Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed RET fusion positive cancer 2 milestones | |||||
| Filed | US (FDA) | — | RET fusion positive cancer | 2013-01-15 | “the New Drug Application (NDA) for its investigational oncology compound afatinib has been accepted for filing” prnewswire.com ↗ |
| Filed | EU (EMA) | — | RET fusion positive cancer | — | “recently submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of afatinib as a treatment” prnewswire.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Filed | US (FDA) | Gilotrif | non-small cell lung cancer with uncommon EGFR mutations | 2017-10-10 | “the supplemental New Drug Application (sNDA) for Gilotrif® (afatinib) has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA).” prnewswire.com ↗ |
| Approved | EU (EMA) | Giotrif | — | 2013-09-25 | europa.eu ↗ |
Trials 189 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05432518 | Jun 2023 → Jul 2027 expected | adult glioblastoma | AHS Cancer Control Alberta | Recruiting | No outcome recorded |
| Phase 151 trials · 3 missed | ||||||
| Phase 1 | NCT06897735 | Nov 2025 → May 2026 | lung cancer, melanoma, oral cavity cancer | Petrov, Andrey | Terminated | No outcome recorded |
| Phase 1 | NCT06741982 | Dec 2024 → Dec 2026 expected | head and neck squamous cell carcinoma | West China Hospital | Recruiting | No outcome recorded |
| Phase 1 | NCT06494189 | Jul 2024 → Apr 2025 | head and neck cancer | West China Hospital | Completed | No outcome recorded |
| Phase 1 | NCT06302621 | Apr 2024 → Dec 2027 expected | cholangiocarcinoma, metastatic neoplasm | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 1 | NCT05927844 | Jun 2023 → Jun 2025 | esophageal squamous cell carcinoma | Fujian Cancer Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT05164848 | Dec 2021 → Oct 2023 | esophageal squamous cell carcinoma | Peking University | Unknown | No outcome recorded |
| Phase 1 | NCT03878524 | Apr → Dec 2020 | acute myeloid leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, castration-resistant prostate carcinoma +14 | OHSU Knight Cancer Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04185883 | Dec 2019 → Dec 2026 expected | cancer | Amgen | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03827070 | Mar 2019 → Feb 2023 | non-small cell lung carcinoma | Center Trials & Treatment Europe | Unknown | No outcome recorded |
| Phase 1 | NCT03711422 | Nov 2018 → Dec 2019 | central nervous system neoplasm, neoplastic meningitis, non-small cell lung carcinoma | National Cancer Centre, Singapore | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03652233 | Nov 2018 → Nov 2021 | head and neck squamous cell carcinoma | Vanderbilt-Ingram Cancer Center | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03054038 | Jul 2017 → Mar 2022 | non-small cell lung carcinoma | Vanderbilt-Ingram Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02423525 | Dec 2016 → Aug 2020 | brain cancer | Santosh Kesari | Completed | No outcome recorded |
| Phase 1 | NCT02975141 | Sep 2016 → Dec 2018 | pancreatic ductal adenocarcinoma | PD Dr. med. Volker Heinemann | Unknown | No outcome recorded |
| Phase 1 | NCT02364609 | Sep 2015 → Apr 2018 | non-small cell lung carcinoma | Jonathan Riess | Completed | No outcome recorded |
| Phase 1 | NCT02145637 | May 2015 → Nov 2017 | non-small cell lung carcinoma | Yonsei University | Completed | No outcome recorded |
| Phase 1 | NCT02191891 | Oct 2014 → Apr 2018 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02216617 | Aug 2014 → Jul 2015 | head and neck squamous cell carcinoma | Groupe Oncologie Radiotherapie Tete et Cou | Completed | No outcome recorded |
| Phase 1 | NCT02096718 | May → Dec 2014 | impaired renal function disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01999985 | Dec 2013 → Mar 2017 | non-small cell lung carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 1 | NCT02020577 | Dec 2013 → Jan 2015 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01836341 | Apr 2013 → Apr 2015 | non-small cell lung carcinoma | Memorial Sloan Kettering Cancer Center | Withdrawn | No outcome recorded |
| Phase 1 | NCT01783587 | Feb 2013 → Nov 2017 | head and neck squamous cell carcinoma | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT01721525 | Nov 2012 → Oct 2017 | head and neck cancer, squamous cell carcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01679405 | Aug 2012 → Apr 2016 | metastatic neoplasm | Johannes Gutenberg University Mainz | Terminated | No outcome recorded |
| Phase 1 | NCT01649271 | Jul 2012 → Jun 2016 | breast cancer, gastric neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01647711 | Jul 2012 → Sep 2015 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01426958 | Aug → Dec 2011 | — | Boehringer Ingelheim | Completed | Missed primary |
| Phase 1 | NCT01396265 | Jul → Aug 2011 | — | Boehringer Ingelheim | Completed | Missed primary |
| Phase 1 | NCT01298063 | Feb 2011 → Jan 2012 | liver disorder | Boehringer Ingelheim | Completed | Missed primary |
| Phase 1 | NCT01206816 | Oct 2010 → Nov 2012 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01214616 | Oct 2010 → May 2013 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01169675 | Jul 2010 → Nov 2012 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01090011 | Mar 2010 → Jan 2013 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT00998296 | Oct 2009 → Dec 2012 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT00993499 | Oct 2009 → Sep 2014 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT00977431 | Sep 2009 → Sep 2017 | glioblastoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02171754 | Sep → Dec 2009 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT00950742 | Aug 2009 → Oct 2013 | breast cancer | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02171767 | Aug → Oct 2009 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT00906698 | Jun 2009 → Jan 2013 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT00716417 | Jul 2008 → Jul 2010 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT00809133 | May 2007 → Feb 2015 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT00730821 | Jan 2007 → Aug 2009 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02171676 | May 2005 → Mar 2008 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02171741 | Apr 2005 → Dec 2007 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02171650 | Dec 2004 → May 2006 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02171702 | Nov 2004 → Mar 2007 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02171728 | Nov 2004 → Sep 2006 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02171663 | Mar 2004 → Feb 2006 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02171637 | Nov 2003 → Feb 2006 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1/213 trials | ||||||
| Phase 1/2 | NCT06753747 | Sep 2025 → Sep 2027 expected | esophageal cancer | West China Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07010120 | Jun 2025 → May 2027 expected | head and neck squamous cell carcinoma | West China Hospital | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06648096 | Nov 2024 → Dec 2028 expected | Fanconi anemia, head and neck squamous cell carcinoma | Sant Pau Research Institute | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06085755 | Sep 2024 → Dec 2025 overdue | gastric neoplasm | Jeeyun Lee | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06071013 | Feb 2024 → Aug 2026 overdue | non-small cell lung carcinoma | China Medical University Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03481842 | Oct 2021 | endometriosis of intestine, ovarian endometriosis | BioGene Pharmaceutical Ltd. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03785249 | Jan 2019 → Dec 2026 expected | metastatic malignant neoplasm | Mirati Therapeutics Inc. | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03623750 | Jul 2018 → Mar 2020 | non-small cell lung carcinoma | Instituto Oncológico Dr Rosell | Completed | No outcome recorded |
| Phase 1/2 | NCT02450656 | Jun 2015 → May 2019 | colorectal neoplasm, non-small cell lung carcinoma, pancreatic neoplasm | The Netherlands Cancer Institute | Unknown | No outcome recorded |
| Phase 1/2 | NCT02372006 | Apr 2015 → Aug 2020 | neuroepithelial neoplasm, rhabdomyosarcoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1/2 | NCT02768337 | Mar 2015 → Aug 2020 | brain cancer, breast cancer, lung cancer | Cambridge University Hospitals NHS Foundation Trust | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT01861223 | May 2013 → May 2015 | non-small cell lung carcinoma | Samsung Medical Center | Unknown | No outcome recorded |
| Phase 1/2 | NCT01732640 | Dec 2012 → Nov 2016 | head and neck squamous cell carcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Terminated | No outcome recorded Stop: Enrollment |
| Phase 295 trials · 4 met primary · 7 missed | ||||||
| Phase 2 | NCT07040956 | Jun 2025 → Jun 2026 | head and neck squamous cell carcinoma | West China Hospital | Completed | No outcome recorded |
| Phase 2 | NCT06709859 | May 2025 → May 2026 overdue | non-small cell lung carcinoma | Shandong Public Health Clinical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06804850 | Jan 2025 → Jun 2026 | head and neck cancer | West China Hospital | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT06062823 | Mar 2024 → Oct 2026 expected | non-small cell lung carcinoma | National University Hospital, Singapore | Recruiting | No outcome recorded |
| Phase 2 | NCT05865132 | Apr 2023 → Apr 2025 | esophageal squamous cell carcinoma | Aiping Zhou | Unknown | No outcome recorded |
| Phase 2 | NCT05818982 | Feb 2023 → Feb 2025 | esophageal squamous cell carcinoma | Peking University | Unknown | No outcome recorded |
| Phase 2 | NCT05519917 | Oct 2022 → Jun 2025 | clivus chordoma | Huashan Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05517330 | Sep 2022 → Dec 2023 | head and neck squamous cell carcinoma | West China Hospital | Completed | No outcome recorded |
| Phase 2 | NCT05516589 | Sep 2022 → Oct 2023 | head and neck squamous cell carcinoma | West China Hospital | Completed | No outcome recorded |
| Phase 2 | NCT04410653 | Jul 2022 → Oct 2023 | — | German Cancer Research Center | Completed | No outcome recorded |
| Phase 2 | NCT05298176 | Jan 2022 → Apr 2024 | non-small cell lung carcinoma | Amsterdam UMC, location VUmc | Completed | No outcome recorded |
| Phase 2 | NCT05070403 | Oct 2021 → Feb 2027 expected | squamous cell carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05215548 | Sep 2021 → Oct 2026 expected | non-small cell lung carcinoma | National Taiwan University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04839471 | Aug 2021 → Jul 2023 | esophageal squamous cell carcinoma | National Health Research Institutes, Taiwan | Completed | No outcome recorded |
| Phase 2 | NCT04497584 | Aug 2021 → Sep 2026 overdue | non-small cell squamous lung carcinoma | University of Texas Southwestern Medical Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04880811 | Jul 2021 → Oct 2022 | esophageal squamous cell carcinoma | Peking University | Unknown | No outcome recorded |
| Phase 2 | NCT05267288 | Feb 2021 → Dec 2024 | — | Qingdao Central Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04533321 | Sep 2020 → Sep 2023 | squamous cell carcinoma | National University Hospital, Singapore | Unknown | No outcome recorded |
| Phase 2 | NCT04201756 | Jul 2020 → Feb 2022 | lung adenocarcinoma | Shanghai Pulmonary Hospital, Shanghai, China | Completed | Met primary |
| Phase 2 | NCT04470076 | Jul 2020 → Dec 2021 | non-small cell lung carcinoma | Fifth Affiliated Hospital, Sun Yat-Sen University | Unknown | No outcome recorded |
| Phase 2 | NCT04183712 | Jun 2020 → Jun 2025 overdue | gallbladder carcinoma | Shanghai Jiao Tong University School of Medicine | Recruiting | No outcome recorded |
| Phase 2 | NCT04158947 | May 2020 → Dec 2023 | HER2 positive breast carcinoma, metastatic malignant neoplasm in the brain | xuexin he | Unknown | No outcome recorded |
| Phase 2 | NCT03940976 | Apr 2019 → Jan 2020 | esophageal squamous cell carcinoma | Peking University | Unknown | Met primary |
| Phase 2 | NCT03695510 | Jan 2019 → Apr 2022 | head and neck neoplasm | National Taiwan University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT03727724 | Dec 2018 → Sep 2022 | non-small cell lung carcinoma | The Netherlands Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT03574402 | Jul 2018 → Dec 2022 | non-small cell lung carcinoma | Guangdong Association of Clinical Trials | Unknown | Met primary |
| Phase 2 | NCT03083678 | Jun 2018 → Jan 2025 | chordoma | Leiden University Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT03486509 | Apr 2018 → Mar 2020 | squamous cell carcinoma | Fujian Cancer Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT06385483 | Feb 2018 → Dec 2022 overdue | adult lymphoma, plasma cell myeloma, refractory malignant neoplasm | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03088059 | Nov 2017 → Jun 2025 | head and neck squamous cell carcinoma | European Organisation for Research and Treatment of Cancer - EORTC | Unknown | No outcome recorded |
| Phase 2 | NCT03157089 | Nov 2017 → Jan 2020 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT02122172 | Sep 2017 → Apr 2024 | ureter cancer, urethra cancer, urinary bladder carcinoma | University of Chicago | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02876081 | Sep 2017 | small cell lung carcinoma | Fondation Hôpital Saint-Joseph | Withdrawn | No outcome recorded |
| Phase 2 | NCT03810872 | Jun 2017 → Dec 2020 | — | University Hospital Brussels | Unknown | No outcome recorded |
| Phase 2 | NCT02979977 | Mar 2017 → Jan 2025 | head and neck squamous cell carcinoma | Yale University | Completed | No outcome recorded |
| Phase 2 | NCT03239015 | Jan 2017 → Jun 2023 | refractory malignant neoplasm | Baodong Qin | Unknown | No outcome recorded |
| Phase 2 | NCT02183883 | Dec 2016 → Mar 2023 | non-small cell lung carcinoma | University College, London | Completed | No outcome recorded |
| Phase 2 | NCT02795156 | Sep 2016 → Aug 2022 | digestive system carcinoma, non-small cell lung carcinoma, upper aerodigestive tract neoplasm, urothelial carcinoma | SCRI Development Innovations, LLC | Completed | No outcome recorded |
| Phase 2 | NCT02925234 | Aug 2016 → Sep 2027 expected | cancer | The Netherlands Cancer Institute | Recruiting | Mixed |
| Phase 2 | NCT02501603 | Jul 2016 → Dec 2021 | gastric cancer, gastroesophageal cancer | Yonsei University | Completed | No outcome recorded |
| Phase 2 | NCT02780687 | Jun 2016 → Sep 2018 | urinary system neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT02629523 | Jun 2016 → Dec 2018 | lung cancer | Chonnam National University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT02716311 | May 2016 → Feb 2019 | non-small cell lung carcinoma | French Cooperative Thoracic Intergroup | Completed | No outcome recorded |
| Phase 2 | NCT02597946 | Mar 2016 → Jul 2018 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT02470065 | Jan 2016 → Sep 2018 | non-small cell lung carcinoma | European Organisation for Research and Treatment of Cancer - EORTC | Suspended | No outcome recorded |
| Phase 2 | NCT02595840 | Nov 2015 → Nov 2017 | lung cancer | University of Duisburg-Essen | Terminated | No outcome recorded |
| Phase 2 | NCT02488694 | Nov 2015 → Dec 2017 | lung cancer | AIO-Studien-gGmbH | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02369484 | Sep 2015 → Sep 2017 | non-small cell lung carcinoma | ETOP IBCSG Partners Foundation | Completed | No outcome recorded |
| Phase 2 | NCT02465060 | Aug 2015 → Dec 2027 expected | breast carcinoma, carcinoma of esophagus, cervical carcinoma, colon carcinoma +17 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04439136 | Aug 2015 → Jan 2021 overdue | adult lymphoma, plasma cell myeloma, refractory malignant neoplasm | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02511847 | Aug 2015 → Jul 2017 | triple-negative breast carcinoma | National Taiwan University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT02506517 | Aug 2015 → May 2023 | cancer | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 2 | NCT02271906 | Jul 2015 → Aug 2017 | lung cancer | M.D. Anderson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02491099 | Jun 2015 → Dec 2026 expected | endometrial serous adenocarcinoma | Yale University | Recruiting | No outcome recorded |
| Phase 2 | NCT02353936 | Jan 2015 → Jan 2020 | esophageal squamous cell carcinoma | Yonsei University | Unknown | No outcome recorded |
| Phase 2 | NCT02115048 | Jul 2014 → Nov 2018 | breast neoplasm | Translational Research in Oncology | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01824823 | Jun 2014 → Dec 2015 | head and neck squamous cell carcinoma | ECOG-ACRIN Cancer Research Group | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02274012 | May 2014 → Aug 2015 | esophageal cancer, gastroesophageal adenocarcinoma, gastroesophageal cancer | Columbia University | Withdrawn | No outcome recorded |
| Phase 2 | NCT02142036 | May 2014 → Aug 2018 | metastatic malignant neoplasm | Oslo University Hospital | Completed | Met primary |
| Phase 2 | NCT01728818 | Apr 2013 → Jan 2017 | — | PD Dr. med. Volker Heinemann | Unknown | Missed primary |
| Phase 2 | NCT01743365 | Feb 2013 → Jun 2019 | gastric cancer, gastroesophageal cancer | Hellenic Cooperative Oncology Group | Completed | No outcome recorded |
| Phase 2 | NCT01932229 | Feb 2013 → Jan 2015 | non-small cell lung carcinoma | Sheba Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT02625168 | Jan 2013 → Sep 2014 | lung cancer | The University of Hong Kong | Completed | No outcome recorded |
| Phase 2 | NCT01415011 | Dec 2012 → Aug 2015 | non-small cell lung carcinoma | University College, London | Completed | No outcome recorded |
| Phase 2 | NCT01919879 | Oct 2012 → Nov 2015 | colorectal cancer | UNICANCER | Completed | No outcome recorded |
| Phase 2 | NCT01531764 | Jul 2012 → Sep 2013 | breast carcinoma | University of Magdeburg | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01538381 | Jul 2012 → Aug 2015 | head and neck squamous cell carcinoma | European Organisation for Research and Treatment of Cancer - EORTC | Completed | No outcome recorded |
| Phase 2 | NCT01594177 | May 2012 → Mar 2014 | HER2 positive breast carcinoma | GBG Forschungs GmbH | Completed | No outcome recorded |
| Phase 2 | NCT01553942 | Apr 2012 → Dec 2024 overdue | lung cancer | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01522768 | Mar 2012 → Feb 2023 | esophageal cancer, gastric cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01480141 | Jan → Aug 2012 | lung cancer | Medical University of South Carolina | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01415674 | Jan 2012 → Dec 2021 | head and neck squamous cell carcinoma | UNICANCER | Completed | No outcome recorded |
| Phase 2 | NCT01542437 | Jan 2012 → Jun 2014 | non-small cell lung carcinoma | National Cancer Institute of Mexico | Completed | No outcome recorded |
| Phase 2 | NCT01466660 | Dec 2011 → Apr 2016 | lung neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT01441596 | Oct 2011 → Feb 2014 | breast cancer, metastatic malignant neoplasm in the brain | Boehringer Ingelheim | Completed | Missed primary |
| Phase 2 | NCT01325428 | Aug 2011 → Nov 2014 | breast neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT01271725 | May 2011 → Mar 2017 | breast cancer | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT01320280 | May 2011 → Nov 2012 | refractory malignant neoplasm | University Medical Center Hamburg-Eppendorf | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01156545 | Oct 2010 → Dec 2016 | non-small cell lung carcinoma | National Cancer Center, Korea | Completed | No outcome recorded |
| Phase 2 | NCT01152437 | Jun 2010 → Mar 2012 | colorectal neoplasm | Boehringer Ingelheim | Completed | Missed primary |
| Phase 2 | NCT01003899 | Oct 2009 → Nov 2011 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | Missed primary |
| Phase 2 | NCT00875433 | Mar 2009 → Apr 2011 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00826267 | Jan 2009 → Aug 2011 | breast neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00796549 | Dec 2008 → May 2012 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00748709 | Oct 2008 → Nov 2010 | neoplasm | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 2 | NCT00727506 | Jul 2008 → May 2011 | glioma | Boehringer Ingelheim | Completed | Missed primary |
| Phase 2 | NCT00730925 | Jun 2008 → Jan 2012 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00711594 | Apr 2008 → Nov 2013 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00525148 | Aug 2007 → Feb 2010 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00514943 | Aug 2007 → Mar 2010 | head and neck neoplasm, squamous cell carcinoma | Boehringer Ingelheim | Completed | Missed primary |
| Phase 2 | NCT00708214 | Jan 2007 → Feb 2010 | breast neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00425854 | Nov 2006 → May 2009 | breast neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00431067 | Sep 2006 → Aug 2009 | breast neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00801294 | Jul 2006 → Nov 2007 | colorectal neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00706628 | Mar 2006 → Dec 2008 | prostate neoplasm | Boehringer Ingelheim | Completed | Missed primary |
| Phase 2/32 trials · 1 missed | ||||||
| Phase 2/3 | NCT07653451 | Jul 2026 → Dec 2027 expected | esophageal squamous cell carcinoma | Peking University Cancer Hospital & Institute | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT02438722 | May 2015 → Sep 2018 | non-small cell lung carcinoma | SWOG Cancer Research Network | Completed | Missed primary |
| Phase 315 trials · 6 met primary · 4 missed | ||||||
| Phase 3 | NCT02131155 | Jul 2014 → Aug 2016 | head and neck neoplasm | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 3 | NCT02044380 | Mar 2014 → Feb 2016 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01953913 | Sep 2013 → Jul 2018 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01853826 | Jul 2013 → Mar 2024 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01856478 | Jun 2013 → Aug 2018 | head and neck neoplasm | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT01814553 | Apr 2013 → Jul 2015 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01523587 | Mar 2012 → Oct 2013 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT01345682 | Jan 2012 → Mar 2014 | head and neck neoplasm, squamous cell carcinoma | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT01345669 | Oct 2011 → Sep 2016 | head and neck neoplasm | Boehringer Ingelheim | Terminated | Missed primary |
| Phase 3 | NCT01427478 | Sep 2011 → Nov 2020 | head and neck squamous cell carcinoma | Centre Leon Berard | Completed | Missed primary |
| Phase 3 | NCT01125566 | Jun 2010 → Jun 2013 | breast cancer | Boehringer Ingelheim | Completed | Missed primary |
| Phase 3 | NCT01121393 | Apr 2010 → Nov 2017 | adenocarcinoma, non-small cell lung carcinoma | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT01085136 | Feb 2010 → Oct 2013 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT00949650 | Aug 2009 → Feb 2012 | adenocarcinoma, non-small cell lung carcinoma | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT00656136 | Apr 2008 → Oct 2013 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | Missed primary |
| Phase 46 trials | ||||||
| Phase 4 | NCT04814056 | Jun 2021 → Sep 2023 | non-small cell lung carcinoma | Shanghai Chest Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04413201 | Sep 2020 → Dec 2026 expected | non-small cell lung carcinoma | Michael Hopp | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04132102 | Nov 2018 → Apr 2021 | squamous cell lung carcinoma | Shanghai Chest Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02695290 | Mar → Aug 2016 | non-small cell lung carcinoma | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 4 | NCT02514174 | Aug 2015 → Mar 2019 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 4 | NCT02208843 | Oct 2014 → May 2017 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT02551718 | Sep 2015 → Jun 2020 | acute leukemia of ambiguous lineage, acute lymphoblastic leukemia | University of Washington | Completed | No outcome recorded |
| — | NCT01074177 | Feb 2011 → Mar 2017 | RET fusion positive cancer, non-small cell lung carcinoma | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase not stated4 trials | ||||||
| — | NCT01649284 | Jul 2012 → Mar 2014 | non-small cell lung carcinoma | Boehringer Ingelheim | Approved for marketing | No outcome recorded |
| — | NCT05107193 | — | cancer | Boehringer Ingelheim | No longer available | No outcome recorded |
| — | NCT01931306 | — | non-small cell lung carcinoma | Boehringer Ingelheim | Approved for marketing | No outcome recorded |
| — | NCT01209650 | — | non-small cell lung carcinoma | Boehringer Ingelheim | Approved for marketing | No outcome recorded |
| Comparator or background therapy10 trials | ||||||
| Phase 1 | NCT07271446 Background | Sep 2018 → Aug 2019 | non-small cell lung carcinoma | Precision Biotech Taiwan Corp. | Completed | No outcome recorded |
| Phase 1/2 | NCT02906163 Background | Oct 2016 → Dec 2019 | lung cancer | SciClone Pharmaceuticals | Unknown | No outcome recorded |
| Phase 2 | NCT05588609 Background | Nov 2022 → Jul 2025 | castration-resistant prostate carcinoma | Partner Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT01746251 Comparator | Jan 2013 → Nov 2020 | non-small cell lung carcinoma | Massachusetts General Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT07185997 Comparator | Dec 2025 → Feb 2029 expected | non-small cell lung carcinoma | ArriVent BioPharma, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06486142 Comparator | Sep 2022 → Sep 2028 expected | non-small cell lung carcinoma | Region Skane | Recruiting | No outcome recorded |
| Phase 3 | NCT06759857 Comparator | Aug 2021 → Mar 2025 overdue | non-small cell lung carcinoma | Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd. | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT04356118 Background | Jun 2020 → Jun 2023 | malignant leptomeningeal tumor | Hui Bu | Unknown | No outcome recorded |
| — | NCT03071705 Background | Mar 2016 → Apr 2017 | lung adenocarcinoma | National Cancer Institute of Mexico | Unknown | Met primary |
| — | NCT01776684 Background | Jun 2012 → May 2014 | lung cancer | Samsung Medical Center | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 28
| Date | Issuer | Release |
|---|---|---|
| 2023-04-14 | AstraZeneca | Results AstraZeneca advances its pipeline and highlights progress in immuno-oncology, ADCs, cell therapy and epigenetics at AACR astrazeneca.com ↗
Combination of T-DXd with the irreversible pan-HER TKI afatinib drives combination benefit in HER2-low gastric and lung tumours |
| 2020-10-13 | Boehringer Ingelheim | Results IASLC NACLC 2020: Boehringer Ingelheim presents new data for Gilotrif® in metastatic, squamous cell carcinoma of the lung, and in EGFR mutation-positive NSCLC prnewswire.com ↗
Boehringer Ingelheim today announced new data for Gilotrif® (afatinib) which further affirm its activity in squamous cell carcinoma of the lung and, in a separate study, epidermal growth factor receptor mutation-positive (EGFR M+) non-small cell lung cancer (NSCLC). |
| 2020-09-02 | Boehringer Ingelheim | Results Final analysis of the observational GioTag study: Sequential afatinib and osimertinib in patients with EGFR mutation-positive non-small cell lung cancer prnewswire.com ↗
Results showed that Asian and Del19-positive patients saw a median OS of 44.8 months (90% CI: 37.0–57.8) and 41.6 months (90% CI: 36.9–45.0) respectively. |
| 2020-08-10 | Boehringer Ingelheim | Results Additional analysis of real-world data confirms sequential Gilotrif® followed by osimertinib provided a median overall survival of nearly four years in U.S.-treated patients with EGFR mutation-positive NSCLC prnewswire.com ↗ |
| 2019-08-05 | Boehringer Ingelheim | Results Updated real-world data show Gilotrif® followed by osimertinib provided a median overall survival of up to almost four years in patients with EGFR Del19 and T790M mutation-positive NSCLC prnewswire.com ↗
Boehringer Ingelheim today announced updated, interim analysis results from the GioTag study, showing that initiating treatment with afatinib followed by osimertinib provided an overall survival (OS) of almost four years (45.7 months) in patients with Del19-positive tumors. |
| 2018-10-22 | Boehringer Ingelheim | Results Real-world study shows sequencing of Gilotrif® followed by osimertinib delivered a combined median time on treatment of 27.6 months in patients with EGFR mutation-positive NSCLC prnewswire.com ↗
According to the study, the median time on treatment for sequential afatinib and osimertinib was 27.6 months. |
| 2018-01-16 | Boehringer Ingelheim | Regulatory FDA approves new indication for Gilotrif® in EGFR mutation-positive NSCLC prnewswire.com ↗ |
| 2017-10-10 | Boehringer Ingelheim | Regulatory FDA grants Priority Review to Gilotrif® for uncommon EGFR mutations in advanced NSCLC prnewswire.com ↗
Boehringer Ingelheim today announced that the supplemental New Drug Application (sNDA) for Gilotrif® (afatinib) has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA). |
| 2016-10-09 | Boehringer Ingelheim | Results Overall survival data from LUX-Lung 7 head-to-head trial of Gilotrif® (afatinib) versus Iressa® (gefitinib) presented at ESMO prnewswire.com ↗
The median survival of patients treated with afatinib was 27.9 months compared to 24.5 months for those receiving gefitinib, without reaching significance. |
| 2016-09-08 | Boehringer Ingelheim | Results New analysis showed dose adjustment of Gilotrif® (afatinib) improved tolerability without an apparent impact on efficacy in patients with EGFR mutation-positive non-small cell lung cancer prnewswire.com ↗
The analysis suggests specific dose reductions, as described in the prescribing information, led to decreases in the incidence and severity of treatment-related adverse events (AEs) in afatinib-treated patients without any apparent compromise in efficacy. |
| 2016-04-15 | Boehringer Ingelheim | Regulatory FDA approves Gilotrif® (afatinib) as new oral treatment option for patients with squamous cell carcinoma of the lung prnewswire.com ↗
Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Gilotrif® (afatinib) tablets for the treatment of patients with advanced squamous cell carcinoma of the lung whose disease has progressed after treatment with platinum-based chemotherapy. |
| 2016-04-13 | Boehringer Ingelheim | Results Head-to-head study demonstrating Gilotrif® (afatinib) significantly improved clinical outcomes compared to Iressa® (gefitinib) in EGFR mutation-positive advanced non-small cell lung cancer published in The Lancet Oncology prnewswire.com ↗
Results from the LUX-Lung 7 trial showed that afatinib significantly reduced the risk of lung cancer progression by 27% versus gefitinib. |
| 2016-01-27 | Boehringer Ingelheim | Results Boehringer Ingelheim's Gilotrif® (afatinib) demonstrated superiority to Iressa® (gefitinib) in reducing the risk of disease progression and treatment failure in first-line treatment of patients with EGFR mutation-positive advanced non-small cell lung cancer prnewswire.com ↗
Superiority in progression-free survival and time to treatment failure was demonstrated with second-generation EGFR-directed therapy afatinib versus first-generation gefitinib in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) with common EGFR mutations (del19 or L858R). |
| 2015-08-25 | Boehringer Ingelheim | Regulatory FDA and EMA accept regulatory applications for Boehringer Ingelheim's Gilotrif® (afatinib) for treatment of advanced squamous cell carcinoma of the lung prnewswire.com ↗ |
| 2015-05-31 | Boehringer Ingelheim | Results ASCO 2015: Superior overall survival for afatinib compared to erlotinib demonstrated in head-to-head trial in patients with previously treated advanced squamous cell carcinoma of the lung prnewswire.com ↗
Treatment with afatinib significantly reduced the risk of death by 19%, extending the survival of patients to a median of 7.9 months compared to 6.8 months on erlotinib. |
| 2015-05-14 | Boehringer Ingelheim | Results Boehringer Ingelheim showcases expanding presence in lung cancer at ASCO with new data including presentation of Gilotrif® (afatinib) overall survival results for squamous cell carcinoma of the lung prnewswire.com ↗
The study met its primary endpoint of progression-free survival, as well as its key secondary endpoint of overall survival (OS). |
| 2015-01-12 | Boehringer Ingelheim | Results The Lancet Oncology publishes phase III data showing Gilotrif® (afatinib) extends overall survival in lung cancer patients whose tumors have the most common EGFR mutation compared with chemotherapy prnewswire.com ↗
In each trial, patients whose tumors have the most common EGFR mutation (deletion in exon 19; Del19) lived more than one year longer when treated with first-line afatinib compared to standard chemotherapy. |
| 2014-09-29 | Boehringer Ingelheim | Results Head-to-head Phase III trial demonstrates superior progression-free survival of afatinib compared to erlotinib in patients with advanced squamous cell carcinoma of the lung prnewswire.com ↗
Phase III data from Boehringer Ingelheim's LUX-Lung 8 trial, the first study to evaluate the superiority of afatinib versus erlotinib in patients with advanced squamous cell carcinoma (SCC) of the lung, demonstrated superior improvement in progression-free survival (PFS) with afatinib compared to erlotinib. |
| 2014-05-14 | Boehringer Ingelheim | Results New data for Boehringer Ingelheim's Gilotrif® (afatinib) shows a significant improvement in overall survival in lung cancer patients whose tumors have the most common EGFR mutation prnewswire.com ↗
Boehringer Ingelheim today announced new overall survival data of two Phase III clinical trials ( LUX-Lung 3 and LUX-Lung 6 ). |
| 2013-07-12 | Boehringer Ingelheim | Regulatory FDA approves GILOTRIF™ (afatinib) as first-line treatment for metastatic non-small cell lung cancer with common EGFR mutations prnewswire.com ↗ |
| 2013-05-15 | Boehringer Ingelheim | Results Boehringer Ingelheim Presents Progression-Free Survival Data for Investigational Afatinib and Nintedanib in Advanced NSCLC prnewswire.com ↗
Patients treated with afatinib lived for almost a year before their tumor started to grow again (progression-free survival [PFS], the primary endpoint) as compared with just under half a year for patients treated with gemcitabine/cisplatin. |
| 2013-01-15 | Boehringer Ingelheim | Regulatory U.S. FDA Grants Priority Review to Boehringer Ingelheim's Afatinib NDA for EGFR Mutation-Positive Advanced NSCLC prnewswire.com ↗
Boehringer Ingelheim Pharmaceuticals Inc. (BIPI) today announced that the New Drug Application (NDA) for its investigational oncology compound afatinib has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA). |
| 2012-09-28 | Boehringer Ingelheim | Results New Boehringer Ingelheim data to be presented on health-related quality of life with afatinib in patients with EGFR mutation-positive advanced NSCLC prnewswire.com ↗
Results showed that a higher proportion of afatinib-treated patients had 10 point or more improvements in cough (67% vs. 60%; p=0.2444), dyspnea (64% vs. 50%; p=0.0103) and pain (59% vs. 48%; p=0.0513) compared with those treated with chemotherapy. |
| 2012-06-04 | Boehringer Ingelheim | Results Afatinib demonstrates significant progression-free survival of almost one year in EGFR mutation-positive advanced NSCLC prnewswire.com ↗
Results showed that within the general study population, patients assigned to the afatinib arm lived for 11.1 months before their tumor started to grow again (PFS) versus 6.9 months for those patients in the chemotherapy arm (pemetrexed/cisplatin). |
| 2011-05-25 | Boehringer Ingelheim | Results Boehringer Ingelheim to present new data at ASCO annual meeting regarding its investigational compound afatinib in EGFR-mutation positive patients with advanced NSCLC prnewswire.com ↗
Researchers observed a tumor size reduction of up to 76 percent over a treatment period of up to five months. |
| 2010-12-09 | Boehringer Ingelheim | Results New Subgroup Analysis of LUX-Lung 1 Trial Suggests Afatinib Increases Progression-Free Survival in Advanced Lung Cancer Patients More Likely to Have EGFR Mutations prnewswire.com ↗
new data from a subgroup analysis of the phase IIb/III LUX-Lung 1 trial show that afatinib (BIBW 2992) reached a four-fold extension (4.4 months vs. 1.0 month for placebo) in progression-free survival |
| 2010-10-11 | Boehringer Ingelheim | Results New Afatinib (BIBW 2992) Data in Non-Small Cell Lung Cancer Patients Presented at the 2010 ESMO Congress prnewswire.com ↗
In the phase IIb/III LUX-Lung 1 study, afatinib tripled the secondary endpoint of progression free survival (PFS) but did not extend the primary endpoint of overall survival (OS) in late-stage patients with non-small cell lung cancer (NSCLC). |
| 2010-05-20 | Boehringer Ingelheim | Results Boehringer Ingelheim to Present New Data Regarding Its Investigational Compound BIBW 2992 in Head and Neck Cancer and Non-Small Cell Lung Cancer prnewswire.com ↗
Twenty-two percent of the 34 patients receiving BIBW 2992 experienced reduction in tumor size (measured as partial response), compared to 13 percent of the 40 patients receiving cetuximab. |
All press releases naming this drug 35 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 204 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Afatinib | “Afatinib-an oral irreversible ErbB family blocker-improves progression-free survival compared with pemetrexed and cisplatin for first-line treatment of patients with EGFR...” PMID 24439929 ↗ Jan 2014169“This is an investigational study. Afatinib is FDA approved and commercially available to be the first treatment for patients with a specific type of NSCLC that has spread. It...” NCT02271906 ↗ “Patients were randomly allocated to receive EGFR-TKIs (erlotinib hydrochloride, afatinib dimaleate, or gefitinib at standard dosage) plus metformin hydrochloride (500 mg twice...” PMID 31486833 ↗ Nov 2019 “evaluate the efficacy and safety of XH-30002 capsule in combination with afatinib maleate tablets in patients with locally advanced or metastatic esophageal squamous cell carcinoma” NCT05927844 ↗ “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” NCT01647711 ↗ “Study to Determine the Maximum Tolerated Dose of BIBW 2992 (Afatinib) When Combined With Cisplatin/Paclitaxel or Cisplatin/5-FU in Patients With Advanced Solid Tumours” NCT00716417 ↗ “A phase II trial to assess the impact of afatinib (BIBW 2992) on the heart (QTcF) and the effectiveness of afatinib (BIBW 2992) in treating certain cancers.” NCT00875433 ↗ “Phase I Open Label Trial to Assess Safety of BIBW 2992 (Afatinib) in Combination With Herceptin® in Patients With HER2-positive Advanced Breast Cancer.” NCT00950742 ↗ “Patients will commence daily oral therapy with the EGFR TKI afatinib as soon as possible, preferably on the same day as low dose cyclophosphamide.” NCT03623750 ↗ “The MTD was determined as afatinib 30 mg in combination with daily TMZ and RT, and afatinib 40 mg in combination with RT alone.” PMID 34787778 ↗ Nov 2021 “PURPOSE: Afatinib, an irreversible ErbB family blocker, has demonstrated preclinical antitumor activity with chemotherapy.” PMID 30088048 ↗ Aug 2018 |
| Known as | Afatinib Dimaleate | “Patients were randomly allocated to receive EGFR-TKIs (erlotinib hydrochloride, afatinib dimaleate, or gefitinib at standard dosage) plus metformin hydrochloride (500 mg twice...” PMID 31486833 ↗ Nov 20191“Drug: Afatinib Dimaleate” NCT02364609 ↗ |
| Known as | BIBW2992 | “A Phase Ib Open-label Clinical Trial of Continuous Once Daily Oral Treatment Using BIBW 2992 Plus Cetuximab (Erbitux®) in Patients With Non-small cell Lung Cancer With...” NCT01090011 ↗68“Trial of Continuous Once Daily Oral Treatment Using BIBW 2992 (Afatinib) Plus Sirolimus (Rapamune®) in Patients With Non-small Cell Lung Cancer Harbouring an EGFR Mutation...” NCT00993499 ↗ “An Open Label Expanded Access Program of Afatinib (BIBW 2992) in Treatment-naive or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-Small Cell Lung...” NCT01931306 ↗ “LUX-Breast 2; An Open Label, Phase II Trial of Afatinib (BIBW 2992) in Patients With Metastatic HER2-overexpressing Breast Cancer Failing HER2-targeted Treatment in the...” NCT01271725 ↗ “So far, there is uncertainty, if afatinib (BIBW 2992), an irreversible HER family blocker can lead to an even more complete blockade of the HER2 pathway when given in...” NCT01594177 ↗ “LUX-Lung EAP US; An Open Label Expanded Access Program of Afatinib (BIBW 2992) for Patients With Locally Advanced or Metastatic Non-small cell Lung Cancer (NSCLC) Harboring...” NCT01649284 ↗ “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” NCT01523587 ↗ “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” NCT01345669 ↗ “An Open Label Phase I Dose Escalation Trial of Intravenous BI 6727 (Volasertib)in Combination With Oral BIBW 2992 (Afatinib) in Patients With Advanced Solid Tumours” NCT01206816 ↗ “Open Label Trial to Explore Safety of Combining Afatinib (BIBW 2992) and Radiotherapy With or Without Temozolomide in Newly Diagnosed Glioblastoma Multiform” NCT00977431 ↗ “A phase II trial to assess the impact of afatinib (BIBW 2992) on the heart (QTcF) and the effectiveness of afatinib (BIBW 2992) in treating certain cancers.” NCT00875433 ↗ |
| Known as | Gilotrif | “This phase I/Ib trial will assess the dose, safety and side effects of the combination of the cancer drugs afatinib (GILOTRIF®) and nivolumab (OPDIVO®) and to assess the...” NCT03652233 ↗3“will be treated with orally administered daily dose of afatinib (Gilotrif®) in a fasting state (1 hour before or 2 hours after meals).” NCT04533321 ↗ “Afatinib (Gilotrif™) is currently used for metastatic non-small-cell lung cancer with EGFR mutations” PMID 34004576 ↗ May 2021 “Afatinib (GILOTRIF) is a highly potent, irreversible inhibitor of the EGFR and HER2.” NCT02274012 ↗ |
| Action | Inhibit | “a dual, irreversible EGFR- and HER2-inhibitor” NCT00425854 ↗ |
| Modality | Small molecule | “Four epidermal growth factor receptor (EGFR)-targeted tyrosine kinase inhibitors - afatinib, erlotinib, icotinib, and gefitinib - are available for first-line treatment of...” PMID 30584317 ↗ Nov 2018 |
| Route | Oral | “Once Daily Oral Dose” NCT00425854 ↗ |
| Target | EGFR | “a dual, irreversible EGFR- and HER2-inhibitor” NCT00425854 ↗ |