging
NCT00453362 (13) [back to overview]	Percentage of Patients With FDG-PET Responses
NCT00453362 (13) [back to overview]	Overall Survival of Groups by FDG Response at Day 56
NCT00453362 (13) [back to overview]	Overall Survival of Groups by FLT Response at Day 56
NCT00453362 (13) [back to overview]	Overall Survival of Patients With FDG CR/PR Versus FDG PD in Patients With CT SD at Day 56
NCT00453362 (13) [back to overview]	Overall Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56
NCT00457392 (6) [back to overview]	EuroQol 5-Dimension Questionnaire (EQ-5D)- Health State Profile Utility Score
NCT00457392 (6) [back to overview]	Progression-Free Survival (PFS)
NCT00457392 (6) [back to overview]	Duration of Response (DR)
NCT00457392 (6) [back to overview]	One-year Survival Probability
NCT00457392 (6) [back to overview]	Overall Survival (OS)
NCT00457392 (6) [back to overview]	Percentage of Participants With Objective Response (OR)
NCT00461708 (10) [back to overview]	Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST
NCT00461708 (10) [back to overview]	OS At 6 Months
NCT00461708 (10) [back to overview]	Percentage of Participants With Disease Control According to RECIST
NCT00461708 (10) [back to overview]	PFS
NCT00461708 (10) [back to overview]	OS By Rash Grade
NCT00461708 (10) [back to overview]	Number of Participants Who Died During the Study By Rash Grade
NCT00461708 (10) [back to overview]	Number of Participants With Disease Progression or Death
NCT00461708 (10) [back to overview]	Number of Participants Who Died at 6 Months
NCT00461708 (10) [back to overview]	Number of Participants Who Died During the Study
NCT00461708 (10) [back to overview]	Overall Survival (OS) During the Study
NCT00466687 (4) [back to overview]	Number of Patients With Response
NCT00466687 (4) [back to overview]	Time to Disease Progression.
NCT00466687 (4) [back to overview]	Progression-free Survival at 6 Months
NCT00466687 (4) [back to overview]	Number of Patients With Each Worst-grade Toxicity Response
NCT00470535 (1) [back to overview]	Progression-free Survival
NCT00476476 (1) [back to overview]	Response Rate
NCT00482625 (6) [back to overview]	Number of Participants Reported at Least 1 Adverse Event With a Grade of 3 and Above
NCT00482625 (6) [back to overview]	Reduction in Number of Positive IPMN Celss and Staining Intensity After Treatment
NCT00482625 (6) [back to overview]	Plasma Calculated Concentration - OSI-774 (ng/mL)
NCT00482625 (6) [back to overview]	Plasma Calculated Concentration - OSI-420 (ng/mL)
NCT00482625 (6) [back to overview]	Pancreas Calculated Concentration - OSI-774 (ng/g)
NCT00482625 (6) [back to overview]	Pancreas Calculated Concentration - OSI-420 (ng/g)
NCT00499655 (5) [back to overview]	Progression-free Survival - EGRF
NCT00499655 (5) [back to overview]	Progression-free Survival - Elevated PGEM
NCT00499655 (5) [back to overview]	Progression-free Survival - Low PGEM
NCT00499655 (5) [back to overview]	Progression-free Survival
NCT00499655 (5) [back to overview]	Number of Participants With Overall Response
NCT00518011 (8) [back to overview]	Disease Control Rate
NCT00518011 (8) [back to overview]	Mean Change in Body Temperature From Baseline
NCT00518011 (8) [back to overview]	Progression Free Survival
NCT00518011 (8) [back to overview]	Duration of Response
NCT00518011 (8) [back to overview]	Mean Change in Blood Pressure From Baseline
NCT00518011 (8) [back to overview]	Mean Change in Pulse Rate From Baseline
NCT00518011 (8) [back to overview]	Overall Survival
NCT00518011 (8) [back to overview]	Objective Response Rate
NCT00520013 (3) [back to overview]	Consolidation Progression-Free Survival
NCT00520013 (3) [back to overview]	Consolidation Treatment-related Toxicity Rate
NCT00520013 (3) [back to overview]	Consolidation Objective Response Rate
NCT00524121 (8) [back to overview]	Response by Epidermal Growth Factor Receptor (EGFR) Expression
NCT00524121 (8) [back to overview]	Response by EGFR Mutation Status
NCT00524121 (8) [back to overview]	Progresssion-Free Survival
NCT00524121 (8) [back to overview]	Overall Survival
NCT00524121 (8) [back to overview]	Effect of Study Therapy on Overall Quality of Life as Assessed by FACT-E Scale
NCT00524121 (8) [back to overview]	Correlation of Smoking Status With Overall Survival
NCT00524121 (8) [back to overview]	Complete Response
NCT00524121 (8) [back to overview]	Response by Phosphor Epidermal Growth Factor Receptor (pEGFR) Expression
NCT00525525 (3) [back to overview]	Unexpected Toxicities During First 2 Cycles of Study Drug
NCT00525525 (3) [back to overview]	Progression-free Survival
NCT00525525 (3) [back to overview]	Overall Survival (OS)
NCT00531934 (32) [back to overview]	Percentage of Participants With Erlotinib Dose Reduction by Reason for Reduction
NCT00531934 (32) [back to overview]	Time Free From Skin Rash (Folliculitis) During the First 4 Months of Treatment - Time to Event
NCT00531934 (32) [back to overview]	Percentage of Participants Estimated to be Event Free at 12 Months
NCT00531934 (32) [back to overview]	Percentage of Participants With Doxycycline Dose Reduction by Reason for Reduction
NCT00531934 (32) [back to overview]	Number of Participants With Skin Rash (Folliculitis) After the First 4 Months of Treatment By Type
NCT00531934 (32) [back to overview]	Percentage of Participants by Best Global Response Under Treatment
NCT00531934 (32) [back to overview]	Percentage of Participants by DLQI Global Score Classification of Disease Effect on Quality of Life
NCT00531934 (32) [back to overview]	Percentage of Participants Estimated to be Alive at 4 and 12 Months
NCT00531934 (32) [back to overview]	Percentage of Participants Estimated to be Progression Free at 4 and 12 Months
NCT00531934 (32) [back to overview]	Number of Skin Rash (Folliculitis) Events During the First 4 Months of Treatment
NCT00531934 (32) [back to overview]	Percentage of Participants With Global Disease Control by Visit
NCT00531934 (32) [back to overview]	Percentage of Participants With Other Skin Lesions During the First 4 Months of Treatment By Maximal Intensity
NCT00531934 (32) [back to overview]	Dermatology Life Quality Index (DLQI) Global Score
NCT00531934 (32) [back to overview]	Number of Skin Rash (Folliculitis) Events After the First 4 Months of Treatment
NCT00531934 (32) [back to overview]	Overall Survival (OS) - Percentage of Participants With an Event
NCT00531934 (32) [back to overview]	Overall Survival (OS) - Time to Event
NCT00531934 (32) [back to overview]	Time Free From Skin Rash (Folliculitis) During the First 4 Months of Treatment - Number of Participants With an Event
NCT00531934 (32) [back to overview]	Progression-Free Survival (PFS) - Time to Event
NCT00531934 (32) [back to overview]	Duration of Skin Rash (Folliculitis) During the Whole Treatment Period
NCT00531934 (32) [back to overview]	Percentage of Participants With Other Skin Lesions During the First 4 Months of Treatment By Type
NCT00531934 (32) [back to overview]	Number of Participants With Skin Rash (Folliculitis) After the First 4 Months of Treatment By Intensity
NCT00531934 (32) [back to overview]	Percentage of Participants With Skin Rash (Folliculitis) During the First 4 Months of Treatment By Maximal Intensity
NCT00531934 (32) [back to overview]	Percentage of Participants With at Least One Skin Rash (Folliculitis) of Any Grade During the First 4 Months of Treatment
NCT00531934 (32) [back to overview]	Progression-Free Survival (PFS) - Percentage of Participants With an Event
NCT00531934 (32) [back to overview]	Percentage of Participants With Skin Rash (Folliculitis) During the First 4 Months of Treatment By Type
NCT00531934 (32) [back to overview]	Quality of Life Score as Assessed by Visual Analog Scale (VAS)
NCT00531934 (32) [back to overview]	Duration of Skin Rash (Folliculitis) During the First 4 Months of Treatment
NCT00531934 (32) [back to overview]	Percentage of Participants With Other Skin Lesions of Any Grade During the First 4 Months of Treatment
NCT00531934 (32) [back to overview]	Percentage of Participants With at Least One Skin Rash (Folliculitis) of Any Grade After the First 4 Months of Treatment
NCT00531934 (32) [back to overview]	Percentage of Participants Estimated to be Event Free at 4 Months
NCT00531934 (32) [back to overview]	Time Free From Skin Rash (Folliculitis) During the Whole Treatment Period - Time to Event
NCT00531934 (32) [back to overview]	Time Free From Skin Rash (Folliculitis) During the Whole Treatment Period - Number of Participants With an Event
NCT00531960 (6) [back to overview]	OS
NCT00531960 (6) [back to overview]	PFS
NCT00531960 (6) [back to overview]	Percentage of Participants Who Died
NCT00531960 (6) [back to overview]	Percentage of Participants With Disease Progression or Death
NCT00531960 (6) [back to overview]	Percentage of Participants With Disease Control According to RECIST V 1.0
NCT00531960 (6) [back to overview]	Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST V 1.0
NCT00532441 (3) [back to overview]	16 Weeks Progression-free Survival
NCT00532441 (3) [back to overview]	Overall Survival
NCT00532441 (3) [back to overview]	Response Rate
NCT00547105 (7) [back to overview]	6 Month Progression-Free Survival
NCT00547105 (7) [back to overview]	In-field Local Control
NCT00547105 (7) [back to overview]	Number of Participants Without Serious Adverse Events Related to Radiation
NCT00547105 (7) [back to overview]	Out-of-field Disease Progression
NCT00547105 (7) [back to overview]	Overall Survival
NCT00547105 (7) [back to overview]	Duration of Erlotinib Use and Time to Initiation of Third-line Systemic Therapy
NCT00547105 (7) [back to overview]	Progression-free Survival
NCT00550173 (8) [back to overview]	Overall Survival (OS)
NCT00550173 (8) [back to overview]	Percentage of Participants With CR, PR, and Stable Disease (SD) - Disease Control Rate (DCR)
NCT00550173 (8) [back to overview]	Number of Participants With Adverse Events
NCT00550173 (8) [back to overview]	Number of Participants With Mutated or Non-Mutated Epidermal Growth Factor Receptor (EGFR) Genotype Status
NCT00550173 (8) [back to overview]	Time to Worsening of Symptoms (TWS) on Lung Cancer Symptoms Scale (LCSS)
NCT00550173 (8) [back to overview]	Progression-Free Survival (PFS)
NCT00550173 (8) [back to overview]	Probability of OS at 12 Months
NCT00550173 (8) [back to overview]	Percentage of Participants With a Tumor Response of Complete Response (CR) or Partial Response (PR) [Tumor Response Rate (TRR)]
NCT00550537 (4) [back to overview]	Progression-free Survival (PFS) for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC
NCT00550537 (4) [back to overview]	Overall Survival for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC
NCT00550537 (4) [back to overview]	Number of Patients With Worst-grade Toxicities Per Grade
NCT00550537 (4) [back to overview]	Response Rate for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC
NCT00550836 (5) [back to overview]	Confirmed Response Rate
NCT00550836 (5) [back to overview]	Frequency and Severity of Observed Adverse Effects
NCT00550836 (5) [back to overview]	Time to Treatment Failure
NCT00550836 (5) [back to overview]	Progression-free Survival
NCT00550836 (5) [back to overview]	Overall Survival
NCT00553462 (3) [back to overview]	Overall Survival at 12 Months
NCT00553462 (3) [back to overview]	Progression-free Survival
NCT00553462 (3) [back to overview]	Response Rate
NCT00553800 (1) [back to overview]	Progression Free Survival (PFS)
NCT00556322 (22) [back to overview]	Probable Percentage of Participants Remaining Without Deterioration in Quality of Life at 6 Months as Assessed by FACT-L
NCT00556322 (22) [back to overview]	Probable Percentage of Participants Remaining Alive and Progression Free at 6 Months
NCT00556322 (22) [back to overview]	Percentage of Participants With Symptomatic Progression Using FACT-L
NCT00556322 (22) [back to overview]	Percentage of Participants With Disease Progression or Death (All Participants; Data Cut Off 07 September 2010)
NCT00556322 (22) [back to overview]	Percentage of Participants With Deterioration in the Trial Outcome Index (TOI)
NCT00556322 (22) [back to overview]	Percentage of Participants With Deterioration in Quality of Life Determined Using Functional Assessment of Cancer Therapy - Lung (FACT-L)
NCT00556322 (22) [back to overview]	Percentage of Participants Who Died (All Participants; Data Cutoff: 07 September 2010)
NCT00556322 (22) [back to overview]	Percentage of Participants Achieving a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator Using RECIST
NCT00556322 (22) [back to overview]	Duration of Overall Survival in All Participants (Data Cutoff 07 September 2010)
NCT00556322 (22) [back to overview]	Probable Percentage of Participants With Deterioration in the TOI at 6 Months as Assessed by FACT-L
NCT00556322 (22) [back to overview]	Probable Percentage of Participants Remaining Alive at 1 Year
NCT00556322 (22) [back to overview]	Time to Deterioration in Quality of Life Using FACT-L
NCT00556322 (22) [back to overview]	Time to Deterioration in the TOI
NCT00556322 (22) [back to overview]	Duration of OS in EGFR Positive and Negative Population
NCT00556322 (22) [back to overview]	Percentage of Participants Who Died in Epidermal Growth Factor Receptor (EGFR) Positive and Negative Population
NCT00556322 (22) [back to overview]	Percentage of Participants With Disease Progression or Death in EGFR Positive and Negative Population (Data Cut Off 07 September 2010)
NCT00556322 (22) [back to overview]	PFS in EGFR Positive and Negative Population (Data Cutoff 07 September 2010)
NCT00556322 (22) [back to overview]	Probable Percentage of Participants Remaining Alive and Progression Free at 6 Months in EGFR Positive and Negative Population
NCT00556322 (22) [back to overview]	Probable Percentage of Participants With Symptomatic Progression at 6 Months as Assessed by FACT-L
NCT00556322 (22) [back to overview]	Progression-Free Survival (PFS) in All Participants (Data Cutoff 07 September 2010)
NCT00556322 (22) [back to overview]	Time to Symptomatic Progression Using FACT-L
NCT00556322 (22) [back to overview]	Probable Percentage of Participants Remaining Alive at 1 Year in the EGFR Positive and Negative Population
NCT00556712 (36) [back to overview]	Change From BL in FACT-L Scores (Data Cutoff 17 May 2008)
NCT00556712 (36) [back to overview]	Time to Symptom Progression (Data Cutoff 17 May 2008)
NCT00556712 (36) [back to overview]	Time to Progression (Data Cutoff 17 May 2008)
NCT00556712 (36) [back to overview]	Time to Deterioration in TOI (Data Cutoff 17 May 2008)
NCT00556712 (36) [back to overview]	Time to Deterioration in QoL (Data Cutoff 17 May 2008)
NCT00556712 (36) [back to overview]	Percentage of EGFR IHC Negative Participants Who Died (Data Cutoff 17 May 2008)
NCT00556712 (36) [back to overview]	Percentage of All Participants Who Died (Data Cutoff 12 January 2012)
NCT00556712 (36) [back to overview]	Overall Survival (OS) in All Participants (Data Cutoff 12 January 2012)
NCT00556712 (36) [back to overview]	OS in EGFR IHC Positive Population (Data Cutoff 12 January 2012)
NCT00556712 (36) [back to overview]	Probable Percentage of Participants Remaining Without Symptom Progression at 6 Months (Data Cutoff 17 May 2008)
NCT00556712 (36) [back to overview]	Probable Percentage of Participants Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008)
NCT00556712 (36) [back to overview]	Probable Percentage of Participants Remaining Alive at 1 Year (Data Cutoff 12 January 2012)
NCT00556712 (36) [back to overview]	Probable Percentage of Participants Remaining Progression-Free in the TTP Analysis at 6 Months (Data Cutoff 17 May 2008)
NCT00556712 (36) [back to overview]	Percentage of Participants With Symptom Progression Assessed Using the Lung Cancer Subscale (LCS) (Data Cutoff 17 May 2008)
NCT00556712 (36) [back to overview]	Probable Percentage of Participants Remaining Without Deterioration in TOI at 6 Months (Data Cutoff 17 May 2008)
NCT00556712 (36) [back to overview]	OS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008)
NCT00556712 (36) [back to overview]	PFS in All Participants (Data Cutoff 17 May 2008)
NCT00556712 (36) [back to overview]	Percentage of Epidermal Growth Factor Receptor (EGFR) Immunohistochemistry (IHC) Positive Participants With PD or Death (Data Cutoff 17 May 2008)
NCT00556712 (36) [back to overview]	Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST (Data Cutoff 17 May 2008)
NCT00556712 (36) [back to overview]	Percentage of Participants With a Response Upgrade From BL According to RECIST (Data Cutoff 17 May 2008)
NCT00556712 (36) [back to overview]	Percentage of Participants With Deterioration Assessed Using the Trial Outcome Index (Data Cutoff 17 May 2008)
NCT00556712 (36) [back to overview]	Percentage of EGFR IHC Negative Participants With PD or Death (Data Cutoff 17 May 2008)
NCT00556712 (36) [back to overview]	PFS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008)
NCT00556712 (36) [back to overview]	Probable Percentage of Participants Remaining Without Deterioration in QoL at 6 Months (Data Cutoff 17 May 2008)
NCT00556712 (36) [back to overview]	PFS in EGFR IHC Positive Population (Data Cutoff 17 May 2008)
NCT00556712 (36) [back to overview]	Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008)
NCT00556712 (36) [back to overview]	Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive at 1 Year (Data Cutoff 17 May 2008)
NCT00556712 (36) [back to overview]	Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive and Progression Free at 6 Months (Data Cutoff 17 May 2008)
NCT00556712 (36) [back to overview]	Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive at 1 Year (Data Cutoff 12 January 2012)
NCT00556712 (36) [back to overview]	Percentage of Participants With CR, PR, or SD or With SD [Maintained For Greater Than (>) 12 Weeks] or CR or PR (Data Cutoff 17 May 2008)
NCT00556712 (36) [back to overview]	Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST (Data Cutoff 17 May 2008)
NCT00556712 (36) [back to overview]	Percentage of Participants With a Change of PR to CR or SD to PR or CR From BL to End of Treatment According to RECIST (Data Cutoff 17 May 2008)
NCT00556712 (36) [back to overview]	Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008)
NCT00556712 (36) [back to overview]	Percentage of Participants With Deterioration in Quality of Life Assessed Using TOI, SWB, and EWB (Data Cutoff 17 May 2008)
NCT00556712 (36) [back to overview]	Percentage of Participants With PD According to Response Evaluation Criteria in Solid Tumors (RECIST) or Death (Data Cutoff 17 May 2008)
NCT00556712 (36) [back to overview]	Percentage of EGFR IHC Positive Participants Who Died (Data Cutoff 12 January 2012)
NCT00563784 (2) [back to overview]	Overall Survival and Disease Local Control Rate
NCT00563784 (2) [back to overview]	Time To First Disease Progression
NCT00567359 (4) [back to overview]	2-year Disease-free Survival
NCT00567359 (4) [back to overview]	Median Disease Free Survival
NCT00567359 (4) [back to overview]	Median Overall Survival
NCT00567359 (4) [back to overview]	Number of Participants With Treat Related Serious Adverse Events
NCT00570232 (3) [back to overview]	Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment
NCT00570232 (3) [back to overview]	Percentage of Participants Demonstrating Survival at 12 Months and 24 Months.
NCT00570232 (3) [back to overview]	Percentage of Participants With Disease Free Status at 12 Months and 24 Months
NCT00573989 (10) [back to overview]	Median Overall Survival
NCT00573989 (10) [back to overview]	Overall Survival
NCT00573989 (10) [back to overview]	Objective Tumor Response
NCT00573989 (10) [back to overview]	Evaluation of Acute and Chronic Toxicity
NCT00573989 (10) [back to overview]	Change in Quality of Life: PSS-HN
NCT00573989 (10) [back to overview]	Change in Quality of Life: MDADI
NCT00573989 (10) [back to overview]	Change in Quality of Life- FACT H&N
NCT00573989 (10) [back to overview]	Progression-free Survival (PFS) at 1 Year (Phase II)
NCT00573989 (10) [back to overview]	Median Progression Free Survival
NCT00573989 (10) [back to overview]	Maximum Tolerated Dose of Erlotinib Hydrochloride (Phase I)
NCT00577707 (1) [back to overview]	Number of Patients With Pathologic Complete Response Rate
NCT00585377 (3) [back to overview]	Evaluation of Response Rate
NCT00585377 (3) [back to overview]	Evaluation of Progression-free Survival
NCT00585377 (3) [back to overview]	Evaluation of Overall Survival
NCT00585533 (2) [back to overview]	Overall Survival
NCT00585533 (2) [back to overview]	Survival Rate at 6-months Chemotherapy-progression-free (CP-free)
NCT00590902 (1) [back to overview]	Overall Objective Response of OSI-774
NCT00591123 (2) [back to overview]	Toxicity of the Combination of FOLFOX, 5-FU, and Erlotinib
NCT00591123 (2) [back to overview]	Overall Response Rate of Previously-untreated Patients With Unresectable or Metastatic Adenocarcinomas of the Upper Gastrointestinal Tract When Treated With the Combination of 5-fluorouracil, Leucovorin, Oxaliplatin, and Erlotinib.
NCT00597597 (5) [back to overview]	Safety of Erlotinib
NCT00597597 (5) [back to overview]	The Primary Objective of the Study is Progression Free Survival.
NCT00597597 (5) [back to overview]	Clinical Benefit, Consisting of Complete and Partial Responses, and Stable Disease for Six Months
NCT00597597 (5) [back to overview]	Number of Participants With Rash
NCT00597597 (5) [back to overview]	Overall Response Rate, Consisting of Complete and Partial Responses According to RECIST Criteria
NCT00600015 (6) [back to overview]	Progression Free Survival (PFS)
NCT00600015 (6) [back to overview]	6-month PFS
NCT00600015 (6) [back to overview]	Disease Control Rate (DCR)
NCT00600015 (6) [back to overview]	Duration of Response
NCT00600015 (6) [back to overview]	Overall Objective Response Rate (ORR)
NCT00600015 (6) [back to overview]	Overall Survival (OS)
NCT00602030 (16) [back to overview]	Tmax: Time to Cmax of Entinostat in the Lead-in Phase
NCT00602030 (16) [back to overview]	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) by Severity in the Double-blind Phase
NCT00602030 (16) [back to overview]	Number of Participants With Grade 3 or 4 Laboratory Variables in the Double-blind Phase
NCT00602030 (16) [back to overview]	Cmax: Maximum Plasma Concentration of Entinostat in the Lead-in Phase
NCT00602030 (16) [back to overview]	AUC(0-last): Area Under the Concentration-time Curve From Time 0 to Last Quantifiable Concentration in the Lead-in Phase
NCT00602030 (16) [back to overview]	AUC(0-24): Area Under the Concentration-time Curve From Time 0 to 24 Hours in the Lead-in Phase
NCT00602030 (16) [back to overview]	Objective Response Rate (ORR) in the Double-blind Phase
NCT00602030 (16) [back to overview]	Identification of Safe-dose for the Phase 2 Double-blind Phase in the Lead-in Phase
NCT00602030 (16) [back to overview]	6-Month PFS Rate in the Double-blind Phase
NCT00602030 (16) [back to overview]	4-Month Progression-free Survival (PFS) Rate in the Double-blind Phase
NCT00602030 (16) [back to overview]	Vital Sign Values: Heart Rate in the Double-blind Phase
NCT00602030 (16) [back to overview]	Vital Sign Values: Respiration Rate in the Double-blind Phase
NCT00602030 (16) [back to overview]	Vital Sign Values: Systolic Blood Pressure in the Double-blind Phase
NCT00602030 (16) [back to overview]	Vital Sign Values: Temperature in the Double-blind Phase
NCT00602030 (16) [back to overview]	Vital Sign Values: Weight in the Double-blind Phase
NCT00602030 (16) [back to overview]	Vital Sign Values: Diastolic Blood Pressure in the Double-blind Phase
NCT00602667 (62) [back to overview]	Methotrexate Volume of Central Compartment in Induction Cycle 2
NCT00602667 (62) [back to overview]	4-OH Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 1
NCT00602667 (62) [back to overview]	Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 4
NCT00602667 (62) [back to overview]	Methotrexate Volume of Central Compartment in Induction Cycle 1
NCT00602667 (62) [back to overview]	Methotrexate Volume of Central Compartment in Induction Cycle 3
NCT00602667 (62) [back to overview]	Methotrexate Volume of Central Compartment in Induction Cycle 4
NCT00602667 (62) [back to overview]	OSI-420 AUC0-24h
NCT00602667 (62) [back to overview]	Overall Survival (OS) Compared to Historical Controls
NCT00602667 (62) [back to overview]	Participants With Empirical Dosage Achieving Target System Exposure of Intravenous Topotecan
NCT00602667 (62) [back to overview]	Methotrexate AUC0-66h in Induction Cycle 2
NCT00602667 (62) [back to overview]	Participants With PK-guided Dosage Adjustment Achieving Target System Exposure of Intravenous Topotecan
NCT00602667 (62) [back to overview]	4-OH Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 2
NCT00602667 (62) [back to overview]	4-OH Cyclophosphamide AUC0-24h in Induction Chemotherapy
NCT00602667 (62) [back to overview]	Percent of Patients With Sustained Objective Responses Rate After Consolidation
NCT00602667 (62) [back to overview]	4-OH Cyclophosphamide AUC0-24h in Maintenance Chemotherapy Cycle A1
NCT00602667 (62) [back to overview]	Percent of PET Scans With Loss of Signal Intensity
NCT00602667 (62) [back to overview]	Percent Probability of Event-free Survival (EFS) for Medulloblastoma Patients
NCT00602667 (62) [back to overview]	Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients
NCT00602667 (62) [back to overview]	Percentage of Patients With Objective Responses Rate to Induction Chemotherapy
NCT00602667 (62) [back to overview]	Cyclophosphamide AUC0-24h in Maintenance Chemotherapy Cycle A1
NCT00602667 (62) [back to overview]	Rate of Distant Disease Progression
NCT00602667 (62) [back to overview]	Rate of Local Disease Progression
NCT00602667 (62) [back to overview]	Topotecan Apparent Oral Clearance in Maintenance Chemotherapy
NCT00602667 (62) [back to overview]	CEPM AUC0-24h in Consolidation Chemotherapy Cycle 1
NCT00602667 (62) [back to overview]	CEPM AUC0-24h in Consolidation Chemotherapy Cycle 2
NCT00602667 (62) [back to overview]	CEPM AUC0-24h in Induction Chemotherapy
NCT00602667 (62) [back to overview]	CEPM AUC0-24h in Maintenance Chemotherapy Cycle A1
NCT00602667 (62) [back to overview]	Cyclophosphamide Apparent Oral Clearance in Maintenance Chemotherapy Cycle A1
NCT00602667 (62) [back to overview]	Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 1
NCT00602667 (62) [back to overview]	Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 2
NCT00602667 (62) [back to overview]	Topotecan AUC0-24h in Consolidation Chemotherapy
NCT00602667 (62) [back to overview]	Topotecan AUC0-24h in Maintenance Chemotherapy
NCT00602667 (62) [back to overview]	Topotecan Clearance in Consolidation Chemotherapy
NCT00602667 (62) [back to overview]	Concentration of Cerebrospinal Fluid Neurotransmitters
NCT00602667 (62) [back to overview]	Number and Type of Genetic Polymorphisms
NCT00602667 (62) [back to overview]	Number of Participants With Chromosomal Abnormalities
NCT00602667 (62) [back to overview]	Number of Successful Collections for Frozen and Fixed Tumor Samples
NCT00602667 (62) [back to overview]	Numbers of Patients With Gene Alterations
NCT00602667 (62) [back to overview]	Numbers of Patients With Molecular Abnormalities by Tumor Type
NCT00602667 (62) [back to overview]	Pharmacogenetic Variation on Central Nervous System Transmitters
NCT00602667 (62) [back to overview]	Feasibility and Toxicity of Administering Oral Maintenance Therapy in Children <3 Years of Age as Measured by the Percentage of Total Scheduled Maintenance Doses Received
NCT00602667 (62) [back to overview]	Cyclophosphamide AUC0-24h in Induction Chemotherapy
NCT00602667 (62) [back to overview]	Cyclophosphamide Clearance in Consolidation Chemotherapy Cycle 1
NCT00602667 (62) [back to overview]	Cyclophosphamide Clearance in Consolidation Chemotherapy Cycle 2
NCT00602667 (62) [back to overview]	Cyclophosphamide Clearance in Induction Chemotherapy
NCT00602667 (62) [back to overview]	Erlotinib Apparent Oral Clearance
NCT00602667 (62) [back to overview]	Erlotinib Apparent Volume of Central Compartment
NCT00602667 (62) [back to overview]	Erlotinib AUC0-24h
NCT00602667 (62) [back to overview]	Event-free Survival (EFS) Compared to Historical Controls
NCT00602667 (62) [back to overview]	Feasibility and Toxicity of Administering Consolidation Therapy Including Cyclophosphamide and Pharmacokinetically Targeted Topotecan to Patients With Metastatic Disease Based on the Percentage of Courses Delayed for More Than 7 Days Due to Toxicity
NCT00602667 (62) [back to overview]	Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients by DNA Methylation Subgroup
NCT00602667 (62) [back to overview]	Feasibility and Toxicity of Administering Vinblastine With Induction Chemotherapy for Patients With Metastatic Disease as Measured by the Percentage of Courses Delayed for More Than 7 Days Due to Toxicity
NCT00602667 (62) [back to overview]	Methotrexate AUC0-66h in Induction Cycle 1
NCT00602667 (62) [back to overview]	Methotrexate AUC0-66h in Induction Cycle 3
NCT00602667 (62) [back to overview]	Methotrexate AUC0-66h in Induction Cycle 4
NCT00602667 (62) [back to overview]	Methotrexate Clearance in Induction Cycle 1
NCT00602667 (62) [back to overview]	Methotrexate Clearance in Induction Cycle 2
NCT00602667 (62) [back to overview]	Methotrexate Clearance in Induction Cycle 3
NCT00602667 (62) [back to overview]	Methotrexate Clearance in Induction Cycle 4
NCT00602667 (62) [back to overview]	Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 1
NCT00602667 (62) [back to overview]	Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 2
NCT00602667 (62) [back to overview]	Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 3
NCT00603915 (2) [back to overview]	Progression Free Survival.
NCT00603915 (2) [back to overview]	Number of Participants With the Responses Outlined
NCT00605722 (7) [back to overview]	Time to Tumor Progression
NCT00605722 (7) [back to overview]	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT00605722 (7) [back to overview]	Disease Control Rate (DCR)
NCT00605722 (7) [back to overview]	Overall Survival (OS)
NCT00605722 (7) [back to overview]	Percentage of Participants With Progression-free Survival (PFS)
NCT00605722 (7) [back to overview]	Overall Response Rate (ORR)
NCT00605722 (7) [back to overview]	Progression-free Survival (PFS)
NCT00606502 (4) [back to overview]	Overall Survival (OS) of Patients Receiving Pralatrexate vs. Erlotinib
NCT00606502 (4) [back to overview]	Progression-free Survival (PFS) of Patients Receiving Pralatrexate vs. Erlotinib
NCT00606502 (4) [back to overview]	Adverse Events of Patients Receiving Pralatrexate vs. Erlotinib
NCT00606502 (4) [back to overview]	Response Rate (RR) to Treatment of Patients Receiving Pralatrexate vs. Erlotinib
NCT00609804 (3) [back to overview]	Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
NCT00609804 (3) [back to overview]	Overall Response Rate
NCT00609804 (3) [back to overview]	Progression-free Survival (PFS)
NCT00611468 (7) [back to overview]	Pharmacokinetic Parameters of Intravenous Topotecan With and Without Erlotinib (Renal Clearance)
NCT00611468 (7) [back to overview]	Pharmacokinetic Parameters of Intravenous Topotecan With and Without Erlotinib (Mean Clearance)
NCT00611468 (7) [back to overview]	Pharmacogenetic Analysis (CYP3A4/5 Polymorphisms, UGT1A1, BCRP, and MDR1 Genotypes)
NCT00611468 (7) [back to overview]	Pharmacokinetic Parameters of Intravenous Topotecan With and Without Erlotinib (Dose-Normalized AUC)
NCT00611468 (7) [back to overview]	Objective Response (as Determined Using RECIST 1.0 Criteria)
NCT00611468 (7) [back to overview]	Dosage Limiting Toxicities
NCT00611468 (7) [back to overview]	Maximum Tolerated Dosage (MTD) of Intravenous Topotecan When Given in Combination With Oral Erlotinib
NCT00611715 (4) [back to overview]	Number of Patients With Anti-tumor Activity: Complete Response (CR) and Partial Response (PR)
NCT00611715 (4) [back to overview]	Number of Patients With Pathological Complete Response.
NCT00611715 (4) [back to overview]	Number of Patients With Worst-grade Toxicities Per Grade
NCT00611715 (4) [back to overview]	Median Time to Progression of Target Lesions
NCT00617708 (5) [back to overview]	Toxicity
NCT00617708 (5) [back to overview]	Maximum Tolerated Dose Determination
NCT00617708 (5) [back to overview]	Overall Survival
NCT00617708 (5) [back to overview]	Progression-Free Survival
NCT00617708 (5) [back to overview]	Response
NCT00621049 (4) [back to overview]	Overall Survival (OS)
NCT00621049 (4) [back to overview]	Disease-free Survival
NCT00621049 (4) [back to overview]	Safety
NCT00621049 (4) [back to overview]	2-year Survival
NCT00633750 (3) [back to overview]	Average Post-treatment Plasma Level of Erlotinib Hydrochloride
NCT00633750 (3) [back to overview]	Number of Participants Experiencing in Situ Anti-tumor Effect of Tarceva
NCT00633750 (3) [back to overview]	Molecular Profile of Participants Who Are Responsive to Tarceva
NCT00640978 (1) [back to overview]	Number of Participants Surviving at 6 Months
NCT00642473 (2) [back to overview]	Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4
NCT00642473 (2) [back to overview]	Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2
NCT00642746 (3) [back to overview]	Second-line Progression Free Survival
NCT00642746 (3) [back to overview]	Time to Second Progression (From Start of First-Line Regimen)
NCT00642746 (3) [back to overview]	Response Rates of Radiographically Measurable Disease
NCT00652340 (2) [back to overview]	Overall Survival
NCT00652340 (2) [back to overview]	Time to Disease Progression (TDP)
NCT00652366 (11) [back to overview]	Percentage of Participants Who Died Assessed From Point of Randomization
NCT00652366 (11) [back to overview]	Percentage of Participants Who Died as Assessed From Start of 4-Week Run-In
NCT00652366 (11) [back to overview]	OS Assessed From Start of 4-Week Run-In
NCT00652366 (11) [back to overview]	OS Assessed From Point of Randomization
NCT00652366 (11) [back to overview]	Percentage of Participants With Disease Progression or Death as Assessed From Point of Randomization
NCT00652366 (11) [back to overview]	Percentage of Participants With Disease Progression or Death as Assessed From the Start of 4-Week Run-In
NCT00652366 (11) [back to overview]	Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST
NCT00652366 (11) [back to overview]	PFS Assessed From Point of Randomization
NCT00652366 (11) [back to overview]	PFS Assessed From the Start of 4-Week Run-In
NCT00652366 (11) [back to overview]	Percentage of Participants With SD (Maintained for at Least 8 Weeks) or CR or PR (Maintained for at Least 4 Weeks) According to RECIST
NCT00652366 (11) [back to overview]	Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST
NCT00654420 (4) [back to overview]	Phase II: Median Overall Survival (OS) in Participants Receiving Dalotuzumab Plus Erlotinib Treatment
NCT00654420 (4) [back to overview]	Phase II: Median Progression Free Survival (PFS) in Participants Receiving Dalotuzumab Plus Erlotinib Treatment
NCT00654420 (4) [back to overview]	Phase I: Number of Participants Experiencing at Least One Dose-Limiting Toxicity (DLT) Adverse Event (AE) During the First Four Weeks of Dalotuzumab Plus Erlotinib Treatment
NCT00654420 (4) [back to overview]	Phase II: Percentage of Participants With Complete Response (CR) or Partial Response (PR) After Dalotuzumab Plus Erlotinib Treatment (Objective Response Rate [ORR])
NCT00660816 (4) [back to overview]	Overall Survival
NCT00660816 (4) [back to overview]	Progression-free Survival
NCT00660816 (4) [back to overview]	Response Rate
NCT00660816 (4) [back to overview]	Disease Stabilization Rate (e.g., Complete Response, Partial Response, and Stable Disease)
NCT00661193 (2) [back to overview]	Response Rate (Confirmed and Unconfirmed, Complete and Partial Response) in a Subset of Patients With Measurable Disease
NCT00661193 (2) [back to overview]	Selection of One of Two Treatment Regimens (Erlotinib Hydrochloride With or Without Carboplatin and Paclitaxel) for Further Study in a Phase III Trial, Based on Median Progression-free Survival for ≥ 3 Months
NCT00671970 (11) [back to overview]	Association of Biomarkers and One-year Survival - Phosphorylated Mitogen-activated Protein Kinase (pMAPK)
NCT00671970 (11) [back to overview]	Association of Biomarkers and One-year Survival - Phosphatase and Tensin Homologue (PTEN)
NCT00671970 (11) [back to overview]	Association of Biomarkers and One-year Survival - Epidermal Growth Factor (EGFR)
NCT00671970 (11) [back to overview]	Association of Biomarkers and One-year Survival - EGFR vIII
NCT00671970 (11) [back to overview]	6 Month Progression-free Survival
NCT00671970 (11) [back to overview]	Pharmacokinetics of Erlotinib: Cmax
NCT00671970 (11) [back to overview]	Radiographic Response
NCT00671970 (11) [back to overview]	Pharmacokinetics of Erlotinib: AUC
NCT00671970 (11) [back to overview]	Association of Biomarkers and One-year Survival - VEGFR-2
NCT00671970 (11) [back to overview]	Association of Biomarkers and One-year Survival - Vascular Endothelial Growth Factor (VEGF)
NCT00671970 (11) [back to overview]	Association of Biomarkers and One-year Survival - Phosphorylated Protein Kinase B (pAKT)
NCT00672243 (5) [back to overview]	Median Progression Free Survival (PFS)
NCT00672243 (5) [back to overview]	Number of Participants Experiencing a ≥ Grade 3, Treatment-related, Non-hematologic Toxicity.
NCT00672243 (5) [back to overview]	Best Radiographic Response
NCT00672243 (5) [back to overview]	6-month Progression-free Survival (PFS)
NCT00672243 (5) [back to overview]	Median Overall Survival (OS)
NCT00673049 (4) [back to overview]	Percentage of Participants With Objective Response
NCT00673049 (4) [back to overview]	Progression Free Survival (PFS)
NCT00673049 (4) [back to overview]	Percentage of Participants Reporting Positive for Total Anti-drug Antibodies (ADA)
NCT00673049 (4) [back to overview]	Overall Survival
NCT00674973 (5) [back to overview]	Percentage of Participants With Best Overall Response Rate
NCT00674973 (5) [back to overview]	Overall Survival
NCT00674973 (5) [back to overview]	Number of Participants With Adverse Events (AEs)
NCT00674973 (5) [back to overview]	Percentage of Participants With Disease Control Rate (DCR)
NCT00674973 (5) [back to overview]	Progression-Free Survival
NCT00696696 (3) [back to overview]	4-month Progression Free Survival (PFS) Rate
NCT00696696 (3) [back to overview]	Objective Response Rate
NCT00696696 (3) [back to overview]	Median Overall Survival (mOS)
NCT00701558 (3) [back to overview]	Time to Disease Progression
NCT00701558 (3) [back to overview]	Overall Survival
NCT00701558 (3) [back to overview]	Overall Response Rate (ORR)
NCT00705874 (1) [back to overview]	Maximum Tolerated Dose (MTD)
NCT00709826 (2) [back to overview]	Overall Survival
NCT00709826 (2) [back to overview]	Progression Free Survival
NCT00716456 (1) [back to overview]	The Maximum Tolerated Dose (MTD) of Cetuximab Given Every 2 Weeks
NCT00718315 (9) [back to overview]	Percentage of Participants With Pain
NCT00718315 (9) [back to overview]	Percentage of Participants Who Develop Skin Rash
NCT00718315 (9) [back to overview]	Percentage of Participants With Erythema
NCT00718315 (9) [back to overview]	Percentage of Participants With Pain Stratified by Severity Grade
NCT00718315 (9) [back to overview]	Percentage of Participants With Erythema Stratified by Severity Grade
NCT00718315 (9) [back to overview]	Time to Appearance of Skin Rash
NCT00718315 (9) [back to overview]	Percentage of Participants With Pruritus
NCT00718315 (9) [back to overview]	Percentage of Participants With Skin Rash Stratified by Severity Grade
NCT00718315 (9) [back to overview]	Percentage of Participants With Pruritus Stratified by Severity Grade
NCT00720356 (7) [back to overview]	Overall Survival at 12 Months
NCT00720356 (7) [back to overview]	Overall Survival at 24 Months
NCT00720356 (7) [back to overview]	Progression Free Survival at 6 Months
NCT00720356 (7) [back to overview]	Progression-free Survival at 12 Months
NCT00720356 (7) [back to overview]	Safety of the Combination of Erlotinib and Bevacizumab in This Patient Population
NCT00720356 (7) [back to overview]	Median Progression Free Survival
NCT00720356 (7) [back to overview]	Overall Survival
NCT00733408 (6) [back to overview]	Percentage of Participants With Response
NCT00733408 (6) [back to overview]	Incidence of Adverse Events as Assessed by National Cancer Institute CTCAE Version 3.0
NCT00733408 (6) [back to overview]	Changes in Levels of Circulating Tumor Cells
NCT00733408 (6) [back to overview]	Changes in Levels of Circulating Endothelial Cells
NCT00733408 (6) [back to overview]	Progression-free Survival (PFS)
NCT00733408 (6) [back to overview]	Overall Survival
NCT00733746 (5) [back to overview]	Number of Participants Experiencing Grade 3 or Higher Adverse Events as Graded by the NCI's Common Toxicity Criteria for Adverse Events
NCT00733746 (5) [back to overview]	Response Rate
NCT00733746 (5) [back to overview]	Resection Rate
NCT00733746 (5) [back to overview]	Relapse/Progression-free Survival
NCT00733746 (5) [back to overview]	Overall Survival at 2 Years
NCT00735306 (3) [back to overview]	Number of Dose Limiting Toxicities
NCT00735306 (3) [back to overview]	Tarceva Maximum Tolerated Dose in mg
NCT00735306 (3) [back to overview]	One Year Overall Survival From Time of Diagnosis
NCT00737243 (2) [back to overview]	Number of Participants With a Tissue of Origin Successfully Predicted by the Assay
NCT00737243 (2) [back to overview]	Overall Survival
NCT00738881 (1) [back to overview]	Progression-free Survival (PFS)
NCT00749892 (1) [back to overview]	Response Rate
NCT00754494 (11) [back to overview]	Plasma Erlotinib Concentration (ng/mL)
NCT00754494 (11) [back to overview]	Number of Participants Reported at Least 1 Side Effect During the Study
NCT00754494 (11) [back to overview]	Number of Participants Reported at Least 1 Rash Side Effect During the Study
NCT00754494 (11) [back to overview]	Number of Participants Reported at Least 1 Diarrhea Side Effect During the Study
NCT00754494 (11) [back to overview]	Plasma OSI-420 Concentration (ng/mL)
NCT00754494 (11) [back to overview]	Normal Mucosa OSI-420 Concentration (ng/mg)
NCT00754494 (11) [back to overview]	Normal Mucosa Erlotinib Concentration (ng/mg)
NCT00754494 (11) [back to overview]	Change in EGF-inducible Markers - Total EGFR in ACF
NCT00754494 (11) [back to overview]	Change in EGF-inducible Markers - pEGFR in Normal Mucosa
NCT00754494 (11) [back to overview]	Change in EGF-inducible Markers - pEGFR in ACF
NCT00754494 (11) [back to overview]	Change in EGF-inducible Markers - Total EGFR in Normal Mucosa
NCT00760929 (5) [back to overview]	Objective Response Rate
NCT00760929 (5) [back to overview]	Number of Participants With Progression Free Survival (PFS)
NCT00760929 (5) [back to overview]	Time to Response
NCT00760929 (5) [back to overview]	Duration of Response
NCT00760929 (5) [back to overview]	Overall Survival (OS)
NCT00761345 (1) [back to overview]	To Determine the Dose Limiting Toxicities
NCT00769067 (11) [back to overview]	Trough Plasma Concentration (Ctrough) of Dacomitinib (PF-00299804)
NCT00769067 (11) [back to overview]	Best Overall Response (BOR)
NCT00769067 (11) [back to overview]	Number of Participants With Kirsten Rat Sarcoma (KRAS) and Epidermal Growth Factor Receptor (EGFR) Status and EGFR T790M Mutation
NCT00769067 (11) [back to overview]	Dermatology Life Quality Index (DLQI)
NCT00769067 (11) [back to overview]	Categorical Summary of Overall Scale Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
NCT00769067 (11) [back to overview]	Categorical Summary of Overall Scale Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13)
NCT00769067 (11) [back to overview]	Progression-Free Survival (PFS)
NCT00769067 (11) [back to overview]	Percentage of Participants With Objective Response
NCT00769067 (11) [back to overview]	Soluble Protein Biomarkers Level
NCT00769067 (11) [back to overview]	Duration of Response (DR)
NCT00769067 (11) [back to overview]	Overall Survival (OS)
NCT00769483 (5) [back to overview]	Progression Free Survival
NCT00769483 (5) [back to overview]	Overall Survival
NCT00769483 (5) [back to overview]	Overall Response Rate
NCT00769483 (5) [back to overview]	Treatment Toxicity
NCT00769483 (5) [back to overview]	MK-0646 Maximum Tolerable Dose
NCT00773383 (4) [back to overview]	Electrocardiogram (ECG)
NCT00773383 (4) [back to overview]	Percentage of Participants With Progression Free Survival (PFS)
NCT00773383 (4) [back to overview]	Number of Participants With Positive Results for Human Anti-human Antibody (HAHA) Testing
NCT00773383 (4) [back to overview]	Fasting Glucose, Highest Post-Baseline Value
NCT00778167 (1) [back to overview]	Safety and Tolerability of IMC-A12 in Combination With Erlotinib Hydrochloride as Graded by Common Terminology Criteria for Adverse Event (CTCAE) Version 3.0 (DLTs During Cycle One)
NCT00800202 (7) [back to overview]	Time to Disease Progression or Death
NCT00800202 (7) [back to overview]	Time to Death
NCT00800202 (7) [back to overview]	Probability of Being Alive at 12 and 18 Months
NCT00800202 (7) [back to overview]	Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months
NCT00800202 (7) [back to overview]	Percentage of Participants Achieving a Best Overall Response of Complete Response or Partial Response as Assessed by the Investigator Using RECIST
NCT00800202 (7) [back to overview]	Percentage of Participants Who Died
NCT00800202 (7) [back to overview]	Percentage of Participants With Disease Progression or Death
NCT00810719 (3) [back to overview]	Response Rate
NCT00810719 (3) [back to overview]	Progression Free Survival
NCT00810719 (3) [back to overview]	Overall Survival
NCT00826449 (3) [back to overview]	Phase II: Progression-Free Survival (PFS) Rate
NCT00826449 (3) [back to overview]	Phase I: Maximum Tolerable Dose (MTD) of Dasatinib Given With Erlotinib Hydrochloride
NCT00826449 (3) [back to overview]	Phase II: Number of Participant With Response According to Response Evaluation Criteria in Solid Tumors (RECIST)
NCT00832637 (5) [back to overview]	Time to Tumor Progression (TTP)
NCT00832637 (5) [back to overview]	Overall Response Rate
NCT00832637 (5) [back to overview]	Tumor Control Rate
NCT00832637 (5) [back to overview]	Median Survival Time (MST)
NCT00832637 (5) [back to overview]	Toxicity
NCT00834678 (7) [back to overview]	Progression-free Survival at 6 Months and 12 Months (Phase II)
NCT00834678 (7) [back to overview]	Dose-limiting Toxicity (Phase I)
NCT00834678 (7) [back to overview]	Objective Response Rate (ORR)
NCT00834678 (7) [back to overview]	Maximum-tolerated Dose of Erlotinib Hydrochloride (Phase I)
NCT00834678 (7) [back to overview]	Duration of Response (DR)
NCT00834678 (7) [back to overview]	Maximum-tolerated Dose of Bendamustine Hydrochloride (Phase I)
NCT00834678 (7) [back to overview]	Overall Survival (OS)
NCT00843531 (3) [back to overview]	Objective Response Rate (ORR)
NCT00843531 (3) [back to overview]	Number of Patients With Dose-limiting Toxicity (DLT)
NCT00843531 (3) [back to overview]	Duration of Objective Response
NCT00848718 (12) [back to overview]	MTD of MK-2206 Administered QOD in Combination With Docetaxel
NCT00848718 (12) [back to overview]	Time to Maximum Plasma Concentration of MK-2206 (Tmax)
NCT00848718 (12) [back to overview]	Number of Participants Who Had a Tumor Response of Complete Response (CR) or Partial Response (PR)
NCT00848718 (12) [back to overview]	Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) During Cycle 1
NCT00848718 (12) [back to overview]	MTD of MK-2206 Administered QOD in Combination With Erlotinib
NCT00848718 (12) [back to overview]	MTD of MK-2206 Administered Q3W in Combination With Docetaxel
NCT00848718 (12) [back to overview]	MTD of MK-2206 Administered Once Every Week (QW) in Combination With Erlotinib
NCT00848718 (12) [back to overview]	MTD of MK-2206 Administered Every Three Weeks (Q3W) in Combination With Carboplatin and Paclitaxel
NCT00848718 (12) [back to overview]	Minimum Plasma Concentration of MK-2206 (Ctrough)
NCT00848718 (12) [back to overview]	Maximum Tolerated Dose (MTD) of MK-2206 Administered Every Other Day (QOD) in Combination With Carboplatin and Paclitaxel
NCT00848718 (12) [back to overview]	Maximum Plasma Concentration of MK-2206 (Cmax)
NCT00848718 (12) [back to overview]	Area Under the MK-2206 Concentration Versus Time Curve From Time Zero to 48 Hours Postdose (AUC 0-48h)
NCT00854308 (4) [back to overview]	Percentage of Participants With Objective Response in Patients With Met Diagnostic-Positive Tumors
NCT00854308 (4) [back to overview]	Progression-free Survival
NCT00854308 (4) [back to overview]	Progression-free Survival in Patients With Met Diagnostic-Positive Tumors
NCT00854308 (4) [back to overview]	Percentage of Participants With Objective Response
NCT00855894 (5) [back to overview]	Percentage of Patients With a 2-deoxy-2-[18F]Fluoro-D-glucose-positron Emission Tomography (FDG-PET) Response at Day 56 in All Patients and in Epidermal Growth Factor Receptor (EGFR) Mutant and Wild-type Subgroups
NCT00855894 (5) [back to overview]	Overall Survival (OS)
NCT00855894 (5) [back to overview]	Percentage of Patients With an Objective Response (OR)
NCT00855894 (5) [back to overview]	Percentage of Patients With Disease Control (DC) at Day 56
NCT00855894 (5) [back to overview]	Progression-free Survival (PFS)
NCT00871923 (2) [back to overview]	Median Survival
NCT00871923 (2) [back to overview]	Number of Participants With Overall Survival
NCT00881751 (4) [back to overview]	Number of SAEs Experienced
NCT00881751 (4) [back to overview]	Overall Survival
NCT00881751 (4) [back to overview]	Response Rate
NCT00881751 (4) [back to overview]	Event-free Survival
NCT00883779 (16) [back to overview]	Percentage of Participants With Deterioration in Quality of Life (QOL) Using FACT-L Version 4.0
NCT00883779 (16) [back to overview]	Time to Deterioration in QOL Using FACT-L Version 4.0
NCT00883779 (16) [back to overview]	Percentage of Participants Alive at the End of Study-Overall and Among Different Subgroups
NCT00883779 (16) [back to overview]	Percentage of Participants With Symptomatic Progression Assessed Using the Lung Cancer Subscale (LCS)
NCT00883779 (16) [back to overview]	Median PFS Time Based on Different Subgroups
NCT00883779 (16) [back to overview]	Median Overall Survival (OS) Time-Overall and Among Different Subgroups
NCT00883779 (16) [back to overview]	Time to Symptomatic Progression
NCT00883779 (16) [back to overview]	Time to Progression
NCT00883779 (16) [back to overview]	Time to Deterioration in TOI Using FACT-L Version 4.0
NCT00883779 (16) [back to overview]	Percentage of Participants With Deterioration in Trial Outcome Index (TOI) Using FACT-L Version 4.0
NCT00883779 (16) [back to overview]	Objective Response Rate: Percentage of Participants With a Confirmed Best Overall Response of CR or PR
NCT00883779 (16) [back to overview]	Non-Progression Rate: Percentage of Participants With a Confirmed Best Overall Response of Either Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) for At Least 16 Weeks
NCT00883779 (16) [back to overview]	Median Progression Free Survival (PFS) Time
NCT00883779 (16) [back to overview]	Median Follow-up Time During the Study
NCT00883779 (16) [back to overview]	Duration of Response
NCT00883779 (16) [back to overview]	Percentage of Participants Alive and Free From Disease Progression
NCT00888511 (1) [back to overview]	Progression Free Survival
NCT00901901 (8) [back to overview]	Overall Survival
NCT00901901 (8) [back to overview]	Time to Radiological Tumor Progression (TTP)
NCT00901901 (8) [back to overview]	Disease Control
NCT00901901 (8) [back to overview]	Duration of Response
NCT00901901 (8) [back to overview]	Time to Response
NCT00901901 (8) [back to overview]	Health-related Quality of Life and Utility Values as Measured by EQ-5D - Index
NCT00901901 (8) [back to overview]	Health-related Quality of Life and Utility Values as Measured by EQ-5D - VAS
NCT00901901 (8) [back to overview]	Tumor Response
NCT00925769 (10) [back to overview]	Part 1: Maximum Serum Concentration (Cmax) of Erlotinib and Its Metabolite OSI-420 (CP373420), Capecitabine and Its Metabolites (5'-Deoxy-5-Fluorocytidine [5'-DFCR] and 5'-Deoxy-5-Fluorouridine [5'-DFUR])
NCT00925769 (10) [back to overview]	Part 1: Last Quantifiable Drug Concentration (Clast) of Erlotinib and Its Metabolite OSI-420 (CP373420), Capecitabine and Its Metabolites (5'-DFCR and 5'-DFUR)
NCT00925769 (10) [back to overview]	Part 1: PRD of Bevacizumab for Part 2
NCT00925769 (10) [back to overview]	Part 1: PRD of Erlotinib for Part 2
NCT00925769 (10) [back to overview]	Part 1: Preliminary Recommended Dose (PRD) of Capecitabine for Part 2
NCT00925769 (10) [back to overview]	Part 1: Maximum Tolerated Dose (MTD) of Capecitabine
NCT00925769 (10) [back to overview]	Part 1: MTD of Bevacizumab
NCT00925769 (10) [back to overview]	Part 1: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast) of Erlotinib and Its Metabolite OSI-420 (CP373420), Capecitabine and Its Metabolites (5'-DFCR and 5'-DFUR)
NCT00925769 (10) [back to overview]	Part 1: MTD of Erlotinib
NCT00925769 (10) [back to overview]	Part 1: Time to Reach Cmax (Tmax) of Erlotinib and Its Metabolite OSI-420 (CP373420), Capecitabine and Its Metabolites (5'-DFCR and 5'-DFUR)
NCT00940316 (4) [back to overview]	Tumor Response Rate Based on Complete Response (CR)+ Partial Response (PR) + Stable Disease (SD)
NCT00940316 (4) [back to overview]	Toxicity of the Combination of Study Drugs
NCT00940316 (4) [back to overview]	Median Overall Survival
NCT00940316 (4) [back to overview]	Progression Free Survival (PFS)
NCT00940875 (6) [back to overview]	Overall Survival (OS)
NCT00940875 (6) [back to overview]	Percentage of Participants Who Achieved Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST V 1.0
NCT00940875 (6) [back to overview]	Percentage of Participants Who Died
NCT00940875 (6) [back to overview]	Percentage of Participants With Non-Progression at Weeks 8 and 16
NCT00940875 (6) [back to overview]	PFS
NCT00940875 (6) [back to overview]	Percentage of Participants With Disease Progression or Death
NCT00942734 (1) [back to overview]	12-Week Progression-Free Survival (PFS)
NCT00947167 (2) [back to overview]	Toxicities Assessed by CTCAE Grading Criteria and Assigned Attributions Accordingly
NCT00947167 (2) [back to overview]	Response Rate (RR) for All Patients Treated With This Strategy (Simon Design)
NCT00949910 (7) [back to overview]	Percentage of Participants With Death or Disease Progression According to RECIST
NCT00949910 (7) [back to overview]	Progression-Free Survival (PFS) According to RECIST
NCT00949910 (7) [back to overview]	Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST)
NCT00949910 (7) [back to overview]	Percentage of Participants With Disease Control According to RECIST
NCT00949910 (7) [back to overview]	Percentage of Participants by Best Overall Response According to RECIST
NCT00949910 (7) [back to overview]	Percentage of Participants Who Died
NCT00949910 (7) [back to overview]	Overall Survival (OS)
NCT00950365 (3) [back to overview]	Overall Survival
NCT00950365 (3) [back to overview]	Objective Response Rate (CR +PR) Evaluated Using RECIST
NCT00950365 (3) [back to overview]	PFS (Progression Free Survival)
NCT00965731 (16) [back to overview]	PF-02341066 (Crizotinib) Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1)
NCT00965731 (16) [back to overview]	PF-06260182 Maximum Observed Plasma Concentration (Cmax) (Phase 1)
NCT00965731 (16) [back to overview]	Erlotinib Apparent Oral Clearance (CL/F) (Phase 1)
NCT00965731 (16) [back to overview]	Number of Participants With Dose-Limiting Toxicities (DLT) (Phase 1)
NCT00965731 (16) [back to overview]	Percentage of Participants With Objective Response (Phase 1)
NCT00965731 (16) [back to overview]	PF-02341066 (Crizotinib) Apparent Oral Clearance (CL/F) (Phase 1)
NCT00965731 (16) [back to overview]	Ratio of Adjusted Means of Erlotinib AUCtau (Crizotinib + Erlotinib / Erlotinib Alone) (Phase 1)
NCT00965731 (16) [back to overview]	Ratio of Adjusted Means of Erlotinib Cmax (Crizotinib + Erlotinib / Erlotinib Alone) (Phase 1)
NCT00965731 (16) [back to overview]	Erlotinib Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1)
NCT00965731 (16) [back to overview]	Erlotinib Maximum Observed Plasma Concentration (Cmax) (Phase 1)
NCT00965731 (16) [back to overview]	PF-06260182 Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1)
NCT00965731 (16) [back to overview]	Recommended Phase 2 Dose (RP2D) of PF-02341066 When Administered in Combination With Erlotinib (Phase 1)
NCT00965731 (16) [back to overview]	Plasma Level of Soluble Marker: c-Met Ectodomain (Phase 1)
NCT00965731 (16) [back to overview]	Maximum Tolerated Dose (MTD) of PF-02341066 When Administered in Combination With Erlotinib (Phase 1)
NCT00965731 (16) [back to overview]	Molecular Weight Adjusted PF-06260182-to-PF-02341006 Ratio of AUCtau (Phase 1)
NCT00965731 (16) [back to overview]	PF-02341066 (Crizotinib) Maximum Observed Plasma Concentration (Cmax) (Phase 1)
NCT00970502 (4) [back to overview]	Locoregional Control, Progression-free Survival, Overall Survival and Late Toxicity
NCT00970502 (4) [back to overview]	Clinical Response
NCT00970502 (4) [back to overview]	Toxicity
NCT00970502 (4) [back to overview]	Locoregional Progression
NCT00976677 (1) [back to overview]	Progression-free Survival (PFS)
NCT00977470 (5) [back to overview]	Treatment Related Toxicity, > 10% Frequency, Any Grade
NCT00977470 (5) [back to overview]	Median Progression Free Survival
NCT00977470 (5) [back to overview]	Nine-month Progression-free Survival Rate
NCT00977470 (5) [back to overview]	Percent of Participants in Which FMISO-PET ([18F]-Fluoromisonidazole-positron Emission Tomography) is Able to Detect and Quantify Changes in Tumor Hypoxia After Erlotinib.
NCT00977470 (5) [back to overview]	Objective Tumor Response Rate Following Treatment With Erlotinib and With Erlotinib/HCQ.
NCT00977548 (4) [back to overview]	Leukemia Free Survival (LFS)
NCT00977548 (4) [back to overview]	Median Overall Survival (OS)
NCT00977548 (4) [back to overview]	Median Progression Free Survival (PFS)
NCT00977548 (4) [back to overview]	Combined Overall Response Rate (ORR)
NCT00983307 (1) [back to overview]	Number of Participants That Experience Progression-free Survival.
NCT00988169 (1) [back to overview]	Radiographic Objective Response Rate
NCT00994123 (4) [back to overview]	Phase 1: Determine the Maximum Tolerated Dose Dependent on Reports of Dose-limiting Toxicities
NCT00994123 (4) [back to overview]	Phase 1: To Determine the Recommended Phase 2 Dose of the MM-121 + Erlotinib Combination Based Upon Either the Maximum Tolerated Dose (MTD) or the Maximum Feasible Dose of the Combination in Patients With NSCLC.
NCT00994123 (4) [back to overview]	Phase 2: Progression-free Survival of the MM-121 + Erlotinib Combination
NCT00994123 (4) [back to overview]	To Explore the Utility of an EGFR Family Receptor-ligand (Heregulin, HRG) as a Predictor of Response to MM-121 and /or Erlotinib in Formalin Fixed (FFPE) Tumor Samples
NCT00997334 (4) [back to overview]	Feasibility Rate
NCT00997334 (4) [back to overview]	Resistance Mechanism
NCT00997334 (4) [back to overview]	Time to Repeat Biopsy
NCT00997334 (4) [back to overview]	Progression-Free Survival
NCT01003938 (2) [back to overview]	CA125 Response Rate With Continuous-infusion Topotecan and Erlotinib
NCT01003938 (2) [back to overview]	Toxicity Profile
NCT01009203 (4) [back to overview]	Overall Survival (OS)
NCT01009203 (4) [back to overview]	Progression Free Survival (PFS)
NCT01009203 (4) [back to overview]	Overall Response Rate (ORR)
NCT01009203 (4) [back to overview]	Toxicity Profile
NCT01026844 (3) [back to overview]	Describe the Number and Type of Observed Dose Limiting Toxcities
NCT01026844 (3) [back to overview]	Objective Tumor Response Rate
NCT01026844 (3) [back to overview]	Determine the Pharmacokinetic (PK) Parameters of Hydroxychloroquine (HCQ) Plus Erlotinib.
NCT01027598 (3) [back to overview]	Progression-free Survival
NCT01027598 (3) [back to overview]	Objective Response Rate (ORR)
NCT01027598 (3) [back to overview]	Overall Survival
NCT01032070 (14) [back to overview]	Apparent Body Clearance (CL/F) of Erlotinib
NCT01032070 (14) [back to overview]	Apparent Volume of Distribution (Vz/F) of Erlotinib
NCT01032070 (14) [back to overview]	Safety Assessed Through Evaluation of Physical Exams, Vital Signs, Clinical Laboratory Tests and Adverse Events (AEs)
NCT01032070 (14) [back to overview]	Time to Maximum Observed Plasma Concentration of Erlotinib (Tmax)
NCT01032070 (14) [back to overview]	Percentage of Participants With Prolonged Stable Disease
NCT01032070 (14) [back to overview]	Percentage of Participants With Disease Control
NCT01032070 (14) [back to overview]	Percentage of Participants With an Objective Response
NCT01032070 (14) [back to overview]	Percentage of Participants With a Minor Response
NCT01032070 (14) [back to overview]	Overall Survival (OS)
NCT01032070 (14) [back to overview]	Maximum Observed Plasma Concentration of Erlotinib (Cmax)
NCT01032070 (14) [back to overview]	Progression Free Survival (PFS)
NCT01032070 (14) [back to overview]	Duration of Response
NCT01032070 (14) [back to overview]	Area Under the Curve From Time 0 to 24 Hours Post-dose for Erlotinib
NCT01032070 (14) [back to overview]	Duration of Stable Disease
NCT01038856 (4) [back to overview]	Improvement in Splenomegaly Size
NCT01038856 (4) [back to overview]	Incidence of Toxicities
NCT01038856 (4) [back to overview]	Overall Response Rate to Include Complete Hematological Response, Complete Molecular Response, Partial Hematological Response, and Minimal Hematological Response
NCT01038856 (4) [back to overview]	Decrease of Mutant JAK2V617F Allele Burden
NCT01064479 (5) [back to overview]	Number of Participants With Tumor Response (Complete Response [CR] + Partial Response [PR])
NCT01064479 (5) [back to overview]	Rash Rates
NCT01064479 (5) [back to overview]	Progression Free Survival (PFS)
NCT01064479 (5) [back to overview]	Overall Survival (OS)
NCT01064479 (5) [back to overview]	Disease Control (CR + PR + Stable Disease [SD])
NCT01093222 (4) [back to overview]	Progression-free Survival
NCT01093222 (4) [back to overview]	Overall Survival
NCT01093222 (4) [back to overview]	Objective Response
NCT01093222 (4) [back to overview]	Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
NCT01101334 (4) [back to overview]	Analysis of Overall Survival Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy
NCT01101334 (4) [back to overview]	Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy
NCT01101334 (4) [back to overview]	Summary of Analysis of Progression-Free Survival Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy
NCT01101334 (4) [back to overview]	Overall Response Rate Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy
NCT01104155 (5) [back to overview]	Objective Response Rate (ORR)
NCT01104155 (5) [back to overview]	Duration of Response (DOR)
NCT01104155 (5) [back to overview]	Overall Survival (OS)
NCT01104155 (5) [back to overview]	Progression-Free Survival (PFS)
NCT01104155 (5) [back to overview]	Disease Control Rate (DCR)
NCT01108458 (6) [back to overview]	No. of Events of Drug-related Toxicity
NCT01108458 (6) [back to overview]	Overall Response Rate by RECIST Criteria
NCT01108458 (6) [back to overview]	Overall Survival (OS)
NCT01108458 (6) [back to overview]	Progression-free Survival (PFS)
NCT01108458 (6) [back to overview]	Proportion of Participants With 50% Decrease in Tumor Marker
NCT01108458 (6) [back to overview]	Quality of Life (QoL)
NCT01110876 (1) [back to overview]	Maximum Tolerated Dose (MTD) of Vorinostat in Combination With Escalating Doses of Erlotinib and Temozolomide
NCT01115803 (7) [back to overview]	Pharmacokinetics, Maximum Observed Plasma Concentration (Cmax) of LY2584702
NCT01115803 (7) [back to overview]	Recommended Dose for Phase 2 Studies
NCT01115803 (7) [back to overview]	Number of Participants Who Died Due to Progressive Disease Within 30 Days of Study Drug Discontinuation
NCT01115803 (7) [back to overview]	Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) [Best Overall Response (BOR) (CR+PR+SD)]
NCT01115803 (7) [back to overview]	Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Response Rate (RR)]
NCT01115803 (7) [back to overview]	Pharmacokinetics, Area Under the Concentration Time Curve (AUC)
NCT01115803 (7) [back to overview]	Clinically Significant Effects (Number of Participants With Adverse Events)
NCT01130519 (5) [back to overview]	Duration of Response
NCT01130519 (5) [back to overview]	Overall Survival (OS)
NCT01130519 (5) [back to overview]	Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
NCT01130519 (5) [back to overview]	Overall Response Rate
NCT01130519 (5) [back to overview]	Progression-free Survival
NCT01135498 (6) [back to overview]	Overall Survival (OS)
NCT01135498 (6) [back to overview]	Percentage of Participants Achieving Disease Control (CR, PR, or No Change [NC])
NCT01135498 (6) [back to overview]	Percentage of Participants Achieving Objective Response (Complete Response [CR] or Partial Response [PR])
NCT01135498 (6) [back to overview]	Percentage of Participants Who Died
NCT01135498 (6) [back to overview]	Progression-Free Survival
NCT01135498 (6) [back to overview]	Percentage of Participants With Disease Progression or Death
NCT01153984 (7) [back to overview]	Time to Disease Progression, as Assessed by Investigator Using RECIST v1.1
NCT01153984 (7) [back to overview]	Progression-Free Survival (PFS), as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
NCT01153984 (7) [back to overview]	Percentage of Participants Who Were Alive One Year After Study Treatment Initiation
NCT01153984 (7) [back to overview]	Number of EGFR Positive Participants Classified Based on Type of EGFR Mutations
NCT01153984 (7) [back to overview]	Percentage of Participants With Complete Response (CR) And Partial Response (PR) as Assessed by the Investigator Using RECIST v1.1
NCT01153984 (7) [back to overview]	Percentage of Participants by Localization of PD, as Assessed by Investigator Using RECIST v1.1
NCT01153984 (7) [back to overview]	Number of EGFR Positive Participants Classified Based on Smoking Status
NCT01161173 (6) [back to overview]	Progression-free Survival
NCT01161173 (6) [back to overview]	Percentage of Participants Who Developed Rash
NCT01161173 (6) [back to overview]	Change From Baseline in the Lung Cancer Symptom Scale (LCSS) Scores
NCT01161173 (6) [back to overview]	Overall Survival
NCT01161173 (6) [back to overview]	Time to Disease Progression
NCT01161173 (6) [back to overview]	Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)
NCT01174043 (3) [back to overview]	Treatment Related Adverse Events Grade 3 or Higher
NCT01174043 (3) [back to overview]	Duration of Response (up to One Year Follow up) in Patients Who Achieve a Complete Remission
NCT01174043 (3) [back to overview]	Overall Response Rate (Defined as Partial Remission or Better) to 3 Months of Treatment With Erlotinib
NCT01174563 (3) [back to overview]	Progression-Free Survival (PFS) in Participants With Erlotinib Dose Reductions Due to Rash Grade 3-4
NCT01174563 (3) [back to overview]	Percentage of Participants With Erlotinib Dose Reductions Due to Rash Grade 3-4
NCT01174563 (3) [back to overview]	Progression-free Survival (PFS) According to Grade of Rash
NCT01180959 (3) [back to overview]	Progression Free Survival (PFS)
NCT01180959 (3) [back to overview]	Overall Survival (OS)
NCT01180959 (3) [back to overview]	Time to Progression (TTP)
NCT01182350 (8) [back to overview]	Feasibility Rate of Molecular Approach to Therapy
NCT01182350 (8) [back to overview]	Grade 3-4 Post-Procedural Surgery-Related Toxicity Rate
NCT01182350 (8) [back to overview]	Median Progression Free Survival (PFS)
NCT01182350 (8) [back to overview]	Rate of Lethal Complications From Surgery
NCT01182350 (8) [back to overview]	9-month Overall Survival (OS) Rate by Molecular Cohort
NCT01182350 (8) [back to overview]	9-month Overall Survival (OS) Rate
NCT01182350 (8) [back to overview]	Number of Participants With Grade 3-4 Treatment-Related Toxicity Over Chemoradiation Therapy
NCT01182350 (8) [back to overview]	Delay in Radiation Therapy Start
NCT01183858 (8) [back to overview]	Number of Participants With Adverse Events (AEs) at the End of the Study
NCT01183858 (8) [back to overview]	Overall Response Rate (ORR)
NCT01183858 (8) [back to overview]	Overall Survival (OS)
NCT01183858 (8) [back to overview]	Disease Control Rate (DCR)
NCT01183858 (8) [back to overview]	Overall Survival (OS) at the End of Study
NCT01183858 (8) [back to overview]	Progression-Free Survival (PFS)
NCT01183858 (8) [back to overview]	Progression-Free Survival (PFS) at the End of Study
NCT01183858 (8) [back to overview]	Time to Progression (TTP)
NCT01187901 (6) [back to overview]	Change in Number of Duodenal Polyps From Baseline to 6 Months in Attenuated FAP Participants
NCT01187901 (6) [back to overview]	Change in Number of Duodenal Polyps From Baseline to 6 Months in Classic FAP Participants
NCT01187901 (6) [back to overview]	Change in Number of Duodenal Polyps From Baseline to 6 Months
NCT01187901 (6) [back to overview]	Change in Duodenal Polyp Burden From Baseline to 6 Months
NCT01187901 (6) [back to overview]	Change in Duodenal Polyp Burden From Baseline to 6 Months in Classic Familial Adenomatous Polyposis (FAP) Participants
NCT01187901 (6) [back to overview]	Change in Duodenal Polyp Burden From Baseline to 6 Months in Attenuated FAP Participants
NCT01192815 (2) [back to overview]	Toxicities, Number of Persons With Adverse Events
NCT01192815 (2) [back to overview]	Time to Disease Progression
NCT01196078 (12) [back to overview]	Overall Survival: Time to Event
NCT01196078 (12) [back to overview]	Percentage of Participants Achieving a Best Overall Response of Complete Response (CR) or Partial Response (PR)
NCT01196078 (12) [back to overview]	Percentage of Participants Achieving Disease Control
NCT01196078 (12) [back to overview]	Changes in Quality of Life as Assessed by FACT-L (Lung Symptoms) Questionnaire
NCT01196078 (12) [back to overview]	Duration of Response Among Participants Who Achieved Either a CR or PR
NCT01196078 (12) [back to overview]	Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT) Questionnaire
NCT01196078 (12) [back to overview]	Time to Disease Progression
NCT01196078 (12) [back to overview]	Percentage of Participants With Changes in Quality of Life as Measured by FACT Questionnaire Scores by Category of Change
NCT01196078 (12) [back to overview]	Percentage of Participants With Changes in FACT-L (Lung Symptoms) by Category of Change
NCT01196078 (12) [back to overview]	Percentage of Participants With Disease Progression
NCT01196078 (12) [back to overview]	Changes in Quality of Life as Measured by the FACT Questionnaire
NCT01196078 (12) [back to overview]	Overall Survival: Percentage of Participants With an Progressive Disease or Death
NCT01198028 (6) [back to overview]	Overall Survival
NCT01198028 (6) [back to overview]	Overall Response Rate
NCT01198028 (6) [back to overview]	Duration of Stable Disease
NCT01198028 (6) [back to overview]	Progression-free Survival
NCT01198028 (6) [back to overview]	Duration of Response
NCT01198028 (6) [back to overview]	Number of Participants With Safety and Tolerability of Erlotinib
NCT01199068 (7) [back to overview]	Progression-free Survival Time Following Administration of CS-7017 in Combination With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) Who Failed First-line Therapy
NCT01199068 (7) [back to overview]	Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Serum Free Form of CS-7017 (R-150033) After CS-7017 and Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer
NCT01199068 (7) [back to overview]	Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
NCT01199068 (7) [back to overview]	CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
NCT01199068 (7) [back to overview]	Best Overall Response and Response Rate Following Administration of CS-7017 in Combination With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) Who Failed First-line Therapy
NCT01199068 (7) [back to overview]	Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Serum Free Form of CS-7017 (R-150033) After CS-7017 and Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer
NCT01199068 (7) [back to overview]	Pharmacokinetic Parameter Observed Serum Concentration (Cmax) of Serum Free Form of CS-7017 (R-150033) After CS-7017 and Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer
NCT01204697 (6) [back to overview]	Duration of Response (DoR)
NCT01204697 (6) [back to overview]	Progression-free Survival (PFS)
NCT01204697 (6) [back to overview]	Percentage of Participants With Disease Control
NCT01204697 (6) [back to overview]	Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR)
NCT01204697 (6) [back to overview]	Overall Survival (OS)
NCT01204697 (6) [back to overview]	Percentage of Participants Free From Disease Progression or Death at 6 Months
NCT01205685 (3) [back to overview]	Anti-tumor Activity of OSI-906
NCT01205685 (3) [back to overview]	Number of Participants With Tumor Response Per RECIST
NCT01205685 (3) [back to overview]	Safety Profile Based on Number of Patients With Each Worst-grade Toxicity
NCT01211483 (14) [back to overview]	Time to Objective Response Following U3-1287 (AMG 888) in Combination With Erlotinib
NCT01211483 (14) [back to overview]	Erlotinib Concentrations at Cycle 3 Day 1 Following U3-1287 (AMG 888) in Combination With Erlotinib
NCT01211483 (14) [back to overview]	Pharmacokinetic Parameter of Erlotinib Trough (Cmin) Concentrations From Participants Receiving 150 mg Erlotinib Following U3-1287 (AMG 888) in Combination With Erlotinib
NCT01211483 (14) [back to overview]	Treatment-Emergent Adverse Events Occurring in ≥10% of Participants Following U3-1287 (AMG 888) in Combination With Erlotinib
NCT01211483 (14) [back to overview]	Progression-Free Survival in Participants With Low Heregulin-Expressing Tumors Following U3-1287 (AMG 888) in Combination With Erlotinib
NCT01211483 (14) [back to overview]	Progression-Free Survival in Participants With High Heregulin-Expressing Tumors Following U3-1287 (AMG 888) in Combination With Erlotinib
NCT01211483 (14) [back to overview]	Progression-Free Survival Following U3-1287 (AMG 888) in Combination With Erlotinib
NCT01211483 (14) [back to overview]	Pharmacokinetic Parameter of Cycle 3 Patritumab Concentration End of Infusion (CEOI) and Minimum (Trough) Concentration (Cmin) Following U3-1287 (AMG 888) in Combination With Erlotinib
NCT01211483 (14) [back to overview]	Overall Survival Following U3-1287 (AMG 888) in Combination With Erlotinib
NCT01211483 (14) [back to overview]	Objective Response Following U3-1287 (AMG 888) in Combination With Erlotinib
NCT01211483 (14) [back to overview]	Pharmacokinetic Parameter of Cycle 3 Patritumab Area Under the Concentration-time Curve Over the Dosing Interval 0 to τ (AUC) Following U3-1287 (AMG 888) in Combination With Erlotinib
NCT01211483 (14) [back to overview]	Duration of Stable Disease Following U3-1287 (AMG 888) in Combination With Erlotinib
NCT01211483 (14) [back to overview]	Time to Disease Progression Following U3-1287 (AMG 888) in Combination With Erlotinib
NCT01211483 (14) [back to overview]	Pharmacokinetic Parameter of Erlotinib Trough (Cmin) Concentrations From Participants Receiving 150 mg Erlotinib Following U3-1287 (AMG 888) in Combination With Erlotinib
NCT01222689 (8) [back to overview]	Progression-free Survival (PFS)
NCT01222689 (8) [back to overview]	Plasma Biomarkers Potentially Predictive of Dual MEK/EGFR Inhibition
NCT01222689 (8) [back to overview]	Number of Patients With Dose Modifications and Reason for Dose Modification.
NCT01222689 (8) [back to overview]	Overall Survival (OS)
NCT01222689 (8) [back to overview]	CA19-9 Biomarker Response (Defined as a 50% Decline in Serum CA19-9 Level From Baseline in Patients With > 2 x ULN CA19-9 Measurement)
NCT01222689 (8) [back to overview]	Incidence of Toxicities Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
NCT01222689 (8) [back to overview]	Survival at 24 Weeks
NCT01222689 (8) [back to overview]	Objective Radiographic Response by RECIST Criteria
NCT01229150 (11) [back to overview]	Change in T Cell Immunoglobulin Mucin 3 (TIM-3) on Tregs
NCT01229150 (11) [back to overview]	Number of Participants With a Reduction in Phosphorylated Extracellular Signal-Regulated Kinases (p-ERK) in Lymphocytes
NCT01229150 (11) [back to overview]	Percentage of Th17 in Cluster of Differentiation 4 (CD4)+T Cells at Baseline in Relation to Response
NCT01229150 (11) [back to overview]	Progression Free Survival
NCT01229150 (11) [back to overview]	Change in Cytotoxic T-lymphocyte Associated Protein 4 (CTLA-4) Expression on Tregs
NCT01229150 (11) [back to overview]	Change in Programmed Cell Death-1 (PD-1) Expression on Cluster of Differentiation 8 (CD8)+T Cells
NCT01229150 (11) [back to overview]	Percentage of Participants With Disease Control/Stabilization
NCT01229150 (11) [back to overview]	Change in Programmed Cell Death-1 (PD-1) Expression on Tregs
NCT01229150 (11) [back to overview]	Number of Participants With Adverse Events
NCT01229150 (11) [back to overview]	Objective Response
NCT01229150 (11) [back to overview]	Overall Survival
NCT01230710 (5) [back to overview]	Progression-free Survival (PFS)
NCT01230710 (5) [back to overview]	Percentage of Participants With Progression-free Survival at Week 52
NCT01230710 (5) [back to overview]	Percentage of Participants With Disease Control
NCT01230710 (5) [back to overview]	Overall Survival
NCT01230710 (5) [back to overview]	Percentage of Participants With a Complete Response (CR) or a Partial Response (PR)
NCT01233687 (5) [back to overview]	Percentage of Participants That Experienced a Dose Limiting Toxicity
NCT01233687 (5) [back to overview]	Progression-free Survival (PFS)
NCT01233687 (5) [back to overview]	Disease Control Rate (DCR)
NCT01233687 (5) [back to overview]	Overall Survival (OS)
NCT01233687 (5) [back to overview]	Objective Response Rate (ORR/Clinical Response)
NCT01244191 (8) [back to overview]	Overall Survival Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer
NCT01244191 (8) [back to overview]	Best Overall Tumor Response Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer
NCT01244191 (8) [back to overview]	Duration of Response Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer
NCT01244191 (8) [back to overview]	Treatment-Emergent Adverse Events Related to Tivantinib/Placebo Experienced by ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous NSCLC
NCT01244191 (8) [back to overview]	Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
NCT01244191 (8) [back to overview]	Progression-free Survival in the Epidermal Growth Factor Receptor (EGFR) Gene Wild-Type Subpopulation Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants Non-Squamous NSCLC
NCT01244191 (8) [back to overview]	Progression-free Survival Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer
NCT01244191 (8) [back to overview]	Overall Survival in the Epidermal Growth Factor Receptor Gene Wild-Type Subpopulation Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous NSCLC
NCT01247922 (3) [back to overview]	Safety Assessed Through Evaluation of Physical Examinations, Vital Signs, Clinical Laboratory Tests, and Adverse Events (AEs)
NCT01247922 (3) [back to overview]	Best Overall Response
NCT01247922 (3) [back to overview]	Median Treatment Duration
NCT01248247 (2) [back to overview]	8-Week Disease Control Rate (DCR)
NCT01248247 (2) [back to overview]	Median Progression-free Survival
NCT01250119 (11) [back to overview]	Probability of Being Alive and Free of Progression by Timepoint
NCT01250119 (11) [back to overview]	Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D
NCT01250119 (11) [back to overview]	Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D
NCT01250119 (11) [back to overview]	Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D
NCT01250119 (11) [back to overview]	Survival Time in Months
NCT01250119 (11) [back to overview]	Percentage of Participants Who Tested Positive for EGFR Mutations
NCT01250119 (11) [back to overview]	Quality of Life Assessment Using EuroQol(EQ) 5D Visual Analog Score (VAS) Instrument
NCT01250119 (11) [back to overview]	Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D
NCT01250119 (11) [back to overview]	Percentage of Participants With EGFR Mutations by Subgroup
NCT01250119 (11) [back to overview]	Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D
NCT01250119 (11) [back to overview]	Percentage of Participants With a Response by Best Objective Tumor Response
NCT01259089 (6) [back to overview]	Overall Survival (Phase II)
NCT01259089 (6) [back to overview]	Progression-free Survival (Phase II)
NCT01259089 (6) [back to overview]	Incidence of Reported Adverse Events in Phase I
NCT01259089 (6) [back to overview]	Maximally Tolerated Dose (MTD) of AUY922 and Erlotinib Treatment Combination (Phase I)
NCT01259089 (6) [back to overview]	Overall Response Rate (ORR), Defined as Complete Response(CR) + Partial Response (PR) Using the Modified RECIST 1.1 Criteria for All Patients Treated at Dose of 70mg/m2 AUG922
NCT01259089 (6) [back to overview]	Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II)
NCT01260181 (6) [back to overview]	Median Time Taken From the First Response Until Disease Progression Based on RECIST v 1.1 as Determined by the Investigator
NCT01260181 (6) [back to overview]	Percentage of Participants With Objective Response (Complete Response [CR]/Partial Response [PR]) Based on Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
NCT01260181 (6) [back to overview]	Percentage of Participants With Adverse Events
NCT01260181 (6) [back to overview]	Overall Survival
NCT01260181 (6) [back to overview]	Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Mutation in Study Population
NCT01260181 (6) [back to overview]	Progression Free Survival (PFS) Based on CT or MRI According to RECIST v 1.1
NCT01284335 (8) [back to overview]	Number of Participants With a Clinically Significant Effects
NCT01284335 (8) [back to overview]	PK: Area Under the Curve Albumin (AUCalb)
NCT01284335 (8) [back to overview]	Pharmacokinetic (PK): Concentration Maximum (Cmax)
NCT01284335 (8) [back to overview]	Percentage of Participants With a Complete (CR) or Partial Response (PR) (Best Overall Tumor Response)
NCT01284335 (8) [back to overview]	Percentage of Participants With a Complete (CR) or Partial Response (PR) (Best Overall Tumor Response)
NCT01284335 (8) [back to overview]	Percentage of Participants With a Complete (CR) or Partial Response (PR) (Best Overall Tumor Response)
NCT01284335 (8) [back to overview]	Percentage of Participants With a Complete (CR) or Partial Response (PR) (Best Overall Tumor Response)
NCT01284335 (8) [back to overview]	Number of Participants With Dose-Limiting Toxicities Cycle 1
NCT01287754 (5) [back to overview]	Number of Erlotinib-Treated Participants With the EGFR Mutation With an Objective Response Per RECIST v1.1
NCT01287754 (5) [back to overview]	Percentage of Participants Alive at 6 and 12 Months
NCT01287754 (5) [back to overview]	Progression-Free Survival (PFS) Among Erlotinib-Treated Participants With the EGFR Mutation
NCT01287754 (5) [back to overview]	Percentage of Participants With EGFR Mutation at Screening
NCT01287754 (5) [back to overview]	Overall Survival (OS) Among Erlotinib-Treated and Untreated Participants
NCT01294306 (5) [back to overview]	Toxicity of Akt Inhibitor MK2206 Plus Erlotinib Hydrochloride
NCT01294306 (5) [back to overview]	Disease-control Rate
NCT01294306 (5) [back to overview]	Median Overall Survival
NCT01294306 (5) [back to overview]	Median Progression-free Survival
NCT01294306 (5) [back to overview]	Objective Response
NCT01302808 (2) [back to overview]	Area Under the Concentration-time Curve (AUC0 t) of Romidepsin in Combination With Erlotinib
NCT01302808 (2) [back to overview]	Number of Participants With Dose Limiting Toxicities and Maximum Tolerated Dose (MTD)
NCT01306045 (10) [back to overview]	Percentage of Enrolled Participants Testing Positive for Genomic Abnormality
NCT01306045 (10) [back to overview]	Number of Evaluable Participants With a Response Based on Molecular Profile Directed Treatments in Non-Small Cell Lung Cancer, (NSCLC), Small Cell Lung Cancer (SCLC), and Thymic Malignancies
NCT01306045 (10) [back to overview]	Number of Evaluable Participants With a Response Based on Molecular Profile Directed Treatments in Non-Small Cell Lung Cancer, (NSCLC), Small Cell Lung Cancer (SCLC), and Thymic Malignancies
NCT01306045 (10) [back to overview]	Number of Evaluable Participants With a Response Based on Molecular Profile Directed Treatments in Non-Small Cell Lung Cancer, (NSCLC), Small Cell Lung Cancer (SCLC), and Thymic Malignancies
NCT01306045 (10) [back to overview]	Here is the Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
NCT01306045 (10) [back to overview]	Percentage of Enrolled Participants Testing Positive for Genomic Abnormality
NCT01306045 (10) [back to overview]	Percentage of Evaluable Participants Overall Response Rate (ORR) Based on the Drug Selected for Their Particular Profile
NCT01306045 (10) [back to overview]	Percentage of Enrolled Participants Testing Positive for Genomic Abnormality
NCT01306045 (10) [back to overview]	Percentage of Evaluable Participants Overall Response Rate (ORR) Based on the Drug Selected for Their Particular Profile
NCT01306045 (10) [back to overview]	Percentage of Evaluable Participants Overall Response Rate (ORR) Based on the Drug Selected for Their Particular Profile
NCT01310036 (7) [back to overview]	Progression-free Survival Per Investigator (PFS2)
NCT01310036 (7) [back to overview]	Progression-free Survival Per RECIST, v. 1.1 (PFS1)
NCT01310036 (7) [back to overview]	Disease Control Rate (DCR) for All Participants and Participants With EGFR Mutation E19del or L858R
NCT01310036 (7) [back to overview]	Objective Response Rate (ORR) for All Participants and Participants With EGFR Mutation E19del or L858R
NCT01310036 (7) [back to overview]	Overall Survival (OS) for All Participants and Participants With EGFR Mutation E19del or L858R
NCT01310036 (7) [back to overview]	Number of Participants With Adverse Events
NCT01310036 (7) [back to overview]	Progression-free Survival for Participants With EGFR Mutation E19del or L858R Per RECIST, v. 1.1 (PFS1)
NCT01328951 (9) [back to overview]	Percentage of Participants by Best Overall Response According to RECIST During Blinded Treatment
NCT01328951 (9) [back to overview]	Overall Survival (OS) as Median Time to Event During the Overall Study
NCT01328951 (9) [back to overview]	Percentage of Participants Event-Free (Alive) at 1 Year During the Overall Study
NCT01328951 (9) [back to overview]	Percentage of Participants Who Died During the Overall Study
NCT01328951 (9) [back to overview]	Percentage of Participants Who Died or Experienced Disease Progression During Blinded Treatment
NCT01328951 (9) [back to overview]	Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to RECIST During Blinded Treatment
NCT01328951 (9) [back to overview]	Percentage of Participants With CR, PR, or SD According to RECIST During Blinded Treatment
NCT01328951 (9) [back to overview]	Progression-Free Survival (PFS) as Median Time to Event During Blinded Treatment
NCT01328951 (9) [back to overview]	Percentage of Participants Event-Free (Alive and No Disease Progression) at 6 Months During Blinded Treatment
NCT01342965 (5) [back to overview]	Duration of Response
NCT01342965 (5) [back to overview]	Investigator-assessed Duration of Progression-free Survival
NCT01342965 (5) [back to overview]	Percentage of Participants With Disease Control
NCT01342965 (5) [back to overview]	Overall Survival
NCT01342965 (5) [back to overview]	Percentage of Responders as Assessed by the Investigator
NCT01344824 (3) [back to overview]	Subjects Experiencing Toxicity
NCT01344824 (3) [back to overview]	Overall Survival
NCT01344824 (3) [back to overview]	Progression-free Survival
NCT01351415 (8) [back to overview]	Time to Progression (TTP) According to RECIST v1.1
NCT01351415 (8) [back to overview]	Percentage of Participants With Disease Control According to RECIST v1.1
NCT01351415 (8) [back to overview]	Duration of Response (DoR) According to RECIST v1.1
NCT01351415 (8) [back to overview]	Overall Survival (OS)
NCT01351415 (8) [back to overview]	Percentage of Participants With Objective Response According to RECIST v1.1
NCT01351415 (8) [back to overview]	Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT01351415 (8) [back to overview]	Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
NCT01351415 (8) [back to overview]	Percentage of Participants Who Are Alive at Month 6, 12, and 18
NCT01360554 (17) [back to overview]	PFS Based on Investigator Review in KRAS-WT Participants.
NCT01360554 (17) [back to overview]	PFS Based on Investigator Review.
NCT01360554 (17) [back to overview]	Progression-Free Survival (PFS) Per Independent Radiologic Review in KRAS Wild-type (WT) Participants.
NCT01360554 (17) [back to overview]	Progression-Free Survival (PFS) Per Independent Radiologic Review.
NCT01360554 (17) [back to overview]	Time to Deterioration (TTD) in Pain, Dyspnea, Fatigue or Cough Patient Reported Disease Symptoms.
NCT01360554 (17) [back to overview]	Best Overall Response (BOR) Per Independent Radiologic Review.
NCT01360554 (17) [back to overview]	BOR Per Investigator Review.
NCT01360554 (17) [back to overview]	Mean and Difference in Mean in Lung Cancer Symptom Scores as Assessed by the EORTC QLQ- LC13.
NCT01360554 (17) [back to overview]	Mean and Difference in Mean in QLQ-C30 Symptoms as Assessed by the EORTC-QLQ-C30.
NCT01360554 (17) [back to overview]	Trough Concentrations (Ctrough) of Dacomitinib.
NCT01360554 (17) [back to overview]	Trough Concentrations (Ctrough) of PF-05199265.
NCT01360554 (17) [back to overview]	Mean and Difference in Mean in Functioning and Global Quality of Life (QOL) as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
NCT01360554 (17) [back to overview]	DR Based on Investigator Review.
NCT01360554 (17) [back to overview]	Duration of Response (DR) Based on Independent Radiologic Review.
NCT01360554 (17) [back to overview]	Mean and Difference in Mean of the EuroQoL-5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) Score
NCT01360554 (17) [back to overview]	OS in KRAS-WT Participants.
NCT01360554 (17) [back to overview]	Overall Survival (OS).
NCT01372384 (4) [back to overview]	Progression-free Survival (Tumour Assessments According to RECIST Criteria)
NCT01372384 (4) [back to overview]	Safety: Incidence of Adverse Events
NCT01372384 (4) [back to overview]	Objective Response Rate (Investigator Assessed)
NCT01372384 (4) [back to overview]	Overall Survival
NCT01376310 (1) [back to overview]	Number of Participants With Adverse Events
NCT01378962 (10) [back to overview]	Overall Survival (OS)
NCT01378962 (10) [back to overview]	Percentage of Participants With Primary and Secondary Resistance
NCT01378962 (10) [back to overview]	Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Mutation by Mutation Type
NCT01378962 (10) [back to overview]	Percentage of Participants Who Died
NCT01378962 (10) [back to overview]	Percentage of Participants Achieving CR, PR, or SD as Best Overall Response
NCT01378962 (10) [back to overview]	Percentage of Participants With a Response by Best Overall Response
NCT01378962 (10) [back to overview]	Progression-Free Survival (PFS)
NCT01378962 (10) [back to overview]	Probability of Being Progression Free 12 Months After Baseline
NCT01378962 (10) [back to overview]	Percentage of Participants With Objective Response
NCT01378962 (10) [back to overview]	Percentage of Participants With Disease Progression or Death at 12 Months After Baseline
NCT01395758 (4) [back to overview]	Objective Response Rate (ORR) Among All Eligible Subjects (ITT Population) Treated With Erlotinib Plus Tivantinib Compared to Chemotherapy.
NCT01395758 (4) [back to overview]	Progression-free Survival (PFS) Among Subjects With KRAS Mutation Positive NSCLC (ITT Population) Treated With Erlotinib Plus Tivantinib Compared to Single Agent Chemotherapy.
NCT01395758 (4) [back to overview]	Overall Survival (OS) Among All Eligible Subjects (ITT Population) Treated With Erlotinib Plus Tivantinib Compared to Chemotherapy.
NCT01395758 (4) [back to overview]	ORR Among Subjects in the Crossover Period Treated With Erlotinib Plus Tivantinib
NCT01454102 (6) [back to overview]	Number of Participants Who Experienced Selected Adverse Events
NCT01454102 (6) [back to overview]	Progression-Free Survival Rate (PFSR) at Week 24
NCT01454102 (6) [back to overview]	Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests
NCT01454102 (6) [back to overview]	Objective Response Rate (ORR)
NCT01454102 (6) [back to overview]	Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests
NCT01454102 (6) [back to overview]	Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death
NCT01487265 (5) [back to overview]	Duration of Response
NCT01487265 (5) [back to overview]	Number of Participants With Serious and Non-serious Adverse Events as a Measure of Safety.
NCT01487265 (5) [back to overview]	Progression Free Survival at 3 Months
NCT01487265 (5) [back to overview]	Overall Survival
NCT01487265 (5) [back to overview]	Objective Response Rate
NCT01523587 (8) [back to overview]	Number of Participants With Disease Control According to RECIST 1.1
NCT01523587 (8) [back to overview]	Number of Participants With Objective Response According to RECIST 1.1
NCT01523587 (8) [back to overview]	Overall Survival
NCT01523587 (8) [back to overview]	Progression-free Survival, Based on Central Independent Review as Determined by Response Evaluation Criteria in Solid Tumours 1.1
NCT01523587 (8) [back to overview]	Summary of Time to Deterioration in Coughing, Dyspnoea and Pain.
NCT01523587 (8) [back to overview]	Number of Participants With Status Change in Cough, Dyspnoea and Pain Related Items Over Time in Health Related Quality of Life Questionnaire
NCT01523587 (8) [back to overview]	Change in Score Over Time in Coughing,Dyspnoea and Pain
NCT01523587 (8) [back to overview]	Tumour Shrinkage
NCT01532089 (5) [back to overview]	Progression Free Survival of Patients With Different Mutation Types (Exon Deletion 19 Versus Exon 21 L858R)
NCT01532089 (5) [back to overview]	Overall Survival
NCT01532089 (5) [back to overview]	Number of Patients Experiencing Toxicity
NCT01532089 (5) [back to overview]	Progression Free Survival (PFS)
NCT01532089 (5) [back to overview]	Response Rate (Complete or Partial) to Each Treatment, Evaluated Using the New International Criteria Proposed by the Revised Response Evaluation Criteria in Solid Tumors Guidelines (Version 1.1)
NCT01557959 (3) [back to overview]	Response Rate Among Subgroups of Patients According to Molecular Profiles Including Tumor Characteristics and Genetic Polymorphisms From Peripheral Blood
NCT01557959 (3) [back to overview]	Time to Progression
NCT01557959 (3) [back to overview]	Median Survival Among Subgroups of Patients According to Molecular Profiles Including Tumor Characteristics and Genetic Polymorphisms From Peripheral Blood
NCT01562028 (5) [back to overview]	Duration of Response
NCT01562028 (5) [back to overview]	Adverse Events
NCT01562028 (5) [back to overview]	Time to Treatment Failure
NCT01562028 (5) [back to overview]	Progression Free Survival
NCT01562028 (5) [back to overview]	Overall Survival
NCT01565538 (3) [back to overview]	Progression-Free Survival
NCT01565538 (3) [back to overview]	Best Tumor Response
NCT01565538 (3) [back to overview]	Overall Survival
NCT01573702 (5) [back to overview]	Toxicity Rate Attributed to Erlotinib
NCT01573702 (5) [back to overview]	Percentage of Participants With Progression Free Survival
NCT01573702 (5) [back to overview]	Percentage of Participants With Local Control of Sites on Erlotinib Following Stereotactic Radiosurgery (SRS)
NCT01573702 (5) [back to overview]	Median Overall Survival
NCT01573702 (5) [back to overview]	Toxicity Rate From Stereotactic Radiosurgery (SRS)
NCT01609543 (3) [back to overview]	Percentage of Participants With Best Overall Response (BOR)
NCT01609543 (3) [back to overview]	Percentage of Participants Who Were Alive at 1 Year
NCT01609543 (3) [back to overview]	Progression-Free Survival (PFS)
NCT01652469 (3) [back to overview]	Overall Survival
NCT01652469 (3) [back to overview]	Progression-free Survival
NCT01652469 (3) [back to overview]	Number of Participants With Adverse Events
NCT01664533 (5) [back to overview]	Percentage of Participants Who Developed Rash
NCT01664533 (5) [back to overview]	Progression-free Survival
NCT01664533 (5) [back to overview]	Best Overall Response
NCT01664533 (5) [back to overview]	Percentage of Participants Who Developed Diarrhea
NCT01664533 (5) [back to overview]	Overall Survival
NCT01664897 (4) [back to overview]	Overall Survival
NCT01664897 (4) [back to overview]	Event-free Survival
NCT01664897 (4) [back to overview]	Participants With a Response
NCT01664897 (4) [back to overview]	Incidence of Clinically Significant, Non-hematologic Grade 3 or 4 Toxicities at Least Possibly Related to Erlotinib Hydrochloride
NCT01667562 (6) [back to overview]	Proportion of Participants With Disease Control as Assessed by RECIST v 1.1
NCT01667562 (6) [back to overview]	Proportion of Participants With Objective Response as Assessed by RECIST v 1.1
NCT01667562 (6) [back to overview]	Proportion of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations
NCT01667562 (6) [back to overview]	Progression-Free Survival as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v 1.1)
NCT01667562 (6) [back to overview]	Change From Baseline to End of Study in Quality of Life Score Using The Functional Assessment of Cancer Therapy Lung (FACT-L)
NCT01667562 (6) [back to overview]	Percentage of Participants With Adverse Events
NCT01683422 (1) [back to overview]	One-year Survival Rate
NCT01688973 (2) [back to overview]	Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
NCT01688973 (2) [back to overview]	Progression-free Survival (PFS)
NCT01708954 (5) [back to overview]	Proportion of Patients With Worst Grade Toxicities of Grade 3 or Higher
NCT01708954 (5) [back to overview]	Proportion of Patients With Objective Response
NCT01708954 (5) [back to overview]	Proportion of Patients With MET Positivity
NCT01708954 (5) [back to overview]	Progression-free Survival (PFS)
NCT01708954 (5) [back to overview]	Overall Survival (OS)
NCT01782690 (13) [back to overview]	Score in Patient Questionnaire: Possible Side Effects
NCT01782690 (13) [back to overview]	Score in Participant Questionnaire: What to Do in Case of Side Effect
NCT01782690 (13) [back to overview]	Score in Participant Questionnaire: Quality of Life
NCT01782690 (13) [back to overview]	Score in Participant Questionnaire: Actual Side Effects of Therapy Compared to Expectation
NCT01782690 (13) [back to overview]	Overall Survival Time Stratified by Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
NCT01782690 (13) [back to overview]	Overall Survival Stratified by Rash
NCT01782690 (13) [back to overview]	Number of Participants With Rash by Severity
NCT01782690 (13) [back to overview]	Time to Disease Progression
NCT01782690 (13) [back to overview]	Time of Onset of Rash After Start Erlotinib Treatment
NCT01782690 (13) [back to overview]	Percentage of Participants With Best Overall Response
NCT01782690 (13) [back to overview]	Number of Participants With Adverse Events (AEs)
NCT01782690 (13) [back to overview]	Number of Dose Modifications and Dose Withdrawals of Gemcitabine
NCT01782690 (13) [back to overview]	Number of Dose Modifications and Dose Withdrawals of Erlotinib
NCT01801111 (34) [back to overview]	Trough Plasma Concentration (Ctrough) of Alectinib
NCT01801111 (34) [back to overview]	Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by IRC in Chemotherapy-Pretreated Participants
NCT01801111 (34) [back to overview]	Area Under the Plasma Concentration-Time Curve From Time 0 to Tlast (AUC[0-last]) of Alectinib
NCT01801111 (34) [back to overview]	Ctrough of Alectinib Metabolite
NCT01801111 (34) [back to overview]	Duration of Response (DoR) as Assessed by IRC in RE Population
NCT01801111 (34) [back to overview]	AUC(0-10) of Alectinib Metabolite
NCT01801111 (34) [back to overview]	AUC(0-last) of Alectinib Metabolite
NCT01801111 (34) [back to overview]	Peak to Trough Ratio of Alectinib
NCT01801111 (34) [back to overview]	Overall Survival (OS)
NCT01801111 (34) [back to overview]	Area Under the Plasma Concentration-Time Curve From Time 0 to 10 Hours Post-dose (AUC[0-10]) of Alectinib
NCT01801111 (34) [back to overview]	Cmax of Alectinib Metabolite
NCT01801111 (34) [back to overview]	Maximum Observed Plasma Concentration (Cmax) of Alectinib
NCT01801111 (34) [back to overview]	Metabolite to Parent Ratio Based on AUC(0-10)
NCT01801111 (34) [back to overview]	Percentage of Participants Achieving Central Nervous System (CNS) Objective Response as Assessed by IRC According to RECIST v1.1
NCT01801111 (34) [back to overview]	Percentage of Participants Achieving CNS Objective Response as Assessed by IRC According to Radiology Assessment in Neuro-Oncology (RANO) Criteria
NCT01801111 (34) [back to overview]	Percentage of Participants Achieving Objective Response (Complete Response [CR] or Partial Response [PR]) as Assessed by Independent Radiological Review Committee (IRC) in Response Evaluable (RE) Population
NCT01801111 (34) [back to overview]	Tmax of Alectinib Metabolite
NCT01801111 (34) [back to overview]	Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by Investigator in Chemotherapy-Naive Participants
NCT01801111 (34) [back to overview]	Time to Last Measurable Plasma Concentration (Tlast) of Alectinib
NCT01801111 (34) [back to overview]	Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by Investigator in Chemotherapy-Pretreated Participants
NCT01801111 (34) [back to overview]	Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by Investigator in RE Population
NCT01801111 (34) [back to overview]	Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by IRC in Chemotherapy-Naive Participants
NCT01801111 (34) [back to overview]	Percentage of Participants Who Died of Any Cause
NCT01801111 (34) [back to overview]	Metabolite to Parent Ratio Based on AUC(0-last)
NCT01801111 (34) [back to overview]	Percentage of Participants With CNS Progression as Assessed by IRC According to RECIST v 1.1
NCT01801111 (34) [back to overview]	Tlast of Alectinib Metabolite
NCT01801111 (34) [back to overview]	Percentage of Participants With PD as Assessed by IRC According to RECIST v1.1 or Death From Any Cause in Safety Population
NCT01801111 (34) [back to overview]	Progression Free Survival (PFS) as Assessed by IRC in Safety Population
NCT01801111 (34) [back to overview]	Time to Cmax (Tmax) of Alectinib
NCT01801111 (34) [back to overview]	Percentage of Participants Achieving CR, PR or Stable Disease (SD) According to RECIST v1.1 in RE Population
NCT01801111 (34) [back to overview]	CNS Duration of Response (CDoR) as Assessed by IRC According to RECIST v1.1
NCT01801111 (34) [back to overview]	CDoR as Assessed by IRC According to RANO Criteria
NCT01801111 (34) [back to overview]	Accumulation Ratio of Alectinib Metabolite
NCT01801111 (34) [back to overview]	Accumulation Ratio of Alectinib
NCT01822496 (6) [back to overview]	Percentage of Patients With Complete or Partial Response
NCT01822496 (6) [back to overview]	Progression-free Survival
NCT01822496 (6) [back to overview]	Overall Survival
NCT01822496 (6) [back to overview]	Distant Progression-free Survival
NCT01822496 (6) [back to overview]	Local-regional Progression-free Survival
NCT01822496 (6) [back to overview]	Number of Patients With Grade 3-5 Adverse Events
NCT01836133 (3) [back to overview]	Percentage of Participants With Overall Response
NCT01836133 (3) [back to overview]	Proportions of Participants With Adverse Events (AEs), Serious AEs, and AEs of Special Interest (AESIs)
NCT01836133 (3) [back to overview]	Progression-Free Survival (PFS)
NCT01866410 (8) [back to overview]	Percentage of Patients With a Greater Than 30% Increase in Tumor Doubling Time
NCT01866410 (8) [back to overview]	Overall Survival
NCT01866410 (8) [back to overview]	Objective Response Rate
NCT01866410 (8) [back to overview]	Number of Adverse Events
NCT01866410 (8) [back to overview]	Progression-free Survival by T790M Mutation Status
NCT01866410 (8) [back to overview]	Best Response Patient Count
NCT01866410 (8) [back to overview]	Progression-free Survival
NCT01866410 (8) [back to overview]	Overall Survival by T790M Mutation Status
NCT01900652 (10) [back to overview]	Time to Progressive Disease
NCT01900652 (10) [back to overview]	Change From Baseline in EORTC Quality of Life Questionnaires Lung Cancer 13 (QLQ-LC13)
NCT01900652 (10) [back to overview]	Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires C30 (QLQ-C30)
NCT01900652 (10) [back to overview]	Secondary: Percentage of Participants Who Achieved Best Overall Disease Response of CR, PR or Stable Disease (SD) [Disease Control Rate (DCR)]
NCT01900652 (10) [back to overview]	Change From Baseline in EuroQol 5-Dimensional Scale (EQ-5D)
NCT01900652 (10) [back to overview]	Overall Survival (OS)
NCT01900652 (10) [back to overview]	Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
NCT01900652 (10) [back to overview]	Pharmacokinetics (PK): Area Under the Concentration (AUC) of Emibetuzumab
NCT01900652 (10) [back to overview]	Progression Free Survival (PFS)
NCT01900652 (10) [back to overview]	Number of Participants With Anti-Emibetuzumab Antibody (ADA) Response
NCT01962896 (1) [back to overview]	The PFR, Defined as the Proportion of Patients With Refractory Germ Cell Tumors Free of Objective Disease Progression After 4 Cycles (16 Weeks) of Therapy With Erlotinib and Sirolimus
NCT01990261 (7) [back to overview]	Overall Survival (OS)
NCT01990261 (7) [back to overview]	Percentage of Participants With Adverse Events (AEs)
NCT01990261 (7) [back to overview]	Progression Free Survival (PFS) at Month 12
NCT01990261 (7) [back to overview]	Progression Free Survival (PFS) at Month 6
NCT01990261 (7) [back to overview]	Survival Rate at Month 6
NCT01990261 (7) [back to overview]	Survival Rate at Month 12
NCT01990261 (7) [back to overview]	Overall Survival According to Prior Chemotherapy Treatment.
NCT01996332 (3) [back to overview]	Time to Disease Progression or Death by Line of Treatment
NCT01996332 (3) [back to overview]	Overall Survival (OS) by Line of Treatment
NCT01996332 (3) [back to overview]	Percentage of Participants Achieving Clinical Benefit by Line of Treatment
NCT01998919 (7) [back to overview]	Overall Survival
NCT01998919 (7) [back to overview]	Duration of Response
NCT01998919 (7) [back to overview]	Percentage of Participants With Confirmed CR or PR as Assessed by RECIST
NCT01998919 (7) [back to overview]	Percentage of Participants With Non-Progression at Week 8 as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
NCT01998919 (7) [back to overview]	Progression-Free Survival (PFS)
NCT01998919 (7) [back to overview]	Percentage of Participants With Non-Progression at Week 16 as Assessed by RECIST
NCT01998919 (7) [back to overview]	Time to Progression
NCT02000531 (2) [back to overview]	Participants With Adverse Events
NCT02000531 (2) [back to overview]	Progression Free Survival (PFS) Based on Well-documented and Verifiable Progression Events
NCT02013206 (8) [back to overview]	Duration of Response
NCT02013206 (8) [back to overview]	Non-Progression Rate (NPR) at 8 Weeks
NCT02013206 (8) [back to overview]	Objective Response Rate
NCT02013206 (8) [back to overview]	Overall Survival
NCT02013206 (8) [back to overview]	Progression-Free Survival
NCT02013206 (8) [back to overview]	Disease Control Rate
NCT02013206 (8) [back to overview]	Safety: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
NCT02013206 (8) [back to overview]	Time to Progression
NCT02039674 (6) [back to overview]	Part 2 Cohorts G+ and G-: Objective Response Rate (ORR)
NCT02039674 (6) [back to overview]	Part 2 Cohorts G+ and G-: Duration of Response (DOR)
NCT02039674 (6) [back to overview]	All Cohorts: Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)
NCT02039674 (6) [back to overview]	Part 2 Cohorts D4 and H: Objective Response Rate (ORR)
NCT02039674 (6) [back to overview]	Part 2 Cohorts G+ and G-: Progression-Free Survival (PFS)
NCT02039674 (6) [back to overview]	Part 2 Cohorts G+ and G-: Overall Survival (OS)
NCT02117024 (6) [back to overview]	Overall Survival (OS)
NCT02117024 (6) [back to overview]	Survival at 6 Months
NCT02117024 (6) [back to overview]	Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
NCT02117024 (6) [back to overview]	Progression-Free Survival (PFS)
NCT02117024 (6) [back to overview]	Time to Progression (TTP)
NCT02117024 (6) [back to overview]	Survival at 12 Months
NCT02134015 (6) [back to overview]	Part A: Objective Response Rate (ORR) in HRG Low Participants
NCT02134015 (6) [back to overview]	Part A: Objective Response Rate (ORR) in HRG High Participants
NCT02134015 (6) [back to overview]	Part A: Key Secondary Efficacy Endpoint: Overall Survival in HRG Low Participants
NCT02134015 (6) [back to overview]	Part A: Overall Survival in HRG High Participants
NCT02134015 (6) [back to overview]	Part A: Progression Free Survival (PFS) in Heregulin-low Participants
NCT02134015 (6) [back to overview]	Part A: Progression Free Survival (PFS) in Heregulin-high Participants
NCT02152631 (7) [back to overview]	Overall Survival (OS)
NCT02152631 (7) [back to overview]	Change From Baseline in European Quality of Life - 5 Dimensions - 5 Level (EQ-5D-5L) Score
NCT02152631 (7) [back to overview]	Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
NCT02152631 (7) [back to overview]	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve During 1 Dosing Interval at Steady State
NCT02152631 (7) [back to overview]	Progression Free Survival (PFS)
NCT02152631 (7) [back to overview]	Resource Utilization: Percentage of Participants Who Are Hospitalized
NCT02152631 (7) [back to overview]	Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Score
NCT02154490 (1) [back to overview]	Screen Success Rate
NCT02155465 (4) [back to overview]	Number of Participants With NCI CTCAE Toxicity
NCT02155465 (4) [back to overview]	Maximally Tolerated Dose (MTD) (Phase I)
NCT02155465 (4) [back to overview]	Progression-free Survival
NCT02155465 (4) [back to overview]	Assess Overall Response Rate
NCT02169284 (9) [back to overview]	Difference Between Normal and Neoplastic Tissue of p53
NCT02169284 (9) [back to overview]	Difference Between Normal and Neoplastic Tissue Phosphorylated ERK
NCT02169284 (9) [back to overview]	EGFR Phosphorylation in Neoplastic Bladder Epithelium 9-18 Hours Post-study Dose
NCT02169284 (9) [back to overview]	Frequency of Urination Symptoms in Men Only, Graded According to International Prostate Symptom Score (I-PSS)
NCT02169284 (9) [back to overview]	EGFR Phosphorylation in Normal Appearing Bladder Epithelium Adjacent to Tumor
NCT02169284 (9) [back to overview]	Expression of E-cadherin
NCT02169284 (9) [back to overview]	Percentage of Cells Expressing Ki67
NCT02169284 (9) [back to overview]	Pharmacokinetic Parameters: Erlotinib in Blood
NCT02169284 (9) [back to overview]	Pharmacokinetic Parameters: OSI-420 in Blood
NCT02186301 (3) [back to overview]	Progression Free Survival (PFS) According to RECIST Version 1.1 as Determined by Investigator Review (invPFS)
NCT02186301 (3) [back to overview]	Confirmed Response Rate
NCT02186301 (3) [back to overview]	Duration of Response
NCT02273362 (2) [back to overview]	Adverse Event Profile
NCT02273362 (2) [back to overview]	Response (at Least a 50% Reduction in Liver Phospho-EGFR Staining)
NCT02296125 (13) [back to overview]	Median Progression Free Survival (PFS) (Months)
NCT02296125 (13) [back to overview]	Objective Response Rate (ORR)
NCT02296125 (13) [back to overview]	Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ) Questionnaires Lung Cancer 13 (QLQ-LC13)
NCT02296125 (13) [back to overview]	Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Items (EORTC QLQ-C30)
NCT02296125 (13) [back to overview]	Overall Survival (OS)- Number of Participants With an Event
NCT02296125 (13) [back to overview]	Participants Reported Outcome by Cancer Therapy Satisfaction Questionnaire 16 Items (CTSQ-16 Questionnaire)
NCT02296125 (13) [back to overview]	Plasma Concentrations of AZD9291
NCT02296125 (13) [back to overview]	Plasma Concentrations of Metabolite AZ7550
NCT02296125 (13) [back to overview]	Percentage of Participants in Progression Free Survival at 6, 12, and 18 Months
NCT02296125 (13) [back to overview]	Depth of Response
NCT02296125 (13) [back to overview]	Disease Control Rate (DCR)
NCT02296125 (13) [back to overview]	Duration of Response (DoR)
NCT02296125 (13) [back to overview]	Plasma Concentrations of Metabolites AZ5104
NCT02318368 (1) [back to overview]	Number of Participants With Adverse Events
NCT02352948 (10) [back to overview]	Objective Response Rate (ORR)
NCT02352948 (10) [back to overview]	OS, Contribution of the Components Analysis of Sub-study B
NCT02352948 (10) [back to overview]	Overall Survival (OS)
NCT02352948 (10) [back to overview]	Percentage of Participants Alive and Progression Free at 12 Months (APF12)
NCT02352948 (10) [back to overview]	Percentage of Participants Alive and Progression Free at 6 Months (APF6)
NCT02352948 (10) [back to overview]	Progression-Free Survival (PFS)
NCT02352948 (10) [back to overview]	Percentage of Participants Alive at 12 Months (OS12)
NCT02352948 (10) [back to overview]	PFS, Contribution of the Components Analysis of Sub-study B
NCT02352948 (10) [back to overview]	Time From Randomisation to Second Progression (PFS2) of Sub-study B
NCT02352948 (10) [back to overview]	Duration of Response (DoR)
NCT02411448 (12) [back to overview]	Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score
NCT02411448 (12) [back to overview]	Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score
NCT02411448 (12) [back to overview]	Part B: Duration of Response (DoR)
NCT02411448 (12) [back to overview]	Part B: Number of Participants With Anti-Ramucirumab Antibodies
NCT02411448 (12) [back to overview]	Part B: Overall Survival (OS)
NCT02411448 (12) [back to overview]	Part B: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
NCT02411448 (12) [back to overview]	Part B: Percentage of Participants With CR, PR, or Stable Disease (SD) (Disease Control Rate [DCR])
NCT02411448 (12) [back to overview]	Part B: Progression Free Survival (PFS)
NCT02411448 (12) [back to overview]	Part B: Best Change From Baseline on the Lung Cancer Symptom Scale (LCSS)
NCT02411448 (12) [back to overview]	Part B: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab
NCT02411448 (12) [back to overview]	Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score
NCT02411448 (12) [back to overview]	Number of Participants With Treatment-Emergent Adverse Events
NCT02488330 (1) [back to overview]	Percentage of Participants With Serious Adverse Events Considered Related to Onartuzumab
NCT02495233 (12) [back to overview]	Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib
NCT02495233 (12) [back to overview]	Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib
NCT02495233 (12) [back to overview]	Number of Participants With Dose Limiting Toxicities (DLTs)
NCT02495233 (12) [back to overview]	Number of Participants With Adverse Events
NCT02495233 (12) [back to overview]	Maximum Concentration (Cmax) for Gilteritinib
NCT02495233 (12) [back to overview]	Ctrough of Erlotinib
NCT02495233 (12) [back to overview]	AUC24 of Erlotinib
NCT02495233 (12) [back to overview]	Cmax of Erlotinib
NCT02495233 (12) [back to overview]	Objective Response Rate (ORR) in Phase 1b
NCT02495233 (12) [back to overview]	Tmax of Erlotinib
NCT02495233 (12) [back to overview]	Area Under the Concentration-time Curve at 24 Hours (AUC24) for Gilteritinib
NCT02495233 (12) [back to overview]	Time After Dosing When Cmax Occurs (Tmax) for Gilteritinib
NCT02507375 (9) [back to overview]	Time of Cmax (Tmax) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC
NCT02507375 (9) [back to overview]	Percentage of Participants With a Complete Response or Partial Response at the End of Cycles 1, 2, 3, 4, and 6
NCT02507375 (9) [back to overview]	Area Under the Plasma Concentration Versus Time Curve (AUC) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With Non-small Cell Lung Cancer (NSCLC)
NCT02507375 (9) [back to overview]	Volume of Distribution at Steady-state (Vss) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC
NCT02507375 (9) [back to overview]	Terminal Phase Plasma Half-life (t ½) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC
NCT02507375 (9) [back to overview]	Percentage of Participants With Dose Limiting Toxicities (DLTs)
NCT02507375 (9) [back to overview]	Percentage of Participants Classified as Responders
NCT02507375 (9) [back to overview]	Peak Plasma Concentration (Cmax) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC
NCT02507375 (9) [back to overview]	Clearance (CL) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC
NCT02535338 (6) [back to overview]	Recommended Phase II Dose
NCT02535338 (6) [back to overview]	Progression-free Survival
NCT02535338 (6) [back to overview]	Number of Subject With Overall Response (Recommended Phase II Dose)
NCT02535338 (6) [back to overview]	Number of Subject With Overall Response
NCT02535338 (6) [back to overview]	Number of Participants With Dose Limiting Toxicities.
NCT02535338 (6) [back to overview]	Number of Participants With at Least One Dose Limiting Toxicity (DLT)
NCT02588261 (11) [back to overview]	Percentage of Participants With Objective Response (OR)
NCT02588261 (11) [back to overview]	PFS as Assessed by the Investigator
NCT02588261 (11) [back to overview]	Progression Free Survival (PFS) as Assessed by Independent Radiologic Review (IRR)
NCT02588261 (11) [back to overview]	EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)
NCT02588261 (11) [back to overview]	Number of Participants With Adverse Events (AEs)
NCT02588261 (11) [back to overview]	European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30)
NCT02588261 (11) [back to overview]	Duration of Response (DOR)
NCT02588261 (11) [back to overview]	European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 (EORTC-QLQ-LC13)
NCT02588261 (11) [back to overview]	Functional Assessment of Cancer Therapy - EGFR Inhibitors Subscale (FACT-EGFRI-18) Questionnaire
NCT02588261 (11) [back to overview]	Percentage of Deaths
NCT02588261 (11) [back to overview]	Percentage of Participants With Disease Control
NCT02595450 (3) [back to overview]	Percentage of Participants With Best Overall Response
NCT02595450 (3) [back to overview]	Progression-free Survival (PFS) Time
NCT02595450 (3) [back to overview]	Overall Survival (OS) Time
NCT02694536 (6) [back to overview]	European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores
NCT02694536 (6) [back to overview]	Overall Survival (OS)
NCT02694536 (6) [back to overview]	Percentage of Participants Who Died
NCT02694536 (6) [back to overview]	Percentage of Participants With Adverse Events (AEs)
NCT02694536 (6) [back to overview]	Percentage of Participants With Death or Disease Progression According to Response Evaluation Criteria in Solid Tumors (RECIST)
NCT02694536 (6) [back to overview]	Progression-Free Survival (PFS) According to RECIST
NCT02770014 (3) [back to overview]	Positive Predictive Value (PPV) And False Negative Rate Of Plasma Genotyping
NCT02770014 (3) [back to overview]	Turnaround Time
NCT02770014 (3) [back to overview]	Overall Response Rate
NCT02774278 (5) [back to overview]	Number of Epidermal Growth Factor Receptor (EGFR) Mutation Participants Who Achieved Clinical Benefit
NCT02774278 (5) [back to overview]	Percentage of Participants With Clinical Benefit (CR, PR, or Stable Disease [SD] for at Least 12 Weeks After Study Entry) Using RECIST
NCT02774278 (5) [back to overview]	Percentage of Participants With Overall Response of Complete Response (CR) or Partial Response (PR) Using Response Evaluation Criteria in Solid Tumors (RECIST)
NCT02774278 (5) [back to overview]	Number of KRAS Mutation Participants Who Achieved Clinical Benefit
NCT02774278 (5) [back to overview]	Number of Differentially Expressed Genes Associated With Clinical Benefit
NCT02961374 (8) [back to overview]	Mean Percent Change in Duodenal Polyp Burden
NCT02961374 (8) [back to overview]	Percent Change in Lower Gastrointestinal Polyp Number
NCT02961374 (8) [back to overview]	Absolute Change in Lower Gastrointestinal Polyp Burden
NCT02961374 (8) [back to overview]	Absolute Change in Lower Gastrointestinal Polyp Number
NCT02961374 (8) [back to overview]	Change in Duodenal Polyp Number
NCT02961374 (8) [back to overview]	Number of Participants With Any Adverse Events
NCT02961374 (8) [back to overview]	Number of Participants With Grade 2/3 Adverse Event (AE)
NCT02961374 (8) [back to overview]	Percent Change in Lower Gastrointestinal Polyp Burden
NCT03076164 (2) [back to overview]	Participants Response Rate
NCT03076164 (2) [back to overview]	Number of Participants Evaluated for Toxicities
NCT03213626 (5) [back to overview]	Overall Survival
NCT03213626 (5) [back to overview]	Progression Free Survival
NCT03213626 (5) [back to overview]	Objective (Radiographic) Response
NCT03213626 (5) [back to overview]	Disease Control Rate
NCT03213626 (5) [back to overview]	Treatment Related Adverse Events Grade 3 or Above
NCT04165031 (2) [back to overview]	Phase 1: Pharmacokinetics (PK): Average Concentration of LY3499446
NCT04165031 (2) [back to overview]	Phase 1: Number or Participants With Dose Limiting Toxicities (DLTs)
NCT04179890 (16) [back to overview]	Uncommon Mutation Cohort: Time on Treatment Until Failure of Second-line (TTF2)
NCT04179890 (16) [back to overview]	Uncommon Epidermal Growth Factor Receptor (EGFR) Mutation Cohort: Overall Response Rate to Index Line Treatment
NCT04179890 (16) [back to overview]	Number of Participants for Each Type of Biological Samples Used for Mutation Detection at First Line Treatment Start
NCT04179890 (16) [back to overview]	Uncommon Mutation Cohort: Number of Participants for Each Type of Methodology Used for Mutation Detection at Index Therapy Start
NCT04179890 (16) [back to overview]	Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Second Line Treatment Stop/End of Observation
NCT04179890 (16) [back to overview]	Uncommon Mutation Cohort: Number of Participants for Each Type of Methodology Used for Mutation Detection at Start of First-line Chemotherapy Before Index Line
NCT04179890 (16) [back to overview]	Time on Treatment With Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI)
NCT04179890 (16) [back to overview]	Uncommon Mutation Cohort: Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Start of First-line Chemotherapy Before Index Line
NCT04179890 (16) [back to overview]	Number of Participants for Each Type of Methodology Used for Mutational Testing at Second-line Treatment Start
NCT04179890 (16) [back to overview]	Number of Participants for Each Type of Methodology Used for Mutational Testing at Second-line Treatment Stop/End of Observation
NCT04179890 (16) [back to overview]	Uncommon Cohort: Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Index Therapy Start
NCT04179890 (16) [back to overview]	Number of Participants for Each Category of Methodology Used for Mutational Testing at First Line Treatment Start
NCT04179890 (16) [back to overview]	Overall Survival
NCT04179890 (16) [back to overview]	Sequencing Cohort: Overall Response Rate to First Line Afatinib
NCT04179890 (16) [back to overview]	Sequencing Cohort: Overall Response Rate to Second-line Treatment Osimertinib
NCT04179890 (16) [back to overview]	Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Second Line Treatment Start

Duration of Objective Response

(NCT00033514)
Timeframe: 5 years

Intervention	participants (Number)
	greater than 6 months	greater than 2 years
Treatment Phase 1 Plus Phase 2	4	2

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Serum Concentration of Herceptin at Specified Time-points.

(NCT00033514)
Timeframe: 4 months

Intervention	mcg/mL (Mean)
	Day 7 peak	Day 7 trough	Day 14 peak	Day 14 trough	Day 21 peak	Day 21 trough
Treatment Phase 2	98.4	46	86	46.9	88.3	50.8

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Incidence of Adverse Events

(NCT00033514)
Timeframe: 5 years

Intervention	participants affected by SAEs (Number)
Treatment Phase 1 Plus Phase 2	16

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Recommended Dose for Phase II

(NCT00033514)
Timeframe: treatment period

Intervention	participants receiving each dose (Number)
	50 dose mg/day	100 dose mg/day	150 dose mg/day
Treatment Phase 1	6	3	5

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The Objective Response Rate as Defined as Stable Disease or the Rate of Complete and Partial Responses Determined on Two Consecutive Occasions Greater Than or Equal to 4 Weeks Apart.

"Complete Response:~The disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured. Also called complete remission.~Partial Response:~A decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment. Also called partial remission." (NCT00033514)
Timeframe: 5 years

Intervention	participants (Number)
	Partial Response	Stable Disease
Treatment Phase 1 Plus Phase 2	4	1

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Overall Survival Newly Diagnosed GBM Post RT

Overall Survival defined as Time from Start of treatment to time of death due to any cause (NCT00045110)
Timeframe: 2 years

Intervention	months (Median)
Phase 2 Newly Diagnosed GBM Post RT	14

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6 Months Progression-free Survival in Recurrent Malignant Gliomas (Phase II)

Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over BL if no decrease), OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). (NCT00045110)
Timeframe: 6 months

Intervention	Participants (Count of Participants)
	Recurrent GBM	Recurrent Anaplastic Glioma
Phase 2 Recurrent Malignant Gliomas	2	14

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Number of Dose Limiting Toxicity (DLT) Each Dose Level Phase I

DLT Definition: any grade 3 thrombocytopenia and grade 4 anemia and neutropenia; any non-hematologic grade 3 toxicity; failure to recover from toxicities to be eligible for re-treatment with erlotinib within 2 weeks of the last dose of erlotinib. (NCT00045110)
Timeframe: 28 days

Intervention	dose limiting toxicities (Number)
	Dose 150mg (Rash)	Dose 200mg	Dose 275mg	Dose 400mg	Dose 525mg	Dose 650mg (DVT/PE)	Dose 775mg (Rash [2])
Phase 1 Dose Escalation	1	0	0	0	0	1	2

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Response Rate (Complete or Partial Response) Graded Using Modified RECIST Criteria Phase II

"Measurable: Bidimensionally measurable lesions w/ clearly defined margins by MRI~Evaluable: Unidimensionally measurable lesions, masses w/margins not clearly defined.~Complete Response (CR): Complete disappearance of all measurable/evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients on minimal/no steroids.~Partial Response (PR): >/= to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. Responders must be on same/decreasing doses of dexamethasone.~Stable/No Response: Does not qualify for CR, PR, or progression.~Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over BL if no decrease), OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer)." (NCT00045110)
Timeframe: At 1 year

Intervention	participants (Number)
	complete response	Partial response	stable disease	Progression
Phase 2 Recurrent Malignant Gliomas	1	1	5	41

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1 Year Survival - Phase II Newly Diagnosed GBM Post RT

12 month survival for newly diagnosed stable GBM post RT treated with erlotinib post RT (NCT00045110)
Timeframe: At 1 year

Intervention	% of participants (Number)
Phase 2 Newly Diagnosed GBM Post RT	57

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Estimation of the Area Under the Curve Per Dose Level Phase I (on Anticonvulsants) -

plasma concentrations relative to erlotiniab administration and sample time and dose level (NCT00045110)
Timeframe: baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5

Intervention	ug* h/mL (Mean)
Phase 1 Dose Escalation - 150 mg	5.33
Phase 1 Dose Escalation - 200 mg	7.28
Phase 1 Dose Escalation - 275 mg	13.58
Phase 1 Dose Escalation - 400 mg	21.09
Phase 1 Dose Escalation - 525 mg	25.94
Phase 1 Dose Escalation - 650 mg	15.77
Phase 1 Dose Escalation - 775 mg	18.83

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Define Maximum Tolerated Dose (MTD) of Erlotinib by Phase 1 Cohorts

standard 3+3 dose escalation design 3 patients in each dose level, observed for 28 days before enrollment to next level. if none of the patients experienced DLT dose escalated, if 1 of 3 experienced DLT 3 more enrolled at that level, if none of the 3 additional pts had DLT escalate to next level, if one or more of the additional pts experienced DLT, the MTD was exceeded and 3 more patients were treated at the next lower dose (if only 3 pts treated at the lower dose). The MTD is the dose at which 0/3 or 1/6 patients have experienced a DLT with the next higher dose having at least 2/3 or 2/6 patients encountering DLT. (NCT00045110)
Timeframe: cycle 1 - 28 days

Intervention	mg (Number)
Phase 1 Dose Escalation	650

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Estimation of Area Under the Curve for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg-

Intervention	ug * h/mL (Mean)
Phase 2 Recurrent Malignant Gliomas	11.86

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Pharmacokinetics (Tissue) Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs

Drug administered 6 days prior to surgery (NCT00045110)
Timeframe: Pre-surgery and time of resection

Intervention	tumor/tissue concentration ng/g dry weig (Mean)
Phase 2 Newly Diagnosed GBM Post RT	497

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Trough Level Per Dose Level Phase I (on Anticonvulsants) -

plasma concentrations relative to erlotiniab administration and sample time and dose level (NCT00045110)
Timeframe: cycle 1 day eight

Intervention	ng/mL (Mean)
Phase 1 Dose Escalation - 150 mg	412
Phase 1 Dose Escalation - 200 mg	227
Phase 1 Dose Escalation - 275 mg	821
Phase 1 Dose Escalation - 400 mg	634
Phase 1 Dose Escalation - 525 mg	1356
Phase 1 Dose Escalation - 650 mg	591
Phase 1 Dose Escalation - 775 mg	942

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Trough Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg -

plasma concentrations relative to erlotiniab administration and sample time and dose level (NCT00045110)
Timeframe: One sample on day 8 cycle 1

Intervention	ng/mL (Mean)
Phase 2 Recurrent Malignant Gliomas	975

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Peak Plasma Concentration Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg -

Intervention	ng/mL (Mean)
Phase 2 Recurrent Malignant Gliomas	872

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Peak Plasma Concentration Per Dose Level Phase I (on Anticonvulsants) -

Intervention	ng/mL (Mean)
Phase 1 Dose Escalation - 150 mg	603
Phase 1 Dose Escalation - 200 mg	722
Phase 1 Dose Escalation - 275 mg	1075
Phase 1 Dose Escalation - 400 mg	487
Phase 1 Dose Escalation - 525 mg	2327
Phase 1 Dose Escalation - 650 mg	1351
Phase 1 Dose Escalation - 775 mg	2009

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Percent of Participants With a Grade 3 or 4 Adverse Events Phase 1

CTCAE (NCT00045110)
Timeframe: 1 year

Intervention	Participants (Count of Participants)
Phase 1 Dose Escalation	4

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Percent of Patients With One or More Grade 3-5 Toxicity Described Based on the CTC Severity Grading Phase II

Summarized by descriptive statistics. (NCT00045110)
Timeframe: Up to 1 year

Intervention	percent of participants (Number)
Phase 2 Recurrent Malignant Gliomas and Stable Disease Post RT	29

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Pharmacokinetics (Plasma) Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs

Drug administered 6 days prior to surgery (NCT00045110)
Timeframe: Pre-surgery and time of resection

Intervention	plasma concentration ng/mL (Mean)
Phase 2 Newly Diagnosed GBM Post RT	761

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Time of Peak Plasma Concentration Per Dose Level Phase I (on Anticonvulsants) -

plasma concentrations relative to erlotiniab administration and sample time and dose level (NCT00045110)
Timeframe: baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1.

Intervention	h (Mean)
Phase 1 Dose Escalation - 150 mg	2.3
Phase 1 Dose Escalation - 200 mg	2.8
Phase 1 Dose Escalation - 275 mg	3.3
Phase 1 Dose Escalation - 400 mg	6
Phase 1 Dose Escalation - 525 mg	3.5
Phase 1 Dose Escalation - 650 mg	2.2
Phase 1 Dose Escalation - 775 mg	2.4

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Time to Peak Plasma Concentration for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg -

Intervention	h (Mean)
Phase 2 Recurrent Malignant Gliomas	3.0

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Number of Patients With Ani-tumor Activity After Taking OSI-774.

Antitumor activity is measured with conventional techniques such as CT, MRI or X-ray. Scans are done at baseline then evaluated for response every 2 months. All tumor measurements must be recorded millimeters (or decimal fractions of centimeters). (NCT00045487)
Timeframe: Disease progression or 52 weeks duration

Intervention	participants (Number)
OSI-774	7

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Duration of Response

The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).Evaluation of Target Lesions Complete Response (CR):Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD (NCT00054132)
Timeframe: From the time measurement criteria are met for CR and PR until the first date that recurrent or progressive disease is objectively documented, assessed up to 12 years

Intervention	months (Number)
Treatment (Erlotinib Hydrochloride, Bevacizumab)	52

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Number of Patients Evaluated for Toxicity

graded according to the National Cancer Institute Common Toxicity Criteria version 4.0 (NCT00054132)
Timeframe: up to 12 years

Intervention	Participants (Count of Participants)
Treatment (Erlotinib Hydrochloride, Bevacizumab)	38

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Participants With Duration of Stable Disease Greater Than or Equal to 6 Months

Duration of stable disease greater than or equal to 6 months (NCT00054132)
Timeframe: From the start of treatment until the first date that recurrent or progressive disease is objectively documented, assessed up to 12 years

Intervention	Participants (Count of Participants)
Treatment (Erlotinib Hydrochloride, Bevacizumab)	0

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Time to Progression

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions (NCT00054132)
Timeframe: From the start of treatment until the first date that recurrent or progressive disease is objectively documented, assessed up to 12 years

Intervention	weeks (Median)
Treatment (Erlotinib Hydrochloride, Bevacizumab)	11

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Level of EGFR Expression

"Estimated at the end of the trial Immunoreactivity will be evaluated qualitatively with regard to intensity as follows: Measured on a scale, ranging from 0-3+ 0=negative (no immunoreactivity)~1+ - 3+ = positive:~faint immunoreactivity (weak staining)~intense immunoreactivity (strong staining) Immunohistochemical studies will be performed on the tumor specimen to correlate the anti-tumor efficacy of OSI-774 and bevacizumab with pre-treatment molecular characteristics." (NCT00054132)
Timeframe: Up to 12 years

Intervention	participants (Number)
	EGFR 0	EGFR 1+	EGFR 2+	EGFR 3+	Insufficient tumor tissue
Treatment (Erlotinib Hydrochloride, Bevacizumab)	24	8	4	0	2

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Response Rate, Defined as Complete Response (CR) + Partial Response (PR), Using the Response Evaluation Criteria in Solid Tumors

Estimated at the end of the trial. Complete Response (CR):Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD 55 Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started (NCT00054132)
Timeframe: Up to 12 years

Intervention	participants (Number)
	Complete Response	Partial Response	Stable Disease	Progression of Disease
Treatment (Erlotinib Hydrochloride, Bevacizumab)	0	1	17	19

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Progression Free Survival(PFS)

Progression free survival was defined as time from the start of treatment to the date of cancer progression, or death, and censored at the date of last follow-up for those without disease progression and still alive. Stable disease is measured from the start of the treatment until progression, taking as reference the smallest measurements recorded since the treatment started. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. (NCT00054275)
Timeframe: 3 years

Intervention	months (Median)
Docetaxel and OSI-774	8.4

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Overall Survival as of 2008

Overall survival (OS) was defined as time from the start of treatment to death, and censored at the time of last assessment for survivors. (NCT00054275)
Timeframe: 5 yrs

Intervention	months (Median)
Docetaxel and OSI-774	22.3

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Disease Response (Tumor Measurements)Per RECIST Criteria v. 2000

Response and progression will be evaluated in this study using the criteria by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive Disease: At least a 20% increase in the sum of the LD of target lesions. Stable Disease: Neither sufficient shrinkage nor sufficient increase. (NCT00054275)
Timeframe: after 6 course (6 months) of combination therapy

Intervention	participants (Number)
	Partial response	Disease progression	Stable disease
Docetaxel and OSI-774	11	14	3

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Pathologic Complete Response Rates

Pathologic complete response was defined as having no pathologic or cytologic evidence of disease following surgical reassessment. (NCT00059787)
Timeframe: Up to 7 years

Intervention	participants (Number)
Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)	8

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To Measure EGFR Gene Amplification in Tumor Specimens

(NCT00059787)
Timeframe: The duration of the study for up to 7 years

Intervention	number of tumor specimens (Number)
	No amplification	Low-level amplification	moderate high amplification
Paclitaxel, Carboplatin, Erlotinib	11	6	3

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To Determine the Tolerability of Twelve Months of Maintenance Treatment

(NCT00059787)
Timeframe: Twelve months of maintenance

Intervention	participants (Number)
	No recurrence	Recurrence
Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)	12	4

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To Determine Progession Free Survival With the Addition of OSI-774 (Tarceva) to the Combination of Paclitaxel and Carboplatin

(NCT00059787)
Timeframe: The duration of the study

Intervention	months (Median)
Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)	34.3

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The Percentage of Participants Experiencing Toxicty (Grade 2 and Grade 3/4) Associated With the Combined Regimen

Adverse event assessment (NCT00059787)
Timeframe: For the duration of the study up to 7 years

Intervention	percentage of participants (Number)
	Grade 3-4 neutropenia	Grade 3-4 skin rash	Grade 3-4 thrombocytopenia	Grade 3-4 infection	Grade 3-4 fatigue	Grade 3 diarrhea	Grade 2 skin rash	Grade 2 diarrhea
Paclitaxel, Carboplatin, Erlotinib	18	17	7	7	5	4	21	7

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Number of Patients With Response

Response defined by tumor assessment using Response Evaluation Criteria In Solid Tumors (RECIST) to learn effectiveness of Tarceva (OSI-774) when combined with standard chemotherapy before surgery. (NCT00063258)
Timeframe: 5 Years to collect outcome information

Intervention	Participants (Number)
	Complete Response	Partial Response	Stable Disease	Progressive Disease
Chemotherapy + Tarceva	0	0	1	0

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Patients With Response (Confirmed Complete, and Partial) With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor When Treated With Erlotinib.

"Complete response - Complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms, normalization of markers and other abnormal lab values.~Partial response - Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease, no new lesions." (NCT00068367)
Timeframe: 25 weeks

Intervention	Participants (Count of Participants)
Arm I (OSI-774)	0

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Toxicity

Only adverse events that are possibly, probably or definitely related to study drug are reported. (NCT00068367)
Timeframe: Up to 25 weeks

Intervention	Participants (Number)
	Anorexia	Diarrhea	Dyspnea (shortness of breath)	Fatigue (asthenia, lethargy, malaise)	Hemoglobin	Nausea	Pain - Abdomen NOS	Pruritus/itching	Rash/desquamation	Somnolence/depressed level of consciousness	Vision-blurred vision
Arm I (OSI-774)	1	1	1	3	1	1	1	1	1	1	1

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Progression-free Survival

Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression. (NCT00085839)
Timeframe: Until time of disease progression (maximum 5 months)

Intervention	months (Median)
Erlotinib	1.91
Standard Chemotherapy	3.52

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Overall Survival

Median number of months from first study treatment until time of death (NCT00085839)
Timeframe: From first study treatment until time of death (maximum 26.8 months)

Intervention	months (Median)
Erlotinib	6.57
Standard Chemotherapy	9.53

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Best Tumor Response

Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor 20% larger than at baseline. (NCT00085839)
Timeframe: While receiving study treatment (maximum 60 weeks)

Intervention	participants (Number)
	Complete Response (CR)	Partial Response (PR)	Stable Disease (SD)	Progressive Disease (PD)	Unable to Determine/Not Evaluable
Erlotinib	0	2	19	23	8
Standard Chemotherapy	0	6	23	10	12

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Progression-free Survival

Median progression-free survival time (time from randomization to disease progression or death from any cause). Analyzed using the Kaplan-Meier (1958) estimator and their associated 95% confidence intervals determined using the method described in Brookmeyer and Crowley. (NCT00091026)
Timeframe: 36 months

Intervention	months (Median)
Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)	5.0
Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)	5.1

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Overall Survival

Time from randomization until death from any cause. Analyzed using the Kaplan-Meier (1958) estimator and their associated 5% confidence intervals determined using the method described in Brookmeyer and Crowley. (NCT00091026)
Timeframe: 36 months

Intervention	Months (Median)
Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)	7.9
Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)	7.1

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Objective Response Rate (Complete or Partial Response) Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST)

(NCT00091026)
Timeframe: Up to 6 months

Intervention	percentage of participants (Number)
Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)	21
Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)	21

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Quality-adjusted Survival as Measured by EuroQol 5-dimension Instrument

Quality-adjusted life years (QALY) incorporate the societal-based utilities of health states into expected life years for a health condition. The QALY model is QALY(h,y) where h is a health state and y is the years of life. Higher quality-adjusted life year values represent a better outcome. A patient's health state will be determined from the index score of the EQ-5D-5L patient questionnaire.The EQ-5D-5L is a 2-part self-assessment questionnaire, a 5-item index score and a visual analogue scale, but only the index score is used for quality-adjusted survival. The index score has 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). (NCT00096265)
Timeframe: From randomization to last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.

Intervention	Quality-adjusted life years (Mean)
WBRT + SRS	16.9
Temozolomide + WBRT + SRS	15.9
Erlotinib + WBRT + SRS	14.4

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Rate of CNS Progression (One Year)

CNS progression is defined as any increase in perpendicular bi-dimensional tumor area for any of the 1-3 tracked brain metastases, by any amount, or the appearance of any new brain metastasis on a follow-up MRI (SRS planning scan will not be used to evaluate CNS progression). For lesions smaller than 1 cm in maximum diameter, a maximum increase of 50% in perpendicular bi-dimensional treatment area is necessary to score as progression. This caveat is included to account for potential variability in measurement, which is most susceptible to proportionate errors at smaller sizes. For greater than 1 cm lesions, the definition uses a 25% rule for change. Rates of CNS progression estimated by the cumulative incidence method, with death treated as a competing risk. (NCT00096265)
Timeframe: From randomization to last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.

Intervention	percentage of participants (Number)
WBRT + SRS	34.1
Temozolomide + WBRT + SRS	47.4
Erlotinib + WBRT + SRS	27.4

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Overall Survival

Survival time is defined as time from randomization to date of death from any cause and estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact. (NCT00096265)
Timeframe: From randomization to date of death or last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.

Intervention	months (Median)
WBRT + SRS	13.4
Temozolomide + WBRT + SRS	6.3
Erlotinib + WBRT + SRS	6.1

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Change in Steroid Dependence at Six Months

Daily steroid dose will be collected at baseline and follow-up, as one of the following: 0-4 mg, >4 to ≤ 8 mg, >8 to ≤12 mg, and >12 mg. Change from baseline at six months will be evaluated to have decreased, remained stable, or increased, based on these categories. (NCT00096265)
Timeframe: From randomization to six months.

Intervention	Participants (Count of Participants)
	Decrease	Stable	Increase
Erlotinib + WBRT + SRS	10	6	1
Temozolomide + WBRT + SRS	10	4	4
WBRT + SRS	12	10	4

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Change in Performance Status at Six Months

Compared between two treatment arms using a two-group chi-squared test. Zubrod score will be collected at baseline and follow-up. The Zubrod performance score runs from 0 to 5, with 0 denoting perfect health and 5 death. Change from baseline is calculated as 6-month value - baseline value. Patients with a baseline score who have died by six months will be included in the analysis with a score of 5 at six months. (NCT00096265)
Timeframe: From randomization to six months.

Intervention	Participants (Count of Participants)
	Improvement (decrease)	Stable (no change)	Deterioration (increase)
Erlotinib + WBRT + SRS	3	2	30
Temozolomide + WBRT + SRS	1	4	30
WBRT + SRS	0	19	21

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Change in Functional Assessment of Cancer Therapy-Brain (FACT-Br) Score at 3 Months

The Functional Assessment of Cancer Therapy-Brain (FACT-Br) is a 19-item self-report instrument designed to measure multidimensional quality of life in patients with brain cancer. It is to be administered with the FACT-General. There are 5 responses options, with 0=Not a lot and 4=Very much. All items are added together to obtain a total score, which ranges from 0 to 76. Certain items must be reversed before it is added by subtracting the response from 4. It requires at least 50% of the items to be completed while the overall response rate of the FACT-Br including the FACT-G must be greater than 80%. If items are missing, the subscale scores can be prorated. A higher score indicates better QOL. A change of 5 points will be considered a minimal clinically meaningful change. Change from baseline at three months (3 month score - baseline score) will be categorized as improvement if increased, stable if no change, or deterioration if decreased. (NCT00096265)
Timeframe: From randomization to three months.

Intervention	Participants (Count of Participants)
	Deterioration/Decrease	Stable	Improvement/Increase
Erlotinib + WBRT + SRS	11	6	1
Temozolomide + WBRT + SRS	10	2	4
WBRT + SRS	12	8	6

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Efficacy - Response Phase 1

"pt must have at least 8 weeks of treatment to receive MRI scan, scans are every other cycle (every 2 months). Response measured by a bidimensionally measured leison and clearly defined margins by CT or MRI scan.~Complete Response (CR): complete disappearance of all measurable and evaluable disease. No new lesions, not on any steroids Partial Response (PR): >= 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. Steriod dose must be no greater than max used in 1st 8wks of therapy Stable: not qualify for CR, PR, or progression. Steriod dose must be no greater than max used in 1st 8wks of therapy Progression (PD): 25% increase in the sum of products of all measurable lesions over smallest sum observed, OR clear worsening or failure to return for evalution due to death or deteriorating condition (unless clearly unrelated to brain cancer)." (NCT00112736)
Timeframe: at least 8 weeks of treatment

Intervention	participants (Number)
	Complete Response	Partial response	Stable	Progressive Disease
Phase I 15mg Temsirolimus (MTD Dose)	0	1	2	9

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Maximum Tolerated Dose (Phase I)

"Oral erlotinab at 150mg constant dose, 3 pts will be treated with temsirolimus IV with escalating doses, starting at 50mg. Doses will increase or decrease based on toxicity observed.~3 pts will be treated at each dose level - 3 dose levels were observed: 50mg, 25mg, and 15mg" (NCT00112736)
Timeframe: based on first 4 weeks of treatment - cycle 1

Intervention	mg (Number)
Phase I - Dose Escalation	15

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Pharmacokinetics (Phase I)

"Tersirolimus Cmax (ng/mL) for cycle 1 is presented in the outcome measure table below for the 3 dose levels~blood samples (5ml) was collected in EDTA containing tubes on days 1 and 2 of cycle 1~Collection time points: prior to dosing of both drugs, at end of temsirolimus infusion and at 1,2,4,6, and 24 hr after erlotinib administration" (NCT00112736)
Timeframe: Days 1, 2 of cycle 1, prior to dosing of both drugs, at end of temsirolimus infusion and at 1,2,4,6, and 24 hr after erlotinib administration

Intervention	ng/mL (Mean)
Phase 1 - 15mg	460
Phase 1 - 25 mg	428
Phase 1 - 50mg	451

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Progression-free Survival at 6 Months (Phase II)

"Progression (PD): 25% increase in the sum of products of all measurable lesions over smallest sum observed, OR clear worsening or failure to return for evalution due to death or deteriorating condition (unless clearly unrelated to brain cancer).~Responses had to be present on 2 consecutive scans and were centrally reviewed." (NCT00112736)
Timeframe: Evaluated at baseline and every other cycle, till Month 6

Intervention	participants (Number)
Phase II n=43	6

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Safety/Dose Limiting Toxities Phase I

"Dose limiting toxities defined as: grade 3 thrombocytopenia, grade 4 anemia and neutropenia, grade >/= nonhematologic toxicity, and failure to recover from toxicites to be eligible for retreatment in 2 weeks of the last dose of either drug. Also grade 3 nonhematologic toxicities only if they wre refractory to maxiaml medical therapy.~MTD defined as dose at which fewer than one-third of patients experienced a DLT~Outcome measure defines number of participants who had a defined dose limiting toxicity." (NCT00112736)
Timeframe: first 4 weeks of treatment

Intervention	participants (Number)
Phase 1 - 50mg	2
Phase 1 - 25 mg	3
Phase 1 - 15mg	3

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Erlotinib Tmax

Although the calculated dose of erlotinib was rounded to the nearest 25 mg, the actual dosage administered to patients was within 12% of the prescribed dosage in all but 1 patient. The latter patient received erlotinib at the lowest dosage level and the actual dosage was 19% higher than the calculated dose. (NCT00124657)
Timeframe: After first dose of therapy

,,,

Intervention	hours (Median)
	Erlotinib, after first dose of therapy	Erlotinib, Day 8 of therapy
120 mg/m^2	2.2	1.75
160 mg/m^2	2.2	2.2
70 mg/m^2	4	2.1
90 mg/m^2	3.1	2.6

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Cmax of Erlotinib and Its Metabolite OSI-420

,,,

Intervention	mg/mL (Median)
	Erlotinib, after first dose of therapy	Erlotinib, Day 8 of therapy	OSI-420, after first dose of therapy	OSI-420, Day 8 of therapy
120 mg/m^2	1.2	1.4	0.14	0.3
160 mg/m^2	1.8	2	0.32	0.3
70 mg/m^2	1.3	1.8	0.13	0.25
90 mg/m^2	1.6	1.3	0.16	0.17

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AUC Time 0-infinite (AUCinf) of Erlotinib and Its Metabolite OSI-420

,,,

Intervention	mg*h/mL (Median)
	Erlotinib, after first dose of therapy	Erlotinib, Day 8 of therapy	OSI-420, after first dose of therapy	OSI-420, Day 8 of therapy
120 mg/m^2	27.8	23.1	2.5	2.8
160 mg/m^2	37.1	35.5	4.2	4.3
70 mg/m^2	34.9	28.8	2.1	3.3
90 mg/m^2	23.9	21.2	1.9	2.1

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Number of Participants With Dose-limiting Toxicity (DLT)

DLT was defined as any of the following toxicities attributable to erlotinib therapy: thrombocytopenia grade 3 and 4; neutropenia grade 4; or any grade 3 and 4 non-hematologic toxicity except for grade 3 diarrhea and grade 3 nausea and vomiting lasting ≤48 hours in participants not receiving optimal supportive therapy, grade 3 skin rash, which did not affect normal daily activities, grade 3 fever or nonneutropenic infection, grade 3 seizures, grade 3 weight gain or loss, and grade 3 transaminase elevation that returned to grade 1 or baseline within 7 days. After enrollment of the first 4 participants, grade 3 and 4 electrolyte abnormalities that resolved to ≤grade 2 within 7 days were excluded as DLT. Toxicities were graded according to the Common Terminology Criteria for Adverse Events version 3.0. (NCT00124657)
Timeframe: During the first 8 weeks of therapy

Intervention	participants (Number)
70 mg/m^2	0
90 mg/m^2	0
120 mg/m^2	1
160 mg/m^2	2

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Maximum Tolerated Dose (MTD) of Erlotinib

MTD was defined as the highest dosage level in which no more than one of six assessable participants experienced dose-limiting toxicities (DLT). The dosage of erlotinib was increased by approximately 30% in each dosage level starting at 80% of the MTD in adults with solid tumors. A traditional 3+3 dose escalation scheme was used to estimate the MTD. (NCT00124657)
Timeframe: During the first 8 weeks of therapy.

Intervention	mg/m^2 (Number)
Phase I	120

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Progression Free Survival (PFS)

"Progression-free survival (PFS) distributions for the Phase II participants with anaplastic astrocytoma (AA) and glioblastoma multiforme (GBM) were calculated using Kaplan-Meier estimates (n=41). PFS was defined as the interval between treatment start and initial failure, including clinical or radiologic progression or death from any cause.~PFS was not calculated for the other disease types." (NCT00124657)
Timeframe: 1 and 2 years after end of therapy

,,,

Intervention	years (Mean)
	1-year PFS	2-year PFS
Phase I AA	0.75	NA
Phase I GBM	0.33	NA
Phase II AA	0.45	0.15
Phase II GBM	0.19	0.19

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Number of Positive Mutations of EGFR and Downstream Pathways

"Statistical analyses of genomic changes, expression profiles and validation studies should be considered in an exploratory and hypothesis-generating context.~Fresh frozen tumor tissue was obtained at the time of tumor resection and diagnosis. DNA was extracted from formalin-fixed, paraffin-embedded tissue. The entire PTEN coding sequence (exons 1-9), exons 1, 9 and 20 of PIK3CA, and exons 17-24 of EGFR were evaluated using exon-specific PCR amplification, and immunohistochemistry was done. Tumor lesions were considered positive if >25% cells were immunoreactive." (NCT00124657)
Timeframe: Once at tumor resection and diagnosis

Intervention	participants (Number)
	Positive for PTEN (R130*)	Positive PIK3CA (H1047R)	Positive EGFR kinase domain
Phase I	1	1	0

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Number of Participants Experiencing Grade 3 or 4 Toxicity Events

Adverse events were collected systematically for each of the 44 Phase II participants from the time of enrollment to the completion of therapy (approximately 2 years from start of therapy). (NCT00124657)
Timeframe: From start of therapy through 2 years.

Intervention	Participants (Number)
	Blood: Hemoglobin	Blood: Lymphopenia	Blood: Neutrophils	Blood: Platelets	Dermatologic: Pruritus	Dermatologic: Rash/Desquamation	Dermatologic: Rash/acne	Gastrointestinal: Anorexia	Gastrointestinal: Diarrhea	Gastrointestinal: Dysphagia	Gastrointestinal: Mucositis	Gastrointestinal: Nausea	Gastrointestinal: Vomiting	Metabolic: ALT/AST	Metabolic: Hypokalemia	Metabolic: Bilirubin	Pain: Headache	Constitutional: Fatigue	Constitutional: Weight Loss
Grade 3 Toxicity	2	7	2	0	3	1	2	3	5	1	1	2	4	2	2	1	1	1	2
Grade 4 Toxicity	1	8	1	1	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0

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Radiographic Response Rates

Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR (NCT00125359)
Timeframe: Through study completion, an average of 1 year

Intervention	Participants (Count of Participants)
Single Arm Erlotinib + Bexarotene	19

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Progression-free Survival and Overall Survival

(NCT00125359)
Timeframe: Through study completion, an average of 1 year

Intervention	Weeks (Median)
	Time to progression	Overall survival
Single Arm Erlotinib + Bexarotene	7	22

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Correlation of Early PET Responses With Objective Radiographic Responses.

PET response is assessed based on the guidelines of the European Organization for Research and Treatment of Cancer (EORTC) PET Study Group (Eur J Cancer 1999; 35(13):1773-82). PET response refers to the presence and measurement of the most current PET scan imaging when compared to baseline imaging. The amount of reduction in the disease from baseline to current imaging determines the extent to which the cancer has responded to treatment. Radiographic response is per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR (NCT00125359)
Timeframe: Through study completion, an average of 1 year

Intervention	Participants (Count of Participants)
	Computed tomography complete response72422520				Computed tomography partial response72422520	Computed tomography stable disease72422520	Computed tomography disease progression72422520
	Early PET progression	Early PET metabolic response	Early PET metabolic progression	Early PET stable disease
Single Arm Erlotinib + Bexarotene	0
Single Arm Erlotinib + Bexarotene	1
Single Arm Erlotinib + Bexarotene	5

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Number of Participants With EGFR Mutations and Correlation of EGFR Mutations With Response

(NCT00125372)
Timeframe: Baseline and 9 days

Intervention	Participants (Count of Participants)
	Wild-type EGFR72125196		EGFR Mutation at Exon 2172125196	EGFR not assessed at baseline72125196
	Therapeutic Response	No Therepeutic Response
Erlotinib and Bexarotene	4
Erlotinib and Bexarotene	1
Erlotinib and Bexarotene	0

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Overall Response Rate

"The proportion of patients who respond (completely or partially) to each combination regimen will be estimated. An exact binomial confidence interval will be computed for these estimates.~Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:~Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions" (NCT00126581)
Timeframe: Duration of Study (up to 3 years)

Intervention	percentage of participants (Number)
Arm A: Erlotinib	35
Arm B: Erlotinib/Carboplatin/Paclitaxel	46

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Number of Participants With Grade 3, 4 or 5 Adverse Event at Least Possibly Related to Treatment.

"The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.~Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death." (NCT00126581)
Timeframe: Duration of study (up to 3 years)

Intervention	participants (Number)
Arm A: Erlotinib	20
Arm B: Erlotinib/Carboplatin/Paclitaxel	52

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18 Weeks Progression Free Survival (PFS) Rate

"The product limit estimator developed by Kaplan Meier will be used to graphically describe progression free survival for patients randomized to each study arm.~The 18 week progression-free survival rate was defined as the proportion of patients that were alive progression-free 18 weeks after registration into the study. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of new lesions. Kaplan-Meier estimate of 18-week progression-free survival was calculated." (NCT00126581)
Timeframe: At 18 weeks

Intervention	percentage of participants (Number)
Arm A: Erlotinib	52
Arm B: Erlotinib/Carboplatin/Paclitaxel	69

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Progression Free Survival With KRAS Mutation Status

Progression free survival is defined in previous outcome measures. GIven the small number of KRAS mutant participants, the analysis combines data from both arms. (NCT00126581)
Timeframe: Duration of study (up to 3 years)

Intervention	months (Median)
Mutant	4
Wild Type	6.7

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Progression Free Survival (PFS) by Epidermal Growth Factor Receptor (EGFR) Mutation Status

"PFS was defined as the time from registration until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. Progression is defined as in the primary outcome measure.~EGFR mutations were performed at the Dana-Farber Cancer Institute using a sensitive heteroduplex method coupled with enzymatic digestion as previously reported (Janne PA, et al: A rapid and sensitive enzymatic method for epidermal growth factor receptor mutation screening. Clin Cancer Res 12:751-758, 2006). All positive findings were independently verified and subjected to sequencing. The mutation analyses were blinded to the participants' clinical outcome." (NCT00126581)
Timeframe: Duration of treatment (up to 3 years)

Intervention	months (Median)
	EGFR Mutant	EGFR Wild Type
Arm A: Erlotinib	14.1	2.6
Arm B: Erlotinib/Carboplatin/Paclitaxel	17.2	4.8

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Overall Response Rate by EGFR Mutation Status

Response and EGFR mutation status are defined in previous outcome measures. (NCT00126581)
Timeframe: Duration of study (up to 3 years)

Intervention	percentage of participants (Number)
	EGFR Mutant	EGFR Wild Type
Arm A: Erlotinib	70	9
Arm B: Erlotinib/Carboplatin/Paclitaxel	73	30

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Overall Survival

Overall survival (OS) is defined as the time from patient randomization (arm assignment) to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method. (NCT00126581)
Timeframe: Time from randomization to death (up to 3 years)

Intervention	months (Median)
Arm A: Erlotinib	24.6
Arm B: Erlotinib/Carboplatin/Paclitaxel	19.8

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Overall Response Rate With KRAS Mutational Status

Overall response is defined in previous outcome measures. GIven the small number of KRAS mutant participants in each treatment arm, the analysis combines data from both arms. (NCT00126581)
Timeframe: Duration of study (up to 3 years)

Intervention	percentage of participants (Number)
Mutant	29
Wild Type	42

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Progression Free Survival(PFS)

PFS was defined as the time from the start of therapy to the time of the first documentation of progression(progression=20% increase in sum of longest diameters of target measurable lesions over smallest sum observed or baseline, progression of non-measurable disease in the opinion of treating physician, appearance of new lesion/site, Death due to disease), symptomatic deterioration (global deterioration of health status requiring discontinuation of treatment without objective evidence of progression), or death due to any cause; (NCT00130520)
Timeframe: June 2005 to October 5, 2009

Intervention	months (Median)
Bevacizumab and Erlotinib	4

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Objective Response (Complete Partial, Stable and Progression)

Objective response was defined using standard RECIST criteria. CR(complete response)= disappearance of all target lesions PR(partial response)=30% decrease in the sum of the longest diameter of target lesions PD(progressive disease)=20% increase in the sum of the longest diameter of target lesions SD(stable disease)= small changes that do not meet above criteria (NCT00130520)
Timeframe: 06.16.2005 to 10.05.2009

Intervention	Participants (Number)
	Complete Response	Partial Response	Stable Disease	Disease Progression
Bevacizumab and Erlotinib	1	8	10	20

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Median Response Duration (Weeks)

Response duration=time (in weeks) between date of measurable response and date of progression (progression=20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed or baseline, progression of non-measurable disease in opinion of treating physician, any new lesion/site, death due to disease)if known or the date the subject went off protocol if they were still considered responders (ie do not qualify as progression) or are stable (Does not qualify for CR, PR, progression or Symptomatic Deterioration) (NCT00130520)
Timeframe: 1 week to 96 weeks

Intervention	weeks (Median)
	Responders	Stable
Bevacizumab and Erlotinib	36.1	25.6

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Overall Survival (OS) Among All Randomized Patients

Overall Survival was defined as the period from the date of randomization until the date of patient death from any cause. For patients who had not died, survival data was censored at the date of last contact. (NCT00130728)
Timeframe: From the date of randomization until the date of patient death from any cause, or the date of last contact. (Up to 3.1 years)

Intervention	months (Median)
Erlotinib HCl + Bevacizumab	9.3
Erlotinib HCl + Placebo	9.2

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Percentage of Participants With Objective Response

Objective response was defined as a complete or partial response determined by RECIST on two consecutive occasions >= 4 weeks apart. (NCT00130728)
Timeframe: The median duration of Objective response was up to 9.7 months

Intervention	Percentage of participants (Number)
Erlotinib HCl + Bevacizumab	12.6
Erlotinib HCl + Placebo	6.2

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Progression-free Survival (PFS)

PFS was defined as the time from randomization to documented disease progression, as determined by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST), or death on study treatment, whichever occurred first. (NCT00130728)
Timeframe: From randomization to documented disease progression or death on study treatment, whichever occurred first. (Up to 3.1 years)

Intervention	months (Median)
Erlotinib HCl + Bevacizumab	3.4
Erlotinib HCl + Placebo	1.7

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Duration of Objective Response

Duration of objective response was defined as the period from the date of the initial partial or complete response until the date of disease progression or death on study treatment from any cause. For patients who had not died, data was censored at the date of last contact. (NCT00130728)
Timeframe: Period from Objective response until disease progression or death on study treatment. (Up to 29.5 months)

Intervention	months (Median)
Erlotinib HCl + Bevacizumab	9.7
Erlotinib HCl + Placebo	8.4

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Overall Response Rate (ORR)

ORR is defined as the percentage of participants who achieve partial response (PR) or better on treatment based on RECIST 1.0 criteria: For target lesions, complete response (CR) is disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD (both require a minimum of 4 weeks). Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or appearance of one or more new target lesions. Stable disease (SD) is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions. (NCT00137839)
Timeframe: In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months.

Intervention	percentage of participants (Number)
Erlotinib	27.7

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Overall Survival (OS)

OS is defined as the time from study entry to death or date last known alive. (NCT00137839)
Timeframe: In this study cohort, participants were followed for survival up to 155 months.

Intervention	months (Median)
Erlotinib	22.9

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Overall Survival by EGFR Mutation Status

OS is defined as the time from study entry to death or date last known alive. (NCT00137839)
Timeframe: In this study cohort, participants were followed for survival up to 155 months.

Intervention	months (Median)
EGFR Mutant	32.6
EGFR Wild Type	9.9
Unevaluable EGFR	15.7

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Overall Response Rate (ORR) by EGFR Mutation Status

ORR is defined as the percentage of participants who achieve partial response (PR) or better on treatment based on RECIST 1.0 criteria: For target lesions, complete response (CR) is disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD (both require a minimum of 4 weeks). Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or appearance of one or more new target lesions. SD is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions. (NCT00137839)
Timeframe: In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months.

Intervention	percentage of participants (Number)
EGFR Mutant	56.4
EGFR Wild Type	2.9
Unevaluable EGFR	0.0

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Tumor Resolution

Complete response (resolution) of tumor on clinical exam. (NCT00140556)
Timeframe: Within 30 days of completing RT

Intervention	Participants (Number)
Entire Study Population	25

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Progression-Free Survival (PFS): Phase 2

Time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause whichever comes first. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from radiological image (where data meet the criteria for progressive disease [PD]). (NCT00147537)
Timeframe: Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization

Intervention	months (Median)
CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 2)	4.4
CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 2)	4.5
Paclitaxel + Carboplatin (Phase 2)	4.3
CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 2 NR)	5.1

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Area Under the Curve From Time Zero to 504 Hours [AUC (0-504)] Post Infusion of CP-751,871 for Cycle 4 in Phase 1b

AUC (0-504)= Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the 21-day cycle, 504 hours(0-504) (NCT00147537)
Timeframe: Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)

Intervention	mg.hr/L (Mean)
CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	77.60
CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	2410
CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	23200
CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	52500
CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	94360
CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	214000
CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)	133200

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Plasma Concentration of CP-751,871 at the End of Infusion (Cendinf) for Cycle 1 in Phase 1b

(NCT00147537)
Timeframe: Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)

Intervention	milligram/liter (mg/L) (Mean)
CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	1.510
CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	17.34
CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	37.47
CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	75.17
CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	147.3
CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	261.3
CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	415.7
CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)	485.0

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Area Under the Curve From Time Zero to Last Quantifiable Concentration of CP-751,871 (AUClast) for Cycle 4 in Phase 1b

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) (NCT00147537)
Timeframe: Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)

Intervention	mg.hr/L (Mean)
CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	64.70
CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	2255
CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	2670
CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	23400
CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	70300
CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	82930
CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	116200
CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)	114000

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Area Under the Curve From Time Zero to Last Quantifiable Concentration of CP-751,871(AUClast) for Cycle 1 in Phase 1b

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) (NCT00147537)
Timeframe: Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)

Intervention	mg.hr/L (Mean)
CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	16.60
CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	1235
CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	5137
CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	11350
CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	25630
CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	49260
CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	71200
CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)	87680

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Number of Participants With Positive Human Anti-human Antibody (HAHA) Values: Phase 1b

HAHA are indicators of immunogenicity to CP-751,871. (NCT00147537)
Timeframe: Day 1 pre-infusion of each cycle up to Cycle 17 (each cycle was 21 day), 150 days after the last CP-751,871 infusion, and last follow up visit (one year post last study dose)

Intervention	number of participants (Number)
CP-751,871 + Paclitaxel + Carboplatin (Phase 1b)	1
CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)	0

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Area Under the Curve From Time Zero to 504 Hours [AUC (0-504)] Post Infusion of CP-751,871 for Cycle 1 in Phase 1b

AUC (0-504)= Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the 21-day cycle, 504 hours(0-504) (NCT00147537)
Timeframe: Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)

Intervention	milligram.hour/Liter (mg.hr/L) (Mean)
CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	22.30
CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	2011
CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	5320
CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	12810
CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	30500
CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	54650
CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	79820
CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)	85240

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Area Under the Curve From Time Zero Extrapolated to Infinite Time [AUCinf] for CP-751,871 for Cycle 1 in Phase 1b

AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) extrapolated to infinite time. (NCT00147537)
Timeframe: Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)

Intervention	mg.hr/L (Mean)
CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	1434
CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	16750
CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	41200
CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	69180
CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	12100
CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)	107400

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Accumulation of CP-751,871 Ratio (Cycle 4 AUC504 / Cycle 1 AUC504) (Rac) in Phase 1b

Accumulation ratio (Cycle 4 AUC504 / Cycle 1 AUC504) (Rac) (NCT00147537)
Timeframe: Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1). Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).

Intervention	ratio (Mean)
CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	3.480
CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	1.009
CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	1.830
CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	1.550
CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	1.984
CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	2.260
CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)	1.962

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CP-751,871 Concentration at 504 Hours Post Dose (C504) for Cycle 1 (End of the 21-day Cycle) in Phase 1b

Concentration at 504 hours post dose (NCT00147537)
Timeframe: Cycle 2 pre-infusion (which is the end of Cycle 1)

Intervention	mg/L (Mean)
CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	0.1610
CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	4.550
CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	9.820
CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	28.20
CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	61.11
CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	95.20
CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)	86.73

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Maximum Observed Plasma CP-751,871 Concentration (Cmax) for Cycle 1 in Phase 1b

Maximum Observed Plasma Concentration (NCT00147537)
Timeframe: Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)

Intervention	mg/L (Mean)
CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	1.510
CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	17.34
CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	38.60
CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	75.17
CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	147.3
CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	275.2
CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	415.7
CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)	483.1

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Maximum Observed Plasma CP-751,871 Concentration (Cmax) for Cycle 4 in Phase 1b

Maximum Observed Plasma Concentration (NCT00147537)
Timeframe: Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is then end of Cycle 4)

Intervention	mg/L (Mean)
CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	2.975
CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	20.25
CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	40.70
CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	100.7
CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	327.0
CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	369.1
CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	611.3
CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)	535.5

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Maximum Tolerated Dose (MTD)of CP-751,871 in Combination With Paclitaxel and Carboplatin: Phase 1b

The maximum tolerated dose of CP-751,871 in combination with paclitaxel and carboplatin is the highest dose level below the Maximum Administered Dose (the dose level at which 2 or more out of 3 to 6 patients experience a Dose Limiting Toxicity at a dose level in Cycle 1) at which none or one out of 6 patients experience a Cycle 1 Dose Limiting Toxicity. (NCT00147537)
Timeframe: Start of treatment (baseline) up to the end of Cycle 1 (Day 21)

Intervention	mg/kg (Number)
CP-751,871 + Paclitaxel + Carboplatin (Phase 1b)	NA

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CP-751,871 Concentration at 504 Hours Post Dose(C504) for Cycle 4 (End of the 21-day Cycle) in Phase 1b

Concentration at 504 hours post dose (NCT00147537)
Timeframe: Cycle 5 pre-infusion (which is the end of Cycle 4)

Intervention	mg/L (Mean)
CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	0.0000
CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	0.4630
CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	27.70
CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	21.20
CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	125.3
CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	357.0
CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)	158.6

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Number of Participants With Positive Human Anti-human Antibody (HAHA) Values: Phase 2

HAHA are indicators of immunogenicity to CP-751,871 (NCT00147537)
Timeframe: Day 1 pre-infusion of each Cycle (each cycle was 21 day) up to Cycle 17 and 150 days after the last CP-751,871 infusion

Intervention	number of participants (Number)
CP-751,871 + Paclitaxel + Carboplatin (Phase 2)	0
Paclitaxel + Carboplatin + Additional CP-751,871 (Phase 2)	0

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Objective Response Rate in Non-Adenocarcinoma Participants: Phase 2

Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response. (NCT00147537)
Timeframe: Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization

Intervention	percentage of participants (Number)
CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 2)	37.0

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Objective Response Rate: Phase 1b

Intervention	percentage of participants (Number)
CP-751,871 + Paclitaxel + Carboplatin (Phase 1b)	33.3
CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)	25.0

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Objective Response Rate: Phase 2

Intervention	percentage of participants (Number)
CP-751,871 + Paclitaxel + Carboplatin (Phase 2)	37.4
Paclitaxel + Carboplatin (Phase 2)	27.5

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Recommended Phase 2 Dose (RP2D): Phase 1b

(NCT00147537)
Timeframe: Start of treatment (baseline) up to the end of Cycle 1 (Day 21)

Intervention	mg/kg (Number)
CP-751,871 + Paclitaxel + Carboplatin (Phase 1b)	20

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Plasma Concentration of CP-751,871 at the End of Infusion (Cendinf) for Cycle 4 in Phase 1b

(NCT00147537)
Timeframe: Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)

Intervention	mg/L (Mean)
CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	2.975
CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	19.15
CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	40.70
CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	100.7
CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	327.0
CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	331.1
CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	440.3
CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)	447.3

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Plasma Decay Half-Life (t1/2) of CP-751,871 for Cycle 1 in Phase 1b

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. (NCT00147537)
Timeframe: Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)

Intervention	Day (Mean)
CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	2.84
CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	10.81
CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	8.350
CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	9.56
CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	11.10
CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)	9.89

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Plasma Decay Half-Life (t1/2) of CP-751,871 for Cycle 4 in Phase 1b

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. (NCT00147537)
Timeframe: Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)

Intervention	Day (Median)
CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	5.360
CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)	15.40

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Percent of Participants Surviving 3 Years

(NCT00153803)
Timeframe: 36 months

Intervention	percentage of participants (Number)
Tarceva	37
Placebo	41

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Overall Survival

(NCT00153803)
Timeframe: From date of randomization until the date of death from any cause, assessed up to 50 months

Intervention	Months (Median)
Tarceva	16.5
Placebo	20.3

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Progression Free Survival

Progression Free Survival is defined as time from randomization until documented disease progression or death from any cause. The Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.0) was used to determine disease progression. Irradiated target lesions were considered non-measurable disease. Symptomatic radiographic changes of irradiated non-measurable disease required pathologically confirmation or positive FDG-PET scan 6 months following completion of concurrent chemoradiation to be considered locoregional disease progression. Global deterioration of health status requiring discontinuation of treatment without objective evidence of progression was considered distant disease progression. (NCT00153803)
Timeframe: 5 years

Intervention	Months (Median)
Tarceva	7.4
Placebo	8.1

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Serious Adverse Event Profile Relating to Death, Disability, Life-threatening, Hospitalization, and Impairment/Damage for Concurrent Chemoradiation

Number of participants with treatment-related serious adverse events (SAEs) observed in each SAE category for each arm relating to death, disability, life-threatening, hospitalization, and impairment/damage is reported. For participants with multiple SAEs, the SAE report having the strongest relationship to study drug is summarized. (NCT00153803)
Timeframe: 18 months

Intervention	Participants (Count of Participants)
	Death	Disability	Life-threatening	Hospitalization	Impairment/damange	Other
Placebo	6	0	4	36	3	0
Tarceva	7	0	2	26	3	1

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Serious Adverse Event Profile Relating to Death, Disability, Life-threatening, Hospitalization, and Impairment/Damage for Erlotinib and Placebo

Intervention	Participants (Count of Participants)
	Death	Disability	Life-threatening	Hospitalization (initial or prolonged)	Impairment/damange	Other
Placebo	6	0	1	23	1	0
Tarceva	10	0	1	30	2	1

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Progression Free Survival

Progression based on MR imaging using the Modified McDonnald Criteria defined as 25% increase in sum of products of all measured lesions or any new lesion (NCT00187486)
Timeframe: every 2 months measure by MR imaging, up to 39 months

Intervention	months (Median)
Temodar Plus Tarceva Plus Radiotherapy	8.2

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Overall Survival

Patients were monitored until death (NCT00187486)
Timeframe: assessment of survival was every 2 months, up to 181 weeks

Intervention	months (Median)
Temodar Plus Tarceva Plus Radiotherapy	19

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Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death

(NCT00193258)
Timeframe: 24 months

Intervention	months (Median)
Bevacizumab/Erlotinib/Imatinib	17.2

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Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease

(NCT00193258)
Timeframe: 18 months

Intervention	months (Median)
Bevacizumab/Erlotinib/Imatinib	8.9

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Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00193258)
Timeframe: 18 months

Intervention	percentage of participants (Number)
Bevacizumab/Erlotinib/Imatinib	17

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To Evaluate the Efficacy of Bevacizumab Plus Erlotinib

(NCT00203424)
Timeframe: Determined by time to tumor recurrence, as measured by rising prostate specific antigen (PSA) after radical prostatectomy.

Intervention	participants (Number)
	completed study without tumor progression	lost to follow-up unaffected by tumor recurrence	withdrawal by subjects unaffected by recurrence	affected by tumor recurrence
Bevacizumab+Erlotinib	9	1	2	7

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Overall Survival

(NCT00203424)
Timeframe: Survival status was assessed every 3 months after completion of study treatment for a maximum of 3 years after administration of first study treatment

Intervention	participants (Number)
	Deceased	Alive	Lost to Follow-up	Withdrawal by subject
Bevacizumab+Erlotinib	0	15	1	6

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Time to Tumor Progression.

Measured once for participants who experienced tumor recurrence per protocol. Imaging done to measure tumor progression only after documented tumor recurrence (NCT00203424)
Timeframe: Tumor progression assessed every 3 months during Follow-up Period for a maximum of 3 years after administration of first study treatment

Intervention	days (Number)
Bevacizumab+Erlotinib	314

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Time to Tumor Recurrence

(NCT00203424)
Timeframe: Tumor progression assessed every 3 months during Follow-up Period for a maximum of 3 years after administration of first study treatment

Intervention	days (Mean)
Bevacizumab+Erlotinib	285

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Disease Control Rate at 12 Weeks

no progression of disease at 12 weeks from starting treatment (NCT00230126)
Timeframe: 12 weeks

Intervention	participants (Number)
Erlotinib: Arm A: 150 mg/Day Cycles 1 - 3.	6
Arm B: Cycle 1 - 175 or 200 mg/Day Depending on Body Weight; C	6

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1-year Survival Rate

(NCT00230126)
Timeframe: 12 months

Intervention	percentage of patients (Number)
A Erlotinib 150 mg/Day Cycles 1 - 3	30
B Erlotinib Cycle 1 Dose Modified According to Weight	26

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Time to Progression

(NCT00230126)
Timeframe: Every 12 weeks

Intervention	months (Median)
A Erlotinib 150 mg/Day Cycles 1 - 3	2.8
B Erlotinib Cycle 1 Dose Modified According to Weight	2.4

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Progression-free Survival (PFS) Rate

Progression free survival (PFS) at 16 weeks of treatment with the combination of Avastin and erlotinib where participant said to be failure free at 16 weeks if they are alive, and their disease has not progressed. PFS Rate is number of participants with PFS at 16 weeks out of total participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT00242502)
Timeframe: Baseline to 16 weeks

Intervention	percentage of participants (Number)
Bevacizumab + Erlotinib	64

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Progressive Disease (PD) as Best Response Based on Response Criteria in Solid Tumors (RECIST)

Progressive disease is defined as a ≥20% increase in the sum of the longest diameter, the appearance of one or more new lesions and/or unequivocal progression of non-target lesions by conventional or spiral CT or MRI (NCT00251589)
Timeframe: Every 57 days beginning with Cycle 3, or more frequently if appropriate

Intervention	Participants (Number)
Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk	7
Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk	0
Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk	0
Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk	0

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Progression-free Survival

Progression-free survival was measured from the start of the treatment to the time when the criteria for progression was met or death due to any cause (whichever is first recorded). (NCT00251589)
Timeframe: Day 1 to disease progression or death

Intervention	Days (Mean)
Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk	57

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Unconfirmed Partial Response (UPR) Based on Response Criteria in Solid Tumors (RECIST)

An unconfirmed partial response is defined as a partial response that has not been confirmed by a follow up CT scan (or MRI) at least 4 weeks after the criteria for response are first met. (A partial response is defined as an at least 30% reduction in the sum of the longest diameter of the target lesions. Non-target lesions must be at least stable) (NCT00251589)
Timeframe: Every 57 days beginning with Cycle 3, or more frequently if appropriate

Intervention	Participants (Number)
Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk	0
Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk	0
Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk	0
Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk	0

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Dose Limiting Toxicity Occurring in Cycles 2 and Beyond of the Phase II Portion of the Study

Adverse event(s) that determined the treatment dose level was not tolerable for that patient in Cycles 2 and beyond of the Phase II portion of the study. (NCT00251589)
Timeframe: After day 28 in the Phase II portion of the study

Intervention	Participants (Number)
Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk	3

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Dose Limiting Toxicity (DLT) Occurring in Cycle 1 of the Phase I Portion of the Study

Adverse event(s) that determined the treatment dose level was not tolerable for that patient in Cycle 1 of the Phase I portion of the study. (NCT00251589)
Timeframe: Day 1 to 28 in the Phase I portion of the study

Intervention	Participants (Number)
Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk	0
Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk	2
Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk	2
Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk	1

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Disease Progression After Week 8 Based on Response Criteria in Solid Tumors (RECIST)

First documentation of Progressive Disease (PD) occurring > 8 weeks on study. (NCT00251589)
Timeframe: Every 57 days beginning with Cycle 3 (Week 8), or more frequently if appropriate

Intervention	Participants (Number)
Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk	3
Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk	0
Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk	0
Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk	0

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Stable Disease (SD) as Best Response Based on Response Criteria in Solid Tumors (RECIST)

Stable disease is defined as less than a radiographic partial response, but not progressive disease (NCT00251589)
Timeframe: Every 57 days beginning with Cycle 3, or more frequently if appropriate

Intervention	Participants (Number)
Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk	6
Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk	1
Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk	1
Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk	1

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Dose Limiting Toxicity Occurring in Cycle 1 of the Phase II Portion of the Study

Adverse event(s) that determined the treatment dose level was not tolerable for that patient in Cycle 1 of the Phase II portion of the study. (NCT00251589)
Timeframe: Day 1 to 28 in the Phase II portion of the study

Intervention	Participants (Number)
Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk	3

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Incidence of Study Treatment Discontinuation

Participants in post-chemotherapy phase were discontinued from the study for the reasons other than disease progression. Data presented Up to data cutoff 18 July 2008. (NCT00257608)
Timeframe: Approximately 3 years

Intervention	participants (Number)
	Bevacizumab: AE	Bevacizumab: Concomitant/ancillary therapy	Bevacizumab: Patient's Decision to Discontinue	Bevacizumab: Investigator's Decision	Bevacizumab: Unwillingness or inability to comply	Bevacizumab: Unrelated intercurrent illness	Bevacizumab: Sponsor's decision	Bevacizumab: Lost to follow-up	Erlotinib/placebo: AE	Erlotinib/placebo: Concomitant/ancillary therapy	Erlotinib/placebo:Patient's Decision	Erlotinib/placebo: Investigator's Decision	Erlotinib/placebo:Unwillingness/inability comply	Erlotinib/placebo: Unrelated intercurrent illness	Erlotinib/placebo: Sponsor's decision	Erlotinib/placebo: Lost to follow-up
Bevacizumab + Erlotinib	38	5	8	11	5	1	0	1	48	7	10	12	2	2	0	1
Bevacizumab + Placebo	34	5	4	8	4	0	1	0	22	4	5	6	4	0	1	0

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Progression-free Survival (PFS)

PFS was defined as the length of time from randomization until documented disease progression or death from any cause, whichever occurred earlier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Data presented until cut-off date 18 July 2008. (NCT00257608)
Timeframe: Approximately 3 years

Intervention	months (Median)
Bevacizumab + Placebo	3.7
Bevacizumab + Erlotinib	4.8

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Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Post-Chemotherapy Phase

Treatment-related adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state and are judged by the investigator to be possibly, probably or definitely related to study medication. Pulmonary hemorrhage, GI perforation, ATE events, proteinuria, CHF, and hypertension were prospectively identified TEAEs of grade >=3. Data presented until cut-off date 28 January 2009. (NCT00257608)
Timeframe: Approximately 3 years

Intervention	participants (Number)
	Pulmonary hemorrhage	GI perforation	ATE events	Proteinuria	CHF	Hypertension
Bevacizumab + Erlotinib	3	1	8	7	3	23
Bevacizumab + Placebo	2	0	5	7	1	22

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Overall Survival

Overall survival was defined as the length of time from randomization to death. (NCT00257608)
Timeframe: Approximately 3.5 years

Intervention	months (Median)
Bevacizumab + Placebo	13.3
Bevacizumab + Erlotinib	14.4

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Number of Participants With Any Adverse Events During Post-Chemotherapy Phase

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event. Data presented up to data cutoff 19 June 2009. (NCT00257608)
Timeframe: Approximately 3.5 years

Intervention	participants (Number)
Bevacizumab + Placebo	319
Bevacizumab + Erlotinib	353

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Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Chemotherapy Phase

Treatment-emergent adverse events were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.. Number of participants who had Grade >=3TEAEs of pulmonary hemorrhage, gastrointestinal (GI) perforation, arterial thromboembolic (ATE) events, proteinuria, congestive heart failure (CHF), and hypertension were presented. Data presented up to data cutoff 18 July 2008. (NCT00257608)
Timeframe: Approximately 3 years

,,,,

Intervention	participants (Number)
	Pulmonary hemorrhage	GI perforation	ATE events	Proteinuria	CHF
Carboplatin + Docetaxel	3	2	2	2	1
Carboplatin + Gemcitabine	2	0	6	5	1
Carboplatin + Paclitaxel	6	6	8	1	3
Cisplatin + Gemcitabine	1	0	1	2	0
Other	2	0	0	0	0

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Incidence of Study Treatment Discontinuation for Reasons Other Than Disease Progression in Chemotherapy Phase

Participants who experienced disease progression were discontinued from the study. Data presented up to data cutoff (18 July 2008). (NCT00257608)
Timeframe: Approximately 3 years

,,,,

Intervention	participants (Number)
	Adverse Event	Concomitant/ancillary therapy	Patient's Decision to Discontinue	Investigator's Decision	Unwillingness or inability to comply with study	Unrelated intercurrent illness
Carboplatin + Docetaxel	22	5	8	7	0	1
Carboplatin + Gemcitabine	40	6	6	5	0	0
Carboplatin + Paclitaxel	54	13	16	13	4	1
Cisplatin + Gemcitabine	14	1	5	3	1	1
Other	8	2	0	0	1	0

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Percentage of Participants With KRAS (V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog) Gene Mutations

Mutations in exons 2-3 of the KRAS gene (including codons 12, 13, and 61) were analyzed by high-performance liquid chromatography using DNA from tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. The percentage of participants with KRAS mutations categorized as mutated, wild type or indeterminate was reported. (NCT00265317)
Timeframe: Baseline

Intervention	Percentage of Participants (Number)
	Mutated	Wild Type	Indeterminate
Erlotinib + Placebo	6	28	66
Sunitinib + Erlotinib	9	34	57

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PFS in Subgroups That Were Defined by EGFR Expression (Using 0% Cutoff)

PFS defined as time in weeks from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in the following subgroups: positive, negative, or unmeasured EGFR expression. EGFR expression was analyzed using a 0% cutoff where positive was greater than 0% of cells demonstrating membranous staining for EGFR. PFS calculated as (first event date minus randomization date plus 1) divided by 7.02. (NCT00265317)
Timeframe: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Intervention	Weeks (Median)
	Positive	Negative	Unmeasured
Erlotinib + Placebo	11.7	8.5	8.4
Sunitinib + Erlotinib	16.0	8.1	12.3

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PFS in Subgroups That Were Defined by EGFR Expression (Using 10% Cutoff)

PFS defined as time in weeks from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in the following subgroups: positive, negative, or unmeasured EGFR expression. EGFR expression was analyzed using a 10% cutoff where positive was greater than 10% of cells demonstrating membranous staining for EGFR. PFS calculated as (first event date minus randomization date plus 1) divided by 7.02. (NCT00265317)
Timeframe: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Intervention	Weeks (Median)
	Positive	Negative	Unmeasured
Erlotinib + Placebo	10.4	8.1	8.4
Sunitinib + Erlotinib	16.0	8.1	12.3

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PFS in Subgroups That Were Defined by EGFR Gene Amplification

PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by EGFR gene amplification (defined as greater than 15) and reported as no or unmeasured. PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02. (NCT00265317)
Timeframe: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Intervention	Weeks (Median)
	No	Unmeasured
Erlotinib + Placebo	11.7	8.1
Sunitinib + Erlotinib	12.3	12.0

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PFS in Subgroups That Were Defined by EGFR Gene Copy Number Increase

PFS, defined as time from date of randomization to the date of the first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by EGFR gene copy number increase (reported as yes, no, or unmeasured). The number of copies corresponding to exon 19 of the EGFR gene was determined and an increase was defined as greater than 4 copies. PFS was calculated as (first event date minus randomization date plus 1)/7.02. (NCT00265317)
Timeframe: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Intervention	Weeks (Median)
	Yes	No	Unmeasured
Erlotinib + Placebo	NA	8.8	8.1
Sunitinib + Erlotinib	NA	12.3	12.0

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PFS in Subgroups That Were Defined by EGFR Gene Mutation

PFS, defined as time from date of randomization to date of first documentation of PD or to death on-study due to any cause, whichever occurred first, in subgroups that were defined by EGFR gene mutation (reported as mutated, wild type, or indeterminate). PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02. (NCT00265317)
Timeframe: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Intervention	Weeks (Median)
	Mutated	Wild Type	Indeterminate
Erlotinib + Placebo	NA	11.7	8.1
Sunitinib + Erlotinib	19.1	9.0	12.0

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PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms

PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by PDGFRB polymorphisms. PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02. (NCT00265317)
Timeframe: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Intervention	Weeks (Median)
	Locus: PDGFRB/rs2304060 Genotype: C/C	Locus: PDGFRB/rs2304060 Genotype: C/A	Locus: PDGFRB/rs2304060 Genotype: A/A	Locus: PDGFRB/rs17656204 Genotype: C/C	Locus: PDGFRB/rs17656204 Genotype: C/T	Locus: PDGFRB/rs17656204 Genotype: T/T	Locus: PDGFRB/rs2304061 Genotype: G/G	Locus: PDGFRB/rs2304061 Genotype: G/A	Locus: PDGFRB/rs2304061 Genotype: A/A	Locus: PDGFRB/rs1077724 Genotype: A/A	Locus: PDGFRB/rs1077724 Genotype: A/T	Locus: PDGFRB/rs1077724 Genotype: T/T	Locus: PDGFRB/rs919751 Genotype: A/A	Locus: PDGFRB/rs919751 Genotype: A/G	Locus: PDGFRB/rs919751 Genotype: G/G	Locus: PDGFRB/rs2304058 Genotype: G/G	Locus: PDGFRB/rs2304058 Genotype: G/C	Locus: PDGFRB/rs2304058 Genotype: C/C	Locus: PDGFRB/rs1864975 Genotype: G/G	Locus: PDGFRB/rs1864975 Genotype: G/A	Locus: PDGFRB/rs1864975 Genotype: A/A	Locus: PDGFRB/rs3733678 Genotype: G/G	Locus: PDGFRB/rs3733678 Genotype: G/A	Locus: PDGFRB/rs246396 Genotype: T/T	Locus: PDGFRB/rs246396 Genotype: T/C	Locus: PDGFRB/rs246396 Genotype: C/C	Locus: PDGFRB/rs34586048 Genotype: C/C	Locus: PDGFRB/rs11740355 Genotype: T/T	Locus: PDGFRB/rs11740355 Genotype: T/G	Locus: PDGFRB/rs11740355 Genotype: G/G	Locus: PDGFRB/rs740751 Genotype: C/C	Locus: PDGFRB/rs740751 Genotype: C/T	Locus: PDGFRB/rs740751 Genotype: T/T	Locus: PDGFRB/rs4705415 Genotype: G/G	Locus: PDGFRB/rs4705415 Genotype: G/A	Locus: PDGFRB/rs4705415 Genotype: A/A	Locus: PDGFRB/rs3776075 Genotype: T/T	Locus: PDGFRB/rs3776075 Genotype: T/G	Locus: PDGFRB/rs3776075 Genotype: G/G	Locus: PDGFRB/rs17708574 Genotype: G/G	Locus: PDGFRB/rs17708574 Genotype: G/A	Locus: PDGFRB/rs10063714 Genotype: T/T	Locus: PDGFRB/rs10063714 Genotype: T/A	Locus: PDGFRB/rs3776081 Genotype: A/A	Locus: PDGFRB/rs3776081 Genotype: A/G	Locus: PDGFRB/rs3776081 Genotype: G/G	Locus: PDGFRB/rs2007637 Genotype: G/G	Locus: PDGFRB/rs2007637 Genotype: G/A	Locus: PDGFRB/rs2007637 Genotype: A/A	Locus: PDGFRB/rs2302273 Genotype: G/G	Locus: PDGFRB/rs2302273 Genotype: G/A	Locus: PDGFRB/rs2302273 Genotype: A/A
Erlotinib + Placebo	19.20	8.00	7.90	8.00	8.00	NA	7.80	8.10	NA	8.00	7.85	19.20	11.70	7.85	7.70	6.35	8.00	8.50	7.85	8.00	8.10	8.00	NA	8.00	8.10	8.00	8.00	8.50	7.40	NA	8.00	8.00	8.10	11.70	7.90	7.70	7.50	8.05	10.10	8.05	7.90	8.00	19.20	7.70	8.10	10.10	8.00	12.80	52.00	10.15	8.00	10.10
Sunitinib + Erlotinib	12.30	9.00	12.00	16.00	17.00	8.65	19.50	7.80	10.90	12.00	17.00	12.30	9.50	12.00	19.50	19.50	9.00	12.30	20.10	8.10	12.30	12.00	20.50	16.00	7.80	12.30	12.30	12.30	16.00	7.80	20.10	8.10	12.30	19.10	8.10	19.50	16.00	12.00	NA	12.30	9.00	12.00	20.50	19.50	12.00	NA	16.00	12.30	4.30	19.50	9.50	NA

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PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms

PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by VEGFR2 polymorphisms. PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02. (NCT00265317)
Timeframe: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Intervention	Weeks (Median)
	Locus: VEGFR2/rs1531289 Genotype: C/C	Locus: VEGFR2/rs1531289 Genotype: C/T	Locus: VEGFR2/rs1531289 Genotype: T/T	Locus: VEGFR2/rs2305945 Genotype: G/G	Locus: VEGFR2/rs2305945 Genotype: G/T	Locus: VEGFR2/rs2305945 Genotype: T/T	Locus: VEGFR2/rs1870377 Genotype: T/T	Locus: VEGFR2/rs1870377 Genotype: T/A	Locus: VEGFR2/rs1870377 Genotype: A/A	Locus: VEGFR2/rs2305948 Genotype: C/C	Locus: VEGFR2/rs2305948 Genotype: C/T	Locus: VEGFR2/rs2305948 Genotype: T/T	Locus: VEGFR2/rs7692791 Genotype: C/C	Locus: VEGFR2/rs7692791 Genotype: C/T	Locus: VEGFR2/rs7692791 Genotype: T/T	Locus: VEGFR2/rs35636987 Genotype: C/C	Locus: VEGFR2/rs7667298 Genotype: C/C	Locus: VEGFR2/rs7667298 Genotype: C/T	Locus: VEGFR2/rs7667298 Genotype: T/T	Locus: VEGFR2/rs41408948 Genotype: G/G	Locus: VEGFR2/rs41408948 Genotype: G/A	Locus: VEGFR2/rs41408948 Genotype: A/A	Locus: VEGFR2/rs2071559 Genotype: G/G	Locus: VEGFR2/rs2071559 Genotype: G/A	Locus: VEGFR2/rs2071559 Genotype: A/A
Erlotinib + Placebo	8.10	8.00	13.00	12.30	7.80	NA	8.00	8.00	20.40	8.00	8.00	12.10	7.70	8.50	7.70	8.00	8.05	7.80	12.80	11.70	7.75	13.60	12.80	7.80	8.00
Sunitinib + Erlotinib	9.00	17.00	NA	17.00	9.00	20.50	8.10	17.00	NA	12.00	12.30	NA	12.00	9.00	16.00	12.30	12.00	17.00	9.50	12.00	17.00	13.45	9.50	17.00	8.10

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PFS in Subgroups That Were Defined by KRAS Gene Mutation

PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by KRAS gene mutation (reported as mutated, wild type, or indeterminate). PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02. (NCT00265317)
Timeframe: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Intervention	Weeks (Median)
	Mutated	Wild Type	Indeterminate
Erlotinib + Placebo	7.5	12.1	8.3
Sunitinib + Erlotinib	20.1	9.5	12.3

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PFS in Subgroups That Were Defined by RNA Expression Profile

PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by RNA Gene expression (CSF-1R, PDGFRalpha, PDGFRbeta, VEGF, VEGF-C, VEGFR1, VEGFR2, VEGFR3, FGF, FLT-3, KIT, and RET). PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02. (NCT00265317)
Timeframe: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Intervention	Weeks (Median)
	CSF-1R/High	CSF-1R/Low	CSF-1R/Indeterminate	PDGFRalpha/High	PDGFRalpha/Low	PDGFRalpha/Indeterminate	PDGFRbeta/High	PDGFRbeta/Low	PDGFRbeta/Indeterminate	VEGF/High	VEGF/Low	VEGF/Indeterminate	VEGF-C/High	VEGF-C/Low	VEGF-C/Indeterminate	VEGFR1/High	VEGFR1/Low	VEGFR1/Indeterminate	VEGFR2/High	VEGFR2/Low	VEGFR2/Indeterminate	VEGFR3/High	VEGFR3/Low	VEGFR3/Indeterminate	FGF/Detected	FGF/Not Detected	FGF/Indeterminate	FLT3/Detected	FLT3/Not Detected	FLT3/Indeterminate	KIT/Detected	KIT/Not Detected	KIT/Indeterminate	RET/Detected	RET/Not Detected	RET/Indeterminate
Erlotinib + Placebo	10.9	12.3	8.1	52.0	7.7	8.1	11.7	12.3	8.1	10.1	11.7	8.1	12.1	8.5	8.1	11.2	11.7	8.1	12.3	8.8	8.1	12.3	8.8	8.0	7.7	12.3	8.1	12.1	8.5	8.1	10.1	11.7	8.1	10.1	11.7	8.1
Sunitinib + Erlotinib	19.1	12.3	9.5	12.3	16.0	9.5	12.3	16.0	9.5	16.0	19.1	9.5	12.3	16.0	9.5	12.5	19.1	9.5	17.0	16.0	9.5	NA	12.3	9.5	11.7	12.3	9.5	16.0	17.0	9.5	19.5	16.0	9.5	10.4	12.3	9.5

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sKIT Ratio to Baseline at Each Timepoint

Plasma sKIT concentration at each time point divided by sKIT concentration at baseline (ratio to baseline) (NCT00265317)
Timeframe: Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)

Intervention	Ratio (Median)
	Cycle 2, Day 1 (n=43, 47)	Cycle 3, Day 1 (n=36, 36)
Erlotinib + Placebo	1.00	0.95
Sunitinib + Erlotinib	0.76	0.58

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Time to Reach Maximum Observed Plasma Concentration (Tmax) for Erlotinib

(NCT00265317)
Timeframe: Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose

Intervention	Hours (Median)
	Cycle 1, Day 1	Cycle 1, Day 22
Sunitinib + Erlotinib (Amended Lead-In Arm A)	2.00	2.00

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Tmax for SU-012662 (Metabolite of Sunitinib)

(NCT00265317)
Timeframe: Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose

Intervention	Hours (Median)
	Cycle 1, Day 1	Cycle 1, Day 15
Sunitinib + Erlotinib (Amended Lead-In Arm B)	4.00	4.00

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Tmax for Sunitinib

(NCT00265317)
Timeframe: Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose

Intervention	Hours (Median)
	Cycle 1, Day 1	Cycle 1, Day 15
Sunitinib + Erlotinib (Amended Lead-In Arm B)	6.00	6.00

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Tmax for Total Drug (Sunitinib + SU-012662)

(NCT00265317)
Timeframe: Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose

Intervention	Hours (Median)
	Cycle 1, Day 1	Cycle 1, Day 15
Sunitinib + Erlotinib (Amended Lead-In Arm B)	6.00	5.00

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VEGF-C Ratio to Baseline at Each Timepoint

Plasma VEGF-C concentration at each time point divided by VEGF-C concentration at baseline (ratio to baseline) (NCT00265317)
Timeframe: Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)

Intervention	Ratio (Median)
	Cycle 2, Day 1 (n=41, 46)	Cycle 3, Day 1 (n=36, 35)
Erlotinib + Placebo	1.02	0.95
Sunitinib + Erlotinib	0.86	0.95

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VEGFR-2 Ratio to Baseline at Each Timepoint

Plasma VEGFR-2 concentration at each time point divided by VEGFR-2 concentration at baseline (ratio to baseline) (NCT00265317)
Timeframe: Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)

Intervention	Ratio (Median)
	Cycle 2, Day 1 (n=43, 46)	Cycle 3, Day 1 (n=36, 36)
Erlotinib + Placebo	0.98	0.99
Sunitinib + Erlotinib	0.71	0.67

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VEGFR-3 Ratio to Baseline at Each Timepoint

Plasma VEGFR-3 concentration at each time point divided by VEGFR-3 concentration at baseline (ratio to baseline) (NCT00265317)
Timeframe: Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)

Intervention	Ratio (Median)
	Cycle 2, Day 1 (n=43, 47)	Cycle 3, Day 1 (n=36, 36)
Erlotinib + Placebo	0.98	0.92
Sunitinib + Erlotinib	0.60	0.57

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Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score

EORTC QLQ-C30: self-administered questionnaire assessing global health status/quality of life (QoL), functional domains (physical, role, cognitive, emotional, and social), symptom scales/items (fatigue, pain, nausea and vomiting, dyspnea, insomnia, loss of appetite, constipation, and diarrhea), and financial difficulties. Recall period: past week; response range: not at all (1) to very much (4); global/QoL range: very poor (1) to excellent (7). Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms. (NCT00265317)
Timeframe: Baseline (Cycle [C] 1, Day [D] 1) to Cycle 18, Day 1

Intervention	score on a scale (Mean)
	Global Health Status/QoL (C1, D1) (n=49, 53)	Global Health Status/QoL (C2, D1) (n=41, 46)	Global Health Status/QoL (C3, D1) (n=27, 32)	Global Health Status/QoL (C4, D1) (n=19, 22)	Global Health Status/QoL (C5, D1) (n=14, 18)	Global Health Status/QoL (C6, D1) (n=8, 14)	Global Health Status/QoL (C7, D1) (n=7, 10)	Global Health Status/QoL (C8, D1) (n=4, 7)	Global Health Status/QoL (C9, D1) (n=4, 5)	Global Health Status/QoL (C10, D1) (n=3, 4)	Global Health Status/QoL (C11, D1) (n=3, 4)	Global Health Status/QoL (C12, D1) (n=3, 4)	Global Health Status/QoL (C13, D1) (n=3, 3)	Global Health Status/QoL (C14, D1) (n=2, 3)	Global Health Status/QoL (C15, D1) (n=1, 2)	Global Health Status/QoL (C16, D1) (n=1, 2)	Global Health Status/QoL (C17, D1) (n=1, 2)	Global Health Status/QoL (C18, D1) (n=1, 2)	Physical Functioning (C1, D1) (n=49, 54)	Physical Functioning (C2, D1) (n=41, 46)	Physical Functioning (C3, D1) (n=28, 32)	Physical Functioning (C4, D1) (n=19, 22)	Physical Functioning (C5, D1) (n=14, 18)	Physical Functioning (C6, D1) (n=9, 14)	Physical Functioning (C7, D1) (n=7, 10)	Physical Functioning (C8, D1) (n=4, 7)	Physical Functioning (C9, D1) (n=4, 5)	Physical Functioning (C10, D1) (n=3, 4)	Physical Functioning (C11, D1) (n=3, 4)	Physical Functioning (C12, D1) (n=3, 4)	Physical Functioning (C13, D1) (n=3, 3)	Physical Functioning (C14, D1) (n=2, 3)	Physical Functioning (C15, D1) (n=1, 2)	Physical Functioning (C16, D1) (n=1, 2)	Physical Functioning (C17, D1) (n=1, 2)	Physical Functioning (C18, D1) (n=1, 2)	Role Functioning (C1, D1) (n=49, 53)	Role Functioning (C2, D1) (n=41, 46)	Role Functioning (C3, D1) (n=28, 32)	Role Functioning (C4, D1) (n=19, 22)	Role Functioning (C5, D1) (n=14, 17)	Role Functioning (C6, D1) (n=9, 14)	Role Functioning (C7, D1) (n=7,10)	Role Functioning (C8, D1) (n=4, 7)	Role Functioning (C9, D1) (n=4, 5)	Role Functioning (C10, D1) (n=3, 4)	Role Functioning (C11, D1) (n=3, 4)	Role Functioning (C12, D1) (n=3, 4)	Role Functioning (C13, D1) (n=3, 3)	Role Functioning (C14, D1) (n=2, 3)	Role Functioning (C15, D1) (n=1, 2)	Role Functioning (C16, D1) (n=1, 2)	Role Functioning (C17, D1) (n=1, 2)	Role Functioning (C18, D1) (n=1, 2)	Cognitive Functioning (C1, D1) (n=49, 54)	Cognitive Functioning (C2, D1) (n=41, 46)	Cognitive Functioning (C3, D1) (n=27, 32)	Cognitive Functioning (C4, D1) (n=19, 22)	Cognitive Functioning (C5, D1) (n=14, 18)	Cognitive Functioning (C6, D1) (n=8, 14)	Cognitive Functioning (C7, D1) (n=7, 10)	Cognitive Functioning (C8, D1) (n=4, 7)	Cognitive Functioning (C9, D1) (n=4, 5)	Cognitive Functioning (C10, D1) (n=3, 4)	Cognitive Functioning (C11, D1) (n=3, 4)	Cognitive Functioning (C12, D1) (n=3, 4)	Cognitive Functioning (C13, D1) (n=3, 3)	Cognitive Functioning (C14, D1) (n=2, 3)	Cognitive Functioning (C15, D1) (n=1, 2)	Cognitive Functioning (C16, D1) (n=1, 2)	Cognitive Functioning (C17, D1) (n=1, 2)	Cognitive Functioning (C18, D1) (n=1, 2)	Emotional Functioning (C1, D1) (n=49, 53)	Emotional Functioning (C2, D1) (n=41, 46)	Emotional Functioning (C3, D1) (n=27, 32)	Emotional Functioning (C4, D1) (n=19, 22)	Emotional Functioning (C5, D1) (n=14, 18)	Emotional Functioning (C6, D1) (n=8, 14)	Emotional Functioning (C7, D1) (n=7, 10)	Emotional Functioning (C8, D1) (n=4, 7)	Emotional Functioning (C9, D1) (n=4, 5)	Emotional Functioning (C10, D1) (n=3, 4)	Emotional Functioning (C11, D1) (n=3, 4)	Emotional Functioning (C12, D1) (n=3, 4)	Emotional Functioning (C13, D1) (n=3, 3)	Emotional Functioning (C14, D1) (n=2, 3)	Emotional Functioning (C15, D1) (n=1, 2)	Emotional Functioning (C16, D1) (n=1, 2)	Emotional Functioning (C17, D1) (n=1, 2)	Emotional Functioning (C18, D1) (n=1, 2)	Social Functioning (C1, D1) (n=49, 53)	Social Functioning (C2, D1) (n=41, 46)	Social Functioning (C3, D1) (n=27, 32)	Social Functioning (C4, D1) (n=19, 22)	Social Functioning (C5, D1) (n=14, 18)	Social Functioning (C6, D1) (n=8, 14)	Social Functioning (C7, D1) (n=7, 10)	Social Functioning (C8, D1) (n=4, 7)	Social Functioning (C9, D1) (n=4, 5)	Social Functioning (C10, D1) (n=3, 4)	Social Functioning (C11, D1) (n=3, 4)	Social Functioning (C12, D1) (n=3, 4)	Social Functioning (C13, D1) (n=3, 3)	Social Functioning (C14, D1) (n=2, 3)	Social Functioning (C15, D1) (n=1, 2)	Social Functioning (C16, D1) (n=1, 2)	Social Functioning (C17, D1) (n=1, 2)	Social Functioning (C18, D1) (n=1, 2)	Fatigue (C1, D1) (n=49, 53)	Fatigue (C2, D1) (n=41, 46)	Fatigue (C3, D1) (n=28, 32)	Fatigue (C4, D1) (n=19, 22)	Fatigue (C5, D1) (n=14, 18)	Fatigue (C6, D1) (n=9, 14)	Fatigue (C7, D1) (n=7, 10)	Fatigue (C8, D1) (n=4, 7)	Fatigue (C9, D1) (n=4, 5)	Fatigue (C10, D1) (n=3, 4)	Fatigue (C11, D1) (n=3, 4)	Fatigue (C12, D1) (n=3, 4)	Fatigue (C13, D1) (n=3, 3)	Fatigue (C14, D1) (n=2, 3)	Fatigue (C15, D1) (n=1, 2)	Fatigue (C16, D1) (n=1, 2)	Fatigue (C17, D1) (n=1, 2)	Fatigue (C18, D1) (n=1, 2)	Nausea/Vomiting (C1, D1) (n=49, 54)	Nausea/Vomiting (C2, D1) (n=41, 46)	Nausea/Vomiting (C3, D1) (n=28, 32)	Nausea/Vomiting (C4, D1) (n=19, 22)	Nausea/Vomiting (C5, D1) (n=14, 18)	Nausea/Vomiting (C6, D1) (n=9, 14)	Nausea/Vomiting (C7, D1) (n=7, 10)	Nausea/Vomiting (C8, D1) (n=4, 7)	Nausea/Vomiting (C9, D1) (n=4, 5)	Nausea/Vomiting (C10, D1) (n=3, 4)	Nausea/Vomiting (C11, D1) (n=3, 4)	Nausea/Vomiting (C12, D1) (n=3, 4)	Nausea/Vomiting (C17, D1) (n=1, 2)	Pain (C1, D1) (n=49, 54)	Pain (C2, D1) (n=41, 46)	Pain (C3, D1) (n=28, 32)	Pain (C4, D1) (n=19, 22)	Pain (C5, D1) (n=14, 18)	Pain (C6, D1) (n=9, 14)	Pain (C7, D1) (n=7, 10)	Pain (C8, D1) (n=4, 7)	Pain (C9, D1) (n=4, 5)	Pain (C10, D1) (n=3, 4)	Pain (C11, D1) (n=3, 4)	Pain (C12, D1) (n=3, 4)	Pain (C13, D1) (n=3, 3)	Pain (C14, D1) (n=2, 3)	Pain (C16, D1) (n=1, 2)	Pain (C17, D1) (n=1, 2)	Pain (C18, D1) (n=1, 2)	Dyspnea (C1, D1) (n=49, 54)	Dyspnea (C2, D1) (n=41, 46)	Dyspnea (C3, D1) (n=28, 32)	Dyspnea (C4, D1) (n=19, 22)	Dyspnea (C5, D1) (n=14, 18)	Dyspnea (C6, D1) (n=9, 14)	Dyspnea (C7, D1) (n=7, 10)	Dyspnea (C8, D1) (n=4, 7)	Dyspnea (C9, D1) (n=4, 5)	Dyspnea (C10, D1) (n=3, 4)	Dyspnea (C11, D1) (n=3, 4)	Dyspnea (C12, D1) (n=3, 4)	Dyspnea (C13, D1) (n=3, 3)	Dyspnea (C14, D1) (n=2, 3)	Dyspnea (C15, D1) (n=1, 2)	Dyspnea (C16, D1) (n=1, 2)	Dyspnea (C17, D1) (n=1, 2)	Dyspnea (C18, D1) (n=1, 2)	Insomnia (C1, D1) (n=49, 54)	Insomnia (C2, D1) (n=41, 46)	Insomnia (C3, D1) (n=28, 32)	Insomnia (C4, D1) (n=19, 22)	Insomnia (C5, D1) (n=14, 18)	Insomnia (C6, D1) (n=9, 14)	Insomnia (C7, D1) (n=7, 10)	Insomnia (C8, D1) (n=4, 7)	Insomnia (C9, D1) (n=4, 5)	Insomnia (C10, D1) (n=3, 4)	Insomnia (C11, D1) (n=3, 4)	Insomnia (C12, D1) (n=3, 4)	Insomnia (C13, D1) (n=3, 3)	Insomnia (C14, D1) (n=2, 3)	Insomnia (C15, D1) (n=1, 2)	Insomnia (C16, D1) (n=1, 2)	Insomnia (C17, D1) (n=1, 2)	Insomnia (C18, D1) (n=1, 2)	Loss of Appetite (C1, D1) (n=49, 54)	Loss of Appetite (C2, D1) (n=41, 46)	Loss of Appetite (C3, D1) (n=28, 32)	Loss of Appetite (C4, D1) (n=19, 22)	Loss of Appetite (C5, D1) (n=14, 18)	Loss of Appetite (C6, D1) (n=9, 14)	Loss of Appetite (C7, D1) (n=7, 10)	Loss of Appetite (C8, D1) (n=4, 7)	Loss of Appetite (C9, D1) (n=4, 5)	Loss of Appetite (C10, D1) (n=3, 4)	Loss of Appetite (C11, D1) (n=3, 4)	Loss of Appetite (C12, D1) (n=3, 4)	Loss of Appetite (C13, D1) (n=3, 3)	Loss of Appetite (C14, D1) (n=2, 3)	Loss of Appetite (C17, D1) (n=1, 2)	Constipation (C1, D1) (n=48, 54)	Constipation (C2, D1) (n=41, 46)	Constipation (C3, D1) (n=28, 32)	Constipation (C4, D1) (n=19, 22)	Constipation (C5, D1) (n=14, 18)	Constipation (C6, D1) (n=8, 13)	Constipation (C7, D1) (n=7, 10)	Constipation (C8, D1) (n=4, 7)	Constipation (C9, D1) (n=4, 5)	Constipation (C10, D1) (n=3, 4)	Constipation (C11, D1) (n=3, 4)	Constipation (C12, D1) (n=3, 4)	Constipation (C13, D1) (n=3, 3)	Constipation (C14, D1) (n=2, 3)	Constipation (C15, D1) (n=1, 2)	Diarrhea (C1, D1) (n=49, 54)	Diarrhea (C2, D1) (n=41, 46)	Diarrhea (C3, D1) (n=27, 32)	Diarrhea (C4, D1) (n=19, 22)	Diarrhea (C5, D1) (n=14, 18)	Diarrhea (C6, D1) (n=8, 14)	Diarrhea (C7, D1) (n=7, 10)	Diarrhea (C8, D1) (n=4, 7)	Diarrhea (C9, D1) (n=4, 5)	Diarrhea (C10, D1) (n=3, 4)	Diarrhea (C11, D1) (n=3, 4)	Diarrhea (C12, D1) (n=3, 4)	Diarrhea (C13, D1) (n=3, 3)	Diarrhea (C14, D1) (n=2, 3)	Diarrhea (C15, D1) (n=1, 2)	Diarrhea (C16, D1) (n=1, 2)	Diarrhea (C17, D1) (n=1, 2)	Diarrhea (C18, D1) (n=1, 2)	Financial Difficulties (C1, D1) (n=49, 53)	Financial Difficulties (C2, D1) (n=41, 45)	Financial Difficulties (C3, D1) (n=27, 32)	Financial Difficulties (C4, D1) (n=19, 22)	Financial Difficulties (C5, D1) (n=14, 18)	Financial Difficulties (C6, D1) (n=8, 14)	Financial Difficulties (C7, D1) (n=7, 10)	Financial Difficulties (C8, D1) (n=4, 7)	Financial Difficulties (C9, D1) (n=4, 5)	Financial Difficulties (C10, D1) (n=3, 4)	Financial Difficulties (C11, D1) (n=3, 4)	Financial Difficulties (C12, D1) (n=3, 4)	Financial Difficulties (C13, D1) (n=3, 3)	Financial Difficulties (C14, D1) (n=2, 3)	Financial Difficulties (C15, D1) (n=1, 2)	Financial Difficulties (C16, D1) (n=1, 2)
Erlotinib + Placebo	62.26	57.43	59.12	60.98	61.12	67.27	63.34	59.51	66.66	56.25	62.50	58.33	61.10	55.53	66.65	66.65	58.30	66.65	74.81	72.03	72.28	74.23	68.89	75.24	71.99	74.29	73.32	70.00	71.68	71.68	73.30	68.90	70.00	66.70	70.00	73.30	69.18	64.13	64.07	67.43	67.65	69.05	73.34	69.04	66.66	50.00	62.50	62.50	72.23	66.67	83.35	66.65	58.35	66.65	82.71	82.24	82.29	81.06	81.48	84.53	89.99	71.43	83.34	79.18	87.50	79.15	83.33	83.33	100.00	91.65	83.35	100.00	71.23	71.37	67.98	71.21	71.30	79.76	70.82	61.90	78.34	66.68	64.60	54.15	69.43	63.90	75.00	75.00	62.50	83.35	80.19	77.53	81.26	75.75	75.93	80.96	85.00	73.81	83.34	83.33	62.50	66.68	72.23	72.20	91.65	91.65	83.35	91.65	33.11	39.85	37.49	33.84	44.44	33.32	33.32	39.69	28.90	36.10	30.55	27.78	25.90	40.73	16.65	38.90	33.35	33.35	9.26	14.13	11.98	6.82	8.34	2.39	8.34	9.51	6.66	12.50	8.35	NA	8.35	30.25	31.52	28.65	28.80	33.34	25.00	23.34	19.04	20.00	16.65	24.98	24.98	22.20	22.20	16.65	16.65	16.65	25.91	26.80	24.99	25.75	29.62	23.79	19.98	23.81	6.66	16.68	8.33	8.33	22.20	22.20	16.65	33.30	33.35	16.65	27.78	29.71	38.54	25.76	33.33	23.81	19.99	38.09	33.32	41.68	33.33	16.65	22.20	44.47	16.65	16.65	16.65	16.65	20.99	26.81	26.04	24.24	24.08	26.19	30.00	14.29	20.00	25.00	33.33	25.00	11.10	11.10	16.65	16.67	13.77	18.75	10.60	14.82	12.82	3.33	NA	13.34	8.33	8.33	8.33	NA	NA	16.65	2.47	21.01	17.69	7.57	14.81	11.90	6.66	14.29	6.66	8.33	16.65	16.65	11.10	11.10	16.65	16.65	16.65	16.65	13.84	11.85	16.66	24.25	16.67	19.05	13.33	38.10	26.66	33.33	33.33	33.33	33.33	33.33	NA	NA
Sunitinib + Erlotinib	66.49	62.60	61.73	66.67	69.05	80.20	71.41	89.60	79.18	88.90	86.10	88.90	80.57	75.00	100.00	100.00	100.00	100.00	79.32	77.24	73.58	71.58	75.72	85.92	80.00	93.35	95.00	93.33	93.33	97.77	95.57	93.35	100.00	100.00	100.00	100.00	80.95	67.89	72.63	68.43	69.06	83.34	85.71	91.68	91.68	94.43	94.43	100.00	88.90	83.35	100.00	100.00	100.00	100.00	85.03	86.99	87.04	89.47	82.14	85.40	85.71	91.65	91.65	94.43	94.43	94.43	94.43	100.00	100.00	100.00	100.00	100.00	74.65	77.85	76.86	82.46	79.18	78.13	79.77	87.50	91.68	97.23	97.23	94.43	86.13	83.35	91.70	91.70	100.00	100.00	80.95	80.09	79.01	81.58	76.19	89.58	90.47	91.68	91.68	88.90	94.43	94.43	88.90	83.35	100.00	100.00	100.00	100.00	32.64	37.93	40.07	36.25	31.73	21.59	25.40	8.33	13.88	7.40	25.90	14.80	11.10	16.65	NA	NA	NA	NA	7.49	16.26	16.67	13.16	16.66	9.26	16.67	NA	4.18	11.10	16.67	5.57	NA	25.85	19.51	19.05	16.67	21.43	12.98	19.06	12.5	8.33	NA	NA	NA	11.10	16.65	NA	NA	NA	26.51	30.07	26.18	36.83	30.94	25.91	33.33	16.65	16.65	22.23	33.33	22.23	11.10	16.65	33.30	NA	NA	NA	29.24	22.76	29.75	14.03	19.04	11.10	14.29	33.33	24.98	22.23	33.33	33.33	22.20	33.30	33.30	33.30	NA	NA	23.12	33.33	36.90	28.06	26.18	22.21	28.56	16.65	16.65	22.23	22.23	22.20	22.20	16.65	NA	12.49	4.88	13.10	1.75	7.14	12.50	4.76	8.33	8.33	NA	NA	11.10	11.10	16.65	NA	6.80	38.21	37.03	38.59	30.94	24.99	42.86	33.30	33.30	33.33	33.33	66.67	33.30	50.00	NA	NA	NA	NA	21.76	17.07	17.27	8.77	21.42	24.99	9.51	41.65	33.33	44.43	44.43	44.43	44.43	66.65	100.00	100

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Erlotinib Clearance at Steady State After Oral Administration (CL/F)

(NCT00265317)
Timeframe: Day 15 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose

Intervention	Liters (L)/hr (Mean)
Sunitinib + Erlotinib (Original Lead-In)	5.52

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Number of Participants With Blood Pressure (BP) Greater Than 150/100 Millimeters of Mercury (mmHg)

Systolic/diastolic BP measured in triplicate (separated by approximately 2 minutes [min]) using validated electronic device (same device for all measurements), recorded to nearest mmHg. Dominant arm used (same one each time) with appropriate cuff size encircling at least 80% of arm. BP measured after 5 min rest and before invasive procedures, while seated in a chair with back supported, arms bared, supported at heart level. No smoking or caffeine use allowed during 30 min before measurement. Number of participants with systolic BP >150 mmHg/diastolic BP >100 mmHg at any timepoint postbaseline. (NCT00265317)
Timeframe: Randomization up until Month 17

Intervention	Participants (Number)
Sunitinib + Erlotinib	10
Erlotinib + Placebo	8

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Number of Participants With BP Greater Than 200/110 mmHg

Intervention	Participants (Number)
Sunitinib + Erlotinib	1
Erlotinib + Placebo	0

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Overall Survival (OS)

OS was defined as time from date of randomization to date of death due to any cause. OS was calculated as (date of death minus date of randomization plus 1) divided by 30.4. For participants still alive at the time of analysis, OS time was censored on last date that participants were known to be alive. (NCT00265317)
Timeframe: From randomization until death (up to Month 17)

Intervention	Months (Median)
Sunitinib + Erlotinib	8.2
Erlotinib + Placebo	7.6

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Percentage of Participants Surviving at 1 Year

Percentage of participants alive at 1 year after date of first administration of study medication. (NCT00265317)
Timeframe: From randomization until death (up until Month 17)

Intervention	Percentage of Participants (Number)
Sunitinib + Erlotinib	32
Erlotinib + Placebo	42

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Percentage of Participants With Objective Response

Objective Response Rate (ORR)=participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST,Version 1.0) based on third party independent imaging review laboratory assessment. A CR was defined as the disappearance of all target lesions that persisted on repeat imaging study at least 4 weeks after initial documentation of response. A PR was defined as a ≥30% decrease in sum of longest dimensions of target lesions taking as a reference the baseline sum longest dimensions. (NCT00265317)
Timeframe: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Intervention	Percentage of Participants (Number)
Sunitinib + Erlotinib	4.62
Erlotinib + Placebo	2.99

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Plasma Concentration of Soluble KIT (sKIT) at Baseline

(NCT00265317)
Timeframe: Baseline (Cycle 1, Day 1)

Intervention	pg/mL (Median)
Sunitinib + Erlotinib	49520
Erlotinib + Placebo	47242.50

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Plasma Concentration of Soluble VEGFR-2 at Baseline

(NCT00265317)
Timeframe: Baseline (Cycle 1, Day 1)

Intervention	pg/mL (Median)
Sunitinib + Erlotinib	10904.50
Erlotinib + Placebo	10027

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Plasma Concentration of Soluble VEGFR-3 at Baseline

(NCT00265317)
Timeframe: Baseline (Cycle 1, Day 1)

Intervention	pg/mL (Median)
Sunitinib + Erlotinib	23190
Erlotinib + Placebo	23350

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Plasma Concentration of VEGF-C at Baseline

(NCT00265317)
Timeframe: Baseline (Cycle 1, Day 1)

Intervention	picograms (pg)/mL (Median)
Sunitinib + Erlotinib	474.15
Erlotinib + Placebo	502.10

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Progression-Free Survival (PFS)

PFS=time from randomization date to date of first documentation of progressive disease (PD; defined as greater than or equal to [≥]20% increase in sum of longest dimensions of target lesions taking as a reference smallest sum of longest dimensions recorded since first dose or appearance of ≥1 new lesions) or death on-study due to any cause, whichever occurred first based on third party independent imaging review laboratory assessment. PFS calculated as (first event date minus randomization date plus 1) divided by 7.02. Used 7.02 days as it equals 365 days per year divided by 52 weeks per year. (NCT00265317)
Timeframe: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Intervention	Weeks (Median)
Sunitinib + Erlotinib	12.3
Erlotinib + Placebo	8.5

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Sunitinib Clearance at Steady State After Oral Administration (CL/F)

(NCT00265317)
Timeframe: Day 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose

Intervention	L/hr (Mean)
Sunitinib + Erlotinib (Original Lead-In)	63.28

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Time to Tumor Progression (TTP)

TTP was defined as the time from date of randomization to first documentation of PD based on third party independent imaging review laboratory assessment. TTP was calculated as (first event date minus randomization date plus 1) divided by 7.02. (NCT00265317)
Timeframe: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Intervention	Weeks (Median)
Sunitinib + Erlotinib	12.3
Erlotinib + Placebo	10.1

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Area Under the Curve From Time Zero to 24 Hours [AUC(0-24)] of Erlotinib

AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of erlotinib (NCT00265317)
Timeframe: Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose

Intervention	micrograms (mcg)*hour(hr)/milliliter (mL (Mean)
	Cycle 1, Day 1	Cycle 1, Day 22
Sunitinib + Erlotinib (Amended Lead-In Arm A)	12.96	11.87

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AUC(0-24) of SU-012662 (Metabolite of Sunitinib)

AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of SU-012662 (metabolite of sunitinib) (NCT00265317)
Timeframe: Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose

Intervention	ng*hr/mL (Mean)
	Cycle 1, Day 1	Cycle 1, Day 15
Sunitinib+Erlotinib (Amended Lead-In Arm B)	50.06	99.57

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AUC(0-24) of Sunitinib

AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of sunitinib (NCT00265317)
Timeframe: Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose

Intervention	nanograms (ng)*hr/mL (Mean)
	Cycle 1, Day 1	Cycle 1, Day 15
Sunitinib+Erlotinib (Amended Lead-In Arm B)	372.76	231.61

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AUC(0-24) of Total Drug (Sunitinib + SU-012662)

AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of total drug (sunitinib + SU-012662) (NCT00265317)
Timeframe: Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose

Intervention	ng*hr/mL (Mean)
	Cycle 1, Day 1	Cycle 1, Day 15
Sunitinib+Erlotinib (Amended Lead-In Arm B)	422.93	331.45

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Cmax of SU-012662 (Metabolite of Sunitinib)

(NCT00265317)
Timeframe: Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose

Intervention	ng/mL (Mean)
	Cycle 1, Day 1	Cycle 1, Day 15
Sunitinib+Erlotinib (Amended Lead-In Arm B)	3.09	6.83

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Cmax of Sunitinib

(NCT00265317)
Timeframe: Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose

Intervention	ng/mL (Mean)
	Cycle 1, Day 1	Cycle 1, Day 15
Sunitinib+Erlotinib (Amended Lead-In Arm B)	21.61	13.59

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Cmax of Total Drug (Sunitinib + SU-012662)

(NCT00265317)
Timeframe: Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose

Intervention	ng/mL (Mean)
	Cycle 1, Day 1	Cycle 1, Day 15
Sunitinib+Erlotinib (Amended Lead-In Arm B)	24.51	20.09

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Dose-Corrected Ctrough for Erlotinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Ctrough = plasma concentration of erlotinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original Cohort predose on Day 15 (Cycle 1, Time Zero) and Day 1 (Cycle 3), in the Amended Lead-In Cohort (Arms A and B) predose on Day 1 (Cycle 3) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18. (NCT00265317)
Timeframe: predose Day 15 (Cycle1); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18)

Intervention	mcg/mL (Mean)
	Cycle 1, Day 15 (n=6)	Cycle 2, Day 1 (n=45)	Cycle 3, Day 1 (n=44)	Cycle 4, Day 1 (n=20)	Cycle 5, Day 1 (n=16)	Cycle 6, Day 1 (n=12)	Cycle 7, Day 1 (n=8)	Cycle 8, Day 1 (n=3)	Cycle 9, Day 1 (n=6)	Cycle 10, Day 1 (n=4)	Cycle 11, Day 1 (n=3)	Cycle 12, Day 1 (n=4)	Cycle 13, Day 1 (n=3)
Sunitinib + Erlotinib (All Combined)	1.14	1.46	1.07	0.99	0.98	1.09	1.08	0.80	0.94	1.71	0.53	1.31	0.75

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Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Ctrough = plasma concentration of SU-012662 prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original and Amended Lead-In (Arms A and B) Cohorts predose on Day 1 (Cycles 3-13) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18. (NCT00265317)
Timeframe: predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18)

Intervention	ng/mL (Mean)
	Cycle 2, Day 1 (n=44)	Cycle 3, Day 1 (n=43)	Cycle 4, Day 1 (n=28)	Cycle 5, Day 1 (n=22)	Cycle 6, Day 1 (n=19)	Cycle 7, Day 1 (n=15)	Cycle 8, Day 1 (n=8)	Cycle 9, Day 1 (n=9)	Cycle 10, Day 1 (n=6)	Cycle 11, Day 1 (n=6)	Cycle 12, Day 1 (n=4)	Cycle 13, Day 1 (n=3)
Sunitinib + Erlotinib (All Combined)	21.02	19.26	15.74	15.38	15.04	17.13	12.50	12.24	14.29	19.35	11.58	15.60

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Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Ctrough = plasma concentration of SU-012662 prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original Cohort predose on Day 15 (Cycle 1, Time Zero) and Day 1 (Cycle 3), in the Amended Lead-In Cohort (Arms A and B) predose on Day 1 (Cycle 3) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18. (NCT00265317)
Timeframe: predose Day 15 (Cycle 1) and Day 1 (Cycle 3); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18)

Intervention	ng/mL (Mean)
	Cycle 1, Day 15 (n=7)	Cycle 2, Day 1 (n=44)	Cycle 3, Day 1 (n=43)	Cycle 4, Day 1 (n=19)	Cycle 5, Day 1 (n=16)	Cycle 6, Day 1 (n=13)	Cycle 7, Day 1 (n=8)	Cycle 8, Day 1 (n=4)	Cycle 9, Day 1 (n=6)	Cycle 10, Day 1 (n=4)	Cycle 11, Day 1 (n=3)	Cycle 12, Day 1 (n=3)	Cycle 13, Day 1 (n=3)
Sunitinib + Erlotinib (All Combined)	18.08	21.02	19.26	16.41	15.26	15.05	15.99	12.80	14.00	16.44	11.98	11.26	15.60

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Dose-Corrected Ctrough for Sunitinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Ctrough = plasma concentration of sunitinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original and Amended Lead-In (Arms A and B) Cohorts predose on Day 1 (Cycles 3-13) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18. (NCT00265317)
Timeframe: predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18)

Intervention	ng/mL (Mean)
	Cycle 2, Day 1 (n=44)	Cycle 3, Day 1 (n=43)	Cycle 4, Day 1 (n=28)	Cycle 5, Day 1 (n=22)	Cycle 6, Day 1 (n=19)	Cycle 7, Day 1 (n=15)	Cycle 8, Day 1 (n=8)	Cycle 9, Day 1 (n=9)	Cycle 10, Day 1 (n=6)	Cycle 11, Day 1 (n=6)	Cycle 12, Day 1 (n=4)	Cycle 13, Day 1 (n=3)
Sunitinib + Erlotinib (All Combined)	22.94	21.48	19.93	18.58	22.07	24.85	18.44	14.81	17.17	21.42	11.67	19.79

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Dose-Corrected Ctrough for Sunitinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Ctrough = plasma concentration of sunitinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original Cohort predose on Day 15 (Cycle 1, Time Zero) and Day 1 (Cycle 3), in the Amended Lead-In Cohort (Arms A and B) predose on Day 1 (Cycle 3) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18. (NCT00265317)
Timeframe: predose Day 15 (Cycle 1) and Day 1 (Cycle 3); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18)

Intervention	ng/mL (Mean)
	Cycle 1, Day 15 (n=7)	Cycle 2, Day 1 (n=44)	Cycle 3, Day 1 (n=43)	Cycle 4, Day 1 (n=19)	Cycle 5, Day 1 (n=16)	Cycle 6, Day 1 (n=13)	Cycle 7, Day 1 (n=8)	Cycle 8, Day 1 (n=4)	Cycle 9, Day 1 (n=6)	Cycle 10, Day 1 (n=4)	Cycle 11, Day 1 (n=3)	Cycle 12, Day 1 (n=3)	Cycle 13, Day 1 (n=3)
Sunitinib + Erlotinib (All Combined)	18.80	22.94	21.48	20.58	17.26	20.16	21.97	13.56	15.17	15.61	15.24	11.99	19.79

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Dose-Corrected Observed Plasma Trough Concentrations (Ctrough) for Erlotinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Ctrough = plasma concentration of erlotinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original and Amended Lead-In (Arms A and B) Cohorts predose on Day 1 (Cycles 3-13) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18. (NCT00265317)
Timeframe: predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18)

Intervention	mcg/mL (Mean)
	Cycle 2, Day 1 (n=45)	Cycle 3, Day 1 (n=44)	Cycle 4, Day 1 (n=31)	Cycle 5, Day 1 (n=22)	Cycle 6, Day 1 (n=18)	Cycle 7, Day 1 (n=15)	Cycle 8, Day 1 (n=8)	Cycle 9, Day 1 (n=10)	Cycle 10, Day 1 (n=6)	Cycle 11, Day 1 (n=6)	Cycle 12, Day 1 (n=5)	Cycle 13, Day 1 (n=3)
Sunitinib + Erlotinib (All Combined)	1.46	1.07	1.11	1.00	1.00	1.16	0.57	0.90	1.52	1.94	1.21	0.75

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EORTC-QLQ-C30 Lung Cancer Module (LC13) Score

The EORTC-QLQ-C30 LC13 is a self-administered questionnaire assessing specific lung cancer disease related symptoms (dyspnea, coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in the chest, arm/shoulder or other parts of the body). Recall period: past week; response range: not at all (1) to very much (4). Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms. (NCT00265317)
Timeframe: Baseline (Cycle 1 [Day 1]) to Cycle 18 (Day 1)

Intervention	score on a scale (Mean)
	Dyspnea Symptom (C1, D1) (n=48, 53)	Dyspnea Symptom (C2, D1) (n=38, 46)	Dyspnea Symptom (C3, D1) (n=26, 32)	Dyspnea Symptom (C4, D1) (n=18, 22)	Dyspnea Symptom (C5, D1) (n=12, 18)	Dyspnea Symptom (C6, D1) (n=8, 14)	Dyspnea Symptom (C7, D1) (n=6, 10)	Dyspnea Symptom (C8, D1) (n=4, 6)	Dyspnea Symptom (C9, D1) (n=4, 3)	Dyspnea Symptom (C10, D1) (n=3, 4)	Dyspnea Symptom (C11, D1) (n=3, 3)	Dyspnea Symptom (C12, D1) (n=3, 4)	Dyspnea Symptom (C13, D1) (n=3, 3)	Dyspnea Symptom (C14, D1) (n=2, 3)	Dyspnea Symptom (C15, D1) (n=1, 2)	Dyspnea Symptom (C16, D1) (n=1, 2)	Dyspnea Symptom (C17, D1) (n=1, 2)	Dyspnea Symptom (C18, D1) (n=1, 2)	Coughing Symptom (C1, D1) (n=49, 53)	Coughing Symptom (C2, D1) (n=41, 46)	Coughing Symptom (C3, D1) (n=27, 32)	Coughing Symptom (C4, D1) (n=19, 22)	Coughing Symptom (C5, D1) (n=14, 18)	Coughing Symptom (C6, D1) (n=9, 14)	Coughing Symptom (C7, D1) (n=7, 10)	Coughing Symptom (C8, D1) (n=4, 7)	Coughing Symptom (C9, D1) (n=4, 4)	Coughing Symptom (C10, D1) (n=3, 4)	Coughing Symptom (C11, D1) (n=3, 3)	Coughing Symptom (C12, D1) (n=3, 4)	Coughing Symptom (C13, D1) (n=3, 3)	Coughing Symptom (C14, D1) (n=2, 3)	Coughing Symptom (C15, D1) (n=1, 2)	Coughing Symptom (C16, D1) (n=1, 2)	Coughing Symptom (C17, D1) (n=1, 2)	Coughing Symptom (C18, D1) (n=1, 2)	Haemoptysis Symptom (C1, D1) (n=49, 54)	Haemoptysis Symptom (C2, D1) (n=41, 46)	Haemoptysis Symptom (C3, D1) (n=27, 32)	Haemoptysis Symptom (C4, D1) (n=19, 22)	Haemoptysis Symptom (C5, D1) (n=14, 18)	Haemoptysis Symptom (C6, D1) (n=9, 14)	Haemoptysis Symptom (C7, D1) (n=7, 10)	Haemoptysis Symptom (C8, D1) (n=4, 6)	Sore Mouth Symptom (C1, D1) (n=49, 54)	Sore Mouth Symptom (C2, D1) (n=41, 46)	Sore Mouth Symptom (C3, D1) (n=27, 32)	Sore Mouth Symptom (C4, D1) (n=19, 22)	Sore Mouth Symptom (C5, D1) (n=14, 18)	Sore Mouth Symptom (C6, D1) (n=9, 14)	Sore Mouth Symptom (C7, D1) (n=7, 10)	Sore Mouth Symptom (C8, D1) (n=4, 6)	Sore Mouth Symptom (C10, D1) (n=3, 4)	Sore Mouth Symptom (C13, D1) (n=3, 3)	Sore Mouth Symptom (C14, D1) (n=2, 3)	Dysphagia Symptom (C1, D1) (n=49, 54)	Dysphagia Symptom (C2, D1) (n=41, 46)	Dysphagia Symptom (C3, D1) (n=26, 32)	Dysphagia Symptom (C4, D1) (n=19, 22)	Dysphagia Symptom (C5, D1) (n=14, 18)	Dysphagia Symptom (C6, D1) (n=9, 14)	Dysphagia Symptom (C7, D1) (n=7, 10)	Dysphagia Symptom (C8, D1) (n=4, 6)	Dysphagia Symptom (C9, D1) (n=4, 3)	Dysphagia Symptom (C10, D1) (n=3, 4)	Dysphagia Symptom (C11, D1) (n=3, 3)	Dysphagia Symptom (C12, D1) (n=3, 4)	Dysphagia Symptom (C13, D1) (n=3, 3)	Dysphagia Symptom (C14, D1) (n=2, 3)	Peripheral Neuropathy Symptom (C1, D1) (n=49, 54)	Peripheral Neuropathy Symptom (C2, D1) (n=41, 46)	Peripheral Neuropathy Symptom (C3, D1) (n=27, 32)	Peripheral Neuropathy Symptom (C4, D1) (n=19, 22)	Peripheral Neuropathy Symptom (C5, D1) (n=14, 18)	Peripheral Neuropathy Symptom (C6, D1) (n=9, 14)	Peripheral Neuropathy Symptom (C7, D1) (n=7, 10)	Peripheral Neuropathy Symptom (C8, D1) (n=4, 6)	Peripheral Neuropathy Symptom (C9, D1) (n=4, 3)	Peripheral Neuropathy Symptom (C10, D1) (n=3, 4)	Peripheral Neuropathy Symptom (C11, D1) (n=3, 3)	Peripheral Neuropathy Symptom (C12, D1) (n=3, 4)	Peripheral Neuropathy Symptom (C13, D1) (n=3, 3)	Peripheral Neuropathy Symptom (C14, D1) (n=2, 3)	Peripheral Neuropathy Symptom (C15, D1) (n=1, 2)	Peripheral Neuropathy Symptom (C16, D1) (n=1, 2)	Peripheral Neuropathy Symptom (C17, D1) (n=1, 2)	Peripheral Neuropathy Symptom (C18, D1) (n=1, 2)	Alopecia Symptom (C1, D1) (n=49, 54)	Alopecia Symptom (C2, D1) (n=41, 46)	Alopecia Symptom (C3, D1) (n=27, 32)	Alopecia Symptom (C4, D1) (n=19, 22)	Alopecia Symptom (C5, D1) (n=14, 18)	Alopecia Symptom (C6, D1) (n=9, 14)	Alopecia Symptom (C7, D1) (n=7, 10)	Alopecia Symptom (C8, D1) (n=4, 6)	Alopecia Symptom (C9, D1) (n=4, 3)	Alopecia Symptom (C10, D1) (n=3, 4)	Alopecia Symptom (C11, D1) (n=3, 3)	Alopecia Symptom (C12, D1) (n=3, 4)	Alopecia Symptom (C13, D1) (n=3, 3)	Alopecia Symptom (C14, D1) (n=2, 3)	Pain in Chest Symptom (C1, D1) (n=49, 53)	Pain in Chest Symptom (C2, D1) (n=41, 46)	Pain in Chest Symptom (C3, D1) (n=27, 32)	Pain in Chest Symptom (C4, D1) (n=18, 22)	Pain in Chest Symptom (C5, D1) (n=14, 18)	Pain in Chest Symptom (C6, D1) (n=9, 14)	Pain in Chest Symptom (C7, D1) (n=7, 10)	Pain in Chest Symptom (C8, D1) (n=4, 6)	Pain in Chest Symptom (C9, D1) (n=4, 3)	Pain in Chest Symptom (C10, D1) (n=3, 4)	Pain in Chest Symptom (C11, D1) (n=3, 3)	Pain in Chest Symptom (C12, D1) (n=3, 4)	Pain in Chest Symptom (C13, D1) (n=3, 3)	Pain in Chest Symptom (C14, D1) (n=2, 3)	Pain in Chest Symptom (C16, D1) (n=1, 2)	Pain in Chest Symptom (C17, D1) (n=1, 2)	Pain in Arm or Shoulder (C1, D1) (n=49, 54)	Pain in Arm or Shoulder (C2, D1) (n=41, 46)	Pain in Arm or Shoulder (C3, D1) (n=27, 32)	Pain in Arm or Shoulder (C4, D1) (n=19, 22)	Pain in Arm or Shoulder (C5, D1) (n=14, 18)	Pain in Arm or Shoulder (C6, D1) (n=9, 14)	Pain in Arm or Shoulder (C7, D1) (n=7, 10)	Pain in Arm or Shoulder (C8, D1) (n=4, 6)	Pain in Arm or Shoulder (C9, D1) (n=4, 3)	Pain in Arm or Shoulder (C10, D1) (n=3, 4)	Pain in Arm or Shoulder (C11, D1) (n=3, 3)	Pain in Arm or Shoulder (C12, D1) (n=3, 4)	Pain in Arm or Shoulder (C13, D1) (n=3, 3)	Pain in Arm or Shoulder (C14, D1) (n=2, 3)	Pain in Arm or Shoulder (C15, D1) (n=1, 2)	Pain in Arm or Shoulder (C16, D1) (n=1, 2)	Pain in Arm or Shoulder (C17, D1) (n=1, 2)	Pain in Arm or Shoulder (C18, D1) (n=1, 2)	Pain in Other Parts of Body (C1, D1) (n=48, 51)	Pain in Other Parts of Body (C2, D1) (n=40, 43)	Pain in Other Parts of Body (C3, D1) (n=26, 31)	Pain in Other Parts of Body (C4, D1) (n=18, 20)	Pain in Other Parts of Body (C5, D1) (n=13, 18)	Pain in Other Parts of Body (C6, D1) (n=9, 14)	Pain in Other Parts of Body (C7, D1) (n=6, 10)	Pain in Other Parts of Body (C8, D1) (n=4, 6)	Pain in Other Parts of Body (C9, D1) (n=4, 3)	Pain in Other Parts of Body (C10, D1) (n=3, 4)	Pain in Other Parts of Body (C11, D1) (n=3, 3)	Pain in Other Parts of Body (C12, D1) (n=3, 4)	Pain in Other Parts of Body (C13, D1) (n=3, 3)	Pain in Other Parts of Body (C14, D1) (n=2, 3)	Pain in Other Parts of Body (C16, D1) (n=1, 2)
Erlotinib + Placebo	25.56	26.08	26.03	23.73	32.71	21.41	29.99	22.22	22.20	33.33	29.60	22.20	22.20	25.90	11.10	22.20	22.20	16.65	37.10	31.87	30.20	15.14	29.62	26.17	16.67	28.56	8.33	25.00	33.33	41.65	33.33	11.10	16.65	16.65	16.65	33.35	6.17	4.34	5.21	1.51	5.56	2.38	NA	5.55	1.23	7.97	6.25	7.58	12.96	2.38	6.67	5.55	8.33	11.10	11.10	6.17	10.14	14.58	12.12	11.11	7.14	10.00	NA	NA	16.65	NA	8.33	22.20	11.10	17.28	20.28	34.37	25.75	22.22	23.81	23.33	22.20	33.30	33.30	44.43	41.65	44.43	44.43	16.65	16.65	33.30	33.30	12.96	5.79	5.20	13.63	22.22	19.04	16.67	11.10	22.23	25.00	NA	25.00	33.33	33.33	15.09	14.48	18.75	10.60	20.37	11.90	16.66	5.55	NA	16.65	11.10	8.33	22.20	11.10	16.65	16.65	11.72	16.66	17.71	21.21	25.92	26.19	23.33	5.55	11.10	8.33	11.10	8.33	22.20	11.10	16.65	16.65	16.65	16.65	35.29	28.68	29.03	20.00	31.48	21.43	33.34	27.77	22.20	8.33	11.10	8.33	22.20	NA	16.65
Sunitinib + Erlotinib	21.05	25.71	24.77	27.16	22.21	18.04	14.80	8.33	11.10	11.10	18.50	14.80	7.40	16.65	22.20	NA	NA	NA	36.72	31.70	32.09	29.81	38.08	33.31	33.33	24.98	24.98	22.20	22.20	22.20	22.20	16.65	NA	NA	NA	NA	2.04	6.50	2.47	1.75	2.38	3.70	4.76	NA	6.12	19.50	16.04	12.27	23.79	11.10	4.76	NA	NA	NA	NA	6.80	13.00	7.68	7.01	11.91	3.70	4.76	8.33	8.33	22.23	11.10	22.23	NA	NA	18.37	14.63	16.04	22.81	26.18	18.51	33.33	24.98	16.65	NA	22.20	22.23	11.10	16.65	NA	NA	NA	NA	12.92	4.87	7.40	10.52	16.66	14.80	14.27	8.33	16.65	11.10	33.30	33.33	33.30	33.35	19.72	11.38	8.64	11.11	16.66	11.10	19.03	8.33	8.33	NA	NA	NA	11.10	16.65	NA	NA	21.08	10.56	14.81	12.27	19.04	14.80	23.80	16.65	16.65	11.10	11.10	11.10	22.20	16.65	NA	NA	NA	NA	26.38	14.17	16.67	14.81	35.90	18.51	16.67	NA	NA	NA	NA	NA	NA	16.65	NA

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Maximum Observed Plasma Concentration (Cmax) of Erlotinib

(NCT00265317)
Timeframe: Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose

Intervention	mcg/mL (Mean)
	Cycle 1, Day 1	Cycle 1, Day 22
Sunitinib + Erlotinib (Amended Lead-In Arm A)	0.99	0.86

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OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms

OS, defined as time from date of randomization to date of death due to any cause, in subgroups that were defined by PDGFRB polymorphisms. OS was calculated as (date of death minus date of randomization plus 1) divided by 30.4. (NCT00265317)
Timeframe: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Intervention	Months (Median)
	Locus: PDGFRB/rs2304060 Genotype: C/C	Locus: PDGFRB/rs2304060 Genotype: C/A	Locus: PDGFRB/rs2304060 Genotype: A/A	Locus: PDGFRB/rs17656204 Genotype: C/C	Locus: PDGFRB/rs17656204 Genotype: C/T	Locus: PDGFRB/rs17656204 Genotype: T/T	Locus: PDGFRB/rs2304061 Genotype: G/G	Locus: PDGFRB/rs2304061 Genotype: G/A	Locus: PDGFRB/rs2304061 Genotype: A/A	Locus: PDGFRB/rs1077724 Genotype: A/A	Locus: PDGFRB/rs1077724 Genotype: A/T	Locus: PDGFRB/rs1077724 Genotype: T/T	Locus: PDGFRB/rs919751 Genotype: A/A	Locus: PDGFRB/rs919751 Genotype: A/G	Locus: PDGFRB/rs919751 Genotype: G/G	Locus: PDGFRB/rs2304058 Genotype: G/G	Locus: PDGFRB/rs2304058 Genotype: G/C	Locus: PDGFRB/rs2304058 Genotype: C/C	Locus: PDGFRB/rs1864972 Genotype: G/G	Locus: PDGFRB/rs1864972 Genotype: G/A	Locus: PDGFRB/rs1864972 Genotype: A/A	Locus: PDGFRB/rs3733678 Genotype: G/G	Locus: PDGFRB/rs3733678 Genotype: G/A	Locus: PDGFRB/rs246396 Genotype: T/T	Locus: PDGFRB/rs246396 Genotype: T/C	Locus: PDGFRB/rs246396 Genotype: C/C	Locus: PDGFRB/rs34586048 Genotype: C/C	Locus: PDGFRB/rs11740355 Genotype: T/T	Locus: PDGFRB/rs11740355 Genotype: T/G	Locus: PDGFRB/rs11740355 Genotype: G/G	Locus: PDGFRB/rs740751 Genotype: C/C	Locus: PDGFRB/rs740751 Genotype: C/T	Locus: PDGFRB/rs740751 Genotype: T/T	Locus: PDGFRB/rs4705415 Genotype: G/G	Locus: PDGFRB/rs4705415 Genotype: G/A	Locus: PDGFRB/rs4705415 Genotype: A/A	Locus: PDGFRB/rs3776075 Genotype: T/T	Locus: PDGFRB/rs3776075 Genotype: T/G	Locus: PDGFRB/rs3776075 Genotype: G/G	Locus: PDGFRB/rs17708574 Genotype: G/G	Locus: PDGFRB/rs17708574 Genotype: G/A	Locus: PDGFRB/rs10063714 Genotype: T/T	Locus: PDGFRB/rs10063714 Genotype: T/A	Locus: PDGFRB/rs3776081 Genotype: A/A	Locus: PDGFRB/rs3776081 Genotype: A/G	Locus: PDGFRB/rs3776081 Genotype: G/G	Locus: PDGFRB/rs2007637 Genotype: G/G	Locus: PDGFRB/rs2007637 Genotype: G/A	Locus: PDGFRB/rs2007637 Genotype: A/A	Locus: PDGFRB/rs2302273 Genotype: G/G	Locus: PDGFRB/rs2302273 Genotype: G/A	Locus: PDGFRB/rs2302273 Genotype: A/A
Erlotinib + Placebo	9.60	6.20	5.60	5.90	7.60	NA	4.75	9.60	NA	5.90	6.20	NA	6.80	10.00	8.20	8.45	7.20	6.20	11.50	6.35	7.90	7.00	5.90	5.40	14.95	6.20	6.80	6.20	14.40	NA	11.50	6.80	7.90	6.70	6.80	8.20	14.35	7.20	4.70	6.20	6.80	7.20	5.90	12.95	6.80	4.80	5.40	13.40	NA	11.50	6.20	4.80
Sunitinib + Erlotinib	12.80	8.20	5.70	8.00	8.20	6.40	6.65	8.40	9.00	6.30	9.70	7.25	8.00	8.20	6.40	6.05	8.20	12.05	6.65	8.00	11.30	6.30	14.00	8.00	7.30	NA	8.00	8.20	6.90	1.80	6.65	8.00	11.30	11.30	8.20	5.60	6.35	9.30	14.00	9.30	5.40	6.40	14.00	6.30	11.30	11.60	6.90	8.20	8.40	7.55	11.30	4.80

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Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms

OS, defined as time from date of randomization to date of death due to any cause, in subgroups that were defined by VEGFR2 polymorphisms. OS was calculated as (date of death minus date of randomization plus 1) divided by 30.4. (NCT00265317)
Timeframe: From randomization until death (up to Month 17)

Intervention	Months (Median)
	Locus: VEGFR2/rs1531289 Genotype: C/C	Locus: VEGFR2/rs1531289 Genotype: C/T	Locus: VEGFR2/rs1531289 Genotype: T/T	Locus: VEGFR2/rs2305945 Genotype: G/G	Locus: VEGFR2/rs2305945 Genotype: G/T	Locus: VEGFR2/rs2305945 Genotype: T/T	Locus: VEGFR2/rs1870377 Genotype: T/T	Locus: VEGFR2/rs1870377 Genotype: T/A	Locus: VEGFR2/rs1870377 Genotype: A/A	Locus: VEGFR2/rs2305948 Genotype: C/C	Locus: VEGFR2/rs2305948 Genotype: C/T	Locus: VEGFR2/rs2305948 Genotype: T/T	Locus: VEGFR2/rs7692791 Genotype: C/C	Locus: VEGFR2/rs7692791 Genotype: C/T	Locus: VEGFR2/rs7692791 Genotype: T/T	Locus: VEGFR2/rs35636987 Genotype: C/C	Locus: VEGFR2/rs7667298 Genotype: C/C	Locus: VEGFR2/rs7667298 Genotype: C/T	Locus: VEGFR2/rs7667298 Genotype: T/T	Locus: VEGFR2/rs41408948 Genotype: G/G	Locus: VEGFR2/rs41408948 Genotype: G/A	Locus: VEGFR2/rs41408948 Genotype: A/A	Locus: VEGFR2/rs2071559 Genotype: G/G	Locus: VEGFR2/rs2071559 Genotype: G/A	Locus: VEGFR2/rs2071559 Genotype: A/A
Erlotinib + Placebo	6.20	5.30	16.50	5.50	7.60	NA	10.00	4.70	NA	10.00	4.90	NA	7.60	5.80	10.00	6.80	13.40	4.90	9.60	8.40	4.40	9.55	8.60	4.90	13.40
Sunitinib + Erlotinib	8.20	6.40	11.60	8.00	6.25	NA	6.40	8.00	NA	8.40	5.80	NA	6.40	9.30	6.30	8.00	9.30	6.65	11.30	6.40	8.00	11.30	11.30	6.90	9.30

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Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile

Includes colony-stimulating factor 1 receptor (CSF-1R), PDGFRalpha, PDGFRbeta, vascular endothelial growth factor (VEGF), VEGF C (VEGF-C), VEGF receptor 1 (VEGFR1), VEGF receptor 2 (VEGFR2), VEGF receptor 3 (VEGFR3), fibroblast growth factor (FGF), FLT-3, KIT (stem cell factor receptor), and RET (rearranged during transfection). Correlative analysis was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. (NCT00265317)
Timeframe: Baseline

Intervention	Percentage of Participants (Number)
	CSF-1R/High	CSF-1R/Low	CSF-1R/Indeterminate	PDGFRalpha/High	PDGFRalpha/Low	PDGFRalpha/Indeterminate	PDGFRbeta/High	PDGFRbeta/Low	PDGFRbeta/Indeterminate	VEGF/High	VEGF/Low	VEGF/Indeterminate	VEGF-C/High	VEGF-C/Low	VEGF-C/Indeterminate	VEGFR1/High	VEGFR1/Low	VEGFR1/Indeterminate	VEGFR2/High	VEGFR2/Low	VEGFR2/Indeterminate	VEGFR3/High	VEGFR3/Low	VEGFR3/Indeterminate	FGF/Detected	FGF/Not Detected	FGF/Indeterminate	FLT3/Detected	FLT3/Not Detected	FLT3/Indeterminate	KIT/Detected	KIT/Not Detected	KIT/Indeterminate	RET/Detected	RET/Not Detected	RET/Indeterminate
Erlotinib + Placebo	44	41	15	48	41	11	44	44	11	41	41	19	41	52	7	44	33	22	48	41	11	48	30	22	19	67	15	19	78	4	30	67	4	30	59	11
Sunitinib + Erlotinib	45	52	3	45	52	3	45	48	6	39	39	23	52	45	3	35	48	16	45	52	3	35	55	10	10	84	6	26	71	3	39	58	3	10	84	6

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Percentage of Participants With EGFR Expression by IHC (Using 10% Cutoff)

Percentage of participants with EGFR Expression by IHC using a 10% cutoff; Reported as positive (positive values were defined as being greater than 10% of cells demonstrating membranous staining for EGFR), negative, or unmeasured. Correlative analysis of EGFR expression was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. (NCT00265317)
Timeframe: Baseline

Intervention	Percentage of Participants (Number)
	Positive	Negative	Unmeasured
Erlotinib + Placebo	54	18	28
Sunitinib + Erlotinib	45	29	26

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Percentage of Participants With EGFR Gene Amplification

The percentage of participants with EGFR gene amplification (defined as greater than 15) was determined and reported as yes, no, or unmeasured. Correlative analysis of EGFR gene amplification was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. (NCT00265317)
Timeframe: Baseline

Intervention	Percentage of Participants (Number)
	Yes	No	Unmeasured
Erlotinib + Placebo	0	43	57
Sunitinib + Erlotinib	0	48	52

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Percentage of Participants With EGFR Gene Copy Number Increase

The number of copies corresponding to exon 19 of the EGFR gene was determined by real-time quantitative polymerase chain reaction (PCR). The percentage of participants with EGFR Gene Copy Number Increase (defined as greater than 4 copies) was determined using deoxyribonucleic acid (DNA) from tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. Reported as yes, no or unmeasured. (NCT00265317)
Timeframe: Baseline

Intervention	Percentage of Participants (Number)
	Yes	No	Unmeasured
Erlotinib + Placebo	1	42	57
Sunitinib + Erlotinib	0	48	52

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Percentage of Participants With EGFR Gene Mutation

Mutations in exons 18 through 21 of the EGFR gene were analyzed by high-performance liquid chromatography using DNA from tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. The percentage of participants with EGFR mutations categorized as mutated, wild type or indeterminate was reported. (NCT00265317)
Timeframe: Baseline

Intervention	Percentage of Participants (Number)
	Mutated	Wild Type	Indeterminate
Erlotinib + Placebo	1	28	70
Sunitinib + Erlotinib	6	32	62

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Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Expression by Immunohistochemistry (IHC) Using 0 Percent [%] Cutoff

Percentage of participants with EGFR expression by IHC using a 0% cutoff; Reported as positive, negative, or unmeasured (where positive was greater than 0% of cells demonstrating membranous staining for EGFR). Correlative analysis of EGFR expression was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. (NCT00265317)
Timeframe: Baseline

Intervention	Percentage of Participants (Number)
	Positive	Negative	Unmeasured
Erlotinib + Placebo	36	36	28
Sunitinib + Erlotinib	35	38	26

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Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms

Blood samples were collected at baseline for multiplex RT analysis of genes expressing proteins that are targets of sunitinib or involved in angiogenesis or tumor growth to determine expression levels. Percentage of participants with germline PDGFRB SNPs was reported for the following genotype frequencies: homozygous C alleles (C/C), T alleles (T/T), G alleles (G/G), or A alleles (A/A), and the following heterozygous genotypes C/T, A/T, A/G, T/C, T/G, G/C, C/A and G/A. (NCT00265317)
Timeframe: Baseline

Intervention	Percentage of Participants (Number)
	Locus: PDGFRB / rs2304060 Genotype:C/C	Locus: PDGFRB / rs2304060 Genotype: C/A	Locus: PDGFRB / rs2304060 Genotype: A/A	Locus: PDGFRB / rs17656204 Genotype: C/C	Locus: PDGFRB / rs17656204 Genotype: C/T	Locus: PDGFRB / rs17656204 Genotype: T/T	Locus: PDGFRB / rs2304061 Genotype: G/G	Locus: PDGFRB / rs2304061 Genotype: G/A	Locus: PDGFRB / rs2304061 Genotype: A/A	Locus: PDGFRB / rs1077724 Genotype: A/A	Locus: PDGFRB / rs1077724 Genotype: A/T	Locus: PDGFRB / rs1077724 Genotype: T/T	Locus: PDGFRB / rs919751 Genotype: A/A	Locus: PDGFRB / rs919751 Genotype: A/G	Locus: PDGFRB / rs919751 Genotype: G/G	Locus: PDGFRB / rs2304058 Genotype: G/G	Locus: PDGFRB / rs2304058 Genotype: G/C	Locus: PDGFRB / rs2304058 Genotype: C/C	Locus: PDGFRB / rs1864972 Genotype: G/G	Locus: PDGFRB / rs1864972 Genotype: G/A	Locus: PDGFRB / rs1864972 Genotype: A/A	Locus: PDGFRB / rs3733678 Genotype: G/G	Locus: PDGFRB / rs3733678 Genotype: G/A	Locus: PDGFRB / rs246396 Genotype: T/T	Locus: PDGFRB / rs246396 Genotype: T/C	Locus: PDGFRB / rs246396 Genotype: C/C	Locus: PDGFRB / rs34586048 Genotype: C/C	Locus: PDGFRB / rs11740355 Genotype: T/T	Locus: PDGFRB / rs11740355 Genotype: T/G	Locus: PDGFRB / rs11740355 Genotype: G/G	Locus: PDGFRB / rs740751 Genotype: C/C	Locus: PDGFRB / rs740751 Genotype: C/T	Locus: PDGFRB / rs740751 Genotype: T/T	Locus: PDGFRB / rs4705415 Genotype: G/G	Locus: PDGFRB / rs4705415 Genotype: G/A	Locus: PDGFRB / rs4705415 Genotype: A/A	Locus: PDGFRB / rs3776075 Genotype: T/T	Locus: PDGFRB / rs3776075 Genotype: T/G	Locus: PDGFRB / rs3776075 Genotype: G/G	Locus: PDGFRB / rs17708574 Genotype: G/G	Locus: PDGFRB / rs17708574 Genotype: G/A	Locus: PDGFRB / rs17708574 Genotype: A/A	Locus: PDGFRB / rs10063714 Genotype: T/T	Locus: PDGFRB / rs10063714 Genotype: T/A	Locus: PDGFRB / rs10063714 Genotype: A/A	Locus: PDGFRB / rs3776081 Genotype: A/A	Locus: PDGFRB / rs3776081 Genotype: A/G	Locus: PDGFRB / rs3776081 Genotype: G/G	Locus: PDGFRB / rs2007637 Genotype: G/G	Locus: PDGFRB / rs2007637 Genotype: G/A	Locus: PDGFRB / rs2007637 Genotype: A/A	Locus: PDGFRB / rs2302273 Genotype: G/G	Locus: PDGFRB / rs2302273 Genotype: G/A	Locus: PDGFRB / rs2302273 Genotype: A/A
All Participants	21.3	52.9	25.7	48.5	44.1	7.4	51.9	44.4	3.7	43.4	46.3	10.3	46.3	39.0	14.7	25.7	49.3	25.0	41.2	41.9	16.9	80.1	19.9	70.6	27.2	2.2	100	80.9	18.4	0.7	41.2	41.2	17.6	36.0	44.1	19.9	22.8	56.6	20.6	79.4	17.6	2.9	76.5	22.1	1.5	39.0	47.1	14.0	79.4	19.1	1.5	56.0	38.1	6.0

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Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms

Blood samples were collected at baseline for multiplex reverse transcription (RT) analysis of genes expressing proteins that are targets of sunitinib or involved in angiogenesis or tumor growth to determine expression levels. Percentage of participants with germline VEGFR2 single nucleotide polymorphisms (SNPs) was reported for the following genotype frequencies: homozygous C alleles (C/C), T alleles (T/T), G alleles (G/G), or A alleles (A/A), and the following heterozygous genotypes C/T, G/T, T/A, and G/A. (NCT00265317)
Timeframe: Baseline

Intervention	Percentage of Participants (Number)
	Locus: VEGFR2 / rs1531289; Genotype: C/C	Locus: VEGFR2 / rs1531289; Genotype: C/T	Locus: VEGFR2 / rs1531289; Genotype: T/T	Locus: VEGFR2 / rs2305945; Genotype: G/G	Locus: VEGFR2 / rs2305945; Genotype: G/T	Locus: VEGFR2 / rs2305945; Genotype: T/T	Locus VEGFR2 / rs1870377; Genotype: T/T	Locus VEGFR2 / rs1870377; Genotype: T/A	Locus VEGFR2 / rs1870377; Genotype: A/A	Locus: VEGFR2 / rs2305948; Genotype: C/C	Locus: VEGFR2 / rs2305948; Genotype: C/T	Locus: VEGFR2 / rs2305948; Genotype: T/T	Locus: VEGFR2 / rs7692791; Genotype: C/C	Locus: VEGFR2 / rs7692791; Genotype: C/T	Locus: VEGFR2 / rs7692791; Genotype: T/T	Locus: VEGFR2 / rs35636987; Genotype: C/C	Locus: VEGFR2 / rs7667298; Genotype: C/C	Locus: VEGFR2 / rs7667298; Genotype: C/T	Locus: VEGFR2 / rs7667298; Genotype: T/T	Locus: VEGFR2 / rs41408948; Genotype: G/A	Locus: VEGFR2 / rs41408948; Genotype: A/A	Locus: VEGFR2 / rs41408948; Genotype: G/G	Locus: VEGFR2 / rs2071559; Genotype: G/G	Locus: VEGFR2 / rs2071559; Genotype: G/A	Locus: VEGFR2 / rs2071559; Genotype: A/A
All Participants	44.9	45.6	9.6	44.1	47.1	8.8	53.7	39.7	6.6	81.6	17.6	0.7	19.9	50.7	29.4	100	27.2	50.0	22.8	57.4	36.0	6.6	26.5	47.8	25.7

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Time to Disease Progression

"Patients were evaluated for response biochemically and radiographically at each response assessment. RECIST 1.0 criteria were used for radiographic response. PSA measurement at a central laboratory was used to assess biochemical response. Patients must have had a baseline PSA of 5 ng/ml to be evaluated for PSA response. PSA was measured every 8 weeks.~For patients with measurable disease radiographically, PSA progression was not considered as having progressive disease. Refer to study publication for details." (NCT00272038)
Timeframe: 25 months

Intervention	months (Median)
Tarceva	2

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Overall Clinical Benefit of Tarceva in CRPC.

Overall Clinical Benefit = percentage of partial responders (PR)+ the percentage of patients with stable disease (SD). Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum. Stable Disease (SD)is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease, using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0). (NCT00272038)
Timeframe: 5 years

Intervention	percentage of pts w/clinical benefit (Number)
Tarceva	36

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Overall Survival

One year survival rate. (NCT00272038)
Timeframe: during study

Intervention	% of partcipants alive at one year (Number)
Tarceva	58

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6-month Overall Survival

Percentage of patients survived at 6 months for patients whose tumors were xenografted and treated in the mouse when treated with the most active agent identified in that model (NCT00276744)
Timeframe: 6 months

Intervention	percentage of participants (Number)
Arm 1	53

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Pathological Complete Response Rate

"Number of participants with an pathological complete response rate using the RECIST criteria.~Complete response: Disappearance of all measurable and evaluable disease Partial response: A 30% or greater decline in the sum of the longest diameter of target lesions compared to the baseline measurement.~Progressive disease: A 20% or greater increase in the sum of the longest diameter of the target lesions compared to the baseline.~Stable disease: Disease that did not meet the criteria for a CR / PR or progressive disease." (NCT00278148)
Timeframe: 2 years

Intervention	participants (Number)
Erlotinib, Paclitaxel, and Carboplatin With Radiation	6

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Progression Free Survival (PFS)

Months from the date of study entry to the date of the corresponding event (recurrence of death) or the date of final follow-up (NCT00278148)
Timeframe: 3 years

Intervention	months (Median)
Erlotinib, Paclitaxel, and Carboplatin With Radiation	41.8

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Overall Survival

Percent of participants still alive from the date of study entry to the date of the corresponding event (recurrence of death) or the date of final follow-up. (NCT00278148)
Timeframe: 3 years

Intervention	percentage of participants (Number)
Erlotinib, Paclitaxel, and Carboplatin With Radiation	69

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Maximum Tolerated Dose of Erlotinib Hydrochloride (Phase I)

The Phase I portion of this study is to determine the Maximum Tolerated Dose (MTD) of combining OSI-774 with the paclitaxel-carboplatin chemoradiation protocol and to assess the safety and feasiblity of this combination. (NCT00278148)
Timeframe: 2 weeks after surgery

Intervention	mg daily (Number)
Erlotinib, Paclitaxel, and Carboplatin With Radiation	150

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Progression-free Survival (PFS)

The length of time during and after the treatment of a stage IIIA/B NSCLC that a patient lives with the disease but it does not get worse. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT00280150)
Timeframe: 5 years

Intervention	Months (Median)
Overall Study	10.2

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Feasibility and Tolerability of Administering Consolidation Therapy

The proportion of patients who were able to complete consolidation therapy after induction therapy and chemoradiotherapy (NCT00280150)
Timeframe: 6 cycles

Intervention	Participants (Count of Participants)
Overall Study	5

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Maximum Dose of Erlotinib When Given Together With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy (Phase I [Closed to Accrual as of 1/3/2008])

Dose-limiting toxicities (DLTs) were used to establish which cohort would be used for the phase II portion of the trial. DLTs were defined as any grade 3 or 4 nonhematologic toxicity with the exception of esophagitis, which had to be grade 4; grade 4 neutropenia lasting greater than or equal to 7 days and thrombocytopenia to less than 20,000/microliter. (NCT00280150)
Timeframe: 6 weeks after completion of therapy

Intervention	DLTs (Number)
Cohort 1	0
Cohort 2	0
Cohort 3	2

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Response Rate to Induction Therapy (Phase I [Closed to Accrual as of 1/3/2008] and II)

"Measurable lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10mm with spiral CT scan or nonmeasurable, but evaluable. Evaluable is nonmeasurable disease that includes ascites, malignant pleural/pericardial effusion, bone lesions, or marrow involvement. The same method of assessment and the same techniques should be used to characterize each identified and reported lesion at baseline and during follow-up.~Complete Response (CR)- Disappearance of all target lesions" (NCT00280150)
Timeframe: 5 years

Intervention	Participants (Count of Participants)
Overall Study	0

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Overall Response Rate and Survival Profile

The overall response rate (ORR) to the two cycles of induction therapy plus bevacizumab in stage IIIA/B NSCLC. ORR is the portion of patients with a tumor size reduction for a minimum time period. Response duration is measured from the time of initial response until documented tumor progression. (NCT00280150)
Timeframe: 5 years

Intervention	percentage of participants (Number)
Overall Study	39

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Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy

A list of Hematologic and nonhematologic toxicities associated with induction and concurrent therapy. This includes the percentage of patients who experienced grades 2-4 based on the National Cancer Institute Common Terminology Criteria for Adverse Events (version 3.0). (NCT00280150)
Timeframe: 6 weeks after completion of therapy

Intervention	percentage of participants (Number)
	Anemia	Neutrophenia	Thrombocytopenia	Febrile neutropenia	Nausea/vomiting	Fatigue	Alopecia	Hypertension	Myalgias/arthralgias	Diarrhea	Neuropathy	Rash	Anorexia	Esophagitis	Dehydration	Hemorrhage	Hypomagnesemia	Proteinuria	Weight loss	Pneumonitis	Hypersensitivity reaction
Concurrent Therapy	17	35	16	2	6	22	9	4	0	2	2	11	6	40	11	6	4	2	9	2	2
Induction Therapy	4	52	0	0	7	20	42	9	27	6	2	2	0	0	0	0	0	0	0	0	4

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Therapeutic Response, Evaluated by Computed Tomography (CT) Scans of Chest & Abdomen.

(NCT00281021)
Timeframe: Measured every 6 weeks after baseline until disease progression, an average of 3 months

Intervention	participants (Number)
	Partial Response	Stable Disease	Progressive Disease
Erlotinib and Digoxin	1	9	14

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Toxicity

Assessments for treatment toxicity will be done with each cycle according to CTCAE v3. Results listed here are grade >=3, treatment related hematologic events (all) and Grade>=3 treatment related non hematologic events that occurred in >=5% of patients in any arm. Adverse events (toxicities) are graded on a 5 point scale from 1 (mild) to 5 (lethal), with grades 3 and higher being severe or life threatening. (NCT00283244)
Timeframe: After each cycle/3 weeks, up to 3 years

Intervention	participants (Number)
	Anemia (Grade>=3; treatment related)	Neutropenia (Grade>=3; treatment related)	Thrombocyopenia (Grade>=3; treatment related)	Dehydration (Grade>=3; treatment related)	Diarrhea (Grade>=3; treatment related)	Dyspnea (Grade>=3; treatment related)	Fatigue (Grade>=3; treatment related)	Rash (Grade>=3; treatment related)
Arm A (Gemcitabine)	1	4	3	0	0	2	4	1
Arm B (Erlotinib)	0	1	1	3	3	0	1	2
Arm C (Gemcitabine + Erlotinib)	4	1	2	2	3	3	5	3

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Quality of Life (QOL)- Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) Trial Outcome Index-L (TOI-L)

"The FACT-L is the FACT-G and a lung cancer specific (LCS) subscale given at baseline, after each cycle and at end of treatment. The FACT-G is a 27 item measure of general QOL assessing function in 4 domains: physical well-being (PWB), social-family well-being (SFWB), emotional well-being (EWB) and functional well-being (FWB). Items are rated by patients on a Likert scale from 0 to 4. Higher scores represent better QOL. The TOI-L sums the PWB, FWB, and LCS subscale scores.~A best response for TOI-L scores is based on change from baseline and coded as:~a change >=+6 improved, <= -6 worsened and otherwise no change.~A best overall score response is coded as:~Improved (2 visit resp. of improved a min. of 28 days apart w/ no interim worsened) No change (not improved; 2 visit resp. of no change or improved a min. of 28 days apart w/ no interim worsened) Worsened (not improved or no change; 2 consecutive worsened) Other (none of the above)" (NCT00283244)
Timeframe: After each cycle/3 weeks

Intervention	participants (Number)
	Improved	No change	Worsened	Other
Arm A (Gemcitabine)	5	12	11	16
Arm B (Erlotinib)	6	9	12	24
Arm C (Gemcitabine + Erlotinib)	7	9	9	26

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Response Rate

The best overall response (BOR) is the best response recorded from the start of the treatment until disease progression-recurrence (taking as reference for progressive disease the smallest measurement recorded since the treatment started. The response rate was defined as the percentage of patients achieving a BOR of complete response or partial response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00283244)
Timeframe: Six months

Intervention	percentage of participants (Number)
Arm A (Gemcitabine)	7
Arm B (Erlotinib)	0
Arm C (Gemcitabine + Erlotinib)	21

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Progression-free Survival

We would consider the combination of gemcitabine plus erlotinib or single agent erlotinib to be worthy of further study if there was an increased progressed-free survival. We would use an increase to 45% progression-free survival at 6 months as significant. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT00283244)
Timeframe: Six months

Intervention	months (Median)
Arm A (Gemcitabine)	3.7
Arm B (Erlotinib)	2.8
Arm C (Gemcitabine + Erlotinib)	4.1

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Overall Survival

Survival calculated from start of treatment to death from any cause for up to three years. (NCT00283244)
Timeframe: Up to 3 years

Intervention	Months (Median)
Arm A (Gemcitabine)	6.8
Arm B (Erlotinib)	5.8
Arm C (Gemcitabine + Erlotinib)	5.6

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Number of Participants Who Remained Free of Progression at the 27th Week.

(NCT00287222)
Timeframe: 27 weeks

Intervention	participants (Number)
Bevacizumab and Erlotinib	21

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Overall Response Rate

Percentage of patients who experienced complete or partial response as defined by RECIST (NCT00287989)
Timeframe: after 6 cycles of chemotherapy

Intervention	percentage of participants (Number)
150 PRE	18
1,500 PRE	34
1,500 POST	28

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Time to Progression

Median number of months until disease progression (NCT00287989)
Timeframe: after cycle 6 of chemotherapy

Intervention	months (Median)
150 PRE	4
1,500 PRE	4
1,500 POST	5

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Progression-free Survival

Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression. (NCT00294762)
Timeframe: Until time of disease progression, as assessed every 21 days (maximum 28.8 months)

Intervention	months (Median)
Erlotinib	2.69
Erlotinib + Chemotherapy (Intercalated)	4.57

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Overall Survival at 12 Months

Percentage of patients alive after 12 months of study treatment (NCT00294762)
Timeframe: 12 months from 1st dose

Intervention	Percent of Patients (Number)
Erlotinib	58.6
Erlotinib + Chemotherapy (Intercalated)	46.4

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6-month Progression-free Survival

Percentage of patients who's disease had not progressed at 6 months. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression. (NCT00294762)
Timeframe: 6 months after first dose

Intervention	Percentage of Patients (Number)
Erlotinib	30.7
Erlotinib + Chemotherapy (Intercalated)	26.4

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Duration of Tumor Response

Median length of time that tumor showed any type of response, ie, CR, PR, or SD (NCT00294762)
Timeframe: While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months).

Intervention	Months (Median)
Erlotinib	6.4
Erlotinib + Chemotherapy (Intercalated)	4.1

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Overall Survival

Median number of months from first study treatment until time of death (NCT00294762)
Timeframe: From first study treatment until time of death (maximum 29.0 months)

Intervention	Months (Median)
Erlotinib	16.72
Erlotinib + Chemotherapy (Intercalated)	11.43

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Best Tumor Response

Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor larger than at baseline (NCT00294762)
Timeframe: While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months)

Intervention	Percent of Patients (Number)
	Complete Response (CR)	Partial Response (PR)	Stable Disease (SD)	Progressive Disease (PD)	Unable to Determine/Not Evaluable
Erlotinib	0	11.6	34.8	46.4	7.2
Erlotinib + Chemotherapy (Intercalated)	0	22.4	49.3	17.9	10.4

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Safety of Twice a Day Oral 150 mg Erlotinib Dosing

Greater than or equal to Grade 2 Adverse Event (NCT00301418)
Timeframe: duration of the trial

Intervention	participants (Number)
Tarceva (Erlotinib)	9

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Overall Survival (OS)

(NCT00301418)
Timeframe: Duration of the trial

Intervention	days (Median)
Tarceva (Erlotinib)	167

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6-month Progression Free Survival (PFS)

(NCT00301418)
Timeframe: Duration of the trial

Intervention	days (Median)
Tarceva (Erlotinib)	56

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Survival Post Treatment

Overall Survival with a minimum follow up of 1year. Relapse/Persistent Disease Rates (NCT00304278)
Timeframe: 22 months

Intervention	participants (Number)
RADPLAT and Tarceva	12

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Summary of Grade 3 or Greater Toxicity

"Summary of grade 3 or greater toxicity by grade and type. All adverse events were evaluated using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.~Grade 3: Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living.~Grade 4 Life-threatening consequences; urgent intervention indicated." (NCT00307736)
Timeframe: 3 years

Intervention	participants (Number)
	Lymphopenia	Diarrhea w/o prior colostomy	Hypophosphatemia	Rash: acne/acneiform	ALT-SGPT	AST-SGOT	Cardiac-ischemia	Colitis	Dehydration	Fatigue	Febrile neutropenia	Hypertension	Hyperuricemia	Hypokalemia	Hyponatremia	Muco/stomatitis (symptom) oral cavity	Muco/stomatitis by exam-oral cavity	Proteinuria	Radiation dermatitis	Rash/desquamation	Rectum-pain
Grade 3	16	6	3	2	1	1	1	1	1	1	0	1	0	1	1	1	1	1	1	1	1
Grade 4	5	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	0	0	0	0

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Maximum Tolerated Dose (MTD) of Erlotinib When Administered in Combination With 5-fluorouracil (5-FU), Bevacizumab, and External Beam Radiation Therapy

MTD of Erlotinib was determined using a traditional 3 + 3 dose escalation scheme of three dose levels (50,100,150mg). Successive cohorts of 3-6 patients were enrolled into dose escalation cohorts for 14 day cycles. MTD reflects the highest dose of Erlotinib that had ≤1 out of 6 patients with Dose-Limiting Toxicity (DLT) at the highest dose level below the maximally administered dose. The maximally administered dose is the first dose that causes DLT in >33% of patients. DLT was defined as: Any grade 4 neutropenia, Any grade 3 thrombocytopenia, or Any ≥ grade 3 non-hematologic toxicity that results in greater than 7 days interruption in therapy. (NCT00307736)
Timeframe: 3 years

Intervention	mg (Number)
5-FU, Bevacizumab, Erlotinib and Radiation	100

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Pathologic Complete Response

The number of subjects who achieved a pathologic complete response as determine by pathologist, following completion of the study therapy. Pathologic complete response represents the absence of residual invasive disease in the rectum and in the regional lymph nodes. (NCT00307736)
Timeframe: 3 years

Intervention	Participants (Count of Participants)
Completed Study Therapy	9
Underwent Resection	10
Treated at MTD	7

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Percentage of Participants With Disease-free Survival

Summary of disease free survival at 1, 2, and 3 years. Disease free survival is the length of time after primary treatment for cancer ends that the participant survives without any clinical signs or symptoms of that cancer. The data is shown of the percentage of participants still in disease free survival at one, two, and three years. (NCT00307736)
Timeframe: 1, 2, 3 years

Intervention	percentage of participants (Number)
	1 Year	2 Years	3 Years
5-fluorocuracil, Bevacizumab, Erlotinib and Radiation	93.4	83.4	75.5

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Post-operative Complications After Resection of Rectal Cancers Following Preoperative 5-FU, Bevacizumab, Erlotinib, and External Beam Radiation Therapy.

Surgical morbidity following R0 resection with one of the following procedures: abdominal perineal resection, low anterior resection, and low anterior resection with coloanal anastomosis. (NCT00307736)
Timeframe: 3 years

Intervention	participants (Number)
	anastomotic leaks	intra-abdominal infection	wound infections	pulmonary embolus	small bowel obstruction	urinary obstruction/retention	fever
Surgery, 5-fluorocuracil, Bevacizumab, Erlotinib and Radiation	4	2	2	1	1	5	1

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Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)

Quality of life (QOL) was assessed before chemoradiation therapy (CRT) was started or during the first week of its administration [baseline (BL)], between completion of CRT and starting maintenance chemotherapy [time 1 (t1)], and within 3 months after completion of maintenance chemotherapy [time 2 (t2)]. European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) assesses quality of life on three domains: symptoms (score ranges from 7-14); function (score range 21-82); and global health status (score range 2-14). Higher or increasing scores mean worse outcomes; lower or decreasing scores mean better outcomes. (NCT00313560)
Timeframe: Up to 3 months after completion of maintenance chemotherapy

Intervention	score on a scale (Mean)
	Global (Time 1 vs. BL)	Global (Time 2 vs. BL)	Global (Time 2 vs. Time 1)	Functional (F) - Physical (Time 1 vs. BL)	F - Physical (Time 2 vs. BL)	F - Physical (Time 2 vs. Time 1)	F - Role (Time 1 vs. BL)	F - Role (Time 2 vs. BL)	F - Role (Time 2 vs. Time 1)	F - Cognition (Time 1 vs. BL)	F - Cognition (Time 2 vs. BL)	F - Cognition (Time 2 vs. Time 1)	F - Emotional (Time 1 vs. BL)	F - Emotional (Time 2 vs. BL)	F - Emotional (Time 2 vs. Time 1)	F - Social (Time 1 vs. BL)	F - Social (Time 2 vs. BL)	F - Social (Time 2 vs. Time 1)	Financial (Time 1 vs. BL)	Financial (Time 2 vs. BL)	Financial (Time 2 vs. Time 1)	General Symptoms (GS) - Fatigue (Time 1 vs. BL)	GS - Fatigue (Time 2 vs. BL)	GS - Fatigue (Time 2 vs. Time 1)	GS - Nausea/Vomiting (Time 1 vs. BL)	GS - Nausea/Vomiting (Time 2 vs. BL)	GS - Nausea/Vomiting (Time 2 vs. Time 1)	GS - Pain (Time 1 vs. BL)	GS - Pain (Time 2 vs. BL)	GS - Pain (Time 2 vs. Time 1)	GS - Dyspnea (Time 1 vs. BL)	GS - Dyspnea Time 2 vs. BL)	GS - Dyspnea (Time 2 vs. Time 1)	GS - Insomnia (Time 1 vs. BL)	GS - Insomnia (Time 2 vs. BL)	GS - Insomnia (Time 2 vs. Time 1)	GS - Appetite Loss (Time 1 vs. BL)	GS - Appetite Loss (Time 2 vs. BL)	GS - Appetite Loss (Time 2 vs. Time 1)	GS - Constipation (Time 1 vs. BL)	GS - Constipation (Time 2 vs. BL)	GS - Constipation (Time 2 vs. Time 1)	GS - Diarrhea (Time 1 vs. BL)	GS - Diarrhea (Time 2 vs. BL)	GS - Diarrhea (Time 2 vs. Time 1)
Erlotinib and EBRT After Pancreatectomy	1	-1.8	4.6	0.5	-3.2	-6.2	-3.1	-0.3	-4.4	-2.6	1.2	-1.2	-0.4	2.2	-0.6	3.9	4.4	-3.8	1.7	2.5	0	5.7	5.2	1.7	2.5	0	1.9	2.7	7.2	5	1.7	3.8	1.2	-2.5	0	2.5	-2.5	-15	-5	-4.2	-2.5	0	14.7	8.8	-6.2

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Change in QoL as Assessed by QLQ-PAN 26

Quality of life (QOL) was assessed before CRT was started or during the first week of its administration (baseline [BL]), between completion of CRT and starting maintenance chemotherapy (time 1 [t1]), and within 3 months after completion of maintenance chemotherapy (time 2 [t2]). QLQ-PAN 26 questionnaire includes 26 questions, organized into 7 scales, with scores for each ranging from 0-100. Higher scores indicate worse health state. Therefore, decreasing (negative) scores indicate a better outcome. (NCT00313560)
Timeframe: 3 months

Intervention	score on a scale (Mean)
	Pancreatic Pain (t1 vs. BL)	Pancreatic Pain (t2 vs. BL)	Pancreatic Pain (t2 vs. t1)	Digestive (t1 vs. BL)	Digestive (t2 vs. BL)	Digestive (t2 vs. t1)	Altered Bowel Habits (t1 vs. BL)	Altered Bowel Habits (t2 vs. BL)	Altered Bowel Habits (t2 vs. t1)	Jaundice (t1 vs. BL)	Jaundice (t2 vs. BL)	Jaundice (t2 vs. t1)	Body Image (t1 vs. BL)	Body Image (t2 vs. BL)	Body Image (t2 vs. t1)	Satisfaction with healthcare (t1 vs. BL)	Satisfaction with health care (t2 vs. BL)	Satisfaction with health care (t2 vs. t1)	Sexual function (t1 vs. BL)	Sexual function (t2 vs. BL)	Sexual function (t2 vs. t1)
Erlotinib and EBRT After Pancreatectomy	-1.9	-3.8	2.4	-0.9	-4.6	-1.4	14.7	7.2	-4.9	-1.3	-2	0	-6.2	-3.1	-0.7	4.1	3.1	0	-0.5	14.7	14.1

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Time to Death as Assessed by Median Overall Survival (Months)

(NCT00313560)
Timeframe: up to 5 years

Intervention	months (Median)
Erlotinib and EBRT After Pancreatectomy	24.39

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Recurrence Free Survival

Time from surgery to recurrence (NCT00313560)
Timeframe: Up to 3 years

Intervention	months (Median)
Erlotinib and EBRT After Pancreatectomy	15.6

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Number of Participants Experiencing Adverse Events

Number of participants experiencing adverse events during chemoradiation and during adjuvant chemotherapy, Grade 2 or higher, as defined by National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0. This is used to determine the Toxicity profile. (NCT00313560)
Timeframe: up to 3 years

Intervention	Participants (Count of Participants)
	Grade 2	Grade 3	Grade 4
Adjuvant Gemcitabine Plus Erlotinib	15	14	3
Chemoradiation Plus Erlotinib	24	15	1

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Clinical Outcome: Documented Progression

Response evaluation was based on pathologic examination of the degree of dysplasia observed and recorded by an expert head and neck pathologist. Pathologic complete response was defined as complete disappearance of dysplasia from the epithelium. Pathologic partial response was defined as improvement of dysplasia by at least one degree (i.e., severe dysplasia becomes moderate dysplasia). Pathologic minor response or stable disease was defined as minor focal improvement without change of degree of dysplasia (i.e., focal improvement from moderate to mild dysplasia with still moderate dysplasia overall) or no pathologic changes after treatment. Pathologic progressive disease was defined as worsening by at least one degree of dysplasia (i.e., mild to moderate dysplasia) or development of invasive cancer on or following treatment. (NCT00314262)
Timeframe: 12 months from time of enrollment

Intervention	participants (Number)
	Complete remission (CR)	Partial remission (PR)	Progressive disease (PD)	Stable disease (SDi)
Erlotinib & Celecoxib	3	1	1	2

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Dose Escalation and Toxicity: Toxicities Including Grades 1 to 4

Participants received a fixed dose of celecoxib 400 mg orally BID continuously for 6 months. Erlotinib was dose escalated at 3 dose levels of 50, 75, and 100 mg orally every day for 6 months. Dose escalation followed a standard 3+3 escalation design. (NCT00314262)
Timeframe: 12 months from time of enrollment

Intervention	participants (Number)
	Abdominal cramping, Grade 1	Alopecia, Grade 1	Anemia, Grade 1	Anemia, Grade 2	Anxiety, Grade 1	Decreased protein, Grade 1	Leukopenia, Grade 1	Leukopenia, Grade 2	Depression, Grade 1	Diarrhea, Grade 1	Dry eyes, Grade 1	Dry skin, Grade 1	Elevated LDH, Grade 1	Elevated serum creatinine, Grade 1	Elevated serum creatinine, Grade 2	Elevated alkaline phosphatase, Grade 1	Elevated ALT, Grade 1	Elevated AST, Grade 4	Fatigue, Grade 1	Hyperbilirubinemia, Grade 1	Hypercholesterolemia, Grade 1	Hyperglycemia, Grade 1	Hyperglycemia, Grade 2	Hypoalbuminemia, Grade 1	Hypoalbuminemia, Grade 2	Hypocalcemia, Grade 1	Hypoglycemia, Grade 1	Hypoglycemia, Grade 2	Hypokalemia, Grade 1	Hyponatremia, Grade 1	Mouth sores, Grade 1	Mouth sores, Grade 2	Mucositis, Grade 1	Mucositis, Grade 3	Nausea, Grade 1	Neuropathy, Grade 1	Pruritis, Grade 1	Rash, Grade 1	Rash, Grade 3	Shortness of breath, Grade 1	Strep throat, Grade 2	Urosepsis, Grade 3	Vomiting, Grade 1
Erlotinib & Celecoxib	2	2	2	1	2	2	1	1	3	5	4	6	3	4	1	3	5	4	6	2	2	7	2	3	1	4	1	1	2	3	9	3	3	1	4	3	2	8	2	3	1	1	2

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Clinical Outcome: Progression to a Higher-grade Dysplasia or Carcinoma

Intervention	participants (Number)
	Stage I invasive carcinoma	Stage II oral cavity carcinoma	Invasive squamous cell carcinoma	Recurrent moderate dysplasia	Recurrent severe dysplasia	Recurrent high-grade dysplasia	Complete remission
Erlotinib & Celecoxib	1	1	1	1	1	1	1

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Plasma Time Curve (AUC) of Group 2 Sorafenib and Temsirolimus (Phase I)

"Day 1 = 12 patients (1 sample not evaluable) Day 15 = 5 patients (8 samples not evaluable)~AUC - Area Under Curve~8 samples collected over 24 hours - 28 day PKs" (NCT00335764)
Timeframe: Cycle 1 (D1, D15, D28) (0,1,2,4,6,8,12,24hr post drug administration)

Intervention	mcg*hr/mL (Mean)
	AUC 0-12 Day 1	AUC 0-12 Day 15	AUC 0-12 Day 28
Group 2 Phase I Sorafenib 200mg	NA	35.45	29.0
Group 2 Phase I Sorafenib 400mg	NA	42.32	32.98
Group 2 Phase I Temsirolimus 25mg QW	1.53	1.35	NA

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Pharmacokinetic Max Concentration (Cmax) of Group 2 Sorafenib and Temsirolimus (Phase I)

Group 2: 13 patients received temsirolimus 25mg IV and 7 patients treated with 200mg Sorafenib and 6 patients treated with 400mg Sorafenib (NCT00335764)
Timeframe: cycle 1 ((Day1, Day15, Day28)

Intervention	ng/mL (Mean)
	Day 1 Cmax	Day 15 Cmax	Day 28 Cmax
Group 2 Phase I Sorafenib 200mg BID	NA	4.04	3.26
Group 2 Phase I Sorafenib 400mg BID	NA	7.49	6.24
Group 2 Phase I Temsirolimus 25mg QW	530	616	NA

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Plasma Time Curve (AUC) of Group 3 Phase I Sorafenib and Tipifarnib 100mg QD (Level -1)

"Group 3: PKs for Dose level -1 100mg QD~Note that although 9 patients were accrued/analyzed some samples were incomplete or inevaluable or missing hence number analyzed difference" (NCT00335764)
Timeframe: Cycle 1 (D1, D15, D28) (0,1,2,4,6,8,12,24hr post drug administration)

Intervention	ng*hr/mL (Mean)
	AUC 0-12 Day 1	AUC 0-12 Day 15	AUC 0-12 Day 28
Group 3 Phase I Sorafenib 200mg BID	NA	30.59	41.43
Group 3 Phase I Tipifarnib 100mg QD	814.5	706	NA

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Pharmacokinetic Cpmax Group 3 Sorafenib and Tipifarnib (Phase I) 100 mg QD (Level -1)

Group 3: Only PKs for Dose level 1 and -1 were collected. (NCT00335764)
Timeframe: Cycle 1 = 28 day PKs D1, D15,D28 (0,1,2,4,6,8,12,24hr post drug administration)

Intervention	ng/mL (Mean)
	Cmax Day 1	Cmax Day 15	Cmax Day 28
Group 3 Phase I Sorafenib 200mg BID	NA	3.34	3.43
Group 3 Phase I Tipifarnib 100mg QD	209.5	169.5	NA

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Plasma Time Curve (AUC) of Group 3 Phase I Sorafenib and Tipifarnib 100mg BID (Level 1)

Group 3: PKs for Dose level 1 Tipifarnib 100mg BID (NCT00335764)
Timeframe: Cycle 1 = 28 day PKs D1, D15,D28 (0,1,2,4,6,8,12,24hr post drug administration)

Intervention	ng*hr/mL (Mean)
	AUC 0-12 Day 1	AUC 0-12 Day 15	AUC 0-12 Day 28
Group 3 Phase I Sorefenib 200mg BID	NA	12.17	36.45
Group 3 Phase I Tipifarnib 100mg QD	631.67	390.25	NA

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Trough Concentration Group 2 Sorafenib and Temsirolimus (Phase I)

Group 2: 12 patients were analyzed for Day 1 (1 patient not evaluable), 5 patients were analyzed for Day 15 (8 patients not evaluable) (NCT00335764)
Timeframe: 15 days

Intervention	ng/mL (Mean)
	Trough Day 1	Trough Day 15
Group 2 Phase I Sorafenib and Temsirolimus QW	24	20

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Pharmacokinetic cMax Group 1 Sorafenib and Erlotinib (Phase I)

"8 samples collected over 24 hours on Day 1, day 15 and day 28~13 total patients treated 100mg Erlotinib and either 200mg or 400mg of Sorafenib" (NCT00335764)
Timeframe: 28days (D1, D15, D28) (0,1,2,4,6,8,12,24hr post administration)

Intervention	ng/mL (Mean)
	cMax Day 1	cMax Day 15	cMax Day 28
Group 1 Phase I Erlotinib 100mg QD	443	662	653
Group 1 Phase I Sorafenib 200mg BID	NA	5.51	4.67
Group 1 Phase I Sorafenib 400mg BID	NA	8.4	4.10

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Pharmacokinetic AUC 0-12 Group 1 Sorafenib and Erlotinib (Phase I)

"8 samples collected over 24 hours on Day 1, day 15 and day 28~16 patients Note that although 16 patients were accrued/analyzed some samples were incomplete or inevaluable or missing hence number analyzed difference AUC - Area Under Curve" (NCT00335764)
Timeframe: 28Days (D1, D15, D28) (0,1,2,4,6,8,12,24hr post administration) AUC 0-12

Intervention	ug xhr/mL (Mean)
	AUC0-12 Day1	AUC0-12 Day 15	AUC0-12 Day 28
Group 1 Phase I Erlotinib 100mg QD	6.3	6.9	7.7
Group 1 Phase I Sorafenib 200mg	NA	45.85	40.29
Group 1 Phase I Sorafenib 400mg	NA	62.4	38.7

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Pharmacokinetic CpMax Concentration of Group 3 Sorafenib and Tipifarnib (Phase I) 100mg BID

"Group 3: patients were studied for their day 1 Cmax, and day 15 Cmax Tipifanib and Day 15 and Day 28 sorafenib~Group 3: Only PKs for Dose level 1 and -1 were collected." (NCT00335764)
Timeframe: Cycle 1 = 28 day PKs D1, D15,D28 (0,1,2,4,6,8,12,24hr post drug administration)

Intervention	ng/mL (Mean)
	Day 1 Cmax	Day 15 Cmax	Day 28 Cmax
Group 3 Phase I Sorafenib 200mg BID	NA	4.17	4.53
Group 3 Phase I Tipifarnib 100mg BID	132.17	233.60	NA

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Objective Response Rate in Patients With Measurable Disease (Phase II)

"Measurable: Bidimensionally measurable lesions w/ clearly defined margins by MRI Evaluable: Unidimensionally measurable lesions, masses w/margins not clearly defined.~Complete Response (CR): Complete disappearance of all measurable/evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients on minimal/no steroids.~Partial Response (PR): >/= to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. Responders must be on same/decreasing doses of dexamethasone.~Stable/No Response: Does not qualify for CR, PR, or progression. Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over BL if no decrease), OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer)." (NCT00335764)
Timeframe: Up to 5 years

Intervention	Participants (Count of Participants)
	Partial Response	Complete Response	Stable Response	Progressive Disease	Unevaluable
Group 1 Phase II Sorafenib and Erlotinib	0	0	7	10	2
Group 2 Phase II Sorafenib and Temsirolimus	2	0	3	13	0

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Number of High Grade (3 and 4) Related Adverse Events of Each Combination Agent Combined With BAY 43-9006 (Phase I)

CTCAE 3.0 (NCT00335764)
Timeframe: 28 days

Intervention	Events (Number)
	Leukopenia Grade 3	Lymphopenia Grade 3	Neutropenia Grade 3	Thrombocytopenia Grade 3	AST, SGOT Grade 3	Cholesterol Grade 3	Diarrhea Grade 3	Hemmorrhoids Grade 3	Hypertriglyceridemia Grade 3	Hypophosphatemia Grade 3	Fatigue Grade 3	Vomiting Grade 3	Lipase Grade 4	Joint - Knee Pain Grade 3	Thrombosis/thrombus/embolism Grade 4	Fever Grade 3	Dysphasia Grade 3	Pain - Head/Headache Grade 3	Encephalopathy Grade 3	Lipase Grade 3	ALT, SGPT Grade 3	Hypertension Grade 3
Group 1 Phase I Sorafenib and Erlotinib QD	0	0	0	0	1	0	0	0	0	3	0	0	0	0	0	0	0	0	0	1	2	1
Group 2 Phase I Sorafenib and Temsirolimus QW	0	2	0	1	1	1	1	1	1	2	0	0	0	0	0	0	0	0	0	0	0	0
Group 3 Phase I Sorafenib and Tipifarnib BID	0	3	0	0	0	0	2	0	0	4	1	1	3	1	1	1	1	1	1	0	0	0

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Number of High Grade (3 and 4) Related Adverse Events of Each Combination Agent Combined With BAY 43-9006 (Phase 2)

(NCT00335764)
Timeframe: 1 year

Intervention	events (Number)
	Lymphopenia Grade 3	Thrombocytopenia Grade 3	Thrombocytopenia Grade 4	Cholesterol (high) Grade 3	Diarrhea Grade 3	Fatigue Grade 3	Hypokalemia Grade 3	Hyponatremia Grade 3	Hypophosphatemia Grade 3	Lipase (high) Grade 3	Pharyngeal mucositis Grade 3	Pruritis Grade 3	Rash Grade 3	Seizures Grade 3	Hypertension Grade 3
Group 1 Phase II Sorafenib and Erlotinib	2	0	0	0	1	3	0	0	0	0	0	0	0	0	1
Group 2 Phase II Sorafenib and Temsirolimus	2	5	2	2	1	2	1	1	3	1	1	1	1	1	0

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Progression-free Survival at 6 Months (Phase II)

Patients with a scan at 6 months without progressive disease Progressive disease defined as Progressive neurological abnormalities not explained by other causes or greater than 25% increase in size of tumor or if new lesion. (NCT00335764)
Timeframe: 6 months

Intervention	weeks (Mean)
Group 1 Phase II Sorafenib and Erlotinib	15.8
Group 2 Phase II Sorafenib and Temsirolimus	8
Group 3 Phase I Sorafenib and Tipifarnib BID	4.2

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Maximum Tolerated Dose (MTD) of the Each Combination Agent Combined With a Fixed Dose of BAY 43-9006 Determined by Dose-limiting Toxicities (DLT) (Phase I)

DLT defined as: any grade 4 hematologic toxicity; grade 3 thrombocytopenia > 7 days, any grade 3/4 non-hematologic toxicity (despite maximal medical therapy), any intolerable grade 2 non-hematological, ro grade 3 hematological toxicity requiring deduction during first 28 days of treatment, any toxicity resulting in delay of >1week during first 28 days of treatment (NCT00335764)
Timeframe: 28 days

Intervention	mg (Number)
Group 1 Phase I Sorafenib and Erlotinib QD	100
Group 2 Phase I Sorafenib and Temsirolimus QW	25
Group 3 Phase I Sorafenib and Tipifarnib BID	NA

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1-year Recurrence Free Survival (RFS)

(NCT00336700)
Timeframe: Up to 60 months

Intervention	percentage of participants (Number)
Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)	56

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2-year Recurrence Free Survival (RFS)

(NCT00336700)
Timeframe: Up to 60 months

Intervention	percentage of participants (Number)
Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)	26

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KRAS Mutational Status

KRAS mutation status in resected tumor specimens. (NCT00336700)
Timeframe: Up to 60 months

Intervention	percentage of participants (Number)
Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)	92

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Recurrence Free Survival (RFS)

The time interval between day 1, cycle 1, of adjuvant treatment to the first date of radiologic recurrence or death. (NCT00336700)
Timeframe: Up to 60 months

Intervention	months (Median)
Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)	14

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Estimated 1&2 Year Overall Survival (OS)

Time from from date of first study therapy to to death from any cause. (NCT00336700)
Timeframe: Up to 60 months

Intervention	percentage of participants (Number)
	Estimated 1-year OS	Estimated 2-year OS
Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)	84	53

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Percentage of Participants With Expression of Epidermal Growth Factor Receptor (EGFR)

Percentage of participants with expression of epidermal growth factor receptor (EGFR) expression in the resected tumors was assessed by fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC). (NCT00336700)
Timeframe: Up to 60 months

Intervention	percentage of participants (Number)
	EGFR FISH - Negative	EGFR FISH - Positive	EGFR IHC - 1+ (incomplete circumferential)	2+ (complete circumferential)	3+ (complete strong circumferential)
Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)	80	20	22	35	43

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Number of Participants With Grade 3 and Grade 4 Adverse Events

By Safety, the intent was to capture, tabulate, list all of the grade 3 and 4 adverse effects seen by this protocol. For each toxicity, we followed the Common Toxicity Criteria(NCI CTC)Version 2.0 Toxicity scale guidelines. (NCT00351039)
Timeframe: 26 Months

Intervention	Participants (Number)
Experimental: Bevacizumab, Erlotinib, Pemetrexed	8

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Progression-free Survival

Time to progression was defined as the time from beginning of therapy until disease progression or death. For subjects who had not progressed at the time of statistical analysis, progression-free survival was censored at the date of their last tumor assessment. Kaplan-Meier method was used to estimate median progression-free survival. Progression was defined as radiographic progression according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria (year 2000 version), non-compliance in obtaining scans, unequivocal clinical progression or the initiation of another medication for the treatment of renal cell carcinoma. (NCT00353301)
Timeframe: Physical exam assessments were performed every 4 weeks during the treatment phase. Survival follow-up information was collected every 4 months following the termination visit until death, loss to follow-up, or study termination up to 275 weeks.

Intervention	Weeks (Median)
Erlotinib and Sirolimus	12

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Overall Survival

For all subjects who had not died at the time of statistical analysis, duration of survival will was censored at the date of last contact. Kaplan-Meier methodology was used to estimate the magnitude of the treatment effect as described for progression-free survival. (NCT00353301)
Timeframe: Survival follow-up information was collected every 4 months following the termination visit until death, loss to follow-up, or study termination up to 275 weeks.

Intervention	Weeks (Median)
Erlotinib and Sirolimus	40

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Time to Disease Progression

Estimated using the method of Kaplan-Meier (1958). (NCT00356889)
Timeframe: From registration to documentation of disease progression, assessed up to 3 years

Intervention	months (Median)
Bevacizumab and Erlotinib Hydrochloride	4.4

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Survival Time

Estimated using the method of Kaplan-Meier (1958). (NCT00356889)
Timeframe: From registration to death due to any cause, assessed up to 3 years

Intervention	months (Median)
Bevacizumab and Erlotinib Hydrochloride	9.9

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Duration of Response

Point estimates and 95% confidence intervals were calculated using the method of Duffy and Santner (1987). (NCT00356889)
Timeframe: From the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented, assessed up to 3 years

Intervention	months (Median)
Bevacizumab and Erlotinib Hydrochloride	8.4

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Number of Confirmed Tumor Responses.

"Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the target lesions.~A confirmed tumor response is defined to be either a Complete Response or a Partial Response noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Confirmed tumor responses will be evaluated using the first 6 cycles of treatment. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment and had one post-baseline disease assessment will be evaluable for response. Forty-nine of the 53 eligible patients had at least one post-baseline disease assessment and were evaluable for this endpoint." (NCT00356889)
Timeframe: After 6 courses of treatment. Each course lasts 28 days.

Intervention	participants (Number)
	Partial Response (PR)	Complete Response (CR)
Bevacizumab and Erlotinib Hydrochloride	6	0

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Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death

(NCT00360360)
Timeframe: 18 months

Intervention	months (Median)
Bevacizumab/Paclitaxel/Carboplatin/Erlotinib	12.6

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Progression-free Survival

Intervention	months (Median)
Bevacizumab/Paclitaxel/Carboplatin/Erlotinib	8

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Progression-Free Survival (PFS)

"Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable Response Evaluation Criteria In Solid Tumors (RECIST) assessment.~Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions." (NCT00364351)
Timeframe: progressionRECIST tumour assessments carried out every 4 weeks up to week 16 then every 8 weeks thereafter from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first, assessed.

Intervention	Weeks (Median)
Vandetanib	11.3
Erlotinib	8.9

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Overall Survival (OS)

Overall survival is defined as the time from date of randomization until death. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie their status must be known at the censored date and should not be lost to follow up or unknown). (NCT00364351)
Timeframe: Time to death in months

Intervention	Months (Median)
Vandetanib	6.9
Erlotinib	7.8

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Objective Response Rate (ORR)

The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions. (NCT00364351)
Timeframe: RECIST tumour assessments every 4 weeks up to week 16 then every 8 weeks thereafter from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first, assessed up to 21 months

Intervention	Participants (Number)
Vandetanib	75
Erlotinib	74

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Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Cough

"Cough was assessed using Question 1 (How much did you cough) of the QLQ-LC13 (or, equivalently, Question 31 of the combined QLQ-C30 and QLQ-LC13 questionnaires).~Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is defined as having a deterioration in symptoms if they have a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 28 days." (NCT00364351)
Timeframe: Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit

Intervention	Weeks (Median)
Vandetanib	15.6
Erlotinib	14.1

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Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Dyspnoea

"Dyspnea was assessed as the average score of four items: Question 8 of the QLQ-C30 (Were you short of breath) and Question 3 of the QLQ-C30 (Were you short of breath when you rested), Questions 4 (Were you short of breath when you walked) and 5 (Were you short of breath when you climbed stairs) of the QLQ-LC13 (or, equivalently, Questions 33, 34 and 35 of the combined QLQ-C30 and QLQ-LC13 questionnaires).~Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is defined as having a deterioration in symptoms if they have a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 28 days." (NCT00364351)
Timeframe: Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit

Intervention	Weeks (Median)
Vandetanib	12
Erlotinib	12.4

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Disease Control Rate (DCR)

Disease control rate is defined as the number of patients who achieved disease control at least 8 weeks following randomisation. Disease control is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 8 weeks as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere, PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions and SD >= 8 is assigned to patients who have not responded and have no evidence of progression at least 8 weeks after randomisation. (NCT00364351)
Timeframe: RECIST tumour assessments carried out every 4 weeks until week 16 then every 8 weeks thereafter (+/- 3 days) from randomisation until objective progression

Intervention	Participants (Number)
Vandetanib	254
Erlotinib	242

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Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Pain

"Pain was assessed as the average score of two items: Question 9 (Have you had pain) and 19 (Did pain interfere with your daily activities) of the QLQ-C30.~Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is defined as having a deterioration in symptoms if they have a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 28 days." (NCT00364351)
Timeframe: Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit

Intervention	Weeks (Median)
Vandetanib	11.1
Erlotinib	9.9

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Time to Tumor Progression

Time to tumor progression (TTP) was defined as the time from initial therapy to the first objective documentation of tumor progression (for patients with measurable disease) or to the data of death, if death was ascribed to progression of disease. (NCT00365144)
Timeframe: from initial therapy to the first objective documentation of tumor progression

Intervention	Days (Median)
Bevacizumab Plus Erlotinib	40

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Proportion of Patients With ≥ 25% Decline in Serum CA19-9 Biomarker

(NCT00365144)
Timeframe: 21 weeks

Intervention	Participants (Count of Participants)
Bevacizumab Plus Erlotinib Hydrochloride	4

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Overall Survival Rate at 6 Months

Number of participants alive at 6 months (NCT00365144)
Timeframe: 6 months

Intervention	participants (Number)
Bevacizumab Plus Erlotinib	8

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Objective Response as Measured by RECIST Criteria

Participants experiencing objecting response, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00365144)
Timeframe: 21 weeks

Intervention	participants (Number)
Bevacizumab Plus Erlotinib	1

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Safety and Toxicity

Treatment associated toxicities. Adverse event assessments were performed on day 1 of each treatment cycle and at the end of treatment; the longest duration of treatment was 7 cycles (x 3 weeks) (NCT00365144)
Timeframe: 21 weeks

Intervention	participants (Number)
	Rash (Grades 1-3)	Diarrhea (Grades 1-3)	Hypertension (grade 3)	Gastrointestinal Bleeding (Grades 1 & 3)	Venous thromboembolic events (Grades 2-3)	Pulmonary embolism	Pancratogastic fistula	Suspected hemorrhage into intrapulmonic metastases
Bevacizumab Plus Erlotinib	26	9	4	2	3	2	1	1

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Survival Time

Survival time is defined as the time from registration to death due to any cause. Estimated using the method of Kaplan-Meier. (NCT00365391)
Timeframe: From registration to death due to any cause, patients are followed up to 3 years after treatment

Intervention	months (Median)
Treatment (Bevacizumab and Erlotinib)	9.5

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Time to Treatment Failure

Time to treatment failure is defined to be the time from the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal. (NCT00365391)
Timeframe: From the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal.

Intervention	months (Median)
Treatment (Bevacizumab and Erlotinib)	2.0

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Time to Disease Progression

Time to disease progression is defined as the time from registration to documentation of disease progression. Estimated using the method of Kaplan-Meier. (NCT00365391)
Timeframe: From registration to documentation of disease progression, up to 3 years after treatment.

Intervention	months (Median)
Treatment (Bevacizumab and Erlotinib)	3.0

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Number of Patients With Confirmed Tumor Response Defined to be Either a Complete Response (CR) or Partial Response (PR).

Responses to erlotinib and bevacizumab treatment were evaluated using Response Evaluation Criteria In Solid Tumors (RECIST). A Complete Response (CR) is defined as the disappearance of all target lesions. A Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum of the longest diameters. (NCT00365391)
Timeframe: Patients were able to continue treatment indefinitely and were evaluated every cycle until discontinued treatment.

Intervention	participants (Number)
	Complete Response (CR)	Partial Response (PR)
Treatment (Bevacizumab and Erlotinib)	0	1

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Toxicity Profile

Grade 3-4 treatment-related toxicities (treatment-related = possible, probable, or definite) Grading system: 1= mild, 2 = moderate, 3 = severe, 4 = life-threatening (NCT00366457)
Timeframe: during and after first 28-day cycle of treatment

Intervention	Participants (Count of Participants)
	Neutrophils	ALT-SGPT	Fatigue	Leukocytes	Rash: acne/acneiform	Thrombosis/thrombus/embolism	Anorexia	AST - SGOT	Hemoglobin	Lymphopenia	Nonneuropathic generalized weakness	Upper GI-hemorrhage NOS	Vascular access-Thrombosis/embolism	Vessel injury - artery - Other NOS	Weight loss
Gemcitabine, Bevacizumab and Erlotinib	4	3	2	2	2	2	1	1	1	1	1	1	1	1	1

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Time to Tumor Progression

"Time to tumor progression (TTP) = time from date of initial treatment to first objective documentation of progressive disease or death; patients who die without a reported prior progression will be considered to have progressed on the day of their death.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions." (NCT00366457)
Timeframe: all patients will be followed for a minimum of 4 months

Intervention	months (Median)
Gemcitabine, Bevacizumab and Erlotinib	3.5

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Overall Survival

overall survival (OS) = time from study entry until death from any cause (NCT00366457)
Timeframe: 5 years

Intervention	months (Median)
Gemcitabine, Bevacizumab and Erlotinib	6.7

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Overall Survival

(NCT00367601)
Timeframe: 12 months

Intervention	months (Median)
Single Arm Assignment	5.1

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Time to Progression

(NCT00367601)
Timeframe: 12 months

Intervention	months (Median)
Single Arm Assignment	3.4

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To Establish Rate of Non-progressive Disease at 4 Months in Patients With Advanced NSCLC Who Have Been Designated PS2 by Their Treating Physician

(NCT00367601)
Timeframe: 4 months

Intervention	percentage of participants (Number)
Single Arm	28

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Median Time to Cancer Recurrence

Per protocol, patients were followed every 3 months for recurrent disease by physical exam and imaging (MRI/CT). Recurrence, in most cases, is detected during routine history/physical exam. If disease was detected during follow-up, every attempt was made to obtain pathological confirmation of recurrence. (NCT00369512)
Timeframe: 2 years

Intervention	months (Median)
Erlotinib	10.5

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Number of Patients With Recurrence at 2 Years

Rate of recurrence at 2 years. (NCT00369512)
Timeframe: 2 years

Intervention	participants (Number)
Erlotinib	4

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Toxicities Associated With Combined Radiotherapy and Erlotinib Treatments.

Number of gradeable toxicities (via CTCAE manual) experienced by patients on this protocol--number of events (NCT00369512)
Timeframe: 2 years

Intervention	number of adverse events (Number)
	Dermatitis	Radiation Dermatitis	Tarceva Dermatitis	Mucositis	Esophagitis	Nausea/Vomitting
Erlotinib	15	14	12	13	11	10

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Overall Survival in Participants With EGFR Mutation - Positive Tumors

"Overall survival is defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive.~Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected." (NCT00373425)
Timeframe: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months)

Intervention	months (Median)
Erlotinib	NA
Placebo	NA

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Overall Survival in Participants With EGFR Mutation - Positive Tumors

"Overall survival is defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive.~Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected." (NCT00373425)
Timeframe: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months)

Intervention	months (Median)
Erlotinib	NA
Placebo	NA

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Overall Survival (OS)

Overall survival was defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive. (NCT00373425)
Timeframe: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).

Intervention	months (Median)
Erlotinib	NA
Placebo	NA

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Disease-free Survival in Participants With EGFR Mutation - Positive Tumors

Disease-free survival (DFS) is the time from the date of randomization until the first day NSCLC relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date. Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected. (NCT00373425)
Timeframe: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months).

Intervention	months (Median)
Erlotinib	47.8
Placebo	28.5

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Disease-free Survival in Participants With EGFR Mutation - Positive Tumors

Disease-free survival (DFS) is the time from the date of randomization until the first day NSCLC relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date. Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected. (NCT00373425)
Timeframe: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).

Intervention	months (Median)
Erlotinib	46.4
Placebo	28.5

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Overall Survival (OS)

Overall survival was defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive. (NCT00373425)
Timeframe: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months).

Intervention	months (Median)
Erlotinib	NA
Placebo	NA

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Disease Free Survival (DFS)

DFS is the time from the date of randomization until the first day that non-small cell lung cancer (NSCLC) relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date. (NCT00373425)
Timeframe: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cutoff date of 11 June 2014 (maximum time on follow-up was 78 months).

Intervention	months (Median)
Erlotinib	55.0
Placebo	56.2

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Disease Free Survival (DFS)

DFS is the time from the date of randomization until the first day non-small cell lung cancer (NSCLC) relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date. (NCT00373425)
Timeframe: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).

Intervention	months (Median)
Erlotinib	50.5
Placebo	48.2

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Number of Participants With Adverse Events (AEs)

"An AE was defined as any untoward medical occurrence in a study participant and did not necessarily have a causal relationship with study treatment.~An AE was considered serious if it resulted in death, a life-threatening situation, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a participant, other important medical events, or is on the Astellas Always Serious List.~A drug-related AE was any AE with at least a possible relationship to study treatment as assessed by the investigator. Severity was graded by the investigator according to the National Cancer Institute Common Terminology Criteria for Adverse Events, v3.0, where Grade 1=Mild AE; Grade=2 Moderate AE; Grade 3=Severe AE; Grade 4=Life-threatening or disabling; Grade 5=Death related to AE. AEs leading to death include deaths that occurred more than 30 days after the last dose of study drug." (NCT00373425)
Timeframe: From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 11.9 months for erlotinib and 21.9 months for placebo. Data are based off the 11 June 2014 data cut-off date.

Intervention	participants (Number)
	Any adverse event (AE)	Grade 3 or higher adverse event	Serious adverse event (SAE)	AE leading to discontinuation of study drug	AE leading to death	AE leading to dose reduction	AE leading to dose interruption	AE leading to dose interruption and reduction	Drug-related AE	Drug-related serious AE	Drug-related AE leading to discontinuation
Erlotinib	599	279	118	205	14	150	114	156	572	15	163
Placebo	307	96	79	29	5	9	23	5	181	5	8

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Median Overall Survival Estimate

(NCT00376948)
Timeframe: up to 17 months

Intervention	months (Median)
Novasoy®, Gemcitabine & Erlotinib	6.3

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Grade 3 or Higher Toxicity Evaluation

Toxicity evaluation using NCI-CTC (Common Terminology Criteria) v.3 criteria; CBC (complete blood count) with differential white cell and platelet counts; Serum sodium, potassium, chloride, bicarbonate, AST, ALT, alkaline phosphatase, total bilirubin, blood urea nitrogen, creatinine, and albumin; Serum CA 19-9 (NCT00376948)
Timeframe: First day of each cycle

Intervention	Participants (Count of Participants)
	diarrhea	fatigue	infection	nausea	neutrophil	pain	platelet	stomach mucostis	vomiting	wbc	other toxicity
Novasoy®, Gemcitabine & Erlotinib	3	5	1	7	4	5	1	1	4	2	4

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Time to Treatment Failure

Intervention	months (Median)
Novasoy®, Gemcitabine & Erlotinib	2.04

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Time to Progression

Intervention	moths (Median)
Novasoy®, Gemcitabine & Erlotinib	2.07

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Response Duration

Imaging tests (CT scan, CXR, MRI or imaging studies as clinically indicated). Progressive disesase is defined as a greater than 20% increase in the sum of the longest diameter of target lesions taking as reference the smalles sum of the longest diameter recorded since the treatment started or the appearance of new lesions. Partial response is defined as greater than or equal to 30% reduction in the sum of the longest diameteres of target lesions, taking as reference the baseline sum of the longest diameters. (NCT00376948)
Timeframe: Every 8 weeks

Intervention	days (Number)
Novasoy®, Gemcitabine & Erlotinib	73

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Patients Alive

(NCT00376948)
Timeframe: at 6 months

Intervention	participants (Number)
Novasoy®, Gemcitabine & Erlotinib	10

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Overall Objective Response Rate (Complete and Partial Response)

Imaging tests (CT scan, CXR [Chest X-Ray], MRI or imaging studies as clinically indicated (NCT00376948)
Timeframe: Every 8 weeks

Intervention	proportion of patients (Number)
Novasoy®, Gemcitabine & Erlotinib	0.056

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Pathological Complete Response Rate

Determine the pathological complete response rate (P0 rate) after undergoing radical cystectomy (RC). Evaluated using Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00380029)
Timeframe: 4 weeks

Intervention	Participants (Count of Participants)
Erlotinib	5

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Number of Subjects Experiencing Adverse Events

The incidence of all toxicities observed during neoadjuvant and adjuvant treatment phase.Toxicity will be graded per the Common Terminology Criteria for Adverse Events (CTCAE) 2.0. (NCT00380029)
Timeframe: 4 weeks - 2 years following surgery

Intervention	Participants (Count of Participants)
	Rash	Anorexia	Diarrea	Fatigue	Lower urinary tract symptoms	Nausea	Cough	Dry skin	Haematuria	Vagal episode	Stomatitus	Pneumonitis	Deep vein thrombosis
Adjuvant Erlotinib	6	0	1	2	0	0	2	1	0	1	2	1	1
Neoadjuvant Erlotinib	15	6	6	6	4	3	3	2	2	1	1	0	0

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Overall Survival Rate

The number of patients who remained alive and with no evidence of disease at the mean (range) follow-up of 24.8 months (3.0-36.6). (NCT00380029)
Timeframe: 25 months

Intervention	Participants (Count of Participants)
Erlotinib	10

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Disease Recurrence and Progression Rates After Cystectomy

To determine disease recurrence/progression rates after cystectomy in patients treated with erlotinib (NCT00380029)
Timeframe: 2 years

Intervention	Participants (Count of Participants)
Erlotinib	4

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EGFR Activation Signal (AKT2) Expression to Predict Sensitivity to Erlotinib

Determine the effect of neoadjuvant erlotinib hydrochloride on histopathological, molecular, and genetic correlates in patients undergoing radical cystectomy for muscle-invasive bladder cancer. Gene expression of pre-treatment and post-treatment tumor samples were analyzed to define molecular determinants of response or resistance to epidermal growth factor receptor (EGFR) inhibition. Both in vitro and in vivo EGFR-associated signatures were evaluated on pre-treatment bladder tumors. Candidate molecular determinants of sensitivity to EGFR inhibition were characterized and examined for their ability to predict sensitivity to EGFR inhibitors in vitro. (NCT00380029)
Timeframe: 4 weeks before treatment and 4 weeks post treatment

Intervention	fold change (Mean)
Downstaged Tumors	-0.29
Not-downstaged	0.128

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Time-to-progression (TTP)

Defined as the time from surgical resection to the time of recurrent disease in the primary or in metastatic sites. (NCT00385996)
Timeframe: Every 3 months for the first 6 months, then yearly for 2 years.

Intervention	Months (Median)
Erlotinib	13.9

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Response Rate Defined as the Percentage of Subjects Achieving at Least 50% Tumor Volume Reduction.

High resolution CT scans for response assessment were obtained at baseline and within 1 week after completion of erlotinib treatment. Volumetric and maximum diameter (RECIST) response criteria was determined by a radiologist blinded to the sequence of treatment. Response rate (RR) is defined as the percentage of subjects achieving at least 50% tumor volume reduction. (NCT00385996)
Timeframe: High resolution CT scans for response assessment will be obtained after 3 weeks of treatment with Tarceva®.

Intervention	Participants (Count of Participants)
Erlotinib	1

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Number of Participants With Grade 3, 4, or 5 Treatment Related Adverse Events as Assessed by CTCAE v3.0.

"Safety will be measured by describing the incidence of AEs, including SAEs and discontinuation of study drug due to AEs, and incidence of abnormal clinical laboratory values from day 1 of treatment.~Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.~Grade 4 - Life-threatening consequences; urgent intervention indicated. Grade 5 - Death related to AE." (NCT00385996)
Timeframe: From Day 1 until 30 days after the last study drug dose,

Intervention	Participants (Count of Participants)
Erlotinib	2

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Disease-free Survival (DFS)

Defined as the time from the start of treatment to the time of recurrent disease in the primary or in metastatic sites. (NCT00385996)
Timeframe: From date of erlotinib start date until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 25 months.

Intervention	Months (Median)
Erlotinib	22.7

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Duration of Progress-free Survival (PFS)

Patients with stable or responding disease will continue treatment until tumor progression is determined (NCT00387894)
Timeframe: Until first observation of progressive disease, non-reversible neurologic progression or permanently increased steroid requirement (stable disease only), death due to any cause (up to 16 weeks)

Intervention	participants (Number)
	2 weeks PFS	3 weeks PFS	6 weeks PFS	12 weeks PFS
Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28	1	1	2	1

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Disease Response Measured Objectively by MRI of Brain

Lack of disease progression indicates response to treatment (NCT00387894)
Timeframe: Every 8 weeks or as indicated

Intervention	participants (Number)
	Disease progression prior to 8 weeks	Disease responsive at 8 Weeks	Disease responsive at 16 Weeks
Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28	4	1	0

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Safety and Toxicity of Erlotinib Hydrochloride and Docetaxel as Measured by NCI CTC v3.0 on Day 8 of Course 1 and on Day 1 of Every Subsequent Course (Phase I [Completed as of 12/01/2004])

(NCT00390429)
Timeframe: Up to 36 months

Intervention	Participants (Count of Participants)
Phase I, Arm A (Completed)	17
Phase I, Arm B (Completed)	25
Phase II	39

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Response Rate (Phase II)

Per Response Evaluation Criteria In Solid Tumors Criteria for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00390429)
Timeframe: Up to 36 months

Intervention	Participants (Count of Participants)
Phase II	11

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Overall Survival (Phase II)

(NCT00390429)
Timeframe: Up to 65 months

Intervention	months (Median)
Phase II	18.2

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Comparison of Toxicity of Two Different Schedules of Erlotinib Hydrochloride and Docetaxel (Phase I [Completed as of 12/01/2004])

(NCT00390429)
Timeframe: up to 36 months

Intervention	participants (Number)
	Neutropenia	Febrile neutropenia	Hemoglobin	Diarrhea	Fatigue	Infection (without neutropenia)	Mucositis	Nausea	Rash
Phase I, Group A (Completed)	10	3	0	0	0	1	0	1	0
Phase I, Group B (Completed)	16	4	1	3	1	3	1	0	1

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Progression-free Survival (Phase II)

(NCT00390429)
Timeframe: Completion of study (up to 65 months)

Intervention	months (Median)
Phase II	4.1

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Frequency and Severity of Toxicities (Phase II)

Treatment-related adverse events Grade ≥3 by NCI CTCAE 2.0. (NCT00390429)
Timeframe: Completion of study (up to 36 months)

Intervention	participants (Number)
	Neutropenia	Febrile neutropenia	Platelets	Diarrhea	Dehydration	Fatigue	Hypokalemia	Hyponatremia	Infection (without neutropenia)	Myalgias	Nausea	Ocular	Pain	Stomatitis
Phase II	14	4	1	7	2	2	1	1	1	1	1	1	1	1

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Maximum Tolerated Dose of Two Different Schedules of Erlotinib Hydrochloride and Docetaxel (Phase I [Completed as of 12/01/2004])

Maximum tolerated dose (MTD) defined as the highest dose level at which no more than one patient experienced DLT when at least 6 patients were treated at that dose level and were assessable for toxicity, graded according to NCI CTCAE 2.0. (NCT00390429)
Timeframe: up to 36 months

Intervention	mg (Number)
Phase I, Group A (Completed)	600
Phase I, Group B (Completed)	200

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Toxicity Profile

Toxicities are assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 3.0. Toxicities are reported as the number of patients who experienced grade 3 or grade 4 adverse events after receiving at least one dose of on-study treatment. (NCT00391586)
Timeframe: 28 days after last on-study treatment

Intervention	participants (Number)
	Acne	Anorexia	Confusion	Dehydration	Diarrhea	Dyspnea	Fatigue	Nasal hemorrhage	Insomnia	Kidney pain	Lymphocyte count decreased	Muscle weakness	Neutrophil count decreased	Desquamating rash	Syncope	Thrombosis (clotting)
Erlotinib Followed by Chemotherapy	1	1	1	1	2	3	8	1	1	1	1	1	2	1	1	1

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Number of Participants With Toxicities According to Severity

Toxicities by Grades 1 or 2 and Grades 3 or 4 in each arm. Grade 4 = life-threatening, Grade 3 = serious, Grade 2 = moderate, Grade 1 = Mild (NCT00392665)
Timeframe: 2 years

Intervention	Participants (Count of Participants)
	Fatigue72408051			Fatigue72408052	Rash72408051	Rash72408052	Diarrhea72408051	Diarrhea72408052	Hypertension72408051	Hypertension72408052	Oral cavity pain72408051	Oral cavity pain72408052	Dry skin72408051	Dry skin72408052	Hearing problems72408051	Hearing problems72408052	Dyspepsia72408052	Dyspepsia72408051	Dry mouth72408051	Dry mouth72408052	Constipation72408051	Constipation72408052	Anorexia72408051	Anorexia72408052	Dehydration72408051	Dehydration72408052	Dyspnea72408051	Dyspnea72408052	Mucositis72408051	Mucositis72408052	Neuropathy-sensory72408052	Neuropathy-sensory72408051	Hemmorrhage72408051	Hemmorrhage72408052	Nausea72408051	Nausea72408052	Vomiting72408051	Vomiting72408052	Insomnia72408051	Insomnia72408052	Pruritus72408051	Pruritus72408052	Hypomagnesemia72408051	Hypomagnesemia72408052
	Did not have	Grades 1 or 2	Grades 3 or 4
Erlotinib + Bevacizumab	10
Erlotinib + Sulindac	8
Erlotinib + Bevacizumab	14
Erlotinib + Sulindac	15
Erlotinib + Bevacizumab	4
Erlotinib + Sulindac	1
Erlotinib + Sulindac	2
Erlotinib + Sulindac	0
Erlotinib + Sulindac	9
Erlotinib + Bevacizumab	18
Erlotinib + Sulindac	3
Erlotinib + Bevacizumab	6
Erlotinib + Bevacizumab	12
Erlotinib + Sulindac	18
Erlotinib + Bevacizumab	2
Erlotinib + Bevacizumab	16
Erlotinib + Bevacizumab	8
Erlotinib + Bevacizumab	0
Erlotinib + Sulindac	16

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Duration of Overall Survival

Median overall survival (OS), determined by the Kaplan-Meier method. (NCT00392665)
Timeframe: 2 years

Intervention	months (Median)
Erlotinib + Bevacizumab	9.38
Erlotinib + Sulindac	8.82

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Efficacy of Erlotinib Plus Bevacizumab (Arm A) or Erlotinib Plus Sulindac (Arm B) as Measured by Progression-free Survival.

The primary outcome will be measured by median progression-free survival (PFS), determined by the Kaplan-Meier method for both Arm A and Arm B. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT00392665)
Timeframe: 1 year

Intervention	months (Median)
Erlotinib + Bevacizumab	9.38
Erlotinib + Sulindac	7.01

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Overall Response Rate (ORR)

"Overall response rate (complete plus partial response=ORR), as determined by RECIST.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR." (NCT00392665)
Timeframe: 2 years

Intervention	percentage of participants (Number)
Erlotinib + Bevacizumab	11.1
Erlotinib + Sulindac	11.1

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Overall Survival (OS)Probability, the Percentage of Patients Estimated to be Alive Two Years After Beginning Protocol Treatment

The Percentage of Patients Estimated to be Alive Two Years After Beginning Protocol Treatment (NCT00392704)
Timeframe: 24 Months

Intervention	percentage of patients (Number)
Intervention	90

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Two-Year Progression Free Survival (PFS) Probability, the Percentage of Patients Estimated to be Alive Without Worsening of Their Disease Two Years After Beginning Protocol Treatment

The percentage of patients estimated to be alive 2 years after beginning protocol treatment (NCT00392704)
Timeframe: 24 months

Intervention	percentage of participants (Number)
Intervention	83

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Progression-Free Survival

Progression-free survival (PFS) was defined as the interval from the date of first treatment until the date of disease progression or death, whichever occurred first. Patients who did not progress were censored at the date of their last tumor assessment. (NCT00393068)
Timeframe: 36 months

Intervention	months (Median)
Treatment	28.58

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Pathologic Complete Response (pCR) Rate

pCR was defined as no residual viable cancer found at the primary site or regional lymph nodes upon pathologic review of the surgical specimen for patients who went to surgical resection. (NCT00393068)
Timeframe: 18 months

Intervention	Participants (Count of Participants)
Treatment	18

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Overall Survival

Overall Survival (OS) is defined as the time interval from the start of treatment until death. Patients who remained alive were censored at the date of their last tumor assessment. (NCT00393068)
Timeframe: 32 months

Intervention	months (Median)
Treatment	30.16

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Oral Cancer-free Survival in Participants Receiving Erlotinib as Compared With the Control Arm or Placebo Group.

Cancer-free survival defined as time from randomization to the development of histologically confirmed oral cancer. (NCT00402779)
Timeframe: 3 years

Intervention	Participants (Count of Participants)
Erlotinib	55
Placebo	18

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Number of Patients Experiencing a DLT

Patients will be followed during cycle 1 for the occurrence of a protocol defined dose limiting toxicity (NCT00408499)
Timeframe: baseline through cycle 1 of treatment

Intervention	Participants (Count of Participants)
Dose Level 1	0
Dose Level 2	1
Dose Level 3	0
Dose Level 4	0

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8 Week Progression-Free Survival Rate (i.e. Disease Control Rate)

"Progression-free survival (i.e. disease control rate) defined as percentage of participants without progression at 8 weeks, evaluation after the second cycle of therapy (i.e., 8 weeks), with confirmation of efficacy 2 cycles after its initial assessment. A success or disease control to treatment is defined as a participant being progression free at 8 weeks after randomization." (NCT00410059)
Timeframe: Radiographic evaluation after cycle 2 (8 weeks of therapy)

Intervention	Participants (Count of Participants)
Erlotinib	20

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Comparison of the Percentage of Participants With a Complete Response in Each Treatment Arm

Complete response requires both a pathological complete response (independent of observer) and a complete response radiologically (RECIST 1.0). (NCT00410826)
Timeframe: 12 weeks after the completion of therapy

Intervention	percentage of participants (Number)
Arm A (Cisplatin and Radiotherapy)	42
Arm B (Cisplatin, Radiotherapy, Erlotinib)	51

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Progression Free Survival of Patients With Locally Advanced Head and Neck Cancer Treated With Cisplatin and Radiotherapy, With and Without Erlotinib Hydrochloride

Intervention	participants (Number)
Arm A (Cisplatin and Radiotherapy)	25
Arm B (Cisplatin, Radiotherapy, Erlotinib)	29

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Number of Participants With 8-week Progression-Free Survival (i.e. Disease Control Rate) Stratified by Cancer Mutation Type

The primary objective is to determine the 8 week progression-free survival rate (i.e. disease control rate) in patients with advanced NSCLC who have failed at least one prior chemotherapy regimen. A radiologist independently assessed DC, which was defined as a complete or partial response or stable disease according to the RECIST(29) at the end of 8 weeks (start of treatment to end of second treatment cycle). PFS was assessed from the date of randomization to the earliest sign of disease progression or death from any cause. OS was assessed from the date of randomization until death from any cause. Tumor response was assessed every 8 weeks until disease progression. Toxicity was assessed in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0. (NCT00411632)
Timeframe: 8 weeks

Intervention	participants (Number)
	EGFR	KRAS/BRAF	VEGF/VEGFR-2	RXR/Cyclin D1	None
Erlotinib + Bexatrtene	11	1	0	1	5

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Number of Participants With Disease Progression

Intervention	participants (Number)
Erlotinib	15
Placebo	11

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Number of Participants Who Died

The number of participants who died from any cause was reported. (NCT00412217)
Timeframe: From inclusion in the study until death from any cause (maximum up to 3 years overall)

Intervention	participants (Number)
Erlotinib	7
Placebo	5

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Time to Progression (TTP)

Tumor response was assessed by the Investigator according to standard-of-care criteria, as there were no protocol-specified criteria for the assessment of tumor response and the instrument for assessment was deferred to the Investigator. TTP was defined as the time from inclusion in the study to the time of disease progression, appearance of second tumor, or death from any cause, whichever occurred first. To ensure comparability, baseline radiological studies later used to verify progression must be performed using identical techniques. The median duration of TTP and corresponding 95% confidence interval (CI) were to be estimated by Kaplan-Meier analysis and expressed in months. (NCT00412217)
Timeframe: From inclusion in the study until disease progression, appearance of second tumor, or death from any cause (maximum up to 3 years overall)

Intervention	months (Median)
Erlotinib	NA
Placebo	NA

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Overall Survival (OS)

OS was defined as the time from inclusion in the study to date of death for any reason. The median duration of OS and corresponding 95% CI were to be estimated by Kaplan-Meier analysis and expressed in months. (NCT00412217)
Timeframe: From inclusion in the study until death from any cause (maximum up to 3 years overall)

Intervention	months (Median)
Erlotinib	NA
Placebo	NA

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To Determine the Safety of Sunitinib in Combination With Erlotinib

(NCT00425386)
Timeframe: For the duration of the study, up to 7 years

Intervention	participants (Number)
	Diarrhea	Rash	Fatigue	Dysguesia	Nausea	Anorexia	Vomitting	Hand-foot syndrome	Stomatitis	Weight loss	Constipation	Dyspepsia	Dry skin	Alopecia	Pruritus	Other skin/hair changes	Dehydration
Sunitinib and Erlotinib	35	35	30	29	21	15	14	13	13	13	12	12	10	9	9	8	5

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Proportion of Patients Whose Best Overall Response is Complete Response, Partial Response, Stable Disease, or Progressive Disease

(NCT00425386)
Timeframe: From the start of treatment until the criteria for response is met.

Intervention	percentage of participants (Number)
	Partial Response	Stable Disease	Progressive Disease
Sunitinib and Erlotinib	22	59	11

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Maximum Tolerated Dose (MTD) of Erlotinib Hydrochloride When Used in Combination With Sunitinib.

The MTD is defined as the dose that produces dose limiting toxicity (DLT) in 33% of the patients. (NCT00425386)
Timeframe: Participants assessed for DLTs weekly during the first cycle of treatment and every 3 weeks in subsequent cycles until at least one DLT occurs in 33% or more of participants at that dose; participants assessed for the duration of the study, up to 7 years

Intervention	milligrams (Number)
	Sunitinib	Erlotinib
Sunitinib and Erlotinib	50	150

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Progression-free Survival at 8 Months

Defined as the proportion of patients who are progression free (CR, PR and SD) at 8 months after initiating treatment with sunitinib in combination with erlotinib in patients with metastatic or unresectable clear cell or papillary carcinoma of the kidney. Complete Response (CR)= disappearance of all target lesions, Partial Response (PR)= At least a 30% decrease in the sum of the longest diameter of target lesions, and Stable Disease (SD)= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (20% increase in the sum). (NCT00425386)
Timeframe: 8 months after initiating treatment with sunitinib in combination with erlotinib in patients with metastatic or unresectable clear cell or papillary carcinoma of the kidney

Intervention	percentage of participants (Number)
Sunitinib and Erlotinib	40

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Median Time to Progression

The Kaplan-Meier method will be used to estimate the median time to progression. (NCT00425386)
Timeframe: For the duration of the study, up to 7 years

Intervention	months (Median)
Sunitinib and Erlotinib	5.8

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Maximum Percent Change in Tumor Measurement

The maximum percent change in Tumor Measurement is the greatest percent change in longest diameter (LD) for the target lesions from the baseline LD. For patients with no change in LD, the maximum percent change is the lowest increase in LD from the baseline LD. (NCT00425386)
Timeframe: Baseline through end of study, up to 7 years

Intervention	percent change in size (Mean)
Sunitinib and Erlotinib	18

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Progression-free Survival

(NCT00436332)
Timeframe: From date of registration to maximum of 3 years

Intervention	months (Median)
Erlotinib and Bevacizumab	5

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Overall Survival

(NCT00436332)
Timeframe: From date of registration to maximum of 3 years

Intervention	months (Median)
Erlotinib and Bevacizumab	21

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Frequency and Severity of Toxicities

(NCT00436332)
Timeframe: From date of registration to maximum of 3 years

Intervention	participants (Number)
	AST, SGOT	Albumin, serum-low (hypoalbuminemia)	Anorexia	Ataxia (incoordination)	CNS cerebrovascular ischemia	Carbon monoxide diffusion capacity (DL(co))	Creatinine	Dehydration	Diarrhea	Dry skin	Dyspnea (shortness of breath)	Extremity-lower (gait/walking)	Fatigue (asthenia, lethargy, malaise)	Hypertension	Hypoxia	Inf w/normal ANC or Gr 1-2 neutrophils - Lung	Left ventricular diastolic dysfunction	Left ventricular systolic dysfunction	Mucositis/stomatitis (clinical exam) - Oral cavity	Mucositis/stomatitis (functional/symp) - Oral cav	Muscle weakness, not d/t neuropathy - body/general	Nail changes	Nausea	Ocular/Visual-Other (Specify)	Pain - Chest wall	Pain - Extremity-limb	Pain - Head/headache	Potassium, serum-high (hyperkalemia)	Potassium, serum-low (hypokalemia)	Proteinuria	Pruritus/itching	Pulmonary/Upper Respiratory-Other (Specify)	Rash/desquamation	Rash: acne/acneiform	Rash: hand-foot skin reaction	Renal failure	Renal/Genitourinary-Other (Specify)	Retinal detachment	Sodium, serum-low (hyponatremia)	Speech impairment (e.g., dysphasia or aphasia)	Syncope (fainting)	Ulcer, GI - Duodenum	Ulcer, GI - Stomach	Ulceration	Vomiting	Weight loss	Wound complication, non-infectious
Erlotinib and Bevacizumab	1	1	2	1	3	1	1	3	12	1	2	1	9	6	2	2	1	1	1	1	2	1	2	1	1	1	2	1	3	3	2	1	5	9	4	1	1	1	2	1	1	1	1	1	1	3	1

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Time to Progression (TTP)

"TTP is defined as the time from initiation of treatment to the date of documented progression.~The median of TTP with 95% confidence interval will be presented.~Progressive disease (target lesions) is defined as at least a 20% increase in the sum of the longest diameter of the target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.~Progressive disease (non-target lesions) is defined as appearance of one or more new lesions. Unequivocal progression of existing non-target lesions." (NCT00442507)
Timeframe: Median follow-up for TTP 6 weeks (6-18 weeks)

Intervention	months (Median)
Erlotinib and Avastin	4.2

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Overall Survival Rate (OS)

OS is defined as the time from initiation of treatment to the date of death for any reason. (NCT00442507)
Timeframe: Median followup time from completion of treatment 325.5 days (44-401 days)

Intervention	months (Median)
Erlotinib and Avastin	10.7

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Incidence and Severity of Toxicities

Grade 3 and higher toxicities using CTCAE Version 3.0. (NCT00442507)
Timeframe: Median follow-up time for toxicities 72 days (72 days-156 days)

Intervention	participants (Number)
	Coagulation: Other, IVC Clot	Death - Disease Progression NOS	Diarrhea	GI: Abdominal hemorrhage, NOS	Pneumonia	Hypernatremia	Confusion
Erlotinib and Avastin	1	1	1	1	1	1	1

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Response Rate (Complete Response (CR), Partial Response (PR), and CR+PR)

"CR = disappearance of all target lesions~PR = at least a 30% decrease in the sum of the LD of the target lesions taking as reference the baseline sum LD." (NCT00442507)
Timeframe: Median follow-up for response 6 weeks (6-18 weeks)

Intervention	participants (Number)
	Complete response	Partial response
Erlotinib and Avastin	0	0

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Overall Survival

death. measured by time of first day of treatment until date of death, assessed up to 2 years. (NCT00445588)
Timeframe: Time of first day of the treatment to death, assessed up to 2 years

Intervention	months (Median)
Treatment	5.7

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6months -Progression-free Survival Rate

defined patient started treatment is alive and progression free at the time of 26-week (6 months) follow-up (NCT00445588)
Timeframe: At 6 months- defined as patient started treatment is alive and progression free at the time of 26-week (6 months) follow-up

Intervention	percentage of participants (Number)
Treatment	14

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Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs

Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included. (NCT00445848)
Timeframe: Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.

Intervention	Participants (Number)
	ALT, SGPT (serum glutamic pyruvic transaminase)	AST, SGOT	Anorexia	Bilirubin (hyperbilirubinemia)	Calcium, serum-low (hypocalcemia)	Colitis, infectious (e.g., Clostridium difficile)	Confusion	Dehydration	Dermatology/Skin-Other (Specify)	Diarrhea	Esophagitis	Fatigue (asthenia, lethargy, malaise)	Hemoglobin	Hemorrhage, GI - Stomach	Hemorrhage, pulmonary/upper respiratory - Lung	Hemorrhage, pulmonary/upper respiratory - Nose	Hypertension	Inf w/normal ANC or Gr 1-2 neutrophils - Lung	Mucositis/stomatitis (clinical exam) - Oral cavity	Mucositis/stomatitis (functional/symp) - Oral cav	Nail changes	Nausea	Neuropathy: motor	Pain - Abdomen NOS	Pain - Bone	Pain - Face	Pain - Joint	Potassium, serum-low (hypokalemia)	Proteinuria	Pruritus/itching	Rash/desquamation	Rash: acne/acneiform	Sodium, serum-low (hyponatremia)	Syncope (fainting)	Ulceration	Voice changes/dysarthria	Weight loss
Erlotinib and Bevacizumab	3	4	1	1	1	1	2	1	1	4	1	5	1	2	1	1	15	1	1	1	1	2	1	1	1	1	1	1	6	1	5	4	4	1	1	1	3

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Progression-free Survival

From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.0), as a 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, or unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided) or appearance of any new lesion/site, or death due to disease without prior documentation of progression and without symptomatic deterioration. (NCT00445848)
Timeframe: Disease assessment is performed every 6 weeks for 18 weeks, then every 9-12 weeks until progression up to 2 years. After disease progression, patients must be followed every 3 months for 1 year and then every 6 months for a maximum of 3 years.

Intervention	months (Median)
Erlotinib and Bevacizumab	7.4

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Overall Survival

From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. (NCT00445848)
Timeframe: Disease assessment is performed every 6 weeks for 18 weeks, then every 9-12 weeks until progression up to 2 years. After disease progression, patients must be followed every 3 months for 1 year and then every 6 months for a maximum of 3 years.

Intervention	months (Median)
Erlotinib and Bevacizumab	29.8

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Response Rate (Complete and Partial)

"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0): Complete Response (CR), Disappearance of all measurable and non-measurable disease; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~All target measurable lesions must be assessed using the same techniques as baseline." (NCT00445848)
Timeframe: Disease assessment is performed every 6 weeks for 18 weeks, then every 9-12 weeks until progression up to 2 years. After disease progression, patients must be followed every 3 months for 1 year and then every 6 months for a maximum of 3 years.

Intervention	participants (Number)
	Complete Response (CR)	Partial Response (PR)	Objective Response Rate (CR + PR)	Stable Disease (SD)	Non-Progression (ORR+SD)	Progressive Disease (PD)	Not Determinable/ Inadequate Assessment
Erlotinib and Bevacizumab	2	31	33	23	56	8	2

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Percentage of Participants Surviving at 1 Year

Overall Survival (OS) rate at 1 year from the date of randomization was determined using the distribution of OS times and was estimated using the Kaplan-Meier method. (NCT00447057)
Timeframe: Baseline to date of death from any cause up to 1 year

Intervention	Percentage participants with OS ≥1 year (Median)
Pemetrexed (Nonsquamous)	34.1
Pemetrexed + Erlotinib (Nonsquamous)	49.4

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Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR) (Response Rate)

"CR: Disappearance of all tumor lesions; PR: Either a) at least a 30% decrease in sum of LD of target lesions or b) complete disappearance of target lesions, with persistence (but not worsening) ≥1 nontarget lesions. In either case, no new lesions may have appeared.~SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.~PD: ≤20% increase in the sum of LD of target lesions. Response Rate (%) = (CR+PR)/number of participants in arm*100." (NCT00447057)
Timeframe: Baseline to measured progressive disease. Maximum follow-up was from Baseline to 34 months

Intervention	percentage of participants (Number)
Pemetrexed (Nonsquamous)	10.8
Pemetrexed + Erlotinib (Nonsquamous)	17.1

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Percentage of Participants With Best Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR) (Disease Control Rate)

"Per RECIST:~CR: Disappearance of all target lesions; PR: Either a) ≤30% decrease in sum of longest diameter (LD) of target lesions or b) complete disappearance of target lesions, with persistence (but not worsening) of ≥1 nontarget lesions. In either case, no new lesions may have appeared.~SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.~PD: ≤20% increase in sum of LD of target lesions. Disease Control Rate (%) = (SD+PR+CR)/number of participants in arm*100." (NCT00447057)
Timeframe: Baseline to measured PD. Maximum follow-up was from Baseline to 34 months

Intervention	percentage of participants (Number)
Pemetrexed (Nonsquamous)	51.8
Pemetrexed + Erlotinib (Nonsquamous)	55.3

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Progression Free Survival (PFS)

PFS per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria using computed tomography (CT) or magnetic resonance imaging (MRI) for objective determination of progressive disease (PD: ≤20% increase in sum of longest diameter of target lesion). For participants alive as of data cut-off date who did not have PD, PFS was censored at date of last CT/MRI. For participants who received subsequent systemic anticancer therapy (after study discontinuation) prior to PD or death, PFS censored at date of last CT/MRI prior to initiation of post discontinuation systemic anticancer therapy. (NCT00447057)
Timeframe: Baseline to date of measured PD or death from any cause. Maximum follow-up was from baseline to 32.2 months

Intervention	months (Median)
Pemetrexed (Nonsquamous)	2.9
Pemetrexed + Erlotinib (Nonsquamous)	3.2

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Time to Treatment Failure (TTTF)

"Defined as the time from randomization to death from any cause, first observation of PD, or study treatment discontinuation due to any reason other than protocol complete or satisfactory response. For participants who discontinued due to protocol complete or satisfactory response, or for participants not known to have discontinued as of the data cut-off date, TTTF was censored at the last contact date." (NCT00447057)
Timeframe: "Baseline to first date among death from any cause, PD, or study treatment discontinuation for any reason other than protocol complete or satisfactory response. Maximum follow-up was from Baseline to 32.2 months"

Intervention	months (Median)
Pemetrexed (Nonsquamous)	2.4
Pemetrexed + Erlotinib (Nonsquamous)	3.0

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Number of Participants With Adverse Events (AEs)

Summaries of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module. (NCT00447057)
Timeframe: Baseline up to 42.2 months

Intervention	participants (Number)
	serious adverse events	other adverse events
Pemetrexed (Nonsquamous and Squamous)	43	91
Pemetrexed + Erlotinib (Nonsquamous and Squamous)	53	98

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Overall Survival (OS)

OS time is the duration from randomization to the date of death from any cause. For each participant who was not known to have died as of the data inclusion cut-off date, OS was censored at the date of last contact. (NCT00447057)
Timeframe: Baseline to date of death from any cause. Maximum follow-up was from Baseline to 42.6 months.

Intervention	months (Median)
Pemetrexed (Nonsquamous)	7.8
Pemetrexed + Erlotinib (Nonsquamous)	11.8

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Phase 2: Overall Survival (OS)

OS was defined as the time from the date of study enrollment (baseline) to the date of death from any cause. For participants not known to have died as of the data cutoff date, OS was censored at the last contact date (last contact for participants in post discontinuation was equal to the last known alive date in mortality status). (NCT00452413)
Timeframe: Phase 2: Baseline to date of death from any cause (up to 23 months)

Intervention	months (Median)
Phase 2 (Enzastaurin 500 mg, Erlotinib 150 mg)	8.3

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Recommended Phase 2 Dose for Enzastaurin Plus Erlotinib Combination Therapy (Assess the Tolerated Dose of the Combination Erlotinib and Enzastaurin)

The recommended Phase 2 daily dose level was to be either 1 dose level below that in which 2 of 6 participants experienced dose-limiting toxicities (DLTs) in Phase 1 or the full doses of both enzastaurin and erlotinib (Phase 1, Dose Level 2) in the event that no more than 1 DLT occurred at the highest dose level (Dose Level 2). DLTs were defined as any of the following events during Phase 1, Cycle 1 that were considered by the investigator to be attributable to enzastaurin or the combination of enzastaurin with erlotinib: Grade 4 hematologic events; Grade 3 or 4 nonhematologic events except toxicities explained by a coexisting condition such as glucose disturbances in a diabetic or electrolyte imbalances from diarrhea or vomiting, and toxicities of nausea, vomiting, diarrhea, or skin rash that were tolerable with appropriate treatment. (NCT00452413)
Timeframe: Phase 1: Predose through end of Cycle 1 (28 days/cycle)

Intervention	milligrams per day (mg/day) (Number)
	Enzastaurin	Erlotinib
Phase 1, Dose 1 and 2 (Enzastaurin and Erlotinib)	500	150

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Phase 2: Progression-Free Survival (PFS) With the Enzastaurin Plus Erlotinib Combination Regimen

PFS was defined as the time from the date of study enrollment (baseline) to the first date of progressive disease (PD) (either objectively determined or clinical progression) or death from any cause. PD was defined by Response Evaluation Criteria in Solid Tumors [RECIST, version (v) 1.0] as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. For participants not known to have died as of the data cut-off date and who did not have PD, PFS was censored at the date of the last visit with adequate assessment. For participants who received subsequent anticancer therapy (after discontinuation from study treatment) prior to disease progression or death, PFS was censored at the date of last visit with adequate assessment prior to the initiation of post discontinuation anticancer therapy. (NCT00452413)
Timeframe: Phase 2: Baseline to measured PD (up to 20 months)

Intervention	months (Median)
Phase 2 (Enzastaurin 500 mg, Erlotinib 150 mg)	1.7

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Phase I: Pharmacokinetic (PK) Interactions Between Enzastaurin and Erlotinib: Apparent Oral Clearance of Erlotinib Under Steady State Conditions During Multiple Dosing (CLss/F)

Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL obtained after an oral dose (apparent oral CL) is influenced by the fraction of the dose absorbed (F). Drug CL is a quantitative measure of the rate at which a drug substance is removed from the blood. Apparent oral CL of erlotinib over 10 hours at steady state (ss) on Day 22 was calculated. (NCT00452413)
Timeframe: Phase 1: Cycle 1, Day 22 [predose, 2 hours (h), 4 h, 6 h, 10 h postdose]

Intervention	Liters per hour (L/h) (Geometric Mean)
Phase 1, Dose 1 (Enzastaurin 250 mg, Erlotinib 150 mg)	6.07
Phase 1, Dose 2 (Enzastaurin 500 mg, Erlotinib 150 mg)	5.75

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Phase 2: Percentage of Participants With Tumor Response

Tumor response was defined using RECIST, v1.0 criteria. CR was the disappearance of all target lesions; PR was either a ≥30% decrease in sum of LD of target lesions or a complete disappearance of target lesions, with persistence (but not worsening) of ≥1 nontarget lesion. PD was a ≥20% increase in sum of LD of target lesions, taking as references the smallest sum LD recorded since treatment started or the appearance of ≥1 new lesion. Stable Disease (SD) was defined as small changes that did not meet the above criteria. Percentage of participants with tumor response=[(number of participants with a CR, PR, SD, PD, and unknown response)/(total number of participants assessed)]*100. (NCT00452413)
Timeframe: Phase 2: Baseline to date of PD (up to 18 months)

Intervention	percentage of participants (Number)
	CR	PR	SD	PD	Unknown
Phase 2 (Enzastaurin 500 mg, Erlotinib 150 mg)	0	10.2	20.4	42.9	26.5

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Phase 2: Number of Participants Who Experienced TEAEs (Safety and AE Profile)

A TEAE is any untoward medical occurrence that either occurred or worsened any time after treatment baseline, which did not necessarily have a causal relationship with this treatment. A summary of serious and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. (NCT00452413)
Timeframe: Phase 2: Baseline through 30 days post last dose (up to 24 Cycles, 28 days/cycle)

Intervention	participants (Number)
Phase 2 (Enzastaurin 500 mg, Erlotinib 150 mg)	48

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Phase I: PK Interactions Between Enzastaurin and Erlotinib: Maximum Observed Plasma Concentration at Steady State (Cmax,ss)

Maximum observed plasma concentration at steady state (Cmax,ss) of enzastaurin, its active metabolite (LSN326020) and total analyte were reported. (NCT00452413)
Timeframe: Phase 1: Cycle 1, Day 22 (predose, 2 h, 4 h, 6 h, 8 h postdose)

Intervention	nanomoles per liter (nmol/L) (Geometric Mean)
	Enzastaurin	LSN326020	Total Analyte
Phase 1, Dose 1 (Enzastaurin 250 mg, Erlotinib 150 mg)	618	431	978
Phase 1, Dose 2 (Enzastaurin 500 mg, Erlotinib 150 mg)	1600	980	2620

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Phase I: Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) (Safety and AE Profile for Enzastaurin/Erlotinib Combination)

A TEAE is any untoward medical occurrence that either occurred or worsened any time after treatment baseline, which did not necessarily have a causal relationship with this treatment. A summary of serious and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. (NCT00452413)
Timeframe: Phase 1: First dose through 30 days post last dose (up to 14 Cycles, 28 days/cycle)

Intervention	Participants (Number)
Phase 1, Dose 1 (Enzastaurin 250 mg, Erlotinib 150 mg)	4
Phase 1, Dose 2 (Enzastaurin 500 mg, Erlotinib 150 mg)	12

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Phase I: PK Interactions Between Enzastaurin and Erlotinib: Area Under the Plasma Concentration Time Curve at Steady State [AUC(Tau,ss)]

Area under the plasma concentration time curve AUC(Tau,ss) of enzastaurin, its active metabolite (LSN326020) and total analyte were reported. (NCT00452413)
Timeframe: Phase 1, Cycle 1, Day 22 (predose, 2 h, 4 h, 6 h, and 8 h postdose)

Intervention	nanomoleshours per liter (nmolh/L) (Geometric Mean)
	Enzastaurin	LSN326020	Total Analyte
Phase 1, Dose 1 (Enzastaurin 250 mg, Erlotinib 150 mg)	6590	7100	14000
Phase 1, Dose 2 (Enzastaurin 500 mg, Erlotinib 150 mg)	18000	18000	37100

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Phase 2: Duration of Response

Duration of response: time from first objective assessment of complete response (CR) or partial response (PR) to first observation of PD. Using RECIST v1.0 criteria, CR was the disappearance of all target lesions; PR was either a ≥30% decrease in sum of LD of target lesions or a complete disappearance of target lesions, with persistence (but not worsening) of ≥1 nontarget lesion; PD was a ≥20% increase in sum of LD of target lesions, taking as references the smallest sum LD recorded since treatment started or the appearance of ≥1 new lesion. For responding participants not known to have died and who did not have PD, duration of response was censored at date of the last visit with adequate assessment. For responding participants who received subsequent anticancer therapy (after discontinuation from study treatment) prior to PD, duration of response was censored at the date of last visit with adequate assessment prior to the initiation of post discontinuation anticancer therapy. (NCT00452413)
Timeframe: Phase 2: Date of first response to date of PD (up to 18 months)

Intervention	months (Median)
Phase 2 (Enzastaurin 500 mg, Erlotinib 150 mg)	8.7

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Progression Free Survival (PFS) of Groups by FDG Response at Day 56

"PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first.~PFS was compared between patients with FDG-PET response and patients without FDG-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib.~Mean of the percent changes in maximal standard uptake values (mSUVmax) from FDG-PET scans was used to define FDG-PET response. Based on European Organization for Research on the Treatment of Cancer (EORTC) definitions, an objective FDG-PET response was defined an mSUVmax <-25%." (NCT00453362)
Timeframe: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years

Intervention	weeks (Median)
Erlotinib_FDG Responders	28.1
Erlotinib_ FDG Non-Responders	12.1

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Progression Free Survival of Groups by FLT Response at Day 56

"PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first.~PFS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib.~FLT-PET response was defined as a mSUVmax from FLT-PET scans <-25%." (NCT00453362)
Timeframe: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years

Intervention	weeks (Median)
Erlotinib_FLT Responders	39.9
Erlotinib_ FLT Non-Responders	13.1

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Progression Free Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56

"PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first.~PFS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of computed tomography (CT) response (per RECIST 1.0) at Day 56 of treatment with erlotinib.~FLT-PET response was defined as a mSUVmax from FLT-PET scans <-25% and FLT-PET disease progression was defined as a mSUVmax from FLT-PET scans >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause." (NCT00453362)
Timeframe: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years

Intervention	weeks (Median)
Erlotinib_FLT Responders With CT SD at Day 56	NA
Erlotinib_FLT Progressive Disease With CT SD at Day 56	12.9

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FDG Response in Subgroups by CT Response at Day 56

"In patients with partial response or progressive disease on CT (per RECIST 1.0) after 56 days of erlotinib treatment, the percentage of patients who demonstrated FDG-PET responses on Day 56 defined as a mSUVmax from FDG-PET scans <-25%.~CT Partial Response defined as a 30% decrease in the sum of the longest diameter (LD) of target lesion taking as reference the baseline sum of the LD.~CT Progressive disease defined as a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum LD since treatment started or appearance of 1 or more new lesions." (NCT00453362)
Timeframe: Day 56

Intervention	Percentage of participants (Number)
	CT Partial response (n=4)	CT Progressive Disease (n=21)
Erlotinib	75	0

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FLT Response in Subgroups by CT Response at Day 56

"In patients with partial response or progressive disease on CT (per RECIST 1.0) after 56 days of erlotinib treatment, the percentage of patients who demonstrated FLT-PET responses on Day 56 defined as a mSUVmax from FLT-PET scans <-25%.~CT Partial Response defined as a 30% decrease in the sum of the longest diameter (LD) of target lesion taking as reference the baseline sum of the LD.~CT Progressive disease defined as a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum LD since treatment started or appearance of 1 or more new lesions." (NCT00453362)
Timeframe: Day 56

Intervention	Percentage of participants (Number)
	CT Partial response (n=4)	CT Progressive Disease (n=20)
Erlotinib	50	0

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Percentage of Patients With FLT-PET Responses

"In patients with CT-stable disease (according to RECIST 1.0) at 56 days of erlotinib treatment, the percentage of patients who demonstrated FLT-PET responses after the initial 14 days and 56 days of erlotinib treatment.~FLT-PET response was defined as a mSUVmax from FLT-PET scans <-25%. CT SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started." (NCT00453362)
Timeframe: Day 14 and Day 56

Intervention	Percentage of Participants (Number)
	Day 14 response	Day 56 response
Erlotinib	7.7	7.7

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PFS of Patients With FDG-PET Complete Response (CR)/Partial Response (PR) Versus FDG-PET Progressive Disease (PD) in Patients With Computed Tomography (CT) Stable Disease (SD) at Day 56

"PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first.~PFS was compared between patients with FDG-PET response (Complete /Partial Responses) and patients with FDG-PET progression, within the subset of patients who demonstrated stable disease on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib. FDG-PET response; defined as a mSUVmax from FDG-PET scans of <-25% and FDG-PET disease progression; defined as a mSUVmax >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause." (NCT00453362)
Timeframe: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years

Intervention	weeks (Median)
Erlotinib_FDG Responders With CT SD at Day 56	32.1
Erlotinib_FDG Progressive Disease With CT SD at Day 56	14.9

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Number of Participants With Adverse Events Due to FLT-PET Imaging

The number of participants who experienced an adverse event judged by the investigator to be related to FLT-PET. (NCT00453362)
Timeframe: From screening to Day 112 assessment visit or study discontinuation or termination, whichever is first. On visits after Day 112, only SAE were recorded.

Intervention	Participants (Number)
Overall Study Participants	0

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Percentage of Patients With FDG-PET Responses

"In patients with computed tomography (CT)-stable disease (according to RECIST 1.0) at 56 days of erlotinib treatment, the percentage of patients who demonstrated FDG-PET responses after the initial 14 days and 56 days of erlotinib treatment.~FDG-PET response was defined as a mSUVmax from FDG-PET scans <-25%.~CT SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started." (NCT00453362)
Timeframe: Day 14 and Day 56

Intervention	Percentage of Participants (Number)
	Day 14 response	Day 56 response
Erlotinib	7.7	11.5

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Overall Survival of Groups by FDG Response at Day 56

"Overall survival (OS) was defined as the time from the date of first erlotinib dose to death.~Overall survival (OS) was compared between patients with FDG-PET response and patients without FDG-PET response, independent of Response Evaluation Criteria in Solid Tumors (RECIST 1.0) computed tomography (CT) response at Day 56 of treatment with erlotinib. FDG-PET response was defined as a mSUVmax from FDG-PET scans <-25%." (NCT00453362)
Timeframe: From first erlotinib treatment to death, assessed up to 2 years

Intervention	months (Median)
Erlotinib_FDG Responders	NA
Erlotinib_ FDG Non-Responder	7.8

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Overall Survival of Groups by FLT Response at Day 56

"Overall survival (OS) was defined as the time from the date of first erlotinib dose to death.~OS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib.~FLT-PET response was defined as a mSUVmax from FLT-PET scans <-25%." (NCT00453362)
Timeframe: From first erlotinib treatment to death, assessed up to 2 years

Intervention	months (Median)
Erlotinib_FLT Responders	NA
Erlotinib_ FLT Non-Responders	8.4

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Overall Survival of Patients With FDG CR/PR Versus FDG PD in Patients With CT SD at Day 56

"Overall survival (OS) was defined as the time from the date of first erlotinib dose to death.~OS was compared between patients with FDG-PET response and patients with FDG-PET progression, within the subset of patients who demonstrated stable disease (SD) on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib.~FDG-PET response was defined as a mSUVmax from FDG-PET scans <-25% and FDG-PET disease progression was defined as a mSUVmax from FDG-PET scans >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause." (NCT00453362)
Timeframe: From first erlotinib treatment to death, assessed up to 2 years

Intervention	months (Median)
Erlotinib_FDG Responders With CT SD at Day 56	12.2
Erlotinib_FDG Progressive Disease With CT SD at Day 56	8.8

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Overall Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56

"Overall survival (OS) was defined as the time from the date of first erlotinib dose to death.~OS was compared between patients with FLT-PET response and patients with FLT-PET progression, within the subset of patients who demonstrated SD on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib.~FLT-PET response was defined as a mSUVmax from FLT-PET scans of <-25% and FLT-PET disease progression was defined as a mSUVmax from FLT-PET scans >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause." (NCT00453362)
Timeframe: From first erlotinib treatment to death, assessed up to 2 years

Intervention	months (Median)
Erlotinib_FLT Responders With CT SD at Day 56	NA
Erlotinib_FLT Progressive Disease With CT SD at Day 56	8

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EuroQol 5-Dimension Questionnaire (EQ-5D)- Health State Profile Utility Score

"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state." (NCT00457392)
Timeframe: Baseline and End of Treatment (EOT) or Withdrawal

Intervention	Units on a scale (Mean)
	Baseline	End of Treatment (n= 285, 301)
Erlotinib	0.716	0.598
Sunitinib + Erlotinib	0.750	0.615

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Progression-Free Survival (PFS)

"Time in weeks from assignment to study medication to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)." (NCT00457392)
Timeframe: Baseline to disease progression or death due to any cause or 28 days after last dose

Intervention	Weeks (Median)
Sunitinib + Erlotinib	15.5
Erlotinib	8.7

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Duration of Response (DR)

Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. (NCT00457392)
Timeframe: Baseline to disease progression or death or discontinuation from study or 28 days after last dose

Intervention	Weeks (Median)
Sunitinib + Erlotinib	39.6
Erlotinib	32.3

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One-year Survival Probability

The 1 year survival probability was defined as the probability of survival at one year after the date of the start of the study treatment based on the Kaplan Meier estimate. (NCT00457392)
Timeframe: Baseline until death or until 28 days after last dose for the last participant

Intervention	Percent chance of survival (Number)
Sunitinib + Erlotinib	40.0
Erlotinib	37.0

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Overall Survival (OS)

Overall survival is the duration from assignment to study medication to death. For participants who are alive, overall survival is censored at the last contact. (NCT00457392)
Timeframe: Baseline to death or 28 days after last dose for the last participant

Intervention	Months (Median)
Sunitinib + Erlotinib	9.0
Erlotinib	8.5

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Percentage of Participants With Objective Response (OR)

Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as disappearance of all lesions (target and/or non target). PR are those with at least 30% decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent. (NCT00457392)
Timeframe: Baseline to disease progression or discontinuation from study or 28 days after last dose

Intervention	Percentage of participants (Number)
Sunitinib + Erlotinib	10.60
Erlotinib	6.90

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Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST

As per RECIST V 1.0: for TLs, a CR was defined as the disappearance of all TLs; and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Participants for whom no assessment of response was available and who had finalized the study due to disease progression or tumor-related death, disease progression was considered the BOR. (NCT00461708)
Timeframe: Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.

Intervention	percentage of participants (Number)
Erlotinib, Gemcitabine: Rash Grade < 2	7.0
Erlotinib, Gemcitabine: Rash Grade ≥ 2	21.1

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OS At 6 Months

OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology. (NCT00461708)
Timeframe: Enrollment through Cycle 6 (4-week cycles), up to 6 months.

Intervention	months (Median)
Erlotinib, Gemcitabine: Rash Grade < 2	4.468
Erlotinib, Gemcitabine: Rash Grade ≥ 2	NA

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Percentage of Participants With Disease Control According to RECIST

Disease control was defined as BOR of CR, PR, or stable disease (SD). As per RECIST V 1.0: for TLs, a CR was defined as the disappearance of all TLs; and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD was defined as the persistence of one or more NTLs and/or maintenance of tumor marker level above the normal limits. Participants for whom no assessment of response was available and who had finalized the study due to disease progression or tumor-related death, disease progression was considered the BOR. (NCT00461708)
Timeframe: Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.

Intervention	percentage of participants (Number)
Erlotinib, Gemcitabine: Rash Grade < 2	42.6
Erlotinib, Gemcitabine: Rash Grade ≥ 2	84.2

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PFS

The time, in months, from enrollment to PFS event. Participants whose last recorded status was not progression or death were censored. PFS was estimated using Kaplan-Meier methodology. (NCT00461708)
Timeframe: Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months

Intervention	months (Median)
Erlotinib, Gemcitabine: Rash Grade < 2	2.497
Erlotinib, Gemcitabine: Rash Grade ≥ 2	6.439

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OS By Rash Grade

Intervention	months (Median)
Erlotinib, Gemcitabine: Rash Grade 0	3.318
Erlotinib, Gemcitabine: Rash Grade 1	6.571
Erlotinib, Gemcitabine: Rash Grade ≥ 2	10.546

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Number of Participants Who Died During the Study By Rash Grade

(NCT00461708)
Timeframe: Enrollment through Cycle 24 (4-week cycles), up to 24 months.

Intervention	participants (Number)
Erlotinib, Gemcitabine: Rash Grade 0	65
Erlotinib, Gemcitabine: Rash Grade 1	37
Erlotinib, Gemcitabine: Rash Grade ≥ 2	27

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Number of Participants With Disease Progression or Death

Progression-free survival (PFS) was defined as the time from the date of enrollment to the date of document disease progression or death due to any cause. As per Response Evaluation Criteria in Solid Tumors (RECIST) V 1.0, progressive disease (PD) was defined for target lesions (TLs) as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment, and for non-target lesions (NTLs) as unequivocal progression of NTLs. Participants whose last recorded status was not PD or death were censored. (NCT00461708)
Timeframe: Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.

Intervention	participants (Number)
Erlotinib, Gemcitabine: Rash Grade < 2	110
Erlotinib, Gemcitabine: Rash Grade ≥ 2	33

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Number of Participants Who Died at 6 Months

(NCT00461708)
Timeframe: Enrollment through Cycle 6 (4-week cycles), up to 6 months.

Intervention	participants (Number)
Erlotinib, Gemcitabine: Rash Grade < 2	69
Erlotinib, Gemcitabine: Rash Grade ≥ 2	8

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Number of Participants Who Died During the Study

(NCT00461708)
Timeframe: Enrollment through Cycle 24 (4-week cycles), up to 24 months.

Intervention	participants (Number)
Erlotinib, Gemcitabine: Rash Grade < 2	102
Erlotinib, Gemcitabine: Rash Grade ≥ 2	27

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Overall Survival (OS) During the Study

Intervention	months (Median)
Erlotinib, Gemcitabine: Rash Grade < 2	4.468
Erlotinib, Gemcitabine: Rash Grade ≥ 2	10.546

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Number of Patients With Response

Per Response Evaluation Criteria in Solid Tumor (RECIST): Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD. (NCT00466687)
Timeframe: At 6 months

Intervention	participants (Number)
	Complete Response	Partial Response	Stable Disease	Progressive Disease
Tarceva/Avastin	0	2	14	15

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Time to Disease Progression.

Time from on study date to date of progression in months, if the progression happened in the patient. Disease progression is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions with reference to the smallest sum LD since treatment began or the appearance of one or more new lesions. (NCT00466687)
Timeframe: up to one year after off-study date

Intervention	Months (Median)
Tarceva/Avastin	3

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Progression-free Survival at 6 Months

Patients with Progression-free survival at 6 months (NCT00466687)
Timeframe: 6 months

Intervention	participants (Number)
Therapeutic Intervention	7

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Number of Patients With Each Worst-grade Toxicity Response

Number of patients with worst-grade toxicity at each of five grades following National Cancer Institute Common Toxicity Criteria with grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening/disabling, 5 = death. (NCT00466687)
Timeframe: Day 1 of each 28-day cycle for 6 cycles (168 days)

Intervention	participants (Number)
	No. of patients with worst-grade toxicity of 1	No. of patients with worst-grade toxicity of 2	No. of patients with worst-grade toxicity of 3	No. of patients with worst-grade toxicity of 4	No. of patients with worst-grade toxicity of 5
Tarceva/Avastin	3	12	7	1	0

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Progression-free Survival

Intervention	months (Median)
Erlotinib (Tarceva)	1.4

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Response Rate

Response is defined as achieving complete or partial response.Complete response (CR) for both cohorts was defined as resolution of all identified tumor masses on the vulva or disappearance of all target and non-target lesions with no evidence of new lesions documented by two disease assessments at least 4 weeks apart. For cohort 1 pts, a partial response (PR) was defined as a 30% reduction in the product of all diameters of the vulva tumor/tumors compared to baseline measurements. For cohort 2 pts, PR defined according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) was at least a 30% decrease in the sum of the longest diameter (LD) of all target measurable lesions (baseline sum LD reference). (NCT00476476)
Timeframe: Assessed prior to definitive surgery or chemoradiation therapy (cohort 1 pts) or after 2 cycles of therapy (cohort 2 pts).

Intervention	proportion of participants (Number)
Erlotinib-Cohort 1	.35
Erlotinib-Cohort 2	.22

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Number of Participants Reported at Least 1 Adverse Event With a Grade of 3 and Above

The worst grade of pre-listed toxicity will be summarized by participant and by visit for each treatment group. Descriptive statistics (frequencies and percents) will be used to summarize data and hypotheses about group differences will be tested where appropriate. (NCT00482625)
Timeframe: Up to 20 weeks

Intervention	participants (Number)
Treatment (Enzyme Inhibitor Therapy)	0

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Reduction in Number of Positive IPMN Celss and Staining Intensity After Treatment

Number of participants showed a reduction in number of positive IPMN cells and staining intensity after treatment (NCT00482625)
Timeframe: Pre-treatment and post-treatment

Intervention	participants (Number)
Treatment (Enzyme Inhibitor Therapy)	2

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Plasma Calculated Concentration - OSI-774 (ng/mL)

Plasma concentration levels of Erlotinib (OSI-774) (NCT00482625)
Timeframe: 20 weeks

Intervention	ng/mL (Mean)
Treatment (Enzyme Inhibitor Therapy)	428.5

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Plasma Calculated Concentration - OSI-420 (ng/mL)

Plasma concentration levels of Erlotinib (OSI-420) (NCT00482625)
Timeframe: 20 weeks

Intervention	ng/mL (Mean)
Treatment (Enzyme Inhibitor Therapy)	27.6

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Pancreas Calculated Concentration - OSI-774 (ng/g)

Pancreatic tissue concentration levels of Erlotinib (OSI-774) (NCT00482625)
Timeframe: 20 weeks

Intervention	ng/g (Mean)
Treatment (Enzyme Inhibitor Therapy)	188.7

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Pancreas Calculated Concentration - OSI-420 (ng/g)

Pancreatic tissue concentration levels of Erlotinib (OSI-420) (NCT00482625)
Timeframe: 20 weeks

Intervention	ng/g (Mean)
Treatment (Enzyme Inhibitor Therapy)	17.3

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Progression-free Survival - EGRF

Estimated using the product-limit method of Kaplan and Meier.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions. (NCT00499655)
Timeframe: Until disease progression, up to 5 years.

Intervention	Months (Median)
ErlotinibPlacebo	1.8
ErlotinibCelecoxib	3.2

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Progression-free Survival - Elevated PGEM

Intervention	Months (Median)
ErlotinibPlacebo	2.2
ErlotinibCelecoxib	5.4

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Progression-free Survival - Low PGEM

Intervention	Months (Median)
ErlotinibPlacebo	5.4
ErlotinibCelecoxib	6.8

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Progression-free Survival

Intervention	Months (Median)
ErlotinibPlacebo	3.5
ErlotinibCelecoxib	5.4

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Number of Participants With Overall Response

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR (NCT00499655)
Timeframe: 16 weeks post start of treatment

Intervention	Participants (Count of Participants)
ErlotinibPlacebo	17
ErlotinibCelecoxib	12

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Disease Control Rate

Disease control rate was defined as the percentage of participants who have any evidence of confirmed objective CR or PR or Stable disease (SD) (where SD was maintained for 8 weeks), as assessed by the RECIST version 1.0 criteria. As per the RECIST Version 1.0 CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum of the LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of the LD since the treatment started. PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum of the LD recorded since the treatment started or the appearance of one or more new lesions. (NCT00518011)
Timeframe: Up to 2 years

Intervention	Percentage of participants (Number)
Gemcitabine	50
Erlotinib + Gemcitabine	85.7

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Mean Change in Body Temperature From Baseline

Mean change in body temperature from Baseline for each cycle calculated as Day 1 of each cycle value minus baseline value. (NCT00518011)
Timeframe: Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)

Intervention	Fahrenheit (Mean)
	Cycle 1 (n=8, 8)	Cycle 2 (n=7, 6)	Cycle 3 (n=4, 5)	Cycle 4 (n=1, 5)	Cycle 5 (n=1, 3)	Cycle 6 (n=1, 2)
Erlotinib + Gemcitabine	-0.012	-0.30	-0.32	-0.24	-0.46	-0.20
Gemcitabine	-0.02	0.14	-0.07	-0.60	-0.70	-0.20

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Progression Free Survival

Progression free survival was defined as the interval between the day of randomization and the date of the first documentation of disease progression or date of death (from any cause), whichever occurs first. (NCT00518011)
Timeframe: Up to 2 years

Intervention	Week (Median)
Gemcitabine	23.3
Erlotinib + Gemcitabine	24.4

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Duration of Response

Duration of response was defined as the interval between the date of CR or PR was first recorded to the date on which progressive disease was first noted or date of death. (NCT00518011)
Timeframe: Up to 2 years

Intervention	Week (Mean)
Erlotinib + Gemcitabine	16.3

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Mean Change in Blood Pressure From Baseline

Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were recorded as vital parameters in this study. Mean change in SBP and DBP from Baseline for each cycle calculated as Day 1 of each cycle value minus baseline value. (NCT00518011)
Timeframe: Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)

Intervention	mm Hg (Mean)
	SBP at Cycle 1 (n=8, 8)	DBP at Cycle 1 (n=8, 8)	SBP at Cycle 2 (n=7, 6)	DBP at Cycle 2 (n=7, 6)	SBP at Cycle 3 (n=4, 5)	DBP at Cycle 3 (n=4, 5)	SBP at Cycle 4 (n=1, 5)	DBP at Cycle 4 (n=1, 5)	SBP at Cycle 5 (n=1, 3)	DBP at Cycle 5 (n=1, 3)	SBP at Cycle 6 (n=1, 2)	DBP at Cycle 6 (n=1, 2)
Erlotinib + Gemcitabine	-0.87	-5.37	-17.83	-9.50	-17.20	-9.20	-10.20	-1.60	-1.66	0.66	5.00	-0.50
Gemcitabine	3.00	-6.87	-4.85	-10.71	-9.00	-8.25	-18.00	-4.00	28.00	12.00	10.00	5.00

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Mean Change in Pulse Rate From Baseline

Mean change in pulse rate from Baseline for each cycle calculated as Day 1 of each cycle value minus Baseline value (NCT00518011)
Timeframe: Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)

Intervention	beats per minute (Mean)
	Cycle 1 (n=8, 8)	Cycle 2 (n=7, 6)	Cycle 3 (n=4, 5)	Cycle 4 (n=1, 5)	Cycle 5 (n=1, 3)	Cycle 6 (n= 1, 2)
Erlotinib + Gemcitabine	3.00	-3.00	-1.80	1.80	-9.00	6.00
Gemcitabine	2.37	3.00	2.75	18.00	-6.00	4.00

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Overall Survival

Overall survival was defined as the interval between the date of randomization to the date of death from any cause. (NCT00518011)
Timeframe: Up to 2 years

Intervention	Week (Median)
Gemcitabine	21.1
Erlotinib + Gemcitabine	39.0

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Objective Response Rate

Objective response rate was defined as the percentage of participants who have any evidence of confirmed objective of complete response (CR) + partial response (PR), as assessed by the Response Evaluation Criteria In Solid Tumors (RECIST version 1.0) criteria. As per the RECIST Version 1.0 CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD. (NCT00518011)
Timeframe: Up to 2 years

Intervention	Percentage of participants (Number)
Gemcitabine	0
Erlotinib + Gemcitabine	28.6

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Consolidation Progression-Free Survival

Consolidation PFS based on the Kaplan-Meier method was defined as the time from the first day of consolidation therapy to documented disease progression (PD) or disease-specific death. Based on RECIST 1.1, radiographic PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum since beginning consolidation, the appearence of one or more new lesions and/or unequivocal progression of existing non-target lesions. Based on Rustin criteria, serlogic PD was a rise in CA125 since beginning of consolidation or previously normal CA125 that rises to >/= 2xULN with either event documented on 2 occasions. Patients who were event-free were censored at the date of their last disease evaluation. (NCT00520013)
Timeframe: Assessments occurred every cycle (serologic) and every 3 cycles (radiologic) on consolidation treatment. Pts were allowed on consolidation therapy for up to 1 year and upon treatment discontinuation were followed for another year.

Intervention	months (Median)
Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab	13.3
Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib	18.9

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Consolidation Treatment-related Toxicity Rate

Consolidation treatment-related toxicity rates based on CTCAEv3 were defined as rates of maximum grade 3 or higher toxicity events with attribution possible, probable or definite occurring during consolidation treatment and up to 30 days post-treatment. (NCT00520013)
Timeframe: Assessed every cycle during consolidation treatment and up to 30 days post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.

Intervention	percentage of participants (Number)
Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab	30.4
Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib	72.0

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Consolidation Objective Response Rate

Consolidation objective response (OR) was based on RECIST 1.0 criteria with OR defined as achieving partial response (PR) or complete response (CR). Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. For CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. If CA125 disease then OR based on Rustin criteria is a 50% decrease in serum CA125 level from two initially elevated samples confirmed by a 4th sample. (NCT00520013)
Timeframe: Assessments occurred every cycle (serologic) and every 3 cycles (radiologic) on consolidation treatment. Pts were allowed on consolidation therapy for up to 1 year.

Intervention	proportion of patients (Number)
Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab	0.65
Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib	.60

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Response by Epidermal Growth Factor Receptor (EGFR) Expression

(NCT00524121)
Timeframe: Radiologic evaluation every 3 months, up to 5 years

Intervention	participants (Number)
	Non-responder	Responder
EGFR<=120 μg/ml	6	2
EGFR>120 μg/ml	5	3

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Response by EGFR Mutation Status

(NCT00524121)
Timeframe: Radiologic evaluation every 3 months, up to 5 years

Intervention	participants (Number)
	Nonresponder	Responder
EGFR Mutation	2	2
No EGFR Mutation	9	3

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Progresssion-Free Survival

Progression is defined as at least a 20% increase in the sum of long distance of target lesions taking as reference the smallest sum long distance recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. (NCT00524121)
Timeframe: Every 3 months, up to 5 years

Intervention	months (Median)
Erlotinib in Combination With Radiotherapy	4.5

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Overall Survival

(NCT00524121)
Timeframe: 5 years

Intervention	months (Median)
Erlotinib in Combination With Radiotherapy	7.3

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Effect of Study Therapy on Overall Quality of Life as Assessed by FACT-E Scale

Functional Assessment of Cancer Therapy-Esophagus (FACT-E) is a health-related quality of life instrument validated in esophageal cancer patients. All of the scales and single-item measures range in score from 0 to 4. The ranges of average quality of life scores was from 0 to 4 and was adjusted as lower scores indicate better outcomes (NCT00524121)
Timeframe: Baseline and Week 3

Intervention	FACT-E Score (Median)
Erlotinib in Combination With Radiotherapy at Baseline	1.05
Erlotinib in Combination With Radiotherapy at Week 3	1.36

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Correlation of Smoking Status With Overall Survival

(NCT00524121)
Timeframe: 5 years

Intervention	months (Median)
Current Smokers	2.4
Former Smokers	7.2
Never Smokers	16.6

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Complete Response

"Response assessment by CT scans and upper endoscopy performed between 4-8 weeks after completion of radiation.~Complete Response (CR) is defined as absence of viable tumor in endoscopic evaluation post chemoradiation, with four-quadrant biopsies taken at 1 cm intervals throughout length of original tumor." (NCT00524121)
Timeframe: 4-8 weeks after completion of radiation.

Intervention	percentage of participants (Number)
Erlotinib in Combination With Radiotherapy	11.76

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Response by Phosphor Epidermal Growth Factor Receptor (pEGFR) Expression

(NCT00524121)
Timeframe: Radiologic evaluation every 3 months, up to 5 years

Intervention	participants (Number)
	Non-responder	Responder
pEGFR<=20 μg/ml	5	3
pEGFR>20 μg/ml	6	2

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Unexpected Toxicities During First 2 Cycles of Study Drug

Unexpected severe study-related adverse events (NCT00525525)
Timeframe: Within 8 weeks of initiating study therapy

Intervention	Events (Number)
Safety Lead-in Group	0

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Progression-free Survival

Progression-free survival was defined from the date of diagnosis to the date that progressive disease was first observed on imaging, or the date at which nonreversible neurologic progression or permanently increased corticosteroid requirement, death from any cause, or early discontinuation of treatment. Imaging guidelines were used to evaluate progression: (i) 25% increase in the sum of products of all measurable lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline; (ii) clear worsening of any assessable disease; (iii) appearance of any new lesion/site; and (iv) clear clinical worsening or failure to return for evaluation as a result of death or deteriorating condition (unless clearly unrelated to this cancer). (NCT00525525)
Timeframe: Approximately 6 months to 1 year

Intervention	months (Median)
Efficacy Group	13.5

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Overall Survival (OS)

Overall survival was defined from the date of diagnosis to date of death from any cause (NCT00525525)
Timeframe: Approximately 6-24 months

Intervention	months (Median)
Efficacy Group	19.8

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Percentage of Participants With Erlotinib Dose Reduction by Reason for Reduction

Erlotinib dose adjustment was done in case of toxicity occurrence. Keratitis, diarrhea, interstitial lung disease, and other toxic occurrences determined erlotinib dose reduction. If erlotinib was previously discontinued for skin rash or diarrhea of Grade 2 and if these symptoms of Grade 2 recurred OR if the symptoms were intolerable for the participants, erlotinib was discontinued until recovery/Grade 1 then the dose was reduced of one level of 50 mg. (NCT00531934)
Timeframe: Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12

Intervention	percentage of participants (Number)
	Adverse event	Investigator's decision	Other
Erlotinib	85.7	2.4	11.9
Erlotinib + Doxycycline	80.0	0	20.0

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Time Free From Skin Rash (Folliculitis) During the First 4 Months of Treatment - Time to Event

Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis. (NCT00531934)
Timeframe: Days 0, 14, 28 and Months 2, 3, and 4

Intervention	days (Median)
Erlotinib + Doxycycline	14
Erlotinib	13

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Percentage of Participants Estimated to be Event Free at 12 Months

Percentage of participants estimated to be without skin rash (folliculitis) at 12 months. (NCT00531934)
Timeframe: Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12

Intervention	percentage of participants (Number)
Erlotinib + Doxycycline	19.8
Erlotinib	11.2

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Percentage of Participants With Doxycycline Dose Reduction by Reason for Reduction

Occurrence of folliculitis-type skin rash of Grade greater than or equal to (≥)2 led to dose modification. Continuation of treatment with doxycycline after occurrence of folliculitis-type skin rash of Grade ≥2 was upon the investigator's opinion. (NCT00531934)
Timeframe: Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12

Intervention	percentage of participants (Number)
	Adverse event	Other
Erlotinib + Doxycycline	50.0	50.0

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Number of Participants With Skin Rash (Folliculitis) After the First 4 Months of Treatment By Type

A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustule, nodule, and crust. (NCT00531934)
Timeframe: Months 7, 10, and 12

Intervention	participants (Number)
	Erythema	Papulo-pustule	Nodule	Crust
Erlotinib	1	1	0	0
Erlotinib + Doxycycline	1	1	0	0

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Percentage of Participants by Best Global Response Under Treatment

Response was determined according to the RECIST criteria for evaluation and was defined as participants with either CR, PR, SD, or progression. No CR was reported. (NCT00531934)
Timeframe: Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12

Intervention	percentage of participants (Number)
	PR	SD	Progression
Erlotinib	10.3	48.3	41.4
Erlotinib + Doxycycline	15.5	36.2	48.3

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Percentage of Participants by DLQI Global Score Classification of Disease Effect on Quality of Life

Quality of life was assessed by participant's responses to a DLQI questionnaire. The DLQI is a 10-item questionnaire assessing quality of life; questions were assessed on a 4-point scale (0=not at all; 1=a little; 2=a lot; and 3=very much). The DLQI was calculated by summing the score of each question resulting in a maximum of 30 (extremely large effect on participant's life) and a minimum of 0 (no effect at all on participant's life). The higher the score, the more quality of life is impaired. The DLQI global score was classified into 5 levels: 0-1 (no effect at all), 2-5 (small effect), 6-10 (moderate effect), 11-20 (very large effect) and 21-30 (extremely large effect). (NCT00531934)
Timeframe: Baseline, Days 14 and 28 and Months 2, 3, and 4

Intervention	percentage of participants (Number)
	Baseline, no effect (n=67,69)	Baseline, small effect (n=67,69)	Day 14, no effect (n=63,62)	Day 14, small effect (n=63,62)	Day 14, moderate effect (n=63,62)	Day 14, very large effect (n=63,62)	Day 14, extremely large effect (n=63,62)	Day 28, no effect (n=60,56)	Day 28, small effect (n=60,56)	Day 28, moderate effect (n=60,56)	Day 28, very large effect (n=60,56)	Day 28, extremely large effect (n=60,56)	Month 2, no effect (n=35,37)	Month 2, small effect (n=35,37)	Month 2, moderate effect (n=35,37)	Month 2, very large effect (n=35,37)	Month 2, extremely large effect (n=35,37)	Month 3, no effect (n=29,27)	Month 3, small effect (n=29,27)	Month 3, moderate effect (n=29,27)	Month 3, very large effect (n=29,27)	Month 4, no effect (n=19,24)	Month 4, small effect (n=19,24)	Month 4, very large effect (n=19,24)
Erlotinib	97.1	2.9	41.9	30.6	21.0	6.5	0.0	41.1	35.7	19.6	1.8	1.8	40.5	27.0	21.6	8.1	2.7	37.0	44.4	11.1	7.4	50.0	41.7	8.3
Erlotinib + Doxycycline	98.5	1.5	69.8	27.0	0.0	1.6	1.6	66.7	25.0	8.3	0.0	0.0	65.7	22.9	5.7	5.7	0.0	69.0	27.6	0.0	3.4	78.9	15.8	5.3

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Percentage of Participants Estimated to be Alive at 4 and 12 Months

(NCT00531934)
Timeframe: Months 4 and 12

Intervention	percentage of participants (Number)
	4 Months	12 Months
Erlotinib	69.7	33.5
Erlotinib + Doxycycline	68.5	27.1

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Percentage of Participants Estimated to be Progression Free at 4 and 12 Months

(NCT00531934)
Timeframe: Months 4 and 12

Intervention	percentage of participants (Number)
	4 Months	12 Months
Erlotinib	31.0	10.8
Erlotinib + Doxycycline	30.1	6.3

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Number of Skin Rash (Folliculitis) Events During the First 4 Months of Treatment

A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustular and nodules. (NCT00531934)
Timeframe: Days 0, 14, 28 and Months 2, 3, and 4

Intervention	rash events (Number)
Erlotinib + Doxycycline	57
Erlotinib	62

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Percentage of Participants With Global Disease Control by Visit

Disease control was determined according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria for evaluation and was defined as participants with either complete response (CR), partial response (PR), or stable disease (SD). (NCT00531934)
Timeframe: Months 2, 4, 7, 10, and 12

Intervention	percentage of participants (Number)
	Month 2 (n=34,33)	Month 4 (n=19,25)	Month 7 (n=11,17)	Month 10 (n=7,12)	Month 12 (n=7,10)
Erlotinib	93.9	80.0	76.5	66.7	40.0
Erlotinib + Doxycycline	88.2	89.5	72.7	100.0	71.4

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Percentage of Participants With Other Skin Lesions During the First 4 Months of Treatment By Maximal Intensity

Other skin lesions included xerosis and paronychia. Intensity was classified according to CTCAE grading. Grade 1=Macular or papular eruption or erythema without associated symptoms; Grade 2=Macular or papular eruption or erythema with pruritus or other associated symptoms; localized desquamation or other lesions covering <50% of BSA; Grade 3=Severe, generalized erythroderma or macular, papular, or vesicular eruption; desquamation; Grade 4=Generalized exfoliative, ulcerative, or bullous dermatitis. If a participant had several skin lesions, the maximal intensity was taken into account. (NCT00531934)
Timeframe: Days 0, 14, 28 and Months 2, 3, and 4

Intervention	percentage of participants (Number)
	Grade 1	Grade 2	Grade 3	Grade 4
Erlotinib	29.0	51.6	16.1	3.2
Erlotinib + Doxycycline	69.0	24.1	6.9	0

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Dermatology Life Quality Index (DLQI) Global Score

Quality of life was assessed by participant's responses to a DLQI questionnaire. The DLQI is a 10-item questionnaire assessing quality of life; questions were assessed on a 4-point scale (0=not at all; 1=a little; 2=a lot; and 3=very much). The DLQI was calculated by summing the score of each question resulting in a maximum of 30 (extremely large effect on participant's life) and a minimum of 0 (no effect at all on participant's life). The higher the score, the more quality of life is impaired. Analysis was performed by visit well as at the last available value after baseline (Endpoint); change from baseline to endpoint was also determined. (NCT00531934)
Timeframe: Baseline, Days 14 and 28 and Months 2, 3, and 4

Intervention	units on a scale (Mean)
	Baseline (n=67,69)	Day 14 (n=63,62)	Day 28 (n=60,56)	Month 2 (n=35,37)	Month 3 (n=29,27)	Month 4 (n=19,24)	Endpoint (n=65,63)	Change at Endpoint (n=35,37)
Erlotinib	0.2	3.7	3.4	4.3	3.2	2.6	3.4	3.2
Erlotinib + Doxycycline	0.2	1.7	1.7	2.3	1.7	1.6	2.0	1.9

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Number of Skin Rash (Folliculitis) Events After the First 4 Months of Treatment

A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustular and nodules. (NCT00531934)
Timeframe: Months 7, 10, and 12

Intervention	rash events (Number)
Erlotinib + Doxycycline	2
Erlotinib	1

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Overall Survival (OS) - Percentage of Participants With an Event

OS was defined by the time between first intake of treatment with erlotinib and death for any cause; analyzed using Kaplan-Meier method. (NCT00531934)
Timeframe: Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12

Intervention	percentage of participants (Number)
Erlotinib + Doxycycline	71.2
Erlotinib	67.6

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Overall Survival (OS) - Time to Event

Intervention	days (Median)
Erlotinib + Doxycycline	227.0
Erlotinib	251.0

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Time Free From Skin Rash (Folliculitis) During the First 4 Months of Treatment - Number of Participants With an Event

Intervention	participants (Number)
Erlotinib + Doxycycline	52
Erlotinib	59

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Progression-Free Survival (PFS) - Time to Event

PFS was defined by the time between first intake of treatment with erlotinib and disease progression or death for any cause; estimated using Kaplan-Meier method. (NCT00531934)
Timeframe: Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12

Intervention	days (Median)
Erlotinib + Doxycycline	63.0
Erlotinib	70.0

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Duration of Skin Rash (Folliculitis) During the Whole Treatment Period

If the end of cutaneous rash was missing, the duration of cutaneous rash was calculated between start of folliculitis and last evaluation date. (NCT00531934)
Timeframe: Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12

Intervention	days (Median)
Erlotinib + Doxycycline	86.7
Erlotinib	99.3

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Percentage of Participants With Other Skin Lesions During the First 4 Months of Treatment By Type

Other skin lesions included xerosis and paronychia. (NCT00531934)
Timeframe: Days 0, 14, 28 and Months 2, 3, and 4

Intervention	percentage of participants (Number)
	Xerosis	Paronychia
Erlotinib	41.1	8.2
Erlotinib + Doxycycline	37.0	6.8

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Number of Participants With Skin Rash (Folliculitis) After the First 4 Months of Treatment By Intensity

Intensity of skin rashes was classified according to CTCAE grading. Grade 1=Macular or papular eruption or erythema without associated symptoms; Grade 2=Macular or papular eruption or erythema with pruritus or other associated symptoms; localized desquamation or other lesions covering <50% of BSA; Grade 3=Severe, generalized erythroderma or macular, papular, or vesicular eruption; desquamation. (NCT00531934)
Timeframe: Months 7, 10, and 12

Intervention	participants (Number)
	Initial intensity: Grade 1	Maximal intensity: Grade 1
Erlotinib	1	1
Erlotinib + Doxycycline	2	2

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Percentage of Participants With Skin Rash (Folliculitis) During the First 4 Months of Treatment By Maximal Intensity

Intensity of skin rashes was classified according to CTCAE grading. Grade 1 equals (=) Macular or papular eruption or erythema without associated symptoms; Grade 2=Macular or papular eruption or erythema with pruritus or other associated symptoms; localized desquamation or other lesions covering less than (<)50 percent (%) of body surface area (BSA); Grade 3=Severe, generalized erythroderma or macular, papular, or vesicular eruption; desquamation. (NCT00531934)
Timeframe: Days 0, 14, 28 and Months 2, 3, and 4

Intervention	percentage of participants (Number)
	Grade 1	Grade 2	Grade 3
Erlotinib	18.6	62.7	18.6
Erlotinib + Doxycycline	61.5	34.6	3.8

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Percentage of Participants With at Least One Skin Rash (Folliculitis) of Any Grade During the First 4 Months of Treatment

Description of skin rash (folliculitis, including erythema, papulo-pustules, nodule, and crust) was according to Common Terminology Criteria for Adverse Events (CTCAE) version 3 scale. Medical pictures of the face (front and sides views) systematically, and of any region presenting with skin lesions were obtained. The pictures were reviewed by a centralized committee of evaluation. (NCT00531934)
Timeframe: Days 0, 14, 28 and Months 2, 3, and 4

Intervention	percentage of participants (Number)
Erlotinib + Doxycycline	71.2
Erlotinib	80.8

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Progression-Free Survival (PFS) - Percentage of Participants With an Event

Intervention	percentage of participants (Number)
Erlotinib + Doxycycline	91.8
Erlotinib	87.8

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Percentage of Participants With Skin Rash (Folliculitis) During the First 4 Months of Treatment By Type

A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustule, nodule, and crust. (NCT00531934)
Timeframe: Days 0, 14, 28 and Months 2, 3, and 4

Intervention	percentage of participants (Number)
	Erythema	Papulo-pustule	Nodule	Crust
Erlotinib	70.7	72.4	0	25.9
Erlotinib + Doxycycline	55.8	65.4	1.9	9.6

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Quality of Life Score as Assessed by Visual Analog Scale (VAS)

Quality of life was assessed by participant's responses to a VAS questionnaire - (evaluation of satisfaction with skin status). VAS was measured on a 100 millimeter (mm) scale where 0 = not at all satisfied and 100 = very satisfied. Participants were asked to mark the line corresponding to their satisfaction at each visit and the distance from the left edge was measured. A negative change from baseline indicates improvement. Analysis was performed by visit well as at the last available value after baseline (Endpoint). (NCT00531934)
Timeframe: Baseline, Days 14 and 28, and Months 2, 3, and 4

Intervention	mm (Mean)
	Baseline (n=64,68)	Day 14 (n=62,63)	Change at Day 14 (n=59,61)	Day 28 (n=59,56)	Change at Day 28 (n=55,54)	Month 2 (n=36,36)	Month 3 (n=28,27)	Month 4 (n=18,24)	Endpoint (n=65,64)	Change at Endpoint (n=60,62)
Erlotinib	87.8	51.0	-39.2	54.8	-35.1	52.6	56.1	59.9	58.3	-30.4
Erlotinib + Doxycycline	81.4	68.8	-16.2	66.5	-15.5	68.9	63.5	71.8	64.0	-18.1

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Duration of Skin Rash (Folliculitis) During the First 4 Months of Treatment

If the cutaneous rash was ongoing at the last visit or Month 4, the duration of cutaneous rash was calculated between start of folliculitis and Visit Month 4 or premature withdrawal visit or death. (NCT00531934)
Timeframe: Days 0, 14, 28 and Months 2, 3, and 4

Intervention	days (Mean)
Erlotinib + Doxycycline	59.6
Erlotinib	60.6

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Percentage of Participants With Other Skin Lesions of Any Grade During the First 4 Months of Treatment

Other skin lesions included presence or absence of xerosis and paronychia. (NCT00531934)
Timeframe: Days 0, 14, 28 and Months 2, 3, and 4

Intervention	percentage of participants (Number)
Erlotinib + Doxycycline	39.7
Erlotinib	42.5

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Percentage of Participants With at Least One Skin Rash (Folliculitis) of Any Grade After the First 4 Months of Treatment

(NCT00531934)
Timeframe: Months 7, 10, and 12

Intervention	percentage of participants (Number)
Erlotinib + Doxycycline	2.7
Erlotinib	1.4

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Percentage of Participants Estimated to be Event Free at 4 Months

Percentage of participants estimated to be without skin rash (folliculitis) at 4 months. (NCT00531934)
Timeframe: Days 0, 14, 28 and Months 2, 3, and 4

Intervention	percentage of participants (Number)
Erlotinib + Doxycycline	24.7
Erlotinib	11.2

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Time Free From Skin Rash (Folliculitis) During the Whole Treatment Period - Time to Event

Intervention	days (Median)
Erlotinib + Doxycycline	14
Erlotinib	13

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Time Free From Skin Rash (Folliculitis) During the Whole Treatment Period - Number of Participants With an Event

Intervention	participants (Number)
Erlotinib + Doxycycline	53
Erlotinib	59

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OS

The median time, in months, from randomization to OS event. Participants were censored at final analysis at the date the participant was last known to be alive. (NCT00531960)
Timeframe: Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.

Intervention	months (Median)
Bevacizumab + Chemotherapy	NA
Bevacizumab + Erlotinib	16.4

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PFS

The median time, in weeks, from randomization to PFS event. Participants were censored at the date of last post-BL tumor assessment where non-progression was documented. If no post-BL tumor assessment was available, the participant was censored at date of randomization. PFS was estimated using Kaplan-Meier methodology. (NCT00531960)
Timeframe: Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.

Intervention	weeks (Median)
Bevacizumab + Chemotherapy	34.6
Bevacizumab + Erlotinib	23.4

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Percentage of Participants Who Died

Overall survival (OS) was defined as the time from randomization to the date of death, due to any cause. Participants were censored at final analysis at the date the participant was last known to be alive. (NCT00531960)
Timeframe: Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.

Intervention	percentage of participants (Number)
Bevacizumab + Chemotherapy	45.9
Bevacizumab + Erlotinib	52.4

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Percentage of Participants With Disease Progression or Death

Progression-free survival (PFS) was defined as the time from randomization to disease progression or death, from any cause. Progressive disease (PD) was defined according to Response Criteria in Solid Tumors (RECIST) version (V) 1.0. For target lesions (TLs), progressive disease (PD) was defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment. For non-target lesions (NTLs), PD was defined as unequivocal progression of existing NTLs. Participants were censored at the date of last post-baseline (BL) tumor assessment where non-progression was documented. If no post-BL tumor assessment was available, the participant was censored at date of randomization. (NCT00531960)
Timeframe: Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.

Intervention	percentage of participants (Number)
Bevacizumab + Chemotherapy	72.1
Bevacizumab + Erlotinib	76.2

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Percentage of Participants With Disease Control According to RECIST V 1.0

Disease control was defined as a BOR of CR, PR, or SD according to RECIST V 1.0 for at least 4 weeks at any time during randomized treatment or disease stabilization, after study entry. Participants without a post-BL assessment of response were considered as having no disease control. The 95% CI for the one sample binomial was calculated using the Pearson-Clopper method. (NCT00531960)
Timeframe: Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis, 12 months after the last participant's 1st visit

Intervention	percentage of participants (Number)
Bevacizumab + Chemotherapy	85.2
Bevacizumab + Erlotinib	73.0

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Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST V 1.0

BOR was defined as the best response recorded from randomization until disease progression/recurrence or death, taking as reference for PD the smallest measurement (nadir) recorded since treatment started. Assignment of PR of CR required confirmation of tumor measurement changes by repeat assessments performed no less than 4 weeks after criteria for response was first met. For TLs, CR was defined as the disappearance of all TLs; and PR was defined as at least a 30% decrease in the SLD of the TLs, taking BL SLD as reference. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% CI for one sample binomial was calculated using the Pearson-Clopper method. (NCT00531960)
Timeframe: Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.

Intervention	percentage of participants (Number)
Bevacizumab + Chemotherapy	44.3
Bevacizumab + Erlotinib	27.0

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16 Weeks Progression-free Survival

To determine the rate of progression-free survival (PFS) at 16 weeks for the combination therapy of erlotinib and docetaxel for subjects in the Biliary stratum, per RECIST criteria. Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum recorded since the treatment started or the appearance of one or more new lesions. (NCT00532441)
Timeframe: Start of treatment until disease progression per RECIST criteria up to 16 weeks

Intervention	months (Median)
Biliary	4.7
Hepatocellular	3.5

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Overall Survival

Determine Overall Survival (NCT00532441)
Timeframe: 18 Months

Intervention	months (Median)
Hepatocellular	6.7
Biliary	5.7

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Response Rate

Determine the Response Rate Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) (NCT00532441)
Timeframe: 18 months

Intervention	participants (Number)
	Complete Response or Partial Response	Stable Disease	Progressive Disease
Erlotinib and Docetaxel: Biliary	0	7	4
Erlotinib and Docetaxel: Hepatocellular	0	6	7

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6 Month Progression-Free Survival

"For liver lesions treated with SBRT, RECIST (Response Evaluation Criteria in Solid Tumors) criteria will be used for evaluation of progression. Progression (PD) is at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.~Evaluation of lung lesions at any time after SBRT is difficult in view of the expected fibrotic reaction. Bone lesions seen only on PET are also not well scored by RECIST criteria and will not be evaluated in that manner. In this study progressive disease (PD) will be defined as residual increased metabolic PET scan in combination with expanded parenchymal opacity that retains mass-like discrete borders and extends outside the volume of lung that received at least 18 Gy." (NCT00547105)
Timeframe: 6 months

Intervention	percentage of participants (Number)
SBRT Combined With Erlotinib	69

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In-field Local Control

In-field local control is defined as number of treated lesions that did not grow in size or increase in metabolic activity. (NCT00547105)
Timeframe: 9 months

Intervention	lesions treated with SBRT (Count of Units)
SBRT Combined With Erlotinib	44

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Number of Participants Without Serious Adverse Events Related to Radiation

Common Terminology Criteria for Adverse Events v4.03 (CTCAE) is used as the standard classification and severity grading scale for adverse events (NCT00547105)
Timeframe: 3 years

Intervention	Participants (Count of Participants)
SBRT Combined With Erlotinib	22

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Out-of-field Disease Progression

Number of Participants with Disease Progression Outside the Radiation treated field at 9 Months (NCT00547105)
Timeframe: 9 months

Intervention	Participants (Count of Participants)
SBRT Combined With Erlotinib	10

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Overall Survival

evaluate overall survival after SBRT in combination with erlotinib (NCT00547105)
Timeframe: up to 5 years

Intervention	months (Median)
SBRT Combined With Erlotinib	20.4

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Duration of Erlotinib Use and Time to Initiation of Third-line Systemic Therapy

To evaluate the duration of erlotinib usage and time to initiation of third line systemic agent (chemotherapy or biologic agent) (NCT00547105)
Timeframe: 3 years

Intervention	days (Median)
SBRT Combined With Erlotinib	183

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Progression-free Survival

Intervention	months (Median)
SBRT Combined With Erlotinib	14.7

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Overall Survival (OS)

OS is defined as the time from randomization to the date of death from any cause. (NCT00550173)
Timeframe: Baseline to date of death from any cause up to 45.5 months

Intervention	months (Median)
Pemetrexed + Erlotinib	20.5
Erlotinib	22.8
Pemetrexed	17.7

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Percentage of Participants With CR, PR, and Stable Disease (SD) - Disease Control Rate (DCR)

DCR was defined as the percentage of participants with CR, PR, or SD divided by the number of randomized and treated participants as assessed using the RECIST criteria. CR was defined as the disappearance of all target lesions; PR was defined as 1) at least a 30% decrease in sum of longest diameter of target lesions or 2) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions; PD was defined as at least a 20% increase in sum of longest diameter of target lesions; SD was defined as small changes that did not meet the above criteria. (NCT00550173)
Timeframe: Randomization to disease progression up to 38 months

Intervention	percentage of participants (Number)
Pemetrexed + Erlotinib	64.5
Erlotinib	52.4
Pemetrexed	56.3

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Number of Participants With Adverse Events

A summary of serious and all other non-serious adverse events (AEs), which include AEs reported for pharmacological toxicity, is located in the Reported Adverse Event module. (NCT00550173)
Timeframe: Randomization up to 39 months

Intervention	participants (Number)
	Serious Adverse Events	Other Non-Serious Adverse Events
Erlotinib	18	76
Pemetrexed	22	67
Pemetrexed + Erlotinib	25	72

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Number of Participants With Mutated or Non-Mutated Epidermal Growth Factor Receptor (EGFR) Genotype Status

EGFR mutation status was defined as: participants with any mutations detected were categorized as mutated and participants without any mutations detected were categorized as non-mutated. (NCT00550173)
Timeframe: Randomization to date of PD or death up to 38 months

Intervention	participants (Number)
	Mutated	Non-mutated	Mutation status unknown (treated as missing)
Erlotinib	8	6	2
Pemetrexed	9	3	3
Pemetrexed + Erlotinib	7	10	5

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Time to Worsening of Symptoms (TWS) on Lung Cancer Symptoms Scale (LCSS)

TWS assessed using the LCSS a participant rated lung cancer instrument which consisted of 9 disease related symptoms and quality of life (QoL) items, with 6 subscales related to major lung cancer symptoms (appetite, cough, fatigue, dyspnea, hemoptysis, and pain) and 3 summation items related to QoL (activity status, symptomatic distress, and overall QoL). Each item is marked on a visual analog scale (VAS) 0 (low symptoms/QoL items) to 100 (high symptoms/QoL items). The mean of the 6 subscales is used to calculate the average symptom burden index. TWS was measured from the date of study enrollment to the first date of a worsening in any 1 of the 6 LCSS symptom-specific items (as defined by a VAS 15-mm increase from baseline in the patient-reported score for any of these 6 items). (NCT00550173)
Timeframe: Randomization to first date of worsening of any of 6 LCSS symptom specific items or up to 12.4 months

Intervention	months (Median)
Pemetrexed + Erlotinib	1.0
Erlotinib	0.8
Pemetrexed	1.5

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Progression-Free Survival (PFS)

PFS is defined as the time from randomization to the first date of progressive disease (PD; either objectively determined or clinical progression) or death from any cause. PD was defined as at least a 20% increase in sum of longest diameter of target lesions as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 guidelines. Time to disease progression was censored at the date of death. (NCT00550173)
Timeframe: Randomization to measured PD up to 38 months

Intervention	months (Median)
Pemetrexed + Erlotinib	7.4
Erlotinib	3.8
Pemetrexed	4.4

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Probability of OS at 12 Months

OS time is censored at the date of last contact for participants who were still alive or lost to follow-up. (NCT00550173)
Timeframe: Month 12

Intervention	percent chance of survival (Number)
Pemetrexed + Erlotinib	40.2
Erlotinib	26.2
Pemetrexed	18.1

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Percentage of Participants With a Tumor Response of Complete Response (CR) or Partial Response (PR) [Tumor Response Rate (TRR)]

TRR was defined as the number of responders (complete or partial) divided by the number of participants qualified for tumor response, as assessed using the RECIST version 1.0 guideline, multiplied by 100. RECIST guidelines: CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; PR was defined as at least a 30% decrease in sum of longest diameter of target lesions. (NCT00550173)
Timeframe: Randomization to measured disease progression up to 38 months

Intervention	percentage of participants (Number)
Pemetrexed + Erlotinib	44.7
Erlotinib	29.3
Pemetrexed	10.0

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Progression-free Survival (PFS) for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC

PFS is defined as the time from on erlotinib treatment date to progression or death (whichever comes first) before cross-over to PC or PC+B. For those did not progressed nor died, they were censored at the last follow up (either the off erlotinib treatment date or lost follow up date). The median survival time and 95% confidence interval were estimated using Kaplan-meier method. (NCT00550537)
Timeframe: Through study completion, an average of 1 year

Intervention	months (Median)
Patients on Erlotinib Segament	3.16

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Overall Survival for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC

The overall survival time is defined as the time from on treatment to death. Patients were censored of they were alive at the last follow up date. The median survival time and its confidence interval were estimated using Kaplan-meier method. (NCT00550537)
Timeframe: Through study completion, an average of 1 year

Intervention	months (Median)
Erlotinib Followed by PC	12.53
Erlotinib Followed by PC+B	17.23
Erlotinib	6.08

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Number of Patients With Worst-grade Toxicities Per Grade

"The intensity of the AE will be graded according to the Common Toxicity Criteria (CTC) of the (US) National Cancer Institute (NCI) - Cancer Therapy Evaluation Program (CTEP) [version 3.0 of December 2003] (Appendix B).~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE" (NCT00550537)
Timeframe: Through study completion, an average of 1 year

Intervention	participants (Number)
	worst-grade 1	worst-grade 2	worst-grade 3	worst-grade 4
Erlotinib Segament	18	51	15	1

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Response Rate for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC

Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. The response rate is calculated as the percentage of PR+CR among patients assessed for response. (NCT00550537)
Timeframe: Through study completion, an average of 1 year

Intervention	percentage of patients assessed (Mean)
Patients on Erlotinib Segament	18.8

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Confirmed Response Rate

Evaluated using RECIST version 1.0. Confirmed tumor response rate was defined as achieving partial response (PR) or complete response (CR) in two consecutive assessments at least 6 weeks apart. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. The confirmed response rate is reported as the number of participants with confirmed responses divided by the number of evaluated participants. (NCT00550836)
Timeframe: Up to 2 years

Intervention	rate of confirmed response (Number)
Arm A: GE	0.087
Arm B: PGE	0.065

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Frequency and Severity of Observed Adverse Effects

"Patients are assessed for Adverse events each cycle using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0). The maximum grade for each type of adverse event will be recorded for each patient, and tables will be reviewed to determine adverse event patterns. The number of patients in each arm that reported a grade 3 or higher adverse event and a grade 4 or higher adverse event are reported.~A complete listing of all adverse events is reported in the Adverse Events section." (NCT00550836)
Timeframe: Up to 2 years

Intervention	participants (Number)
	Grade 3+ Adverse Event	Grade 4+ Adverse Event
Arm A: GE	41	15
Arm B: PGE	41	14

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Time to Treatment Failure

Time to treatment failure is defined to be the time from the date of randomization to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a nonprotocol failure, the patient will be censored on the date they are removed from treatment. The time to treatment failure will be estimated using the method of Kaplan-Meier. (NCT00550836)
Timeframe: Up to 2 years

Intervention	months (Median)
Arm A: GE	2.0
Arm B: PGE	3.8

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Progression-free Survival

Progression-free survival is defined as the time from randomization to documentation of disease progression or death, whichever comes first. Progression is defined as at least a 20% increase in the sum of longest dimension (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. The progression-free survival curves will be compared between the 2 arms using a log-rank test. (NCT00550836)
Timeframe: Up to 2 years

Intervention	months (Median)
Arm A: GE	2.0
Arm B: PGE	3.6

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Overall Survival

Overall Survival is defined as the time from registration to death due to any cause. The estimate will be done using the Kaplan-Meier method. The primary goal of this trial is to compare the experimental arm (Arm B) to the standard arm (Arm A). The primary analysis will be a comparison of Arm A to Arm B using a one-sided log-rank test between the 2 Kaplan-Meier curves. (NCT00550836)
Timeframe: Up to 2 years

Intervention	months (Median)
Arm A: GE	4.2
Arm B: PGE	8.3

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Overall Survival at 12 Months

Percentage of participants who were alive at 12 months. (NCT00553462)
Timeframe: At 12 months

Intervention	percentage of participants (Number)
Paclitaxel + Carboplatin + Radiation + Erlotinib	57

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Progression-free Survival

Progression free survival (PFS) is defined as the time from registration to disease progression or death of any cause, which ever comes first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. (NCT00553462)
Timeframe: Duration of study (up to 2 years)

Intervention	months (Median)
Paclitaxel + Carboplatin + Radiation + Erlotinib	11

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Response Rate

"Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:~Complete Response (CR): disappearance of all target lesions;~Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;~Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions;~Stable Disease (SD): small changes that do not meet above criteria.~Response rate is reported as the percentage of participants who achieved each response." (NCT00553462)
Timeframe: Duration of study (up to 2 years)

Intervention	percentage of participants (Number)
	Complete Response (CR)	Partial Response (PR)	Stable Disease (SD)	Progressive Disease (PD)
Paclitaxel + Carboplatin + Radiation + Erlotinib	8	59	27	7

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Progression Free Survival (PFS)

Intervention	months (Median)
Bevacizumab & Erlotinib	6.6

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Probable Percentage of Participants Remaining Without Deterioration in Quality of Life at 6 Months as Assessed by FACT-L

Intervention	percentage of participants (Number)
Comparator	25.0
Erlotinib	19.0

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Probable Percentage of Participants Remaining Alive and Progression Free at 6 Months

Intervention	percentage of participants (Number)
Comparator	17.0
Erlotinib	13.0

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Percentage of Participants With Symptomatic Progression Using FACT-L

Participants' responses on the FACT-L were scored according to the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system manual. Time to symptom progression is the time from randomization until the earlier of a clinically meaningful decline from baseline in LCS score, or death on study. A change in 2 to 3 points on the LCS is a clinically meaningful change. Meaningful declines in scores as measured by the FACIT instruments have been found to be larger than improvements. Thus, deterioration in disease-related symptoms was defined by the upper bound (3 points) of the range of clinically meaningful change. However, participants who demonstrated early lung cancer progression demonstrated smaller changes from baseline score on the LCS. Therefore, the clinically meaningful decline that was used to determine progression of symptoms in this study was at least 1.5-point decline in LCS score from baseline. (NCT00556322)
Timeframe: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months

Intervention	percentage of participants (Number)
Comparator	60.6
Erlotinib	62.0

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Percentage of Participants With Disease Progression or Death (All Participants; Data Cut Off 07 September 2010)

Tumor response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.0). Progressive Disease was defined as at least a 20 percent (%) increase in the sum of the Longest Diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. The primary analysis of PFS used objective progression (RECIST) plus clinical progression (based on relevant clinical findings - if any). A further assessment of PFS was made on objective (radiological) progression. If clinical progression was diagnosed first, the participant was censored at the date of the last tumor assessment, where non-progression was documented. (NCT00556322)
Timeframe: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Until Data Cut off (07 September 2010) up to 52 months

Intervention	percentage of participants (Number)
Comparator	83.3
Erlotinib	92.6

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Percentage of Participants With Deterioration in the Trial Outcome Index (TOI)

TOI is defined as the sum of the scores of the Physical Well- Being (PWB), Functional Well-Being (FWB), and LCS of the FACT-L instrument. Trial Outcome Index measures the physical functioning of participants. Time to deterioration in TOI is defined as time from randomization until the earlier of a clinically meaningful decline from baseline in TOI or death on study. The clinically meaningful decline used to determine deterioration in TOI was ≥6-point decline from baseline. (NCT00556322)
Timeframe: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months

Intervention	percentage of participants (Number)
Comparator	60.0
Erlotinib	63.3

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Percentage of Participants With Deterioration in Quality of Life Determined Using Functional Assessment of Cancer Therapy - Lung (FACT-L)

The FACT-L measures health related QOL and composes of five domains: the four domains (physical well being, emotional well being, social well being, functional well being) from the Functional Assessment of Cancer Treatment-General scale (FACT-G) and the lung cancer subscale (LCS). The FACT-L total score ranges from 0 to 136, higher scores represent better QOL. (NCT00556322)
Timeframe: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months

Intervention	percentage of participants (Number)
Comparator	66.1
Erlotinib	66.9

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Percentage of Participants Who Died (All Participants; Data Cutoff: 07 September 2010)

Overall survival (OS) was determined from the date of randomization to the date of death irrespective of the cause of death. (NCT00556322)
Timeframe: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 or Death and Every 12 Weeks until Death or Data Cut off (07 September 2010) up to 52 months

Intervention	percentage of participants (Number)
Comparator	81.0
Erlotinib	77.8

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Percentage of Participants Achieving a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator Using RECIST

Best overall response was defined as the best response according to RECIST recorded from the date of randomization until disease progression or recurrence. CR: disappearance of all target lesions; PR: reduction by at least 30% of the sum of the longest diameters of each target lesion, taking the initial sum of the longest diameters as a reference; Stable disease (SD): insufficient tumor reduction to define partial response and/or tumor increase less than that necessary to define tumor progression, taking as a reference the smallest sum of the longest diameter since the start of treatment; Progressive Disease (PD): increase by at least 20% in the sum of LD of each target lesion, taking as a reference the smallest sum of the longest diameters, reported since the start of treatment, or appearance of one or more new lesions. 95% Confidence Interval (CI) for one sample binomial using Pearson-Clopper method. Participants with a missing response were considered non-responders. (NCT00556322)
Timeframe: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Death or up to 52 months

Intervention	percentage of participants (Number)
Comparator	6.3
Erlotinib	7.9

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Duration of Overall Survival in All Participants (Data Cutoff 07 September 2010)

OS was determined from the date of randomization to the date of death irrespective of the cause of death. Kaplan-Meier estimates were used for analysis. (NCT00556322)
Timeframe: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months

Intervention	months (Median)
Comparator	5.5
Erlotinib	5.3

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Probable Percentage of Participants With Deterioration in the TOI at 6 Months as Assessed by FACT-L

TOI is defined as the sum of the scores of the PW, FWB, and LCS of the FACT-L instrument. Trial Outcome Index measures the physical functioning of participants. Time to deterioration in TOI is defined as time from randomization until the earlier of a clinically meaningful decline from baseline in TOI or death on study. The clinically meaningful decline used to determine deterioration in TOI was ≥6-point decline from baseline. Kaplan-Meier estimates were used for analysis. (NCT00556322)
Timeframe: 6 Months

Intervention	percentage of participants (Number)
Comparator	28
Erlotinib	21

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Probable Percentage of Participants Remaining Alive at 1 Year

OS was determined from the date of randomization to the date of death irrespective of the cause of death. Kaplan-Meier estimates were used for analysis. (NCT00556322)
Timeframe: 1 Year

Intervention	percentage of participants (Number)
Comparator	24.0
Erlotinib	26.0

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Time to Deterioration in Quality of Life Using FACT-L

The FACT-L measures health related QOL and composes of five domains: the four domains (physical well being, emotional well being, social well being, functional well being) from the FACT-G and the LCS. The FACT-L total score ranges from 0 to 136, higher scores represent better QOL. Time to deterioration of QoL or symptom progression is defined as time from randomization until either a clinically meaningful decline from baseline in Total FACT-L or, death on study, whichever occurs first. The clinically meaningful decline that was used to determine deterioration in QoL was ≥6-point decline from baseline. Participants without deterioration in QoL at the time of analysis were censored at the time of the last FACT-L assessment. Kaplan-Meier estimate was used to determine time to event. (NCT00556322)
Timeframe: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months

Intervention	weeks (Median)
Comparator	9.0
Erlotinib	6.3

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Time to Deterioration in the TOI

TOI is defined as the sum of the scores of the PW, FWB, and LCS of the FACT-L instrument. Trial Outcome Index measures the physical functioning of participants. Time to deterioration in TOI is defined as time from randomization until the earlier of a clinically meaningful decline from baseline in TOI or death on study. The clinically meaningful decline used to determine deterioration in TOI was ≥6- point decline from baseline. Kaplan-Meier estimates were used for analysis. (NCT00556322)
Timeframe: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months

Intervention	weeks (Median)
Comparator	9.3
Erlotinib	6.7

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Duration of OS in EGFR Positive and Negative Population

EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC. OS was determined from the date of randomization to the date of death irrespective of the cause of death in EGFR positive and negative populations. Kaplan-Meier estimates were used for analysis. (NCT00556322)
Timeframe: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months

Intervention	months (Median)
	EGFR Positive (n=149,143)	EGFR Negative (n=39,32)
Comparator	5.5	6.7
Erlotinib	5.6	5.4

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Percentage of Participants Who Died in Epidermal Growth Factor Receptor (EGFR) Positive and Negative Population

EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by immunohistochemistry (IHC). OS was determined from the date of randomization to the date of death irrespective of the cause of death in EGFR positive and negative populations. Kaplan-Meier estimates were used for analysis. (NCT00556322)
Timeframe: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months

Intervention	percentage of participants (Number)
	EGFR Positive (n=149,143)	EGFR Negative (n=39,32)
Comparator	79.9	79.5
Erlotinib	76.9	75.0

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Percentage of Participants With Disease Progression or Death in EGFR Positive and Negative Population (Data Cut Off 07 September 2010)

EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC.Tumor response was evaluated according to RECIST criteria (version 1.0). Progressive Disease was defined as At least a 20 % increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT00556322)
Timeframe: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months

Intervention	percentage of participants (Number)
	EGFR Positive (n=149,143)	EGFR Negative (n=39,32)
Comparator	79.9	89.7
Erlotinib	93.7	90.6

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PFS in EGFR Positive and Negative Population (Data Cutoff 07 September 2010)

EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC. PFS was defined as time from randomization to the date of documented disease progression or death, whichever occurred first in EGFR positive and negative populations. Participants without progression were censored at the date of last tumor assessment where non progression was documented. If a participant receives a second anti-cancer therapy without prior documentation of disease progression, the participant was censored at the date of last tumor assessment before starting new chemotherapy. Kaplan-Meier estimates were used for analysis. (NCT00556322)
Timeframe: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Until Data Cut off (07 September 2010) up to 52 months

Intervention	weeks (Median)
	EGFR Positive (n=149,143)	EGFR Negative (n=39,32)
Comparator	8.9	11.5
Erlotinib	6.3	6.7

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Probable Percentage of Participants Remaining Alive and Progression Free at 6 Months in EGFR Positive and Negative Population

EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC. Tumor response was evaluated according to RECIST criteria (version 1.0). PFS was defined as time from randomization to the date of documented disease progression or death, whichever occurred first in EGFR positive and negative populations. Participants without progression were censored at the date of last tumor assessment where non progression was documented. If a participant receives a second anti-cancer therapy without prior documentation of disease progression, the participant was censored at the date of last tumor assessment before starting new chemotherapy. Event free estimates were determined using Kaplan-Meier estimates. (NCT00556322)
Timeframe: 6 Months

Intervention	percentage of participants (Number)
	EGFR Positive (n=23,18)	EGFR Negative (n=4,5)
Comparator	20.0	11.0
Erlotinib	13.0	16.0

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Probable Percentage of Participants With Symptomatic Progression at 6 Months as Assessed by FACT-L

Participants' responses on the FACT-L were scored according to FACIT measurement system manual. Time to symptom progression is the time from randomization until the earlier of a clinically meaningful decline from baseline in LCS score, or death on study. A change in 2 to 3 points on the LCS is a clinically meaningful change. Meaningful declines in scores as measured by the FACIT instruments have been found to be larger than improvements. Thus, deterioration in disease-related symptoms was defined by the upper bound (3 points) of the range of clinically meaningful change. However, participants who demonstrated early lung cancer progression demonstrated smaller changes from baseline score on the LCS. Therefore, the clinically meaningful decline that was used to determine progression of symptoms in this study was at least 1.5-point decline in LCS score from baseline. Kaplan Meier estimated were used for analysis. (NCT00556322)
Timeframe: 6 Months

Intervention	percentage of participants (Number)
Comparator	27
Erlotinib	27

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Progression-Free Survival (PFS) in All Participants (Data Cutoff 07 September 2010)

Tumor response was evaluated according to RECIST criteria (version 1.0). Progressive Disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PFS was defined as time from randomization to the date of documented disease progression or death, whichever occurred first. Participants without progression were censored at the date of last tumor assessment where non progression was documented. If a participant receives a second anti-cancer therapy without prior documentation of disease progression, the participant was censored at the date of last tumor assessment before starting new chemotherapy. (NCT00556322)
Timeframe: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Until Data Cut off (07 September 2010) up to 52 months

Intervention	weeks (Median)
Comparator	8.6
Erlotinib	6.3

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Time to Symptomatic Progression Using FACT-L

Intervention	weeks (Median)
Comparator	9.0
Erlotinib	7.1

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Probable Percentage of Participants Remaining Alive at 1 Year in the EGFR Positive and Negative Population

Intervention	percentage of participants (Number)
	EGFR Positive (n=30,32)	EGFR Negative (n=8,4)
Comparator	27.0	28.0
Erlotinib	30.0	20.0

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Change From BL in FACT-L Scores (Data Cutoff 17 May 2008)

"Total FACT-L score=sum of TOI, SWB, and EWB of FACT-L questionnaires. TOI (PWB+FWB+LCS), SWB, and EWB scores obtained from 7-item (6-item for EWB) questionnaires from FACT-L V4. Participants responded to questions assessing symptoms (scale 0-4; 0=not at all and 4=very much). Higher score=more severe symptoms. The 7-item LCS assessed symptoms such as shortness of breath, loss of weight, tightness in chest. Participants responded to questions assessing symptoms (scale: 0-4; 0=not at all and 4=very much). Scores from 0-35; higher score=more severe symptoms. The 27 items of FACT-G were scored in the following domains: PWB (7 items, total score 0-28), SWB (7 items; total score 0-28), EWB (6 items, total score 0-24), and FWB (7 items; total score 0-28), higher scores=better QoL. Participants responded to items on 5-point Likert scale (0=Not at all to 4=Very much; total score: 0-108). Higher score=better QOL. TOI score=PWB+FWB+LCS; Total TOI score: 0-92; higher scores=better QOL." (NCT00556712)
Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Intervention	score on a scale (Mean)
	Week 6: Physical Well-Being (n=274,303)	Week 6: Social Well-Being (n=274,303)	Week 6: Emotional Well-Being (n=274,302)	Week 6: Functional Well-Being (n=275,302)	Week 6: FACT-L Subscale Score (n=275,298)	Week 6: Lung Cancer Subscale Score (n=275,298)	Week 6: Total FACT-G Score (n=273,299)	Week 6: Trial Outcome Index (n=274,296)	Week 6: Total FACT-L Score (n=273,294)	Week 12: Physical Well-Being (n=144,193)	Week 12: Social Well-Being (n=143,194)	Week 12: Emotional Well-Being (n=144,194)	Week 12: Functional Well-Being (n=144,196)	Week 12: FACT-L Subscale Score (n=144,196)	Week 12: Lung Cancer Subscale Score (n=144,196)	Week 12: Total FACT-G Score (n=144,191)	Week 12: Trial Outcome Index (n=144,193)	Week 12: Total FACT-L Score (n=144,191)	Week 18: Physical Well-Being (n=86,143)	Week 18: Social Well-Being (n=86,143)	Week 18: Emotional Well-Being (n=86,143)	Week 18: Functional Well-Being (n=86,143)	Week 18: FACT-L Subscale Score (n=86,143)	Week 18: Lung Cancer Subscale Score (n=86,143)	Week 18: Total FACT-G Score (n=86,143)	Week 18: Trial Outcome Index (n=86,143)	Week 18: Total FACT-L Score (n=86,143)	Week 24: Physical Well-Being (n=59,101)	Week 24: Social Well-Being (n=59,101)	Week 24: Emotional Well-Being (n=59,100)	Week 24: Functional Well-Being (n=59,100)	Week 24: FACT-L Subscale Score (n=59,101)	Week 24: Lung Cancer Subscale Score (n=59,101)	Week 24: Total FACT-G Score (n=59,99)	Week 24: Trial Outcome Index (n=59,100)	Week 24: Total FACT-L Score (n=59,99)	Week 30: Physical Well-Being (n=37,66)	Week 30: Social Well-Being (n=37,66)	Week 30: Emotional Well-Being (n=37,66)	Week 30: Functional Well-Being (n=37,66)	Week 30: FACT-L Subscale Score (n=37,66)	Week 30: Lung Cancer Subscale Score (n=37,66)	Week 30: Total FACT-G Score (n=37,66)	Week 30: Trial Outcome Index (n=37,66)	Week 30: Total FACT-L Score (n=37,66)	Week 36: Physical Well-Being (n=25,47)	Week 36: Social Well-Being (n=25,47)	Week 36: Emotional Well-Being (n=25,47)	Week 36: Functional Well-Being (n=25,47)	Week 36: FACT-L Subscale Score (n=25,47)	Week 36: Lung Cancer Subscale Score (n=25,47)	Week 36: Total FACT-G Score (n=25,47)	Week 36: Trial Outcome Index (n=25,47)	Week 36: Total Fact-L Score (n=25,47)	Week 42: Physical Well-Being (n=19,35)	Week 42: Social Well-Being (n=19,35)	Week 42: Emotional Well-Being (n=19,35)	Week 42: Functional Well-Being (n=19,35)	Week 42: FACT-L Subscale Score (n=19,35)	Week 42: Lung Cancer Subscale Score (n=19,35)	Week 42: FACT-G Score (n=19,35)	Week 42: Trial Outcome Index (n=19,35)	Week 42: FACT-L Score (n=19,35)	Week 48: Physical Well-Being (n=13,29)	Week 48: Social Well-Being (n=13,29)	Week 48: Emotional Well-Being (n=13,29)	Week 48: Functional Well-Being (n=13,29)	Week 48: FACT-L Subscale Score (n=12,29)	Week 48: Lung Cancer Subscale Score (n=12,29)	Week 48: Total FACT-G Score (n=13,29)	Week 48: Trial Outcome Index (n=12,29)	Week 48: Total FACT-L Score (n=12,29)	Week 60: Physical Well-Being (n=9,17)	Week 60: Social Well-Being (n=9,17)	Week 60: Emotional Well-Being (n=9,17)	Week 60: Functional Well-Being (n=9,17)	Week 60: FACT-L Subscale Score (n=9,17)	Week 60: Lung Cancer Subscale Score (n=9,17)	Week 60: Total FACT-G Score (n=9,17)	Week 60: Trial Outcome Index (n=9,17)	Week 60: Total FACT-L Score (n=9,17)	Week 72: Physical Well-Being (n=6,8)	Week 72: Social Well-Being (n=6,8)	Week 72: Emotional Well-Being (n=6,8)	Week 72: Functional Well-Being (n=6,8)	Week 72: FACT-L Subscale Score (n=6,8)	Week 72: Lung Cancer Subscale Score (n=6,8)	Week 72: Total FACT-G Score (n=6,8)	Week 72: Trial Outcome Index (n=6,8)	Week 72: Total FACT-L Score (n=6,8)	Week 84: Physical Well-Being (n=1,0)	Week 84: Social Well-Being (n=1,0)	Week 84: Emotional Well-Being (n=1,0)	Week 84: Functional Well-Being (n=1,0)	Week 84: FACT-L Subscale Score (n=1,0)	Week 84: Lung Cancer Subscale Score (n=1,0)	Week 84: Total FACT-G Score (n=1,0)	Week 84: Trial Outcome Index (n=1,0)	Week 84: Total FACT-L Score (n=1,0)	Off Trtmt: Physical Well-Being (n=264,214)	Off Trtmt: Social Well-Being (n=263,216)	Off Trtmt: Emotional Well-Being (n=264,216)	Off Trtmt: Functional Well-Being (n=264,216)	Off Trtmt: FACT-L Subscale Score (n=263,212)	Off Trtmt: Lung Cancer Subscale Score (n=263,212)	Off Trtmt: Total FACT-G Score (n=260,213)	Off Trtmt: Trial Outcome Index (n=261,210)	Off Trtmt: Total FACT-L Score (n=258,209)
Erlotinib, 150 mg/Day	-0.47	0.23	0.29	-0.09	0.24	-0.03	0.01	-0.73	0.14	-0.14	-0.43	0.20	-0.38	-0.06	-0.48	-0.84	-1.04	-0.90	0.40	-0.51	0.60	0.18	0.27	-0.26	0.68	0.32	0.95	0.16	0.04	-0.05	0.42	0.50	-0.12	0.52	0.43	1.10	0.49	-0.19	0.74	0.83	0.99	0.38	1.88	1.70	2.86	0.77	-0.16	0.65	1.10	0.43	-0.06	2.37	1.82	2.79	0.27	0.28	0.59	0.65	0.87	0.51	1.80	1.44	2.67	1.37	-0.68	0.41	0.55	0.82	0.34	1.64	2.26	2.46	1.82	0.06	0.28	-0.53	0.43	0.47	1.64	1.76	2.07	2.63	0.30	-0.13	-1.13	1.03	1.78	1.67	3.28	2.70	NA	NA	NA	NA	NA	NA	NA	NA	NA	-2.19	0.09	-1.56	-1.98	-1.32	-1.78	-5.71	-6.05	-7.10
Placebo	0.22	-0.24	-0.41	0.24	-0.06	-0.32	-0.20	0.16	-0.20	1.00	-0.43	0.25	1.00	0.88	0.19	1.83	2.20	2.72	1.31	-0.01	0.59	1.06	1.48	0.49	2.95	2.86	4.43	1.29	-0.25	0.21	1.64	1.45	0.48	2.89	3.42	4.34	1.61	0.00	-0.07	2.17	1.79	0.69	3.71	4.47	5.50	2.21	-0.36	0.86	1.31	0.67	-0.10	4.02	3.42	4.68	1.82	-1.14	-0.11	0.05	1.40	0.42	0.62	2.29	2.03	0.46	-1.96	-0.08	-2.00	0.03	-0.79	-3.57	-1.79	-1.60	1.89	-0.57	-1.56	-0.56	1.61	-0.22	-0.79	1.11	0.82	1.33	0.31	-1.50	-1.67	-0.50	-1.17	-1.53	-1.50	-2.03	1.33	-2.00	-3.00	-1.00	6.0	2.0	-4.67	2.33	1.33	-1.07	-0.66	-2.04	-1.20	-1.27	-1.74	-4.91	-4.03	-6.26

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Time to Symptom Progression (Data Cutoff 17 May 2008)

"The median time, in weeks, from the date of randomization to the date of documented clinically meaningful decline in LCS from BL or death, whichever occurred first. LCS scores were obtained from a 7-item questionnaire from the FACT-L V 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline. The 95% CI was determined using Kaplan-Meier methodology." (NCT00556712)
Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Intervention	weeks (Median)
Placebo	17.6
Erlotinib, 150 mg/Day	18.3

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Time to Progression (Data Cutoff 17 May 2008)

The median time, in weeks, between randomization and TTP event. Participants without PD were censored at the date of last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of PD, the participant was censored at the date of last tumor assessment before starting new chemotherapy. (NCT00556712)
Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Intervention	weeks (Median)
Placebo	11.3
Erlotinib, 150 mg/Day	12.3

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Time to Deterioration in TOI (Data Cutoff 17 May 2008)

"The median time, in weeks, from the date of randomization until a clinically meaningful decline from BL in TOI or death, whichever occurred first. TOI was defined as the sum of PWB, FWB, and LCS scores, which were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was determined using Kaplan-Meier methodology." (NCT00556712)
Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Intervention	weeks (Median)
Placebo	18.9
Erlotinib, 150 mg/Day	18.1

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Time to Deterioration in QoL (Data Cutoff 17 May 2008)

"The median time, in weeks, from the date of randomization until a clinically meaningful decline from BL in total FACT-L or death, whichever occurred first. Total FACT-L score was defined as the sum of the TOI, SWB and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was determined using Kaplan-Meier methodology." (NCT00556712)
Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Intervention	weeks (Median)
Placebo	12.3
Erlotinib, 150 mg/Day	12.6

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Percentage of EGFR IHC Negative Participants Who Died (Data Cutoff 17 May 2008)

(NCT00556712)
Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Intervention	percentage of participants (Number)
Placebo	50.8
Erlotinib, 150 mg/Day	41.9

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Percentage of All Participants Who Died (Data Cutoff 12 January 2012)

Intervention	percentage of participants (Number)
Placebo	87.1
Erlotinib, 150 mg/Day	82.0

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Overall Survival (OS) in All Participants (Data Cutoff 12 January 2012)

OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology. (NCT00556712)
Timeframe: Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months)

Intervention	months (Median)
Placebo	11.0
Erlotinib, 150 mg/Day	12.4

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OS in EGFR IHC Positive Population (Data Cutoff 12 January 2012)

OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology. (NCT00556712)
Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months)

Intervention	months (Median)
Placebo	11.0
Erlotinib, 150 mg/Day	12.8

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Probable Percentage of Participants Remaining Without Symptom Progression at 6 Months (Data Cutoff 17 May 2008)

"LCS scores were obtained from a 7-item questionnaire from the FACT-L V 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline. The 95% CI was estimated using Kaplan-Meier methodology." (NCT00556712)
Timeframe: 6 months

Intervention	percentage of participants (Number)
Placebo	35.0
Erlotinib, 150 mg/Day	41.0

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Probable Percentage of Participants Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008)

PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from BL more the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology. (NCT00556712)
Timeframe: 6 months

Intervention	percentage of participants (Number)
Placebo	15.0
Erlotinib, 150 mg/Day	25.0

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Probable Percentage of Participants Remaining Alive at 1 Year (Data Cutoff 12 January 2012)

Intervention	percentage of participants (Number)
Placebo	45.0
Erlotinib, 150 mg/Day	50.0

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Probable Percentage of Participants Remaining Progression-Free in the TTP Analysis at 6 Months (Data Cutoff 17 May 2008)

TTP was defined as the time from the date of randomization to the first date PD was recorded. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD were censored at the date of last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of PD, the participant was censored at the date of last tumor assessment before starting new chemotherapy. The 95% CI was estimated using Kaplan-Meier methodology. (NCT00556712)
Timeframe: 6 months

Intervention	percentage of participants (Number)
Placebo	15.0
Erlotinib, 150 mg/Day	26.0

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Percentage of Participants With Symptom Progression Assessed Using the Lung Cancer Subscale (LCS) (Data Cutoff 17 May 2008)

"LCS scores were obtained from a 7-item questionnaire from the Functional Assessment of Cancer Therapy - Lung (FACT-L) version (V) 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 equaled (=) not at all and 4 = very much. The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline." (NCT00556712)
Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Intervention	percentage of participants (Number)
Placebo	44.1
Erlotinib, 150 mg/Day	47.7

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Probable Percentage of Participants Remaining Without Deterioration in TOI at 6 Months (Data Cutoff 17 May 2008)

"TOI was defined as the sum of the scores of the PWB, FWB, and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was estimated using Kaplan-Meier methodology." (NCT00556712)
Timeframe: 6 months

Intervention	percentage of participants (Number)
Placebo	41.0
Erlotinib, 150 mg/Day	39.0

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OS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008)

OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology. (NCT00556712)
Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Intervention	months (Median)
Placebo	10.2
Erlotinib, 150 mg/Day	8.6

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PFS in All Participants (Data Cutoff 17 May 2008)

The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% confidence interval (CI) was estimated using Kaplan-Meier methodology. (NCT00556712)
Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Intervention	weeks (Median)
Placebo	11.1
Erlotinib, 150 mg/Day	12.3

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Percentage of Epidermal Growth Factor Receptor (EGFR) Immunohistochemistry (IHC) Positive Participants With PD or Death (Data Cutoff 17 May 2008)

PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. (NCT00556712)
Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Intervention	percentage of participants (Number)
Placebo	89.4
Erlotinib, 150 mg/Day	79.5

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Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST (Data Cutoff 17 May 2008)

BOR was defined as CR or PR confirmed by repeat assessments performed no less than 4 weeks after the criteria for response was first met. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% CI for one sample binomial was determined using the Pearson-Clopper method. (NCT00556712)
Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Intervention	percentage of participants (Number)
Placebo	5.4
Erlotinib, 150 mg/Day	11.9

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Percentage of Participants With a Response Upgrade From BL According to RECIST (Data Cutoff 17 May 2008)

Response upgrade was defined by a change of PR to CR or of SD to PR or CR from BL to the end of treatment. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method. (NCT00556712)
Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Intervention	percentage of participants (Number)
Placebo	1.3
Erlotinib, 150 mg/Day	5.5

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Percentage of Participants With Deterioration Assessed Using the Trial Outcome Index (Data Cutoff 17 May 2008)

"The Trial Outcome Index (TOI) was defined as the sum of the scores of the Physical Well-Being (PWB), Functional Well-Being (FWB), and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment." (NCT00556712)
Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Intervention	percentage of participants (Number)
Placebo	43.1
Erlotinib, 150 mg/Day	50.9

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Percentage of EGFR IHC Negative Participants With PD or Death (Data Cutoff 17 May 2008)

PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. (NCT00556712)
Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 71 months)

Intervention	percentage of participants (Number)
Placebo	89.8
Erlotinib, 150 mg/Day	77.4

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PFS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008)

The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology. (NCT00556712)
Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Intervention	weeks (Median)
Placebo	9.0
Erlotinib, 150 mg/Day	11.0

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Probable Percentage of Participants Remaining Without Deterioration in QoL at 6 Months (Data Cutoff 17 May 2008)

"Deterioration in QoL was defined as a clinically meaningful decline in the total FACT-L score, the sum of the TOI, SWB and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L. The 95% CI was estimated using Kaplan-Meier methodology." (NCT00556712)
Timeframe: 6 months

Intervention	percentage of participants (Number)
Placebo	34.0
Erlotinib, 150 mg/Day	32.0

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PFS in EGFR IHC Positive Population (Data Cutoff 17 May 2008)

The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology. (NCT00556712)
Timeframe: Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Intervention	weeks (Median)
Placebo	11.1
Erlotinib, 150 mg/Day	12.3

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Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008)

PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology. (NCT00556712)
Timeframe: 6 months

Intervention	percentage of participants (Number)
Placebo	11.0
Erlotinib, 150 mg/Day	22.0

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Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive at 1 Year (Data Cutoff 17 May 2008)

Intervention	percentage of participants (Number)
Placebo	20.0
Erlotinib, 150 mg/Day	42.0

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Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive and Progression Free at 6 Months (Data Cutoff 17 May 2008)

PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology. (NCT00556712)
Timeframe: 6 months

Intervention	percentage of participants (Number)
Placebo	16.0
Erlotinib, 150 mg/Day	27.0

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Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive at 1 Year (Data Cutoff 12 January 2012)

Intervention	percentage of participants (Number)
Placebo	47.0
Erlotinib, 150 mg/Day	52.0

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Percentage of Participants With CR, PR, or SD or With SD [Maintained For Greater Than (>) 12 Weeks] or CR or PR (Data Cutoff 17 May 2008)

Disease control was defined as a best response of CR or PR or SD or a best response of SD for more than 12 weeks, or CR or PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits. The 95% CI for one sample binomial was determined using the Pearson-Clopper method. (NCT00556712)
Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Intervention	percentage of participants (Number)
	CR Plus (+) PR + SD	CR + PR + SD >12 Weeks
Erlotinib, 150 mg/Day	60.6	40.8
Placebo	50.8	27.4

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Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST (Data Cutoff 17 May 2008)

For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method. (NCT00556712)
Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Intervention	percentage of participants (Number)
	CR	PR	SD	PD
Erlotinib, 150 mg/Day	0.9	11.0	48.6	35.6
Placebo	0.7	4.7	45.4	47.6

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Percentage of Participants With a Change of PR to CR or SD to PR or CR From BL to End of Treatment According to RECIST (Data Cutoff 17 May 2008)

Intervention	percentage of participants (Number)
	PR to CR	SD to PR	SD to CR
Erlotinib, 150 mg/Day	0.5	4.8	0.2
Placebo	0.4	0.9	0.0

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Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008)

Intervention	score on a scale (Mean)
	BL: Physical Well-Being (n=397,392)	BL: Social Well-Being (n=397,392)	BL: Emotional Well-Being (n=397,393)	BL: Functional Well-Being (n=397,393)	BL: FACT-L Subscale Score (n=397,391)	BL: Lung Cancer Subscale Score (n=397,391)	BL: Total FACT-General (FACT-G) Score (n=396,391)	BL: Trial Outcome Index (n=396,390)	BL: Total FACT-L Score (n=395,389)	Week 6: Physical Well-Being (n=274,304)	Week 6: Social Well-Being (n=274,303	Week 6: Emotional Well-Being (n=275,302)	Week 6: Functional Well-Being (n=275,302)	Week 6: FACT-L Subscale Score (n=275,300)	Week 6: Lung Cancer Subscale Score (n=275,300)	Week 6: Total FACT-G Score (n=274,300)	Week 6: Trial Outcome Index (n=274,299)	Week 6: Total FACT-L Score (n=274,297)	Week 12: Physical Well-Being (n=144,194)	Week 12: Social Well-Being (n=143,194)	Week 12: Emotional Well-Being (n=144,194)	Week 12: Functional Well-Being (n=144,196)	Week 12: FACT-L Subscale Score (n=144,196)	Week 12: Lung Cancer Subscale Score (n=144,196)	Week 12: Total FACT-G Score (n=144,192)	Week 12: Trial Outcome Index (n=144,194)	Week 12: Total FACT-L Score (n=144,192)	Week 18: Physical Well-Being (n=86,143)	Week 18: Social Well-Being (n=86,143)	Week 18: Emotional Well-Being (n=86,143)	Week 18: Functional Well-Being (n=86,143)	Week 18: FACT-L Subscale Score (n=86,143)	Week 18: Lung Cancer Subscale Score (n=86,143)	Week 18: Total FACT-G Score (n=86,143)	Week 18: Trial Outcome Index (n=86,143)	Week 18: Total FACT-L Score (n=86,143)	Week 24: Physical Well-Being (n=59,101)	Week 24: Social Well-Being (n=59,101)	Week 24: Emotional Well-Being (n=59,100)	Week 24: Functional Well-Being (n=59,100)	Week 24: FACT-L Subscale Score (n=59,101)	Week 24: Lung Cancer Subscale Score (n=59,101)	Week 24: Total FACT-G Score (n=59,99)	Week 24: Trial Outcome Index (n=59,100)	Week 24: Total FACT-L Score (n=59,99)	Week 30: Physical Well-Being (n=37,66)	Week 30: Social Well-Being (n=37,66)	Week 30: Emotional Well-Being (n=37,66)	Week 30: Functional Well-Being (n=37,66)	Week 30: FACT-L Subscale Score (n=37,66)	Week 30: Lung Cancer Subscale Score (n=37,66)	Week 30: Total FACT-G Score (n=37,66)	Week 30: Trial Outcome Index (n=37,66)	Week 30: Total FACT-L Score (n=37,66)	Week 36: Physical Well-Being (n=25,47)	Week 36: Social Well-Being (n=25,47)	Week 36: Emotional Well-Being (n=25,47)	Week 36: Fuctional Well-Being (n=25,47)	Week 36: FACT-L Subscale Score (n=25,47)	Week 36: Lung Cancer Subscale Score (n=25,47)	Week 36: Total FACT-G Score (n=25,47)	Week 36: Trial Outcome Index (n=25,47)	Week 36: Total FACT-L Score (n=25,47)	Week 42: Physical Well-Being (n=19,35)	Week 42: Social Well-Being (n=19,35)	Week 42: Emotional Well-Being (n=19,35)	Week 42: Functional Well-Being (n=19,35)	Week 42: FACT-L Subscale Score (n=19,35)	Week 42: Lung Cancer Subscale Score (n=19,35)	Week 42: FACT-G Score (n=19,35)	Week 42: Trial Outcome Index (n=19,35)	Week 42: FACT-L Score (n=19,35)	Week 48: Physical Well-Being (n=13,29)	Week 48: Social Well-Being (n=13,29)	Week 48: Emotional Well-Being (n=13,29)	Week 48: Functional Well-Being (n=13,29)	Week 48: FACT-L Subscale Score (n=12,29)	Week 48: Lung Cancer Subscale Score (n=12,29)	Week 48: FACT-G Score (n=12,29)	Week 48: Trial Outcome Index (n=12,29)	Week 48: FACT-L Score (n=12,29)	Week 60: Physical Well-Being (n=9,17)	Week 60: Social Well-Being (n=9,17)	Week 60: Emotional Well-Being (n=9,17)	Week 60: Functional Well-Being (n=9,17)	Week 60: FACT-L Subscale Score (n=9,17)	Week 60: Lung Cancer Subscale Score (n=9,17)	Week 60: Total FACT-G Score (n=9,17)	Week 60: Trial Outcome Index (n=9,17)	Week 60: Total FACT-L Score (n=9,17)	Week 72: Physical Well-Being (n=6,8)	Week 72: Social Well-Being (n=6,8)	Week 72: Emotional Well-Being (n=6,8)	Week 72: Functional Well-Being (n=6,8)	Week 72: FACT-L Subscale Score (n=6,8)	Week 72: Lung Cancer Subscale Score (n=6,8)	Week 72: Total FACT-G Score (n=6,8)	Week 72: Trial Outcome Index (n=6,8)	Week 72: Total FACT-L Score (n=6,8)	Week 84: Physical Well-Being (n=1,0)	Week 84: Social Well-Being (n=1,0)	Week 84: Emotional Well-Being (n=1,0)	Week 84: Functional Well-Being (n=1,0)	Week 84: FACT-L Subscale Score (n=1,0)	Week 84: Lung Cancer Subscale Score (n=1,0)	Week 84: Total FACT-G Score (n=1,0)	Week 84: Trial Outcome Index (n=1,0)	Week 84: Total FACT-L Score (n=1,0)	Off Trtmt: Physical Well-Being (n=265,215)	Off Trtmt: Social Well-Being (n=263,216)	Off Trtmt: Emotional Well-Being (n=265,216)	Off Trtmt: Functional Well-Being (n=265,216)	Off Trtmt: FACT-L Subscale Score (n=264,214)	Off Trtmt: Lung Cancer Subscale Score (n=264,214)	Off Trtmt:Total FACT-G Score (n=261,214)	Off Trtmt:Trial Outcome Index (n=263,213)	Off Trtmt:Total FACT-L Score (n=260,212)
Erlotinib, 150 mg/Day	20.96	20.98	16.77	16.84	24.46	20.07	75.52	57.90	100.02	20.69	21.43	17.17	16.87	24.80	20.13	76.14	57.64	100.95	20.78	20.04	16.85	16.35	24.19	19.50	74.06	56.57	98.30	21.40	19.94	17.14	16.83	24.52	19.64	75.31	57.87	99.83	21.21	20.49	16.54	17.23	25.13	19.94	75.50	58.37	100.69	21.77	20.74	17.23	17.93	25.86	20.61	77.66	60.30	103.52	22.26	20.15	17.54	18.06	25.83	20.55	78.02	60.87	103.86	22.19	20.40	17.43	18.57	26.67	21.21	78.59	61.97	105.25	23.23	20.24	17.59	18.48	26.80	21.21	79.53	62.92	106.33	23.65	21.31	19.12	18.65	25.99	20.47	82.73	62.76	108.71	23.25	21.44	18.25	16.50	26.48	21.40	79.44	61.15	105.92	NA	NA	NA	NA	NA	NA	NA	NA	NA	18.50	20.68	15.11	14.58	22.88	18.16	68.94	51.34	91.89
Placebo	20.85	20.84	16.92	16.15	24.17	19.82	74.68	56.83	98.85	21.44	20.62	16.53	16.41	24.45	19.78	74.82	57.59	99.27	21.93	20.38	17.21	17.04	25.15	20.22	76.42	59.19	101.56	21.60	21.08	17.33	16.89	25.44	20.28	76.89	58.76	102.33	21.78	20.79	16.86	17.14	25.18	20.07	76.58	58.99	101.75	21.74	20.50	16.37	17.92	25.90	20.66	76.54	60.32	102.44	21.60	20.02	17.31	16.06	24.48	19.36	74.99	57.02	99.27	21.76	18.45	16.95	15.32	24.63	19.50	72.74	56.58	97.11	21.38	17.23	18.69	14.15	23.35	18.75	71.46	54.58	96.19	22.67	17.78	16.78	15.11	23.43	17.89	72.34	55.67	95.77	22.17	19.00	17.17	15.22	21.23	17.17	73.67	54.67	94.90	20.00	14.00	13.00	18.00	17.00	13.00	65.00	51.00	82.00	19.57	20.01	14.76	14.90	22.80	18.06	69.29	52.61	92.14

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Percentage of Participants With Deterioration in Quality of Life Assessed Using TOI, SWB, and EWB (Data Cutoff 17 May 2008)

"Deterioration in quality of life (QoL) was defined as a clinically meaningful decline in the total FACT-L score, the sum of the TOI, Social/Family Well-Being (SWB) and Emotional Well-Being (EWB) of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L." (NCT00556712)
Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Intervention	percentage of participants (Number)
Placebo	51.7
Erlotinib, 150 mg/Day	55.3

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Percentage of Participants With PD According to Response Evaluation Criteria in Solid Tumors (RECIST) or Death (Data Cutoff 17 May 2008)

Progression-free survival (PFS) was defined as the time from randomization to PD or death, whichever occurred first. For target lesions (TLs), PD was defined at least a 20 percent (%) increase in the sum of the largest diameter (SLD), taking as reference the smallest SLD recorded from baseline (BL) more the appearance of one or more new lesions. For non-target lesions (NTLs), PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. (NCT00556712)
Timeframe: Screening, BL [≤21 days after randomization], every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Intervention	percentage of participants (Number)
Placebo	89.5
Erlotinib, 150 mg/Day	79.9

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Percentage of EGFR IHC Positive Participants Who Died (Data Cutoff 12 January 2012)

Intervention	percentage of participants (Number)
Placebo	87.5
Erlotinib, 150 mg/Day	80.5

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Overall Survival and Disease Local Control Rate

"The Secondary Endpoints is Overall Survival (OS)and Disease Local Control (DLC)Rate. All patients will be followed up to evaluate Overall Survival and Disease Local Control by one month after treatment, once a month until recovery from treatment related toxicities, then every 3 months for 2 years, then every 4 months for 2 years (total of 4 years), then annually up to 5 years.~CT scan of the chest/upper abdomen, MRI of brain or CT, and/or PET scan images are recommended to confirm the recurrence.~Survival endpoints were estimated using the Kaplan-Meier method." (NCT00563784)
Timeframe: OS: From date of registration until the date of first documented death or lost to follow up, whichever came first, accessed up to 5 years. DLC: From date of registration until the date of first documented local disease recurrence, accessed up to 5 years.

Intervention	percentage of participants (Number)
	Overall Survival:5-year	Disease Free Survival:5-year	Local Regional Survival:5-year	Distant Metastasis Free Survival:5-year
Phase II TARCEVA (Erlotinib) With Chemoradiation in Stage IIIA	35.9	25.8	55.8	36.5

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Time To First Disease Progression

Primary Endpoints is efficacy of concurrent erlotinib and chemoradiation as measured by time to progression. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions. All patients will be evaluated by followed up one month after treatment, once a month until recovery from treatment related toxicities, then every 3 months for 2 years, then every 4 months for 2 years (total of 4 years), then annually up to 5 years. (NCT00563784)
Timeframe: From date of registration until the date of first documented progression or death from any cause, or lost to follow up, whichever came first, assessed up to 5 years.

Intervention	Month (Median)
Phase II TARCEVA (Erlotinib) With Chemoradiation in Stage IIIA	14

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2-year Disease-free Survival

The number of participants alive and free from disease recurrence 2 years after enrollment. Participants were monitored for disease recurrence with the use of surveillance radiographs. When possible and medically appropriate, tissue biopsies were obtained to prove recurrence. (NCT00567359)
Timeframe: 2 years

Intervention	Participants (Count of Participants)
Erlotinib	88

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Median Disease Free Survival

The median amount of time measured from the time of registration until the time of disease recurrence or death. (NCT00567359)
Timeframe: From registration to disease recurrence or death, up to approximately 9 years

Intervention	years (Median)
Erlotinib	NA

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Median Overall Survival

The median amount of time from the time of registration until death due to any cause (NCT00567359)
Timeframe: From the time of registration until death, up to approximately 9 years

Intervention	years (Median)
Erlotinib	NA

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Number of Participants With Treat Related Serious Adverse Events

Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 3.0) from the start of treatment until 30 days after the end of treatment. Serious adverse events were defined as adverse events that were grade 3 or greater and deemed to be possibly, probably or definitely related to the study treatment. (NCT00567359)
Timeframe: From the start of treatment until 30 days after the end of treatment, up 13 months total

Intervention	Participants (Count of Participants)
Erlotinib	20

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Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment

Number of participants who had the most frequently observed undesirable effects after exposure to study drug (NCT00570232)
Timeframe: 12 - 24 months

Intervention	participants (Number)
	rash	diarrhea	fatigue	nausea	vomiting	headache
Tarceva	26	22	22	6	6	4

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Percentage of Participants Demonstrating Survival at 12 Months and 24 Months.

Percentage of participants who were still alive at 12 months following completion of study drug therapy and at 24 months following completion of study drug therapy (NCT00570232)
Timeframe: 12 - 24 months

Intervention	percentage of participants (Number)
	survival rate at 12 months	survival rate at 24 months
Tarceva	61	56

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Percentage of Participants With Disease Free Status at 12 Months and 24 Months

Percentage of participants who were disease free at 12 months (12 months after initiation of study drug treatment) and 24 months (12 months after completion of study drug treatment) (NCT00570232)
Timeframe: 12 - 24 months

Intervention	percentage of participants (Number)
	disease free rate at 12 months	disease free rate at 24 months
Tarceva	54	45

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Median Overall Survival

Median Overall Survival of participants reported after 2 years. (NCT00573989)
Timeframe: up to 5 years

Intervention	years (Median)
Erlotinib	1.01

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Overall Survival

Overall survival of participants reported after 2 years. (NCT00573989)
Timeframe: 1 and 2 years

Intervention	Participants (Count of Participants)
	1 year	2 years
Erlotinib	9	7

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Objective Tumor Response

Objective Tumor Response reported on participants at 1 year (complete, partial, progression, or stable response). (NCT00573989)
Timeframe: 1 year

Intervention	Participants (Count of Participants)
	Complete	Partial	Progression	Stable
Erlotinib	7	5	4	2

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Evaluation of Acute and Chronic Toxicity

Evaluate acute and chronic toxicity of the combined re-irradiation with radiosensitizing drugs: Pemetrexed and Erlotinib. Adverse events with Common Toxicity Criteria grades of 4 and 5 are reported for phase I and II. (NCT00573989)
Timeframe: 1 year

Intervention	events (Number)
	phase I	phase II
Erlotinib	18	6

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Change in Quality of Life: PSS-HN

The Performance Status Scale for Head & Neck Cancer Patients (PSS-HN) is s designed to evaluate performance in areas of functioning most likely affected by head and neck cancer and its treatment, specifically Normalcy of Diet, Eating in Public, and Understandability of Speech. Each subscale is rated from 0 to 100, with higher scores indicating better performance (NCT00573989)
Timeframe: baseline and 6 months

Intervention	units on a scale (Mean)
	Eating Baseline	Eating 6 months	Speech Baseline	Speech 6 months	Diet Baseline	Diet 6 months
Erlotinib	56.25	43.75	81.25	75.0	44.44	25.0

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Change in Quality of Life: MDADI

The M.D. Anderson Dysphagia Inventory (MDADI) was used to assess effects of dysphagia on the quality of life of patients with head and neck cancer. It incorporates 3 domains (emotional, functional, and physical) as well as 1 global question. Each subscale with five possible responses scored on a scale of 1 to 5 (strongly agree, agree, no opinion, disagree and strongly disagree). Scores range from 0 (extremely low functioning) to 100 (higher functioning). Higher MDADI score represents better day-to-day functioning and better quality of life. (NCT00573989)
Timeframe: baseline and 12 months

Intervention	units on a scale (Mean)
	baseline- global	12 months- global	baseline- emotion	12 months- emotion	baseline- function	12 months- function	baseline- physical	12 months- physical
Erlotinib	64.44	90.0	70.37	78.33	65.78	84.0	60.0	73.75

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Change in Quality of Life- FACT H&N

The Functional Assessment of Cancer Therapy-Head and Neck (FACT H&N) consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for head and neck related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce subscale scores for each domain. Score range is 0-156. Higher scores denotes better outcomes (NCT00573989)
Timeframe: baseline and 12 months

Intervention	units on a scale (Mean)
	baseline	12 months
Erlotinib	84.87	88.61

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Progression-free Survival (PFS) at 1 Year (Phase II)

Determine Progression Free Survival at 1 year defined as the percentage of patients who are alive at 1 year after beginning of their concurrent re-irradiation and chemotherapy without loco-regional progression of their disease as measured by CT scan or MRI. (NCT00573989)
Timeframe: 1 year

Intervention	Participants (Count of Participants)
Erlotinib	5

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Median Progression Free Survival

Median Progression Free Survival of participants reported after 2 years. (NCT00573989)
Timeframe: 2 years

Intervention	years (Median)
Erlotinib	.71

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Maximum Tolerated Dose of Erlotinib Hydrochloride (Phase I)

Dose at which 100% of participants tolerated the dose (NCT00573989)
Timeframe: 56 Days

Intervention	mg (Number)
Erlotinib	125

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Number of Patients With Pathologic Complete Response Rate

Complete Response (CR): Disappearance of all clinical evidence of tumor. Partial Response (PR): A 50% or greater decrease in the sum of the products of measured lesions. No simultaneous increase in the size of any lesion or the appearance of new lesions may occur. Non-measurable lesions must remain stable or regress for this category. Minor Response (MR): A > 25% and < 50% decrease in the sum of the products of measured lesions. No simultaneous increase in the size of any lesion or the appearance of new lesions may occur. Non-measurable lesions must remain stable or regress for this category. Stable Disease (SD): A less than 25% decrease. This includes a decrease of less than 25% in the sum of the products of the measured lesions, and any increase of less than 25% in the sum of the products of the measured lesions. There may be no appearance of new disease sites for this category. Progressive Disease (PD): A ≥25% increase in one or more lesions, or appearance of new lesions. (NCT00577707)
Timeframe: Patients will undergo a CT scan of chest every 3 months for year 1 and every 4 months for year 2. In years 3 and 4, a chest CT or chest x-ray every 6 months.

Intervention	participants (Number)
	Minor Response (MR)	Partial Response (PR)	Stable Disease (SD)	Progressive Disease (POD)
Patients With Stage IB-IIIA NSCLC With EGFR Mutations	1	1	2	2

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Evaluation of Response Rate

The percentage of patients in which response (CR + PR) was observed: Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions (NCT00585377)
Timeframe: 2 years

Intervention	percentage of participants (Number)
Arm 1:Bevacizumab and Erlotinib	24

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Evaluation of Progression-free Survival

The length of time during and after bevacizumab-erlotinib that a patient lives with the disease but does not progress according to RECIST 1.0 Criteria. Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by CT: Progressive Disease (PD), >=20% increase in the sum of the longest diameter of target lesions (NCT00585377)
Timeframe: 2 years

Intervention	weeks (Median)
Arm 1:Bevacizumab and Erlotinib	15.5

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Evaluation of Overall Survival

The length of time from the start of treatment for a disease that patients are still alive. (NCT00585377)
Timeframe: 2 years

Intervention	weeks (Median)
Arm 1:Bevacizumab and Erlotinib	50.4

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Overall Survival

Estimated via a Kaplan-Meier curves. Survival will be counted from the first dose of Tarceva. (NCT00585533)
Timeframe: 24 months

Intervention	weeks (Median)
All Participants	50.1

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Survival Rate at 6-months Chemotherapy-progression-free (CP-free)

Will determine if 6-month chemotherapy-progression-free (CP-free) survival rate (using RECIST) is significantly higher than the historically observed 31%. A one-sided binomial test at a 5% nominal significance was used. (NCT00585533)
Timeframe: 6 months

Intervention	percentage of participants (Number)
All Participants	55

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Overall Objective Response of OSI-774

(complete and partial responses) Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. A complete response is the disappearance of all target lesions, and a partial response (PR) is defined as at least a 30% decrease in the sum of the target lesions. Stable disease is defined as fitting the criteria neither for progressive disease nor a PR. (NCT00590902)
Timeframe: 53 weeks

Intervention	participants (Number)
	Complete Response (CR)	Partial Response (PR)	Stable Disease (SD)	Progression of Disease (POD)
1 - OSI-774	1	18	31	30

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Toxicity of the Combination of FOLFOX, 5-FU, and Erlotinib

Adverse event assessment by investigators and as reported by subjects from time of consent to 30 days after last dose. Up to 3.5 years. (NCT00591123)
Timeframe: 3.5 years

Intervention	participants (Number)
	Diarrhea / dehydration	Anorexia	Nausea/Vomiting	Rash	Fatigue	Peripheral neuropathy	Neutropenia	Neutropenic Fever	Hypokalemia	AST / ALT Elevation
FOLFOX Plus 5-FU and Erlotinib	9	5	4	3	4	3	5	1	2	2

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Overall Response Rate of Previously-untreated Patients With Unresectable or Metastatic Adenocarcinomas of the Upper Gastrointestinal Tract When Treated With the Combination of 5-fluorouracil, Leucovorin, Oxaliplatin, and Erlotinib.

"Per response evaluation criteria in solid tumors criteria (RECIST) for target lesions and assessed by computerized tomography (CT) scan.~Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions" (NCT00591123)
Timeframe: 3.5 years

Intervention	percent of subjects that had response (Number)
FOLFOX Plus 5-FU and Erlotinib	51.5

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Safety of Erlotinib

Number of Participants With Adverse Events (NCT00597597)
Timeframe: 2 years

Intervention	participants (Number)
Erlotinib: 150mg/Day	2

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The Primary Objective of the Study is Progression Free Survival.

From the Day of Initial Treatment (Day 0) Until Documented Disease Progression or Death. (NCT00597597)
Timeframe: From the Day of Initial Treatment (Day 0) Until Documented Disease Progression or Death, whichever came first, assessed up to 6 months.

Intervention	years (Median)
A Phase II Open-Label Clinical Trial to Evaluate the Efficacy	0.08

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Clinical Benefit, Consisting of Complete and Partial Responses, and Stable Disease for Six Months

We measured the clinical benefit, consisting of complete and partial responses, and stable disease for six months (NCT00597597)
Timeframe: very 8 weeks, up to 6 months

Intervention	participants (Number)
Erlotinib: 150mg/Day	2

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Number of Participants With Rash

We evaluated the number of Participants with Rash (NCT00597597)
Timeframe: every 8 weeks, up to 6 months

Intervention	Participants (Count of Participants)
Erlotinib: 150mg/Day	1

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Overall Response Rate, Consisting of Complete and Partial Responses According to RECIST Criteria

"Overall response rate, consisting of complete and partial responses according to RECIST criteria Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR." (NCT00597597)
Timeframe: every 8 weeks, up to 6 months

Intervention	Participants (Count of Participants)
Erlotinib: 150mg/Day	0

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Progression Free Survival (PFS)

"Progression-free survival is defined as the time from the first day of treatment until the day tumor progression was documented. Response was evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST).~Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions" (NCT00600015)
Timeframe: 18 months

Intervention	Months (Median)
Combination Therapy	3.38
Placebo	1.94

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6-month PFS

Progression free survival is defined as the time from the first day of treatment until the day tumor progression was documented. Response was evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST). Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions (1). Percentage of participants who were progression free at 6 month from the start of treatment is reported here. (NCT00600015)
Timeframe: 6 months

Intervention	percentage of participants (Number)
Combination Therapy	29
Placebo	22

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Disease Control Rate (DCR)

"Disease Control Rate (DCR) is defined as the percentage of patients who have a partial/complete/stable response to therapy. Responses were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.0).~Complete Response: Disappearance of all target lesions, and disappearance of all non-target lesions.~Partial Response: At least a 30% decrease in the sum of the longest diameter of target lesions (taking as reference the baseline sum of longest diameters) Stable Response: Neither sufficient shrinkage to qualify for partial response, nor sufficient increase to qualify for progressive disease (taking as reference the smallest sum of diameters since the treatment started)." (NCT00600015)
Timeframe: 18 months

Intervention	percentage of participants (Number)
Combination Therapy	54
Placebo	38

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Duration of Response

Duration of response is defined as the time from when objective response is realized until time to first documented disease progression. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Objective Response = CR + PR. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. (NCT00600015)
Timeframe: 18 months

Intervention	months (Mean)
Combination Therapy	4.6430
Placebo	5.2234

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Overall Objective Response Rate (ORR)

"Overall response rate (ORR) is defined as the percentage of patients who have a partial or complete response to therapy. Responses were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.0).~Complete Response: Disappearance of all target lesions, and disappearance of all non-target lesions.~Partial Response: At least a 30% decrease in the sum of the longest diameter of target lesions (taking as reference the baseline sum of longest diameters)" (NCT00600015)
Timeframe: 18 months

Intervention	percentage of participants (Number)
Combination Therapy	8.1
Placebo	10.9

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Overall Survival (OS)

OS is defined as the time from the first treatment until date of death due to any cause. In the absence of confirmation of death or lack of data beyond follow-up period, the survival time was censored to last date the participant was known to be alive. (NCT00600015)
Timeframe: 18 months

Intervention	Months (Median)
Combination Therapy	7.62
Placebo	7.23

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Tmax: Time to Cmax of Entinostat in the Lead-in Phase

(NCT00602030)
Timeframe: Day 1 predose and 0.5, 1, 2, 4 and 6 hours after dose; Days 2 and 8 predose (entinostat alone); Day 15 predose and 0.5, 1, 2, 4, 6 and 24 hours after dose

Intervention	hour (Mean)
	Day 1 (entinostat alone)	Day 15 (entinostat + erlotinib)
Lead-in Phase: Erlotinib + Entinostat 10 mg	0.50	1.3
Lead-in Phase: Erlotinib + Entinostat 5 mg	0.83	1.0

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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) by Severity in the Double-blind Phase

"An AE is defined as any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Worsening of a pre-existing medical condition was considered an AE if there was either an increase in severity, frequency, or duration of the condition or an association with significantly worse outcomes. A TEAE is an AE that starts after the administration of study drug.~A SAE is any AE that is fatal, life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth effect or other significant medical hazard.~TEAE severity was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 scale where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, medically significant, Grade 4=Life-threatening and 5=Death." (NCT00602030)
Timeframe: First dose of study drug to within 30 days past last dose (Up to 7 months)

Intervention	Participants (Count of Participants)
	Any SAE	Any TEAE	Grade 1 TEAE	Grade 2 TEAE	Grade 3 TEAE	Grade 4 TEAE	Grade 5 TEAE
Double-blind Phase: Erlotinib + Entinostat 10 mg	32	65	1	12	34	6	12
Double-blind Phase: Erlotinib + Placebo	29	63	7	16	20	5	15

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Number of Participants With Grade 3 or 4 Laboratory Variables in the Double-blind Phase

Laboratory tests included tests of Hematology and Chemistry. The individual laboratory values were graded by the investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 scale where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, medically significant, Grade 4=Life-threatening and 5=Death. (NCT00602030)
Timeframe: Day 1 and 15 of each cycle to safety follow-up 30 days past last dose (up to 7 months)

Intervention	Participants (Count of Participants)
	White Blood Count decreased	Absolute Neutrophil Count decreased	Lymphocytes decreased	Platelets decreased	Phosphorus decreased	Alanine aminotransferase increased	Sodium decreased	Glucose increased	Albumin decreased	Potassium decreased	Aspartate aminotransferase increased	Bilirubin increased	Creatinine abnormal	Magnesium decreased	Potassium increased	Calcium increased	Calcium decreased
Double-blind Phase: Erlotinib + Entinostat 10 mg	1	2	18	2	6	6	4	3	2	2	2	0	1	1	1	0	0
Double-blind Phase: Erlotinib + Placebo	1	1	9	1	4	1	5	2	4	2	0	3	1	0	0	2	1

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Cmax: Maximum Plasma Concentration of Entinostat in the Lead-in Phase

(NCT00602030)
Timeframe: Day 1 predose and 0.5, 1, 2, 4 and 6 hours after dose; Days 2 and 8 predose (entinostat alone); Day 15 predose and 0.5, 1, 2, 4, 6 and 24 hours after dose

Intervention	ng/mL (Mean)
	Day 1 (entinostat alone)	Day 15 (entinostat + erlotinib)
Lead-in Phase: Erlotinib + Entinostat 10 mg	123.1	99.4
Lead-in Phase: Erlotinib + Entinostat 5 mg	19.6	30.2

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AUC(0-last): Area Under the Concentration-time Curve From Time 0 to Last Quantifiable Concentration in the Lead-in Phase

(NCT00602030)
Timeframe: Day 1 predose and 0.5, 1, 2, 4 and 6 hours after dose; Days 2 and 8 predose (entinostat alone); Day 15 predose and 0.5, 1, 2, 4, 6 and 24 hours after dose

Intervention	ng*hr/mL (Mean)
	Day 1 (entinostat alone)	Day 15 (entinostat + erlotinib)
Lead-in Phase: Erlotinib + Entinostat 10 mg	325.8	106.4
Lead-in Phase: Erlotinib + Entinostat 5 mg	152.1	51.7

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AUC(0-24): Area Under the Concentration-time Curve From Time 0 to 24 Hours in the Lead-in Phase

(NCT00602030)
Timeframe: Day 1 predose and 0.5, 1, 2, 4 and 6 hours after dose; Days 2 and 8 predose (entinostat alone); Day 15 predose and 0.5, 1, 2, 4, 6 and 24 hours after dose

Intervention	ng*hr/mL (Mean)
	Day 1 (entinostat alone)	Day 15 (entinostat + erlotinib)
Lead-in Phase: Erlotinib + Entinostat 10 mg	133.3	110.2
Lead-in Phase: Erlotinib + Entinostat 5 mg	46.5	51.7

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Objective Response Rate (ORR) in the Double-blind Phase

ORR was defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) as assessed by the investigator. CR=disappearance of all target lesions; disappearance of non-target lesions and normalization of tumor marker level. PR=At least a 30% decrease in the sum of the longest diameter of target lesions, taking at reference the baseline sum longest diameter. (NCT00602030)
Timeframe: Month 6

Intervention	percentage of participants (Number)
Double-blind Phase: Erlotinib + Placebo	9.2
Double-blind Phase: Erlotinib + Entinostat 10 mg	3.0

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Identification of Safe-dose for the Phase 2 Double-blind Phase in the Lead-in Phase

Safe recommended Phase 2 dose was determined based on dose-limiting toxicities (DLT) in Cycle 1. A DLT was defined as any of the following occurring in Cycle 1: Grade 3 or greater nonhematologic toxicity that was considered related to either entinostat or erlotinib or a Grade 4 hematologic toxicity lasting more than 7 days and/or resulting in a dose delay. Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 scale was used where Grade 1=mild, Grade 2=Moderate, Grade 3=Severe, medically significant, Grade 4=life-threatening and 5=death. The dose that was found to be safe is reported. (NCT00602030)
Timeframe: Cycle 1 of Lead-in Phase

Intervention	milligrams (mg) (Number)
Lead-in Phase: Erlotinib + Entinostat	10

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6-Month PFS Rate in the Double-blind Phase

PFS rate at 6 months is defined as the percentage of participants who are progression-free at 6 months. (NCT00602030)
Timeframe: Month 6

Intervention	percentage of participants (Number)
Double-blind Phase: Erlotinib + Placebo	10.8
Double-blind Phase: Erlotinib + Entinostat 10 mg	11.9

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4-Month Progression-free Survival (PFS) Rate in the Double-blind Phase

PFS rate at 4 months was defined as the percentage of participants who are progression-free at 4 months. (NCT00602030)
Timeframe: Month 4

Intervention	percentage of participants (Number)
Double-blind Phase: Erlotinib + Placebo	24.0
Double-blind Phase: Erlotinib + Entinostat 10 mg	20.8

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