Therapy Detail

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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) 58 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
ALK rearrange lung non-small cell carcinoma no benefit Afatinib 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...
ROS1 rearrange lung non-small cell carcinoma no benefit Afatinib 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...

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
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 | ESP 2
NCT02122172 Phase II Afatinib Afatinib in Advanced Refractory Urothelial Cancer Recruiting USA 0
NCT02541903 Phase II Afatinib Trial Using Gilotrif for Advanced Penile Squamous Cell Carcinoma Terminated 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) Active, not recruiting USA 0
NCT01553942 Phase II Afatinib Cisplatin Pemetrexed Disodium Afatinib With CT and RT for EGFR-Mutant NSCLC Unknown status 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
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 Active, not recruiting USA 0
NCT02514174 FDA approved Afatinib Afatinib Treatment for Patients With EGFR Mutation Positive NSCLC Who Are Age 70 or Older Completed USA 0
NCT02506517 Phase II Afatinib A Study of Afatinib in Patients With Advanced Cancer With Changes in the HER Gene Active, not recruiting CAN 0
NCT05432518 Phase I Olaparib Palbociclib Afatinib Everolimus Dasatinib GBM Personalized Trial Not yet recruiting CAN 0
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
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 | ITA | FRA | ESP | DEU | CAN | BEL | AUT 21
NCT04410653 Phase II Afatinib Afatinib in Advanced NRG1-Rearranged Malignancies Recruiting DEU 0
NCT01746251 Phase II Afatinib Adjuvant Afatinib in Stage I-III NSCLC With EGFR Mutation Unknown status USA 0
NCT02693535 Phase II Cobimetinib + Vemurafenib Atezolizumab + Talazoparib Regorafenib Larotrectinib Trastuzumab + Tucatinib Ipilimumab + Nivolumab Palbociclib Afatinib Entrectinib Talazoparib Pembrolizumab Temsirolimus Pertuzumab + Trastuzumab Atezolizumab + Pertuzumab/trastuzumab/hyaluronidase-zzxf Crizotinib Abemaciclib Sunitinib Olaparib TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer (TAPUR) Recruiting USA 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
NCT02271906 Phase II Afatinib The ATTAIN Study: A Therapeutic Trial of Afatinib In the Neoadjuvant Setting Terminated USA 0
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 CAN 0
NCT02768337 Phase Ib/II Afatinib Cambridge Brain Mets Trial 1 (CamBMT1) Unknown status 1
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
NCT05070403 Phase II Afatinib Study of Afatinib in Advanced Cutaneous Squamous Cell Carcinoma Recruiting USA 0
NCT02372006 Phase Ib/II Afatinib Trial of Afatinib in Pediatric Tumours Completed USA | ITA | FRA | ESP | DEU | CAN | AUT 5
NCT02491099 Phase II Afatinib A Phase II Evaluation of Afatinib in Patients With Persistent or Recurrent HER2-positive Uterine Serous Carcinoma Recruiting USA 0
NCT01649284 Phase I Afatinib Afatinib Expanded Access Program Approved for marketing USA 0
NCT02183883 Phase II Afatinib Deciphering Afatinib Response and Resistance With INtratumour Heterogeneity (DARWIN1) Active, not recruiting 1
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
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) Recruiting ITA | FRA | ESP | BEL 1
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
NCT01783587 Phase I Afatinib Docetaxel Safety Study of Afatinib and Postoperative Radiation Therapy to Treat Head and Neck Cancer Completed USA 0
NCT02423525 Phase I Afatinib Safety Study of Afatinib for Brain Cancer Completed USA 0
NCT03083678 Phase II Afatinib Afatinib in Locally Advanced and Metastatic Chordoma Active, not recruiting ITA 2


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