Missing content? – Request curation!
Request curation for specific Genes, Variants, or PubMed publications.
Have questions, comments, or suggestions? - Let us know!
Email us at : ckbsupport@genomenon.com
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). |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Afatinib | Gilotrif | BIBW 2992|Giotrif | EGFR Inhibitor (Pan) 64 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). |
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... |
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 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
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 |
NCT02122172 | Phase II | Afatinib | Afatinib in Advanced Refractory Urothelial Cancer | Terminated | USA | 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 |
NCT02271906 | Phase II | Afatinib | The ATTAIN Study: A Therapeutic Trial of Afatinib In the Neoadjuvant Setting | 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 |
NCT02183883 | Phase II | Afatinib | Deciphering Afatinib Response and Resistance With INtratumour Heterogeneity (DARWIN1) | Completed | GBR | 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 |
NCT02695290 | Phase III | Afatinib | Afatinib in EGFR+NSCLC (Recurrent or Stage IV) - Patients With Poor Performance Status (ECOG 2 or 3) | Terminated | USA | 0 |
NCT01746251 | Phase II | Afatinib | Adjuvant Afatinib in Stage I-III NSCLC With EGFR Mutation | Unknown status | USA | 0 |
NCT03083678 | Phase II | Afatinib | Afatinib in Locally Advanced and Metastatic Chordoma | Unknown status | NLD | ITA | GBR | 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 |
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 |
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) | Active, not recruiting | ITA | GBR | FRA | ESP | BEL | 0 |
NCT05432518 | Phase I | Olaparib Palbociclib Afatinib Everolimus Dasatinib | GBM Personalized Trial | Recruiting | CAN | 0 |
NCT01783587 | Phase I | Afatinib Docetaxel | Safety Study of Afatinib and Postoperative Radiation Therapy to Treat Head and Neck Cancer | 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 |
NCT05070403 | Phase II | Afatinib | Study of Afatinib in Advanced Cutaneous Squamous Cell Carcinoma | Recruiting | USA | 0 |
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 |
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) | Recruiting | NLD | 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 |
NCT02514174 | FDA approved | Afatinib | Afatinib Treatment for Patients With EGFR Mutation Positive NSCLC Who Are Age 70 or Older | Completed | USA | 0 |
NCT01553942 | Phase II | Afatinib Cisplatin Pemetrexed Disodium | Afatinib With CT and RT for EGFR-Mutant NSCLC | Active, not recruiting | 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 |
NCT02372006 | Phase Ib/II | Afatinib | Trial of Afatinib in Pediatric Tumours | Completed | USA | NLD | ITA | GBR | FRA | ESP | DNK | DEU | CAN | AUT | AUS | 1 |
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 |
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 |
NCT06486142 | Phase III | Osimertinib Afatinib Dacomitinib | EGFR-mutated Lung Cancer in Randomized Investigator-Initiated Study (ERIS) | Recruiting | SWE | 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 |
NCT02541903 | Phase II | Afatinib | Trial Using Gilotrif for Advanced Penile Squamous Cell Carcinoma | Terminated | USA | 0 |
NCT02423525 | Phase I | Afatinib | Safety Study of Afatinib for Brain Cancer | Completed | USA | 0 |
NCT04410653 | Phase II | Afatinib | Afatinib in Advanced NRG1-Rearranged Malignancies | Completed | DEU | 0 |
NCT01649284 | Phase I | 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 |
NCT02768337 | Phase Ib/II | Afatinib | Cambridge Brain Mets Trial 1 (CamBMT1) | Terminated | GBR | 0 |