Therapy Detail

Therapy Name Erlotinib
Synonym
Therapy Description

Tarceva (erlotinib) is a first-generation EGFR inhibitor, which is FDA approved for non-small cell lung carcinoma patients with EGFR exon 19 deletions and/or EGFR L858R and in combination with gemcitabine for patients with advanced pancreatic cancer (FDA.gov; PMID: 25302162).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Erlotinib Tarceva CP358774 EGFR Inhibitor (Pan) 42 EGFR Inhibitor 1st gen 3 Tarceva (erlotinib) is a first-generation EGFR inhibitor, which is FDA approved for non-small cell lung carcinoma patients with EGFR exon 19 deletions and/or EGFR L858R and in combination with gemcitabine for patients with advanced pancreatic cancer (FDA.gov; PMID: 25302162).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
KRAS wild-type non-small cell lung carcinoma sensitive Erlotinib Phase I Actionable In a Phase I trial, Tarceva (erlotinib) treatment resulted in a greater survival benefit in non-small cell lung cancer patients with wild-type KRAS compared to treatment in those patients harboring KRAS mutations (PMID: 18626007). 18626007
KRAS G12X lung adenocarcinoma predicted - resistant Erlotinib Clinical Study - Cohort Actionable In a clinical study, KRAS mutations in codon 12 were associated with resistance to Tarceva (erlotinib) in patients with lung adenocarcinoma (PMID: 15696205). 15696205
ERBB2 G660D Advanced Solid Tumor no benefit Erlotinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G660D did not benefit from treatment with Tarceva (erlotinib) in culture when compared to Erbb2 (Her2) inhibitors (PMID: 30449325). 30449325
ERBB2 R678Q Advanced Solid Tumor no benefit Erlotinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) R678Q did not benefit from treatment with Tarceva (erlotinib) in culture when compared to Erbb2 (Her2) inhibitors (PMID: 30449325). 30449325
ROS1 rearrange non-small cell lung carcinoma no benefit Erlotinib Guideline Actionable EGFR tyrosine kinase inhibitors including Tarceva (erlotinib), Iressa (gefitinib), Gilotrif (afatinib), and Tagrisso (osimertinib) are not indicated for use as subsequent therapy in ROS1 rearranged non-small cell lung cancer patients who relapsed on Alecensa (alectinib), Xalkori (crizotinib), or Zykadia (ceritinib) (NCCN.org). detail...
ERBB2 Y772_A775dup Advanced Solid Tumor resistant Erlotinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Y772_A775dup (reported as A775_G776insYVMA) were resistant to Tarceva (erlotinib) in culture (PMID: 30527195). 30527195
ERBB2 G660R Advanced Solid Tumor no benefit Erlotinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G660R did not benefit from treatment with Tarceva (erlotinib) in culture when compared to Erbb2 (Her2) inhibitors (PMID: 30449325). 30449325
ERBB2 G776delinsVC Advanced Solid Tumor decreased response Erlotinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVC demonstrated decreased response to Tarceva (erlotinib) compared to Poziotinib (HM781-36B) in culture (PMID: 30527195). 30527195
ERBB2 Y772_A775dup ERBB2 C805S Advanced Solid Tumor resistant Erlotinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Y772_A775dup (reported as A775_G776insYVMA) and an acquired ERBB2 (HER2) C805S were resistant to Tarceva (erlotinib) in culture (PMID: 30527195). 30527195
ERBB2 Y772_A775dup non-small cell lung carcinoma no benefit Erlotinib Clinical Study Actionable In a retrospective analysis, Tarceva (erlotinib) treatment resulted in an objective response rate of 0% (0/1) in non-small cell lung cancer patients harboring ERBB2 (HER2) Y772_A775dup (reported as (A775_G776insYVMA) (PMID: 30527195). 30527195
ERBB2 L663P Advanced Solid Tumor no benefit Erlotinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) L663P did not benefit from treatment with Tarceva (erlotinib) in culture when compared to Erbb2 (Her2) inhibitors (PMID: 30449325). 30449325
ERBB2 V659E Advanced Solid Tumor no benefit Erlotinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) V659E did not benefit from treatment with Tarceva (erlotinib) in culture when compared to Erbb2 (Her2) inhibitors (PMID: 30449325). 30449325
ERBB2 G776delinsVC ERBB2 C805S Advanced Solid Tumor resistant Erlotinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVC and an acquired ERBB2 (HER2) C805S were resistant to Tarceva (erlotinib) in culture (PMID: 30527195). 30527195
ERBB2 G776delinsVC non-small cell lung carcinoma no benefit Erlotinib Clinical Study Actionable In a retrospective analysis, Tarceva (erlotinib) treatment resulted in an objective response rate of 0% (0/1) in non-small cell lung cancer patients harboring ERBB2 (HER2) G776delinsVC (PMID: 30527195). 30527195
ERBB2 G778_P780dup Advanced Solid Tumor resistant Erlotinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G778_P780dup (reported as P780_Y781insGSP) were resistant to Tarceva (erlotinib) in culture (PMID: 30527195). 30527195
KRAS G12S lung adenocarcinoma no benefit Erlotinib Preclinical - Cell line xenograft Actionable In a preclinical study, lung adenocarcinoma cells harboring KRAS G12S were insensitive to treatment with Tarceva (erlotinib) in culture, demonstrating no change in Erk, Mek, and Akt activity and minimal inhibition of cell growth (PMID: 29925635). 29925635
KRAS mutant non-small cell lung carcinoma no benefit Erlotinib Guideline Actionable KRAS mutations are associated with lack of efficacy with EGFR tyrosine kinase inhibitors including Tarceva (erlotinib), Iressa (gefitinib), Gilotrif (afatinib), and Tagrisso (osimertinib) in patients with non-small cell lung cancer (NCCN.org). detail...
KRAS mutant non-small cell lung carcinoma no benefit Erlotinib Phase II Actionable In a Phase II trial, Tarceva (erlotinib) treatment resulted in comparable 8-week disease control rate in KRAS wild-type (36%, 5/14) and KRAS mutated (20%, 1/5) patients with advanced non-small cell lung carcinoma (PMID: 27480147). 27480147
ALK rearrange non-small cell lung carcinoma no benefit Erlotinib Guideline Actionable EGFR tyrosine kinase inhibitors including Tarceva (erlotinib), Iressa (gefitinib), Gilotrif (afatinib), and Tagrisso (osimertinib) are not indicated for use as subsequent therapy in ALK rearranged non-small cell lung cancer patients who relapsed on Alecensa (alectinib), Xalkori (crizotinib), or Zykadia (ceritinib) (NCCN.org). detail...
ERBB2 Q709L Advanced Solid Tumor no benefit Erlotinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Q709L did not benefit from treatment with Tarceva (erlotinib) in culture when compared to Erbb2 (Her2) inhibitors (PMID: 30449325). 30449325
ERBB4 G1109C head and neck squamous cell carcinoma no benefit Erlotinib Preclinical - Cell culture Actionable In a preclinical study, head and neck squamous cell carcinoma cells harboring ERBB4 (HER4) G1109C were insensitive to treatment with Tarceva (erlotinib) in culture (PMID: 27207775). 27207775
Clinical Trial Phase Therapies Title Recruitment Status
NCT02318368 Phase II Erlotinib Erlotinib + Ficlatuzumab A Phase 2, Multicenter, 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 Terminated
NCT02355431 Phase II Erlotinib Itacitinib INCB039110 in Combination With Erlotinib in Non Small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Activating Mutations Withdrawn
NCT02152631 Phase III Erlotinib Abemaciclib A Study of LY2835219 in Participants With Previously Treated Lung Cancer Active, not recruiting
NCT01455389 Phase Ib/II DOTAP:chol-Fus1 Erlotinib Diphenhydramine Dexamethasone FUS1-nanoparticles and Erlotinib in Stage IV Lung Cancer Active, not recruiting
NCT02588261 Phase III Naquotinib Gefitinib Erlotinib A 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 Terminated
NCT00301418 Phase Ib/II Erlotinib Oral Tarceva Study for Recurrent/Residual Glioblastoma Multiforme and Anaplastic Astrocytoma Completed
NCT01573702 Phase II Erlotinib Stereotactic Radiosurgery or Other Local Ablation Then Erlotinib in Epidermal Growth Factor Receptor (EGFR) Active, not recruiting
NCT02194738 Phase I Nivolumab Crizotinib Erlotinib Genetic Testing in Screening Patients With Stage IB-IIIA Non-Small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial) Recruiting
NCT02788201 Phase II Erlotinib Thiotepa Imatinib Dacarbazine Arsenic trioxide Idarubicin Mitomycin C Thioguanine Mercaptopurine Methotrexate Cladribine Epirubicin Gemcitabine Doxorubicin Bleomycin Etoposide Gefitinib Daunorubicin Lomustine Sorafenib Sunitinib Ifosfamide Asparaginase Ixabepilone Abiraterone Azacitidine Ruxolitinib Decitabine Axitinib Estramustine Floxuridine Lapatinib Carmustine Fludarabine Nilotinib Cisplatin Vismodegib Vandetanib Melphalan Busulfan Carboplatin Toremifene Crizotinib Dactinomycin Temsirolimus Vorinostat Romidepsin Fluorouracil Irinotecan Bortezomib Tamoxifen Topotecan Chlorambucil Pentostatin Eribulin Carfilzomib Vemurafenib Hydroxyurea Exemestane Vincristine Dasatinib Mitoxantrone Vinblastine Cytarabine Tretinoin Clofarabine Teniposide Docetaxel Pazopanib Oxaliplatin Streptozocin Paclitaxel Bendamustine Mechlorethamine Mitotane Genomic Based Assignment of Therapy in Advanced Urothelial Carcinoma Recruiting
NCT02574078 Phase Ib/II Crizotinib + Nivolumab Erlotinib + Nivolumab Nivolumab + Pemetrexed Bevacizumab Carboplatin + Pemetrexed Bevacizumab + Nivolumab Nivolumab Erlotinib Carboplatin + Paclitaxel Carboplatin + Docetaxel Carboplatin + Nab-paclitaxel Carboplatin + Gemcitabine Paclitaxel Docetaxel Pemetrexed Gemcitabine A Study of Nivolumab in Advanced Non-Small Cell Lung Cancer (NSCLC) (CheckMate370) Active, not recruiting
NCT02551718 Phase I Bosutinib Irinotecan Romidepsin Busulfan Melphalan Nilotinib Crizotinib Cytarabine Mitoxantrone Dasatinib Pazopanib Paclitaxel Clofarabine Hydroxyurea Tretinoin Carfilzomib Nelarabine Bexarotene Pentostatin Everolimus Cabozantinib Mercaptopurine Methotrexate Cladribine Thioguanine Daunorubicin Ponatinib Etoposide Afatinib Gefitinib Gemcitabine Regorafenib Arsenic trioxide Trametinib Imatinib Erlotinib Dabrafenib Decitabine Axitinib Azacitidine Ruxolitinib Fludarabine Lapatinib Ceritinib Sirolimus Sorafenib Lomustine Sunitinib Cabazitaxel Temsirolimus Topotecan Bortezomib Pralatrexate High Throughput Drug Sensitivity Assay and Genomics- Guided Treatment of Patients With Relapsed or Refractory Acute Leukemia Recruiting
NCT02296125 Phase III Erlotinib Osimertinib Gefitinib AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLAURA) Active, not recruiting
NCT02169284 Phase II Erlotinib Erlotinib Hydrochloride in Treating Patients With Bladder Cancer Undergoing Surgery Terminated
NCT01197170 Phase I Erlotinib Everolimus Sorafenib Anastrozole Bevacizumab Hormone Blockade in Combination With Targeted Agents Active, not recruiting
NCT02015728 Phase I Erlotinib Everolimus Dasatinib Etoposide + Temozolomide Sorafenib Selecting Patient-Specific Biologically Targeted Therapy for Pediatric Patients With Refractory Or Recurrent Brain Tumors Unknown status
NCT02770014 Phase II Erlotinib Rapid Plasma Genotyping For Early Initiation Of Erlotinib In EGFR Mutant Lung Cancer Active, not recruiting
NCT03137771 Phase II Docetaxel Pemetrexed Gemcitabine Erlotinib Maintenance Chemotherapy With or Without Stereotactic Body Radiation Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer Recruiting
NCT00547105 Phase II Erlotinib Erlotinib and Stereotactic Body Radiation Therapy in Treating Patients With Locally Advanced or Metastatic Non-Small Call Lung Cancer Completed
NCT01116336 Phase I Erlotinib Phase I Chemoprevention Trial With Green Tea Polyphenon E and Erlotinib in Patients With Premalignant Lesions of the Head and Neck Completed
NCT00997334 Phase II Erlotinib Erlotinib Therapy and Subsequent Development of Mechanisms of Secondary Resistance in Patients With NSCLC Completed
NCT02004262 Phase II Irinotecan Erlotinib Cyclophosphamide Capecitabine + Fluorouracil + Gemcitabine Safety and Efficacy of Combination Listeria/GVAX Pancreas Vaccine in the Pancreatic Cancer Setting Completed
NCT03878524 Phase I Oxaliplatin Palbociclib Vemurafenib Sirolimus Tretinoin Celecoxib Ipilimumab Ruxolitinib Dasatinib Abiraterone Idelalisib Trametinib Imatinib Erlotinib Carboplatin Olaparib Panobinostat Bortezomib Afatinib Fluorouracil Vorinostat Pembrolizumab Leucovorin Enzalutamide Ponatinib Nivolumab Everolimus Sunitinib Cabazitaxel Cabozantinib Lenvatinib Pertuzumab Sorafenib Venetoclax Bevacizumab A Personalized Medicine Study for Patients With Advanced Cancer of the Breast, Prostate, Pancreas or Those With Refractory Acute Myelogenous Leukemia (SMMART) Not yet recruiting
NCT01456325 Phase III Erlotinib Onartuzumab A Study of Onartuzumab (MetMAb) in Combination With Tarceva (Erlotinib) in Patients With Met Diagnostic-Positive Non-Small Cell Lung Cancer Who Have Received Chemotherapy For Advanced or Metastatic Disease (MetLung) Completed
NCT01233687 Phase Ib/II Rilotumumab Erlotinib AMG 102 and Erlotinib for Advanced Non-Small Cell Lung Cancer Completed
NCT01532089 Phase II Bevacizumab Erlotinib Erlotinib With or Without Bevacizumab in Treating Patients With Stage IV Non-Small Cell Lung Cancer With EGFR Mutations Active, not recruiting
NCT01064479 Phase II Erlotinib Carboplatin Docetaxel Cisplatin Docetaxel And Cisplatin With or Without Erlotinib For Metastatic Or Recurrent Squamous Cell Carcinoma Of Head And Neck Active, not recruiting
NCT01471964 Phase Ib/II Erlotinib Alisertib Study to Assess Safety and Tolerability of MLN8237, In Combination With Erlotinib to Treat Non-Small Cell Lung Cancer Terminated
NCT02411448 Phase III Erlotinib Gefitinib + Ramucirumab Erlotinib + Ramucirumab Osimertinib + Ramucirumab A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY) Active, not recruiting
NCT02117024 Phase II Cyclophosphamide + HS-110 Pemetrexed Vinorelbine Erlotinib Gemcitabine Docetaxel Paclitaxel A Phase 2 Study of Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer Completed
NCT02450591 Phase I Erlotinib Local Therapies for Oligometastatic Non-Small Cell Lung Cancer Harboring Sensitizing EGFR Mutations Completed
NCT01592383 Phase II Erlotinib Erlotinib Hydrochloride in Treating Patients With Malignant Peritoneal Mesothelioma Completed
NCT01801111 Phase II Erlotinib Alectinib A Study of RO5424802 in Patients With Non-Small Cell Lung Cancer Who Have ALK Mutation and Failed Crizotinib Treatment Completed
NCT02193282 Phase III Erlotinib Erlotinib Hydrochloride in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Completely Removed by Surgery (An ALCHEMIST Treatment Trial) Recruiting
NCT02154490 Phase II Docetaxel Palbociclib Durvalumab AZD4547 Taselisib Erlotinib Rilotumumab Lung-MAP: S1400 Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IIIB-IV Squamous Cell Lung Cancer Recruiting
NCT02277457 Phase I Crizotinib Erlotinib Personalized Adaptive Radiation Therapy With Individualized Systemic Targeted Therapy (PARTIST) for Locally Advanced, Non-small Cell Lung Cancer With Genomic Driver Mutations Withdrawn
NCT02134886 Phase I Erlotinib Erlotinib Hydrochloride in Treating Non-Small Cell Lung Cancer That is Metastatic or Cannot be Removed by Surgery in Patients With HIV Infection Terminated
NCT02961374 Phase II Erlotinib Erlotinib Hydrochloride in Reducing Duodenal Polyp Burden in Patients With Familial Adenomatous Polyposis at Risk of Developing Colon Cancer Recruiting
NCT00054496 Phase II Erlotinib Erlotinib in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme Unknown status
NCT01967095 Phase I Erlotinib Low Dose Daily Erlotinib in Combination With High Dose Twice Weekly Erlotinib in Patients With EGFR-Mutant Lung Cancer Completed
NCT01857271 Phase II Erlotinib Erlotinib Hydrochloride Before Surgery in Treating Patients With Stage III Non-Small Cell Lung Cancer Terminated
NCT01454102 Phase I Bevacizumab Ipilimumab Cisplatin Pemetrexed Gemcitabine Erlotinib Carboplatin Paclitaxel Nivolumab Study of Nivolumab (BMS-936558) 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 Cancer (NSCLC) (CheckMate 012) Active, not recruiting
NCT03297606 Phase II Bosutinib Palbociclib Vismodegib Ipilimumab + Nivolumab Cobimetinib + Vemurafenib Temsirolimus Olaparib Erlotinib Crizotinib Sunitinib Afatinib Dasatinib Pertuzumab + Trastuzumab Axitinib Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) (CAPTUR) Recruiting
NCT01472016 Phase I Docetaxel ABT-700 Cetuximab Erlotinib Fluorouracil + Irinotecan + Leucovorin Study of ABT-700 in Subjects With Advanced Solid Tumors Completed
NCT02091141 Phase II Erlotinib Alectinib Cobimetinib + Vemurafenib Pertuzumab + Trastuzumab Vismodegib Atezolizumab My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors Recruiting
NCT02134015 Phase III Erlotinib Erlotinib + Patritumab Study of Patritumab in Combination With Erlotinib in Subjects With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC). (HER3-Lung) Terminated
NCT01344824 Phase II Bevacizumab Erlotinib Carboplatin Pemetrexed Carboplatin, Pemetrexed Disodium, and Bevacizumab in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Who Are Light or Never Smokers Completed
NCT01248247 Phase I Erlotinib MK2206 + Selumetinib Sorafenib Erlotinib + MK2206 BATTLE-2 Program: A Biomarker-Integrated Targeted Therapy Study Active, not recruiting
NCT02186301 Phase II Rociletinib Erlotinib TIGER-1: Safety and Efficacy Study of Rociletinib (CO-1686) or Erlotinib in Patients With EGFR Mutant NSCLC Who Have Not Had Any Previous EGFR Directed Therapy Terminated
NCT02468661 Phase I Capmatinib Capmatinib + Erlotinib Erlotinib Cisplatin + Pemetrexed Carboplatin + Pemetrexed A Safety and Efficacy Study of INC280 Alone, and in Combination With Erlotinib, Compared to Chemotherapy, in Advanced/Metastatic Non-small Cell Lung Cancer Patients With EGFR Mutation and cMET Amplification Recruiting
NCT01306045 Phase II Erlotinib Lapatinib MK2206 Sunitinib Selumetinib Molecular Profiling and Targeted Therapy for Advanced Non-Small Cell Lung Cancer, Small Cell Lung Cancer, and Thymic Malignancies Recruiting