Therapy Detail

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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
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

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Showing 1 to 33 of 33 entries

Clinical Trial	Phase	Therapies	Title	Recruitment Status	Covered Countries	Other Countries
NCT01553942	Phase II	Afatinib Cisplatin Pemetrexed Disodium	Afatinib With CT and RT for EGFR-Mutant NSCLC	Active, not recruiting	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
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
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
NCT01649284	Expanded access	Afatinib	Afatinib Expanded Access Program	Approved for marketing	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
NCT01783587	Phase I	Afatinib Docetaxel	Safety Study of Afatinib and Postoperative Radiation Therapy to Treat Head and Neck Cancer	Completed	USA	0
NCT02183883	Phase II	Afatinib	Deciphering Afatinib Response and Resistance With INtratumour Heterogeneity (DARWIN1)	Completed	GBR	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
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
NCT02506517	Phase II	Afatinib	A Study of Afatinib in Patients With Advanced Cancer With Changes in the HER Gene	Completed	CAN	0
NCT02514174	FDA approved	Afatinib	Afatinib Treatment for Patients With EGFR Mutation Positive NSCLC Who Are Age 70 or Older	Completed	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
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
NCT03083678	Phase II	Afatinib	Afatinib in Locally Advanced and Metastatic Chordoma	Completed	NLD \| ITA \| GBR	0
NCT04410653	Phase II	Afatinib	Afatinib in Advanced NRG1-Rearranged Malignancies	Completed	DEU	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
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
NCT05070403	Phase II	Afatinib	Study of Afatinib in Advanced Cutaneous Squamous Cell Carcinoma	Recruiting	USA	0
NCT05432518	Phase I	Olaparib Palbociclib Afatinib Everolimus Dasatinib	GBM Personalized Trial	Recruiting	CAN	0
NCT06486142	Phase III	Osimertinib Afatinib Dacomitinib	EGFR-mutated Lung Cancer in Randomized Investigator-Initiated Study (ERIS)	Recruiting	SWE	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
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
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
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
NCT02122172	Phase II	Afatinib	Afatinib in Advanced Refractory Urothelial Cancer	Terminated	USA	0
NCT02271906	Phase II	Afatinib	The ATTAIN Study: A Therapeutic Trial of Afatinib In the Neoadjuvant Setting	Terminated	USA	0
NCT02541903	Phase II	Afatinib	Trial Using Gilotrif for Advanced Penile Squamous Cell Carcinoma	Terminated	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
NCT02768337	Phase Ib/II	Afatinib	Cambridge Brain Mets Trial 1 (CamBMT1)	Terminated	GBR	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
NCT01746251	Phase II	Afatinib	Adjuvant Afatinib in Stage I-III NSCLC With EGFR Mutation	Unknown status	USA	0

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