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Therapy Name Afatinib
Synonyms
Therapy Description

Gilotrif (afatinib) is a second-generation pan-Egfr inhibitor with activity against EGFR T790M and EGFR exon 19 and 21 deletions, and also inhibits ERBB2 (HER2), ERBB3 (HER3), ERBB4 (HER4) (PMID: 24435321, PMID: 25505694). Gilotrif (afatinib) is FDA approved for use in non-small cell lung cancer patients harboring non-resistant EGFR mutations, including exon 19 deletions, L858R, S768I, G719X, and L861Q, and for patients with metastatic squamous NSCLC (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Afatinib Gilotrif BIBW 2992|Giotrif EGFR Inhibitor (Pan) 63 EGFR Inhibitor 2nd gen 5 HER inhibitor (Pan) 6 Gilotrif (afatinib) is a second-generation pan-Egfr inhibitor with activity against EGFR T790M and EGFR exon 19 and 21 deletions, and also inhibits ERBB2 (HER2), ERBB3 (HER3), ERBB4 (HER4) (PMID: 24435321, PMID: 25505694). Gilotrif (afatinib) is FDA approved for use in non-small cell lung cancer patients harboring non-resistant EGFR mutations, including exon 19 deletions, L858R, S768I, G719X, and L861Q, and for patients with metastatic squamous NSCLC (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ERBB4 G1109C head and neck squamous cell carcinoma sensitive Afatinib Preclinical - Cell line xenograft Actionable In a preclinical study, Gilotrif (afatinib) treatment induced apoptosis in head and neck squamous cell carcinoma cells harboring ERBB4 (HER4) G1109C in culture and inhibited tumor growth in cell line xenograft models (PMID: 27207775). 27207775
ERBB3 V104M urinary bladder cancer predicted - sensitive Afatinib Case Reports/Case Series Actionable In a Phase II clinical trial, a patient with ERBB3 V104M mutant urothelial carcinoma had improved progression free survival when treated with Gilotrif (afatinib), and median PFS was 6.6 months for patients with ERBB2 or ERBB3 alterations relative to 1.4 months for patients lacking alterations (PMID: 27044931). 27044931
ERBB3 V104L Her2-receptor positive breast cancer sensitive Afatinib Preclinical - Cell culture Actionable In a preclinical study, Gilotrif (afatinib) treatment inhibited activation of Erbb2 (Her2) and decreased viability and proliferation in an ERBB2 (HER2)-positive breast cancer cell line expressing ERBB3 (HER3) V104L in culture (PMID: 38751013). 38751013
ERBB4 A17V hematologic cancer sensitive Afatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB4 A17V demonstrated sensitivity to Gilotrif (afatinib) similar to wild-type Erbb4 in culture, resulting in decreased cell viability (PMID: 33323455). 33323455
BRAF G469V lung adenocarcinoma sensitive Afatinib Preclinical - Pdx & cell culture Actionable In a preclinical study, Gilotrif (afatinib) treatment inhibited viability of cells derived from a patient-derived xenograft (PDX) model of lung adenocarcinoma harboring BRAF G469V in culture and led to inhibition of tumor growth in a patient-derived xenograft (PDX) model (PMID: 34648945). 34648945
ERBB4 mutant lung squamous cell carcinoma predicted - sensitive Afatinib Phase III Actionable In a Phase III trial (LUX-Lung 8), secondary analysis demonstrated favorable outcomes with Gilotrif (afatinib) treatment compared to Tarceva (erlotinib) in lung squamous cell carcinoma patients with ERBB (HER) family mutations, and ERBB4 (HER4) mutations predicted an OS (HR=0.22) and PFS (HR=0.21) benefit for Gilotrif (afatinib) over Tarceva (erlotinib) treatment (PMID: 29902295; NCT01523587). 29902295
ERBB4 R687K Advanced Solid Tumor sensitive Afatinib Preclinical - Cell culture Actionable In a preclinical study, Gilotrif (afatinib) inhibited growth of a transformed cell line expressing ERBB4 R687K in culture (PMID: 36860695). 36860695
ERBB4 G936R Advanced Solid Tumor sensitive Afatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB4 G936R demonstrated sensitivity to Gilotrif (afatinib) similar to wild-type Erbb2 in culture, resulting in decreased cell viability (PMID: 33323455). 33323455
ERBB3 G284R urinary bladder cancer sensitive Afatinib Case Reports/Case Series Actionable In a Phase II clinical trial, a patient with ERBB3 G284R mutant urothelial carcinoma had improved progression free survival when treated with Gilotrif (afatinib), and median PFS was 6.6 months for patients with ERBB2 or ERBB3 alterations relative to 1.4 months for patients lacking alterations (PMID: 27044931). 27044931
ERBB3 G284R transitional cell carcinoma sensitive Afatinib Case Reports/Case Series Actionable In a Phase II trial, a patient with urothelial carcinioma harboring ERBB3 G284R demonstrated stable disease for 7 months when treated with Gilotrif (afatinib) (J Clin Oncol 33, 2015 (suppl 7; abstr 312)). detail...
ERBB4 E715K Advanced Solid Tumor sensitive Afatinib Preclinical - Cell culture Actionable In a preclinical study, Gilotrif (afatinib) inhibited growth of a transformed cell line expressing ERBB4 E715K in culture (PMID: 36860695). 36860695
ERBB4 G741R Advanced Solid Tumor sensitive Afatinib Preclinical - Cell culture Actionable In a preclinical study, Gilotrif (afatinib) inhibited growth of a transformed cell line expressing ERBB4 G741R in culture (PMID: 36860695). 36860695

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02271906 Phase II Afatinib The ATTAIN Study: A Therapeutic Trial of Afatinib In the Neoadjuvant Setting Terminated USA 0
NCT01647711 Phase I Afatinib A Study of Intermittent, High-dose Afatinib to Determine the Maximal Tolerated Dose and Assess Activity of This Dose Against Non-small Cell Lung Cancer With T790M Mutations Completed USA 0
NCT02506517 Phase II Afatinib A Study of Afatinib in Patients With Advanced Cancer With Changes in the HER Gene Completed CAN 0
NCT02695290 Phase III Afatinib Afatinib in EGFR+NSCLC (Recurrent or Stage IV) - Patients With Poor Performance Status (ECOG 2 or 3) Terminated USA 0
NCT02451553 Phase I Afatinib Capecitabine Afatinib Dimaleate and Capecitabine in Treating Patients With Advanced Refractory Solid Tumors, Pancreatic Cancer or Biliary Cancer Completed USA 0
NCT02514174 FDA approved Afatinib Afatinib Treatment for Patients With EGFR Mutation Positive NSCLC Who Are Age 70 or Older Completed USA 0
NCT01649284 Expanded access Afatinib Afatinib Expanded Access Program Approved for marketing USA 0
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 Completed USA 0
NCT05298176 Phase II Afatinib Afatinib + Carboplatin + Pemetrexed Disodium Carboplatin + Osimertinib + Pemetrexed Disodium Osimertinib Combining Afatinib and Concurrent Chemotherapy, Followed by Osimertinib and Concurrent Chemotherapy, in Untreated EGFR Positive NSCLC Tumors (COMBINATION) Completed NLD 0
NCT03083678 Phase II Afatinib Afatinib in Locally Advanced and Metastatic Chordoma Completed NLD | ITA | GBR 0
NCT01345669 Phase III Afatinib LUX-Head&Neck 2: A Phase III Trial of Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy Terminated USA | SWE | NLD | ITA | ISR | HUN | GRC | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CHE | CAN | BRA | BEL | AUT | AUS | ARG 8
NCT07185997 Phase III Furmonertinib Afatinib Osimertinib Study to Evaluate Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of EGFR Inhibitor as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic NSCLC With EGFR P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations Recruiting USA | ITA | GRC | GBR | FRA | ESP | CAN | AUS 7
NCT01824823 Phase II Afatinib Afatinib After Chemoradiation and Surgery in Treating Patients With Stage III-IV Squamous Cell Carcinoma of the Head and Neck at High-Risk of Recurrence Terminated USA 0
NCT02491099 Phase II Afatinib A Phase II Evaluation of Afatinib in Patients With Persistent or Recurrent HER2-positive Uterine Serous Carcinoma (Afatinib) Recruiting USA 0
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) Terminated USA 0
NCT01783587 Phase I Afatinib Docetaxel Safety Study of Afatinib and Postoperative Radiation Therapy to Treat Head and Neck Cancer Completed USA 0
NCT03088059 Phase II Niraparib Durvalumab + Monalizumab Methotrexate Carboplatin Rogaratinib Mitomycin C Docetaxel Afatinib Paclitaxel Durvalumab Monalizumab Palbociclib Bleomycin Gemcitabine Fluorouracil Biomarker-based Study in R/M SCCHN (UPSTREAM) Unknown status ITA | GBR | FRA | ESP | BEL 0
NCT01746251 Phase II Afatinib Adjuvant Afatinib in Stage I-III NSCLC With EGFR Mutation Unknown status USA 0
NCT01553942 Phase II Afatinib Cisplatin Pemetrexed Disodium Afatinib With CT and RT for EGFR-Mutant NSCLC Active, not recruiting USA 0
NCT02122172 Phase II Afatinib Afatinib in Advanced Refractory Urothelial Cancer Terminated USA 0
NCT02183883 Phase II Afatinib Deciphering Afatinib Response and Resistance With INtratumour Heterogeneity (DARWIN1) Completed GBR 0
NCT02438722 Phase II Afatinib Afatinib + Cetuximab S1403, Afatinib Dimaleate With or Without Cetuximab in Treating Patients With Newly Diagnosed Stage IV or Recurrent, EGFR Mutation Positive Non-small Cell Lung Cancer Completed USA 0
NCT02465060 Phase II Erdafitinib Trametinib Crizotinib Sapanisertib Fexagratinib Dasatinib Osimertinib Palbociclib Capivasertib Larotrectinib Ulixertinib Nivolumab + Relatlimab Copanlisib Sunitinib Nivolumab Pertuzumab + Trastuzumab Ipatasertib Dabrafenib + Trametinib Binimetinib Adavosertib Afatinib Defactinib GSK2636771 Vismodegib Ado-trastuzumab emtansine Taselisib Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) Active, not recruiting USA 2
NCT02795156 Phase II Cabozantinib Afatinib Regorafenib Study Assessing Activity of Molecularly Matched Targeted Therapies in Select Tumor Types Based on Genomic Alterations Completed USA 0
NCT06648096 Phase Ib/II Afatinib Afatinib in Patients with Fanconi Anemia (FA) and Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) (AFAN) Recruiting ESP | DEU 0
NCT02372006 Phase Ib/II Afatinib Trial of Afatinib in Pediatric Tumours Completed USA | NLD | ITA | GBR | FRA | ESP | DNK | DEU | CAN | AUT | AUS 1
NCT02423525 Phase I Afatinib Safety Study of Afatinib for Brain Cancer Completed USA 0
NCT05070403 Phase II Afatinib Study of Afatinib in Advanced Cutaneous Squamous Cell Carcinoma Active, not recruiting USA 0
NCT02541903 Phase II Afatinib Trial Using Gilotrif for Advanced Penile Squamous Cell Carcinoma Terminated USA 0
NCT02115048 Phase II Afatinib Letrozole Clinical Study for the Treatment of Breast Cancer the Patient Will Receive Afatinib Plus Letrozole or Letrozole Alone Terminated USA | ROU | ESP 1
NCT02768337 Phase Ib/II Afatinib Cambridge Brain Mets Trial 1 (CamBMT1) Terminated GBR 0
NCT04410653 Phase II Afatinib Afatinib in Advanced NRG1-Rearranged Malignancies Completed DEU 0
NCT06486142 Phase III Osimertinib Afatinib Dacomitinib EGFR-mutated Lung Cancer in Randomized Investigator-Initiated Study (ERIS) Recruiting SWE 0
NCT05432518 Phase I Olaparib Palbociclib Afatinib Everolimus Dasatinib GBM Personalized Trial Recruiting CAN 0


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