Afatinib
Information
- Drug Name
- Afatinib
- Description
- Entry(CIViC)
- 50
CIViC
Annotation
| Description | Associated Genes | Associated Variants | Sensitivity | Supported | Source | Links |
|---|---|---|---|---|---|---|
| With multiple mechanisms of HER reprogramming thou... | ERBB2 |
ERBB2 AMPLIFICATION ( ENST00000269571.10 ) ERBB2 AMPLIFICATION ( ENST00000269571.10 ) |
Sensitivity | true | CIViC Evidence | detail |
| This Phase II trial (LUX-Breast 3 - NCT01441596) c... | ERBB2 |
ERBB2 AMPLIFICATION ( ENST00000269571.10 ) ERBB2 AMPLIFICATION ( ENST00000269571.10 ) |
Sensitivity | true | CIViC Evidence | detail |
| LUX-Breast 1 is a phase 3 trial (NCT01125566) whic... | ERBB2 |
ERBB2 AMPLIFICATION ( ENST00000269571.10 ) ERBB2 AMPLIFICATION ( ENST00000269571.10 ) |
Sensitivity | false | CIViC Evidence | detail |
| Trastuzumab resistance is thought to consist of mu... | ERBB2 |
ERBB2 AMPLIFICATION ( ENST00000269571.10 ) ERBB2 AMPLIFICATION ( ENST00000269571.10 ) |
Sensitivity | true | CIViC Evidence | detail |
| A 55 year old heavily pretreated patient with equi... | ERBB2 |
ERBB2 p.Tyr772_Ala775dup (p.Y772_A775dup) ( ENST00000269571.10, ENST00000406381.6, ENST00000445658.6, ENST00000541774.5, ENST00000584450.5, ENST00000584601.5 ) ERBB2 p.Tyr772_Ala775dup (p.Y772_A775dup) ( ENST00000541774.5, ENST00000269571.10, ENST00000445658.6, ENST00000406381.6, ENST00000584450.5, ENST00000584601.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| Human HER2 with YVMA insertion was put under a cla... | ERBB2 |
ERBB2 p.Tyr772_Ala775dup (p.Y772_A775dup) ( ENST00000269571.10, ENST00000406381.6, ENST00000445658.6, ENST00000541774.5, ENST00000584450.5, ENST00000584601.5 ) ERBB2 p.Tyr772_Ala775dup (p.Y772_A775dup) ( ENST00000541774.5, ENST00000269571.10, ENST00000445658.6, ENST00000406381.6, ENST00000584450.5, ENST00000584601.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| Preclinical study in KRAS mutant lung and colon ca... | ERBB3 |
ERBB3 OVEREXPRESSION ( ENST00000267101.8 ) ERBB3 OVEREXPRESSION ( ENST00000267101.8 ) |
Sensitivity | true | CIViC Evidence | detail |
| Phase III trial to compare afatinib or metothrexat... | CDKN2A | CDKN2A p16 EXPRESSION CDKN2A p16 EXPRESSION | Resitance or Non-Reponse | true | CIViC Evidence | detail |
| 48 tumor samples from 41 patients with EGFR mutant... | EGFR |
EGFR p.Thr790Met (p.T790M) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) EGFR p.Thr790Met (p.T790M) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| 48 tumor samples from 41 patients with EGFR mutant... | PIK3CA |
PIK3CA p.Glu545Lys (p.E545K) ( ENST00000263967.4, ENST00000643187.1 ) PIK3CA p.Glu545Lys (p.E545K) ( ENST00000263967.4, ENST00000643187.1 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In the LUX-LUNG 7 trial, (NCT01466660) stage IIIB ... | EGFR | EGFR MUTATION EGFR MUTATION | Sensitivity | true | CIViC Evidence | detail |
| In this phase II trial, patients with metastatic p... | ERBB3 |
ERBB3 p.Val104Met (p.V104M) ( ENST00000267101.8, ENST00000411731.6, ENST00000415288.6, ENST00000683018.1, ENST00000683059.1, ENST00000683164.1 ) ERBB3 p.Val104Met (p.V104M) ( ENST00000267101.8, ENST00000411731.6, ENST00000415288.6, ENST00000683018.1, ENST00000683059.1, ENST00000683164.1 ) |
Sensitivity | true | CIViC Evidence | detail |
| In this phase II trial, patients with metastatic p... | ERBB3 |
ERBB3 p.Arg103Gly (p.R103G) ( ENST00000683059.1, ENST00000683018.1, ENST00000683164.1, ENST00000267101.8, ENST00000415288.6, ENST00000411731.6 ) ERBB3 p.Arg103Gly (p.R103G) ( ENST00000267101.8, ENST00000411731.6, ENST00000415288.6, ENST00000683018.1, ENST00000683059.1, ENST00000683164.1 ) |
Sensitivity | true | CIViC Evidence | detail |
| In this phase II trial, patients with metastatic p... | ERBB3 |
ERBB3 p.Gly284Arg (p.G284R) ( ENST00000415288.6, ENST00000267101.8, ENST00000683018.1, ENST00000683059.1, ENST00000683164.1 ) ERBB3 p.Gly284Arg (p.G284R) ( ENST00000267101.8, ENST00000415288.6, ENST00000683018.1, ENST00000683059.1, ENST00000683164.1 ) |
Sensitivity | true | CIViC Evidence | detail |
| In retrospective analysis of trials, afatinib conf... | EGFR | EGFR EXON 20 INSERTION EGFR EXON 20 INSERTION | Resitance or Non-Reponse | true | CIViC Evidence | detail |
| Case report on a novel V855A mutation located in e... | ERBB3 |
ERBB3 p.Val855Ala (p.V855A) ( ENST00000267101.8, ENST00000415288.6, ENST00000683018.1, ENST00000683059.1, ENST00000683164.1 ) ERBB3 p.Val855Ala (p.V855A) ( ENST00000683164.1, ENST00000683018.1, ENST00000267101.8, ENST00000415288.6, ENST00000683059.1 ) |
Sensitivity | true | CIViC Evidence | detail |
| Patients with advanced NSCLC and acquired resistan... | EGFR |
EGFR p.Thr790Met (p.T790M) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) EGFR p.Thr790Met (p.T790M) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| A Phase II study for use of Afatinib in non- or li... | ERBB2 |
ERBB2 p.Tyr772_Ala775dup (p.Y772_A775dup) ( ENST00000269571.10, ENST00000406381.6, ENST00000445658.6, ENST00000541774.5, ENST00000584450.5, ENST00000584601.5 ) ERBB2 p.Tyr772_Ala775dup (p.Y772_A775dup) ( ENST00000541774.5, ENST00000269571.10, ENST00000445658.6, ENST00000406381.6, ENST00000584450.5, ENST00000584601.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| A Phase II study for use of Afatinib in non- or li... | ERBB2 |
ERBB2 p.Gly776Leu (p.G776L) ( ENST00000541774.5, ENST00000406381.6, ENST00000445658.6, ENST00000584450.5, ENST00000269571.10, ENST00000584601.5 ) ERBB2 p.Gly776Leu (p.G776L) ( ENST00000269571.10, ENST00000406381.6, ENST00000445658.6, ENST00000541774.5, ENST00000584450.5, ENST00000584601.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| A Phase II study for use of Afatinib in non- or li... | ERBB2 |
ERBB2 p.Gly778_Pro780dup (p.G778_P780dup) ( ENST00000584450.5, ENST00000406381.6, ENST00000584601.5, ENST00000541774.5, ENST00000269571.10, ENST00000445658.6 ) ERBB2 p.Gly778_Pro780dup (p.G778_P780dup) ( ENST00000269571.10, ENST00000406381.6, ENST00000445658.6, ENST00000541774.5, ENST00000584450.5, ENST00000584601.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| In a phase 2b/3 study of 585 stage IIIB-IV lung ad... | EGFR | EGFR MUTATION EGFR MUTATION | Sensitivity | true | CIViC Evidence | detail |
| In an in vitro study using NCI-H1666 cells (wildty... | EGFR |
EGFR p.Thr790Met (p.T790M) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) EGFR p.Thr790Met (p.T790M) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| In an in vitro study using purified EGFR protein, ... | EGFR |
EGFR p.Thr790Met (p.T790M) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) EGFR p.Thr790Met (p.T790M) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| In an in vitro study using NCI-H1666 cells (wildty... | EGFR |
EGFR p.Leu858Arg (p.L858R) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) EGFR p.Leu858Arg (p.L858R) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| Afatinib, an irreversible inhibitor of the ErbB fa... | EGFR |
EGFR EXON 19 DELETION ( ENST00000275493.7 ) EGFR EXON 19 DELETION ( ENST00000275493.7 ) |
Sensitivity | true | CIViC Evidence | detail |
| Afatinib, an irreversible inhibitor of the ErbB fa... | EGFR |
EGFR p.Leu858Arg (p.L858R) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) EGFR p.Leu858Arg (p.L858R) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| In a single patient with presumed cholangiocarcino... | NRG1 | NRG1 ATP1B1-NRG1 fusion | Sensitivity | true | CIViC Evidence | detail |
| In patient with lung adenocarcinoma an SDC4-NRG1 g... | NRG1 | NRG1 SDC4-NRG1 | Sensitivity | true | CIViC Evidence | detail |
| In patients with KRAS wild-type (KRASwt) tumors dr... | NRG1 | NRG1 NRG1 FUSIONS NRG1 NRG1 FUSIONS | Sensitivity | true | CIViC Evidence | detail |
| Whole genome sequencing and transcriptomic analysi... | NRG1 | NRG1 ATP1B1-NRG1 fusion | Sensitivity | true | CIViC Evidence | detail |
| Whole genome sequencing and transcriptomic analysi... | NRG1 | NRG1 APP-NRG1 fusion | Sensitivity | true | CIViC Evidence | detail |
| Case report of a 58-year old patient with disease ... | EGFR | EGFR VIII EGFR VIII | Sensitivity | true | CIViC Evidence | detail |
| A phase III clinical trial (NCT00949650) found tha... | EGFR |
EGFR p.Leu858Arg (p.L858R) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) EGFR p.Leu858Arg (p.L858R) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| A phase III clinical trial (NCT00949650) found tha... | EGFR |
EGFR EXON 19 DELETION ( ENST00000275493.7 ) EGFR EXON 19 DELETION ( ENST00000275493.7 ) |
Sensitivity | true | CIViC Evidence | detail |
| Stable HEK293 cell lines expressing mutant EGFR cD... | EGFR |
EGFR EXON 19 DELETION ( ENST00000275493.7 ) EGFR EXON 19 DELETION ( ENST00000275493.7 ) |
Sensitivity | true | CIViC Evidence | detail |
| In a phase 2 study (NCT00525148), patients with lu... | EGFR |
EGFR EXON 19 DELETION ( ENST00000275493.7 ) EGFR EXON 19 DELETION ( ENST00000275493.7 ) |
Sensitivity | true | CIViC Evidence | detail |
| In a phase 2 study of patients with lung adenocarc... | EGFR |
EGFR p.Leu858Arg (p.L858R) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) EGFR p.Leu858Arg (p.L858R) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| Eight uterine cancer cell lines (four with ERBB2 a... | ERBB2 |
ERBB2 AMPLIFICATION ( ENST00000269571.10 ) ERBB2 AMPLIFICATION ( ENST00000269571.10 ) |
Sensitivity | true | CIViC Evidence | detail |
| In this phase 2 trial, treatment-naive, ERBB2-posi... | ERBB2 |
ERBB2 AMPLIFICATION ( ENST00000269571.10 ) ERBB2 AMPLIFICATION ( ENST00000269571.10 ) |
Sensitivity | true | CIViC Evidence | detail |
| A Phase II study for use of Afatinib in non- or li... | ERBB2 | ERBB2 KINASE DOMAIN MUTATION ERBB2 KINASE DOMAIN MUTATION | Sensitivity | true | CIViC Evidence | detail |
| In preclinical studies of transgenic mice and xeno... | ERBB2 |
ERBB2 p.Tyr772_Ala775dup (p.Y772_A775dup) ( ENST00000269571.10, ENST00000406381.6, ENST00000445658.6, ENST00000541774.5, ENST00000584450.5, ENST00000584601.5 ) ERBB2 p.Tyr772_Ala775dup (p.Y772_A775dup) ( ENST00000541774.5, ENST00000269571.10, ENST00000445658.6, ENST00000406381.6, ENST00000584450.5, ENST00000584601.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| A phase II study involving adult female patients, ... | ERBB2 |
ERBB2 AMPLIFICATION ( ENST00000269571.10 ) ERBB2 AMPLIFICATION ( ENST00000269571.10 ) |
Sensitivity | true | CIViC Evidence | detail |
| Afatinib was growth-inhibitory for three pancreati... | ERBB2 |
ERBB2 AMPLIFICATION ( ENST00000269571.10 ) ERBB2 AMPLIFICATION ( ENST00000269571.10 ) |
Sensitivity | true | CIViC Evidence | detail |
| Cells harboring L858R were sensitive to afatinib. ... | EGFR |
EGFR p.Leu858Arg (p.L858R) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) EGFR p.Leu858Arg (p.L858R) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| Cells harboring an exon 19 deletion were sensitive... | EGFR |
EGFR EXON 19 DELETION ( ENST00000275493.7 ) EGFR EXON 19 DELETION ( ENST00000275493.7 ) |
Sensitivity | true | CIViC Evidence | detail |
| Afatinib is an irreversible covalent inhibitor of ... | EGFR |
EGFR EXON 19 DELETION ( ENST00000275493.7 ) EGFR EXON 19 DELETION ( ENST00000275493.7 ) |
Sensitivity | true | CIViC Evidence | detail |
| Afatinib is an irreversible covalent inhibitor of ... | EGFR |
EGFR p.Leu858Arg (p.L858R) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) EGFR p.Leu858Arg (p.L858R) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| In analysis of LUX-Lung 3 and LUX-Lung 6 trials (N... | EGFR |
EGFR EXON 19 DELETION ( ENST00000275493.7 ) EGFR EXON 19 DELETION ( ENST00000275493.7 ) |
Sensitivity | true | CIViC Evidence | detail |
| An shDNA Screen identified synergy betwenn ERBB3 I... | KRAS | KRAS MUTATION KRAS MUTATION | Sensitivity | true | CIViC Evidence | detail |
| An shDNA screen identified synergy between ERBB3 I... | KRAS | KRAS MUTATION KRAS MUTATION | Sensitivity | true | CIViC Evidence | detail |
| NCT ID | Status | Phase | Summary | Start date | Completion date |
|---|---|---|---|---|---|
| NCT03827070 | Active, not recruiting | Phase 1 | Dry Pleurodesis With Talcum and Afatinib is Used to Treat Patients With Non-Small Cell Lung Carcinoma | March 5, 2019 | July 21, 2023 |
| NCT03088059 | Active, not recruiting | Phase 2 | Biomarker-based Study in R/M SCCHN | November 16, 2017 | December 2025 |
| NCT02465060 | Active, not recruiting | Phase 2 | Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) | August 17, 2015 | December 31, 2025 |
| NCT06385483 | Active, not recruiting | Phase 2 | Testing Afatinib as Potentially Targeted Treatment in Cancers With EGFR Genetic Changes (MATCH - Subprotocol A) | August 11, 2015 | December 6, 2024 |
| NCT04413201 | Active, not recruiting | Phase 4 | AFAMOSI: Efficacy and Safety of Afatinib Followed by Osimertinib Compared to Osimertinib in Patients With EGFRmutated/T790M Mutation Negative Nonsquamous NSCLC | September 11, 2020 | June 30, 2024 |
| NCT01856478 | Active, not recruiting | Phase 3 | LUX-Head&Neck 3: Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy | May 23, 2013 | August 31, 2024 |
| NCT01649284 | Approved for marketing | Afatinib Expanded Access Program | July 2012 | March 2014 | |
| NCT01931306 | Approved for marketing | Expanded Access Study of Afatinib in Treatment-naive or Chemotherapy Pre-treated Patients With Non-small Cell Lung Cancer (NSCLC) | |||
| NCT01466660 | Completed | Phase 2 | LUX-Lung 7: A Phase IIb Trial of Afatinib(BIBW2992) Versus Gefitinib for the Treatment of 1st Line EGFR Mutation Positive Adenocarcinoma of the Lung | December 13, 2011 | April 12, 2019 |
| NCT01523587 | Completed | Phase 3 | LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy | March 5, 2012 | December 27, 2017 |
| NCT01538381 | Completed | Phase 2 | Neoadjuvant Afatinib Window Study in Squamous Cell Carcinoma of the Head and Neck | July 2012 | August 2015 |
| NCT01594177 | Completed | Phase 2 | Dual Blockage With Afatinib and Trastuzumab as Neoadjuvant Treatment for Patients With Locally Advanced or Operable Breast Cancer Receiving Taxane-anthracycline Containing Chemotherapy | May 2012 | March 2014 |
| NCT01649271 | Completed | Phase 1 | Phase I Trial of Afatinib and Trastuzumab in HER2 Overexpressing Cancer. | July 23, 2012 | June 23, 2016 |
| NCT01783587 | Completed | Phase 1 | Safety Study of Afatinib and Postoperative Radiation Therapy to Treat Head and Neck Cancer | February 2013 | June 1, 2018 |
| NCT01814553 | Completed | Phase 3 | ADAM-Afatinib Diarrhea Assessment and Management | April 2013 | July 2015 |
| NCT01853826 | Completed | Phase 3 | An Open Label Trial of Afatinib (Giotrif) in Treatment-naive (1st Line) or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s) | July 17, 2013 | March 6, 2024 |
| NCT01953913 | Completed | Phase 3 | Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation | September 30, 2013 | July 6, 2018 |
| NCT01298063 | Completed | Phase 1 | Influence of Mild and Moderate Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of Various Doses of Afatinib | February 2011 | |
| NCT01345682 | Completed | Phase 3 | LUX-Head&Neck 1: A Phase III Trial of Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic (R/M) Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy | January 5, 2012 | December 6, 2016 |
| NCT01396265 | Completed | Phase 1 | Drug Interaction Study With Rifampicin and Afatinib | July 2011 | |
| NCT01415674 | Completed | Phase 2 | Research of Biomarkers of Activity and Efficacy of BIBW2992 in Untreated Non-metastatic HNSCC Patients | January 2012 | December 2021 |
| NCT01426958 | Completed | Phase 1 | Investigation of Ritonavir Effects on Afatinib Exposure in Healthy Subjects | August 2011 | |
| NCT01427478 | Completed | Phase 3 | Evaluation of Afatinib in Maintenance Therapy in Squamous Cell Carcinoma of the Head and Neck | September 2011 | May 2021 |
| NCT01441596 | Completed | Phase 2 | Lux-Breast 3; Afatinib Alone or in Combination With Vinorelbine in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer Suffering From Brain Metastases | October 2011 | August 2014 |
| NCT01251653 | Completed | A Phase I Dose Escalation Trial of Afatinib Plus Gemcitabine or Plus Docetaxel | November 2010 | April 2015 | |
| NCT02020577 | Completed | Phase 1 | Trial of Afatinib (BIBW 2992) + Cetuximab in Advanced Solid Tumours | December 2013 | April 2016 |
| NCT02044380 | Completed | Phase 3 | Afatinib in Patients With Non Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Mutations | March 2014 | February 2016 |
| NCT02047903 | Completed | GIOTRIF in First Line Therapy of Advanced NSCLC With EGFR-mutations | March 5, 2014 | December 31, 2018 | |
| NCT02183883 | Completed | Phase 2 | Deciphering Afatinib Response and Resistance With INtratumour Heterogeneity | December 16, 2016 | March 22, 2023 |
| NCT02191891 | Completed | Phase 1 | Xentuzumab (BI 836845) Plus Afatinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC) | October 21, 2014 | April 18, 2018 |
| NCT02208843 | Completed | Phase 4 | Afatinib as Second-line Therapy for Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation | October 2, 2014 | June 13, 2017 |
| NCT02369484 | Completed | Phase 2 | Afatinib in NSCLC With HER2 Mutation | September 16, 2015 | September 15, 2017 |
| NCT02372006 | Completed | Phase 1/Phase 2 | Trial of Afatinib in Pediatric Tumours | April 29, 2015 | August 5, 2020 |
| NCT02423525 | Completed | Phase 1 | Safety Study of Afatinib for Brain Cancer | December 2016 | August 2021 |
| NCT02440854 | Completed | Evaluate the Impact of Afatinib on Quality of Life and Symptom Burden of Greek Subjects With Advanced NSCLC in Routine Patient Care Settings | February 16, 2016 | February 17, 2021 | |
| NCT02501603 | Completed | Phase 2 | Afatinib, Paclitaxel, 2nd Line, Advanced Gastric Cancer | July 2016 | December 20, 2022 |
| NCT02506517 | Completed | Phase 2 | A Study of Afatinib in Patients With Advanced Cancer With Changes in the HER Gene | August 2015 | May 4, 2023 |
| NCT02514174 | Completed | Phase 4 | Afatinib Treatment for Patients With EGFR Mutation Positive NSCLC Who Are Age 70 or Older | August 18, 2015 | April 25, 2019 |
| NCT02597946 | Completed | Phase 2 | Afatinib in NSCLC With HER2 Mutation | March 18, 2016 | July 22, 2018 |
| NCT02625168 | Completed | Phase 2 | Afatinib vs Erlotinib as 2nd TKI After Failure to 1st TKI and Chemotherapy for Metastatic NSCLC | January 2013 | December 2014 |
| NCT02629523 | Completed | Phase 2 | Afatinib in Lung Cancer With EGFR Mutation From Circulating Tumor DNA | June 1, 2016 | May 11, 2020 |
| NCT02716311 | Completed | Phase 2 | Combination of Cetuximab With Afatinib for Patient With EGFR Mutated Lung Cancer | May 2016 | April 7, 2021 |
| NCT02780687 | Completed | Phase 2 | Afatinib Monotherapy in Patients With ERBB-deregulated Metastatic Urothelial Tract Carcinoma After Failure of Platinum Based Chemotherapy | June 9, 2016 | September 2, 2019 |
| NCT02795156 | Completed | Phase 2 | Study Assessing Activity of Molecularly Matched Targeted Therapies in Select Tumor Types Based on Genomic Alterations | September 28, 2016 | August 17, 2022 |
| NCT03157089 | Completed | Phase 2 | Testing Afatinib in Combination With Pembrolizumab in Patients With Squamous Cell Carcinoma of the Lung | November 2, 2017 | January 13, 2020 |
| NCT03370770 | Completed | Afatinib Osimertinib Sequencing NIS | December 28, 2017 | November 28, 2019 | |
| NCT03727724 | Completed | Phase 2 | Afatinib and Cetuximab in Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Positive Non-small-cell Lung Cancer | December 4, 2018 | September 6, 2022 |
| NCT04201756 | Completed | Phase 2 | Neoadjuvant Afatinib Therapy for Potentially Resectable Stage III EGFR Mutation-Positive Lung Adenocarcinoma | July 26, 2020 | August 30, 2022 |
| NCT04206787 | Completed | The START Study Observes Afatinib as First-line Treatment and Sequential Therapy in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation-positive Advanced Nonsmall Cell Lung Cancer | May 20, 2020 | December 22, 2023 | |
| NCT04640870 | Completed | The Molecular Epidemiology of Epidermal Growth Factor Receptor (EGFR) Mutations in Patients With Advanced EGFR Mutation-positive Non-small Cell Lung Cancer Treated With Afatinib | March 15, 2015 | May 2020 | |
| NCT04750824 | Completed | Real-World Effectiveness of Afatinib (Gilotrif) Following Immunotherapy in the Treatment of Metastatic, Squamous Cell Carcinoma of the Lung: A Multi-Site Retrospective Chart Review Study in the U.S. | October 15, 2020 | December 20, 2021 | |
| NCT04795245 | Completed | Non-interventional Study for Real-world Data of Afatinib Treatment in First-line Setting and of Subsequent Therapies for Patients With Advanced Epidermal Growth Factor Receptor (EGFR) Mutation-positive Lung Adenocarcinoma | August 26, 2021 | October 16, 2023 | |
| NCT05107193 | No longer available | Afatinib (GILOTRIF®) in Patients Suffering From Tumors Harboring Neuregulin 1 (NRG1) Gene Alterations (Specifically NRG1 Gene Fusion-positive Advanced Solid Tumors) | |||
| NCT05519917 | Not yet recruiting | Phase 2 | Study to Evaluate the Efficacy of Afatinib in Skull Base Chordoma | October 1, 2022 | December 30, 2025 |
| NCT06085755 | Not yet recruiting | Phase 1/Phase 2 | Trastuzumab Deruxtecan(T-DXd) and Afatinib Combination in HER2-low Advanced Gastric Cancer | June 2024 | December 2026 |
| NCT02925234 | Recruiting | Phase 2 | The Drug Rediscovery Protocol (DRUP Trial) | August 2016 | December 2027 |
| NCT04185883 | Recruiting | Phase 1 | Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) | December 17, 2019 | December 31, 2027 |
| NCT04183712 | Recruiting | Phase 2 | Target Therapy With GEMOX in Recectable Gallbladder Carcinoma Patients Monitored by ctDNA | June 1, 2020 | December 2023 |
| NCT02979977 | Recruiting | Phase 2 | Dual Inhibition of EGFR With Afatinib and Cetuximab in the Treatment of Advanced Squamous Cell Cancers of the Head and Neck | March 24, 2017 | January 2025 |
| NCT05267288 | Recruiting | Phase 2 | Phase II Study of Afatinib Plus Bevacizumab in the Treatment Epidermal Growth Factor Receptor (EGFR) Exon G719X, S768I, and L861Q Mutation Metastatic Non-Small Cell Lung Cancer | February 1, 2021 | June 1, 2025 |
| NCT04909073 | Recruiting | Observational Study of Afatinib 30 mg Daily | October 25, 2022 | December 2025 | |
| NCT05432518 | Recruiting | Early Phase 1 | Pilot Trial for Treatment of Recurrent Glioblastoma | June 27, 2023 | December 1, 2027 |
| NCT05517330 | Recruiting | Phase 2 | Neoadjuvant Tislelizumab With Afatinib for Resectable Head and Neck Squamous Cell Carcinoma | December 20, 2022 | August 19, 2024 |
| NCT05215548 | Recruiting | Phase 2 | Primary Tumor Resection With EGFR TKI for Stage IV NSCLC | September 27, 2021 | July 2026 |
| NCT02491099 | Recruiting | Phase 2 | A Phase II Evaluation of Afatinibin Patients With Persistent or Recurrent HER2-positive Uterine Serous Carcinoma | June 2015 | July 2028 |
| NCT03574402 | Recruiting | Phase 2 | Phase II Umbrella Study Directed by Next Generation Sequencing | July 9, 2018 | December 30, 2024 |
| NCT03785249 | Recruiting | Phase 1/Phase 2 | Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1 | December 26, 2018 | January 2026 |
| NCT05865132 | Recruiting | Phase 2 | Palbociclib Combined With Afatinib for Advanced Squamous Carcinoma of Esophagus or Gastroesophageal Junction | April 6, 2023 | April 2026 |
| NCT05834348 | Recruiting | A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway. | June 26, 2023 | February 3, 2025 | |
| NCT06302621 | Recruiting | Phase 1 | Pemigatinib + Afatinib in Advanced Refractory Solid Tumors | July 1, 2024 | December 1, 2025 |
| NCT05516589 | Recruiting | Phase 2 | Neoadjuvant Chemotherapy, Tislelizumab With Afatinib for HNSCC | August 20, 2022 | August 19, 2024 |
| NCT05818982 | Recruiting | Phase 2 | To Evaluate the Efficacy and Safety of Afatinib for Advanced ALTRK-negative ESCC | February 9, 2023 | February 2026 |
| NCT02470065 | Suspended | Phase 2 | Neoadjuvant Afatinib in Early Stage Non Small Cell Lung Cancer. | January 2016 | January 2021 |
| NCT01345669 | Terminated | Phase 3 | 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 | October 17, 2011 | September 12, 2016 |
| NCT02695290 | Terminated | Phase 4 | Afatinib in EGFR+NSCLC (Recurrent or Stage IV) - Patients With Poor Performance Status (ECOG 2 or 3) | March 17, 2016 | August 26, 2016 |
| NCT02768337 | Terminated | Phase 1/Phase 2 | Cambridge Brain Mets Trial 1 | March 10, 2015 | August 12, 2021 |
| NCT03054038 | Terminated | Phase 1 | Afatinib and Necitumumab in Patients With EGFR Mutation Positive Advanced or Metastatic Non-small Cell Lung Cancer | July 20, 2017 | March 23, 2022 |
| NCT01732640 | Terminated | Phase 1/Phase 2 | A Phase I/II Study Afatinib/Carboplatin/Paclitaxel Induction Chemotherapy In HPV-Negative HNSCC. | December 2012 | January 2017 |
| NCT03711422 | Terminated | Phase 1 | Afatinib on CNS Metastases and LMD in EGFR Mutation Positive NSCLC | November 16, 2018 | December 20, 2019 |
| NCT03878524 | Terminated | Phase 1 | Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial | April 1, 2020 | December 10, 2020 |
| NCT01824823 | Terminated | Phase 2 | 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 | June 30, 2014 | December 2020 |
| NCT02115048 | Terminated | Phase 2 | Clinical Study for the Treatment of Breast Cancer: the Patient Will Receive Afatinib Plus Letrozole or Letrozole Alone | July 2014 | November 2018 |
| NCT02131155 | Terminated | Phase 3 | LUX-Head & Neck 4: Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy | July 17, 2014 | August 22, 2016 |
| NCT02488694 | Terminated | Phase 2 | Maintaining ERBB Blockade in EGFR-mutated Lung Cancer | November 2015 | December 2017 |
| NCT02595840 | Terminated | Phase 2 | Biomarker Study Accompanying the AIO-TRK-0114 Study (MARBLE) | November 25, 2015 | November 20, 2017 |
| NCT04158947 | Unknown status | Phase 2 | A Study of HER2+ Breast Cancer Patients With Active Brain Metastases Treated With Afatinib & T-DM1 vs. T-DM1 Alone | May 10, 2020 | March 31, 2024 |
| NCT04132102 | Unknown status | Phase 4 | To Evaluate the Efficacy of Afatinib in Advanced Lung Squamous Cell Carcinoma With EGFR Sensitive Mutation | November 27, 2018 | August 31, 2021 |
| NCT03083678 | Unknown status | Phase 2 | Afatinib in Locally Advanced and Metastatic Chordoma | June 21, 2018 | October 1, 2023 |
| NCT05164848 | Unknown status | Phase 1 | JMT101 Combined With Afatinib in Patients With Advanced Esophageal Squamous Cell Carcinoma After Standard Therapy | December 25, 2021 | October 2023 |
| NCT04533321 | Unknown status | Phase 2 | A Biomarker-implemented Clinical Study Evaluating Mutations in MET and TP53 in a Population of Treatment-refractory Squamous Cell Carcinoma | September 2020 | September 2023 |
| NCT04575415 | Unknown status | Bevacizumab Plus EGFR-TKIs in Chinese Patients With EGFR-mutant NSCLC: a Real-world Study | October 7, 2020 | December 2023 | |
| NCT01728818 | Unknown status | Phase 2 | Afatinib as Cancer Therapy for Exocrine Pancreatic Tumours | April 2013 | January 2018 |
| NCT03810872 | Unknown status | Phase 2 | An Explorative Study of Afatinib in the Treatment of Advanced Cancer Carrying an EGFR, a HER2 or a HER3 Mutation | June 21, 2017 | December 2022 |
| NCT02450656 | Unknown status | Phase 1/Phase 2 | Afatinib and Selumetinib in Advanced KRAS Mutant and PIK3CA Wildtype Non-small Cell Lung Cancer | June 2015 | December 2019 |
| NCT01746251 | Unknown status | Phase 2 | Adjuvant Afatinib in Stage I-III NSCLC With EGFR Mutation | January 2013 | November 2021 |
| NCT01553942 | Unknown status | Phase 2 | Afatinib With CT and RT for EGFR-Mutant NSCLC | April 2012 | December 2021 |
| NCT03940976 | Unknown status | Phase 2 | Afatinib in Previously Treated ESCC With EGFR Overexpression or EGFR Amplification (ESCC-A01) | April 28, 2019 | May 1, 2020 |
| NCT03486509 | Unknown status | Phase 2 | Afatinib Plus Chemotherapy Against Esophageal or Lung Squamous Cell Carcinoma | April 1, 2018 | July 1, 2020 |
| NCT03239015 | Unknown status | Phase 2 | Efficacy and Safety of Precision Therapy in Refractory Tumor | January 1, 2017 | December 31, 2023 |
| NCT04880811 | Unknown status | Phase 2 | Afatinib Plus Toripalimab in Previously Treated ESCC With EGFR Overexpression or EGFR Amplification | July 2021 | May 2023 |
| NCT02511847 | Unknown status | Phase 2 | Trial of Afatinib With Paclitaxel for Neoadjuvant Therapy of TNBC and Research of Biomarkers of Afatinib | August 2015 | July 2017 |
| NCT03652233 | Withdrawn | Phase 1 | Afatinib and Nivolumab as Treatment for Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck | November 2, 2018 | November 2022 |
| NCT02274012 | Withdrawn | Phase 2 | Trial of Afatinib in Combination With Weekly Paclitaxel in the Second Line Treatment | May 29, 2014 | August 12, 2015 |
| NCT01836341 | Withdrawn | Phase 1 | Afatinib In Combination With Cisplatin Or Carboplatin + Pemetrexed In Patients With EGFR-Mutant Lung Cancers Undergoing Definitive Chemoradiation | April 2013 | April 2015 |
| NCT02876081 | Withdrawn | Phase 2 | Phase II Study of Afatinib as Third- or Further-line Treatment for Patients With Stage IV Bronchial Adenocarcinoma, Harboring Wild-type EGFR, Expressing the Neurotensin - Neurotensin Receptor Complex | September 1, 2017 | December 2018 |
- Trade name (Drug list of Screening Committee of Anticancer Drugs)
- Gilotrif
- US Approved Year (20160209) (Drug list of Screening Committee of Anticancer Drugs)
- 2013
- Japan Approved Year (20160209) (Drug list of Screening Committee of Anticancer Drugs)
- 2014
- Target (Drug list of Screening Committee of Anticancer Drugs)
- EGFR
- Target (Drug list of Screening Committee of Anticancer Drugs)
- Her2
- Disease name (Drug list of Screening Committee of Anticancer Drugs)
- 非小細胞肺がん（EGFR /exon19del
- Disease name (Drug list of Screening Committee of Anticancer Drugs)
- L858R）