Clinical Trials

Numerous clinical trials evaluate the efficacy and safety of afatinib across Phase 1 through Phase 4 investigations, encompassing studies that are recruiting, completed, or active but not recruiting. Research targets advanced solid tumors, cholangiocarcinoma, head and neck squamous cell carcinoma, and non-small cell lung cancer of both squamous and non-squamous histologies. Sponsored by pharmaceutical companies such as Boehringer Ingelheim and Incyte Corporation alongside academic institutions like Massachusetts General Hospital and the University of Texas Southwestern Medical Center, these trials investigate afatinib as both monotherapy and in combination with chemotherapy or targeted agents.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07185997 RECRUITING
Non-Small-Cell Lung Cancer; Metastatic Non-Small-Cell Lung Cancer; Advanced Non-Small-Cell Lung Cancer; EGFR P-Loop and Alpha C-Helix Compressing; EGFR PACC; EGFR Uncommon Mutations
ArriVent BioPharma, Inc.
 2025-12-17 PHASE3
NCT06648096 RECRUITING
Fanconi Anemia; Head and Neck Squamous Cell Carcinoma
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
 2024-11-08 PHASE1; PHASE2
NCT06486142 RECRUITING
Non-Small Cell Lung Cancer
Region Skane
 2022-09-21 PHASE3
NCT07653451 NOT_YET_RECRUITING
Esophageal Squamous Cell Carcinoma
Peking University Cancer Hospital & Institute
 2026-07-01 PHASE2; PHASE3
NCT06302621 RECRUITING
Advanced Solid Tumor; Unresectable Solid Tumor; Metastatic Solid Tumor; Cholangiocarcinoma
Massachusetts General Hospital
 2024-04-17 PHASE1
NCT02925234 RECRUITING
Cancer; Tumors; Neoplasm; Neoplasia
The Netherlands Cancer Institute
 2016-08 PHASE2
NCT06753747 RECRUITING
Esophagus Cancer
West China Hospital
 2025-09-10 PHASE1; PHASE2
NCT05432518 RECRUITING
Glioblastoma; Recurrent Disease; Recurrent Glioblastoma
AHS Cancer Control Alberta
 2023-06-27 EARLY_PHASE1
NCT07010120 ACTIVE_NOT_RECRUITING
HNSCC; Lysogenic HSV Virus; Neoadjuvant Therapy; Immunotherapy; Targeted Therapy
West China Hospital
 2025-06-10 PHASE1; PHASE2
NCT05070403 ACTIVE_NOT_RECRUITING
Squamous Cell Carcinoma
H. Lee Moffitt Cancer Center and Research Institute
 2021-10-01 PHASE2
NCT02465060 ACTIVE_NOT_RECRUITING
Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Bladder Carcinoma; Breast Carcinoma; Cervical Carcinoma; Colon Carcinoma; Colorectal Carcinoma; Endometrial Carcinoma; Esophageal Carcinoma; Exocrine Pancreas Carcinoma; Gastric Carcinoma; Glioma; Head and Neck Carcinoma; Hematopoietic and Lymphoid Cell Neoplasm; Kidney Carcinoma; Liver Carcinoma; Lung Carcinoma; Lymphoma; Malignant Uterine Corpus Neoplasm; Malignant Uterine Neoplasm; Melanoma; Multiple Myeloma; Ovarian Carcinoma; Prostate Carcinoma; Rectal Carcinoma; Recurrent Bladder Carcinoma; Recurrent Breast Carcinoma; Recurrent Cervical Carcinoma; Recurrent Colon Carcinoma; Recurrent Colorectal Carcinoma; Recurrent Esophageal Carcinoma; Recurrent Gastric Carcinoma; Recurrent Glioma; Recurrent Head and Neck Carcinoma; Recurrent Liver Carcinoma; Recurrent Lung Carcinoma; Recurrent Lymphoma; Recurrent Malignant Solid Neoplasm; Recurrent Malignant Uterine Corpus Neoplasm; Recurrent Melanoma; Recurrent Multiple Myeloma; Recurrent Ovarian Carcinoma; Recurrent Pancreatic Carcinoma; Recurrent Prostate Carcinoma; Recurrent Rectal Carcinoma; Recurrent Skin Carcinoma; Recurrent Thyroid Gland Carcinoma; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma; Skin Carcinoma; Thyroid Gland Carcinoma
National Cancer Institute (NCI)
 2015-08-17 PHASE2
NCT04413201 ACTIVE_NOT_RECRUITING
Non-squamous NSCLC
Michael Hopp
 2020-09-11 PHASE4
NCT04185883 ACTIVE_NOT_RECRUITING
Advanced Solid Tumors; Kirsten Rat Sarcoma (KRAS) pG12C Mutation
Amgen
 2019-12-17 PHASE1
NCT06741982 RECRUITING
HNSCC; Lysogenic HSV Virus; Neoadjuvant Therapy; Immunotherapy; Targeted Therapy
West China Hospital
 2024-12-15 PHASE1
NCT02491099 RECRUITING
HER2/Neu+ Uterine Serous Carcinoma
Yale University
 2015-06 PHASE2
NCT06062823 RECRUITING
NSCLC
National University Hospital, Singapore
 2024-03-25 PHASE2
NCT05215548 ACTIVE_NOT_RECRUITING
NSCLC Stage IV
National Taiwan University Hospital
 2021-09-27 PHASE2
NCT04497584 ACTIVE_NOT_RECRUITING
Advanced Squamous Non Small Cell Lung Cancer
University of Texas Southwestern Medical Center
 2021-08-04 PHASE2
NCT06071013 RECRUITING
Non-small Cell Lung Cancer; EGFR Gene Mutation; EGFR-TKI Resistant Mutation
China Medical University Hospital
 2024-02-23 PHASE1; PHASE2
NCT06804850 WITHDRAWN
Head and Neck Cancer
West China Hospital
 2025-01-20 PHASE2
NCT07040956 COMPLETED
Head and Neck Squamous Cell Carcinoma; Low-dose Radiotherapy; Immunotherapy; Targeted Therapy
West China Hospital
 2025-06-28 PHASE2
NCT03785249 ACTIVE_NOT_RECRUITING
Advanced Cancer; Metastatic Cancer; Malignant Neoplastic Disease
Mirati Therapeutics Inc.
 2019-01-15 PHASE1; PHASE2
NCT06709859 RECRUITING
Carcinoma, Non-Small-Cell Lung
Shandong Public Health Clinical Center
 2025-05-01 PHASE2
NCT06897735 TERMINATED
Lung Cancer; Oral Cancer; Melanoma
Petrov, Andrey
 2025-11-09 PHASE1
NCT06085755 RECRUITING
Stomach Neoplasm
Jeeyun Lee
 2024-09-30 PHASE1; PHASE2
NCT05588609 TERMINATED
NSCLC Harboring NRG1 Fusion; Metastatic Castration-resistant Prostate Cancer
Partner Therapeutics, Inc.
 2022-11-17 PHASE2
NCT05519917 UNKNOWN
Chordoma of Clivus
Huashan Hospital
 2022-10-01 PHASE2
NCT03088059 UNKNOWN
Carcinoma, Squamous Cell of Head and Neck
European Organisation for Research and Treatment of Cancer - EORTC
 2017-11-16 PHASE2
NCT04183712 RECRUITING
Gallbladder Carcinoma
Shanghai Jiao Tong University School of Medicine
 2020-06-01 PHASE2
NCT05927844 UNKNOWN
Esophageal Squamous Cell Carcinoma
Fujian Cancer Hospital
 2023-06 PHASE1
NCT06494189 COMPLETED
Head and Neck Cancer
West China Hospital
 2024-07-31 PHASE1
NCT05865132 UNKNOWN
Esophagus Squamous Cell Carcinoma
AIPING ZHOU
 2023-04-06 PHASE2
NCT06759857 ENROLLING_BY_INVITATION
Non Small Cell Lung Cancer
Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.
 2021-08-01 PHASE3
NCT05818982 UNKNOWN
Advanced Esophageal Squamous Cell Carcinoma
Peking University
 2023-02-09 PHASE2
NCT03083678 COMPLETED
Chordoma
Leiden University Medical Center
 2018-06-21 PHASE2
NCT02979977 COMPLETED
Squamous Cell Cancers of the Head and Neck
Yale University
 2017-03-24 PHASE2
NCT05267288 UNKNOWN
PFS
Qingdao Central Hospital
 2021-02-01 PHASE2
NCT01553942 ACTIVE_NOT_RECRUITING
Lung Cancer
Massachusetts General Hospital
 2012-04 PHASE2
NCT06302621 Recruiting
Advanced Solid Tumor|Unresectable Solid Tumor|Metastatic Solid Tumor|Cholangiocarcinoma
Massachusetts General Hospital|Boehringer Ingelheim|Incyte Corporation
 2024-07-01 Phase 1
NCT02122172 TERMINATED
Distal Urethral Cancer; Proximal Urethral Cancer; Recurrent Bladder Cancer; Recurrent Urethral Cancer; Stage III Bladder Cancer; Stage III Urethral Cancer; Stage IV Bladder Cancer; Stage IV Urethral Cancer; Ureter Cancer
University of Chicago
 2017-09-13 PHASE2
NCT05298176 COMPLETED
Non-Small Cell Lung Cancer
Amsterdam UMC, location VUmc
 2022-01-04 PHASE2
NCT01853826 COMPLETED
Carcinoma, Non-Small-Cell Lung
Boehringer Ingelheim
 2013-07-17 PHASE3
NCT05517330 COMPLETED
Head and Neck Cancer
West China Hospital
 2022-09-19 PHASE2
NCT04158947 UNKNOWN
HER2-positive Breast Cancer; Brain Metastases
xuexin he
 2020-05-10 PHASE2
NCT05516589 COMPLETED
Head and Neck Squamous Cell Carcinoma
West China Hospital
 2022-09-12 PHASE2
NCT04410653 COMPLETED
Metastatic and Locally Advanced NRG1-rearranged Malignancies
German Cancer Research Center
 2022-07-31 PHASE2
NCT05164848 UNKNOWN
Esophageal Squamous Carcinoma
Peking University
 2021-12-25 PHASE1
NCT04814056 UNKNOWN
NRG1-fused Non-small Cell Lung Cancer
Shanghai Chest Hospital
 2021-06-01 PHASE4
NCT04533321 UNKNOWN
Squamous Cell Carcinoma
National University Hospital, Singapore
 2020-09 PHASE2
NCT04839471 COMPLETED
Esophageal Squamous Cell Carcinoma (ESCC)
National Health Research Institutes, Taiwan
 2021-08-06 PHASE2
NCT03239015 UNKNOWN
Rare Tumor; Refractory Tumor
Baodong Qin
 2017-01-01 PHASE2
NCT02506517 COMPLETED
Solid Tumors
University Health Network, Toronto
 2015-08 PHASE2
NCT02183883 COMPLETED
Non-small Cell Lung Cancer
University College, London
 2016-12-16 PHASE2
NCT03827070 UNKNOWN
Non Small Cell Lung Cancer
Center Trials & Treatment Europe
 2019-03-05 PHASE1
NCT01522768 COMPLETED
Esophageal Cancer; Gastric Cancer
Memorial Sloan Kettering Cancer Center
 2012-03 PHASE2
NCT03574402 UNKNOWN
Carcinoma, Non-Small-Cell Lung
Guangdong Association of Clinical Trials
 2018-07-09 PHASE2
NCT06385483 ACTIVE_NOT_RECRUITING
Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma
National Cancer Institute (NCI)
 2018-02-28 PHASE2
NCT03908892 UNKNOWN
Paronychia
Guangzhou University of Traditional Chinese Medicine
 2019-06-12
NCT04880811 UNKNOWN
Esophageal Squamous Cell Carcinoma
Peking University
 2021-07 PHASE2
NCT03727724 COMPLETED
Carcinoma, Non-Small-Cell Lung
The Netherlands Cancer Institute
 2018-12-04 PHASE2
NCT02795156 COMPLETED
Non-small Cell Lung Carcinoma; Urothelial Carcinoma; Gastrointestinal Carcinoma, Non-colon; Upper Aerodigestive Tract Carcinoma
SCRI Development Innovations, LLC
 2016-09-28 PHASE2
NCT02451553 COMPLETED
Advanced Malignant Solid Neoplasm; Bile Duct Carcinoma; Recurrent Malignant Solid Neoplasm; Recurrent Pancreatic Carcinoma; Stage III Pancreatic Cancer AJCC v6 and v7; Stage IVA Pancreatic Cancer; Stage IVB Pancreatic Cancer
University of Washington
 2015-11-05 PHASE1
NCT03695510 COMPLETED
Head and Neck Neoplasms
National Taiwan University Hospital
 2019-01-24 PHASE2
NCT03054038 TERMINATED
Non-Small Cell Lung Carcinoma
Vanderbilt-Ingram Cancer Center
 2017-07-20 PHASE1
NCT04201756 COMPLETED
Lung Adenocarcinoma Stage III; EGFR Gene Mutation
Shanghai Pulmonary Hospital, Shanghai, China
 2020-07-26 PHASE2
NCT05298176 Recruiting
Non-Small Cell Lung Cancer
Amsterdam UMC location VUmc
 2022-01-04 Phase 2
NCT02501603 COMPLETED
Gastric Cancer; Gastroesophageal Junction Cancer
Yonsei University
 2016-07 PHASE2
NCT04448379 UNKNOWN
Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Shanghai JMT-Bio Inc.
 2020-06-29 PHASE1
NCT04470076 UNKNOWN
Non Small Cell Lung Cancer; Surgery; EGFR Activating Mutation; Chemotherapy; EGFR TKI
Fifth Affiliated Hospital, Sun Yat-Sen University
 2020-07-10 PHASE2
NCT01415674 COMPLETED
Carcinoma, Squamous Cell of Head and Neck
UNICANCER
 2012-01 PHASE2
NCT03652233 WITHDRAWN
Recurrent Squamous Cell Carcinoma of the Head or Neck; Metastatic Squamous Cell Carcinoma of the Head or Neck; Squamous Cell Carcinoma
Vanderbilt-Ingram Cancer Center
 2018-11-02 PHASE1
NCT04795245 Completed
Non-squamous Non-Small Cell Lung Cancer
Boehringer Ingelheim
 2021-08-26 --
NCT04497584 Recruiting
Advanced Squamous Non Small Cell Lung Cancer
University of Texas Southwestern Medical Center
 2021-08-04 Phase 2
NCT04132102 UNKNOWN
Lung Squamous Cell Carcinoma
Shanghai Chest Hospital
 2018-11-27 PHASE4
NCT04439136 ACTIVE_NOT_RECRUITING
Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma
National Cancer Institute (NCI)
 2015-08-12 PHASE2
NCT03878524 TERMINATED
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Anatomic Stage IV Breast Cancer AJCC v8; Anemia; Ann Arbor Stage III Hodgkin Lymphoma; Ann Arbor Stage III Non-Hodgkin Lymphoma; Ann Arbor Stage IV Hodgkin Lymphoma; Ann Arbor Stage IV Non-Hodgkin Lymphoma; Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative; Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Castration-Resistant Prostate Carcinoma; Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Hematopoietic and Lymphoid System Neoplasm; Locally Advanced Pancreatic Adenocarcinoma; Metastatic Breast Carcinoma; Metastatic Malignant Solid Neoplasm; Metastatic Pancreatic Adenocarcinoma; Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis; Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Primary Myelofibrosis; Recurrent Acute Lymphoblastic Leukemia; Recurrent Acute Myeloid Leukemia; Recurrent Chronic Lymphocytic Leukemia; Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Recurrent Hematologic Malignancy; Recurrent Hodgkin Lymphoma; Recurrent Myelodysplastic Syndrome; Recurrent Myelodysplastic/Myeloproliferative Neoplasm; Recurrent Myeloproliferative Neoplasm; Recurrent Non-Hodgkin Lymphoma; Recurrent Plasma Cell Myeloma; Recurrent Small Lymphocytic Lymphoma; Refractory Acute Lymphoblastic Leukemia; Refractory Acute Myeloid Leukemia; Refractory Chronic Lymphocytic Leukemia; Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Refractory Chronic Myelomonocytic Leukemia; Refractory Hematologic Malignancy; Refractory Hodgkin Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Myelodysplastic Syndrome; Refractory Myelodysplastic/Myeloproliferative Neoplasm; Refractory Non-Hodgkin Lymphoma; Refractory Plasma Cell Myeloma; Refractory Primary Myelofibrosis; Refractory Small Lymphocytic Lymphoma; Stage II Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Stage IV Prostate Cancer AJCC v8; Unresectable Pancreatic Adenocarcinoma
OHSU Knight Cancer Institute
 2020-04-01 PHASE1
NCT03810872 UNKNOWN
Cancers Harbouring an EGFR Mutation, (Excluding Non-squamous Non- Small Cell Lung Cancer, a Registered Indication), a HER2 Mutation or a HER3 Mutation
Universitair Ziekenhuis Brussel
 2017-06-21 PHASE2
NCT01746251 UNKNOWN
Non Small Cell Lung Cancer
Massachusetts General Hospital
 2013-01 PHASE2
NCT01427478 COMPLETED
Head and Neck Squamous Cell Carcinoma
Centre Leon Berard
 2011-09 PHASE3
NCT04413201 Active not recruiting
Non-squamous NSCLC
Michael Hopp|Boehringer Ingelheim|Johannes Gutenberg University Mainz
 2020-09-11 Phase 4
NCT03486587 TERMINATED
Diarrhea; Treatment Side Effects
Sun Yat-sen University
 2018-04-15 PHASE2
NCT02768337 TERMINATED
Lung Cancer; Breast Cancer; Brain Cancer; Advanced Breast Cancer; Advanced Lung Cancer
Cambridge University Hospitals NHS Foundation Trust
 2015-03-10 PHASE1; PHASE2
NCT02372006 COMPLETED
Neuroectodermal Tumors; Rhabdomyosarcoma
Boehringer Ingelheim
 2015-04-29 PHASE1; PHASE2
NCT02423525 COMPLETED
Brain Cancer
Santosh Kesari
 2016-12 PHASE1
NCT03486509 UNKNOWN
Squamous Cell Carcinoma
Fujian Cancer Hospital
 2018-04-01 PHASE2
NCT03157089 COMPLETED
Carcinoma, Non-Small-Cell Lung
Boehringer Ingelheim
 2017-11-02 PHASE2
NCT03940976 UNKNOWN
Esophageal Squamous Cell Carcinoma
Peking University
 2019-04-28 PHASE2
NCT02353936 UNKNOWN
Squamous Cell Carcinoma of Esophagus
Yonsei University
 2015-01 PHASE2
NCT03711422 TERMINATED
Non-small Cell Lung Cancer; Leptomeningeal Disease; Central Nervous System Metastases
National Cancer Centre, Singapore
 2018-11-16 PHASE1
NCT07271446 COMPLETED
Non-small Cell Lung Cancer
Precision Biotech Taiwan Corp.
 2018-09-01 PHASE1
NCT01743365 COMPLETED
Gastric Cancer; Gastroesophageal Junction Cancer
Hellenic Cooperative Oncology Group
 2013-02-11 PHASE2
NCT02450656 UNKNOWN
Colorectal Neoplasms; Gastrointestinal Neoplasms; Pancreatic Neoplasms; Carcinoma, Non-Small-Cell Lung
The Netherlands Cancer Institute
 2015-06 PHASE1; PHASE2
NCT02514174 COMPLETED
Carcinoma, Non-Small-Cell Lung; ErbB Receptors
Boehringer Ingelheim
 2015-08-18 PHASE4
NCT02716311 COMPLETED
Non Small Cell Lung Cancer
Intergroupe Francophone de Cancerologie Thoracique
 2016-05 PHASE2
NCT02629523 COMPLETED
Lung Neoplasms; EGFR Gene Mutation
Chonnam National University Hospital
 2016-06-01 PHASE2
NCT02975141 UNKNOWN
Metastatic Pancreatic Cancer
PD Dr. med. Volker Heinemann
 2016-09 PHASE1
NCT02115048 TERMINATED
Breast Neoplasms
Translational Research in Oncology
 2014-07 PHASE2
NCT02438722 COMPLETED
Recurrent Non-Small Cell Lung Carcinoma; Stage IV Non-Small Cell Lung Cancer
SWOG Cancer Research Network
 2015-05-07 PHASE2; PHASE3
NCT02780687 COMPLETED
Urologic Neoplasms
Boehringer Ingelheim
 2016-06-09 PHASE2
NCT02470065 SUSPENDED
Non Small Cell Lung Cancer
European Organisation for Research and Treatment of Cancer - EORTC
 2016-01 PHASE2
NCT01856478 COMPLETED
Head and Neck Neoplasms
Boehringer Ingelheim
 2013-06-07 PHASE3
NCT02597946 COMPLETED
Carcinoma, Non-Small-Cell Lung
Boehringer Ingelheim
 2016-03-18 PHASE2
NCT01953913 COMPLETED
Carcinoma, Non-Small-Cell Lung
Boehringer Ingelheim
 2013-09-30 PHASE3
NCT02364609 COMPLETED
Recurrent Non-Small Cell Lung Carcinoma; Stage IIIA Non-Small Cell Lung Cancer; Stage IIIB Non-Small Cell Lung Cancer; Stage IV Non-Small Cell Lung Cancer
Jonathan Riess
 2015-09-30 PHASE1
NCT02191891 COMPLETED
Carcinoma, Non-Small-Cell Lung
Boehringer Ingelheim
 2014-10-21 PHASE1
NCT02488694 TERMINATED
Non-small-cell Lung Cancer With Somatic EGFR Mutations
AIO-Studien-gGmbH
 2015-11 PHASE2
NCT01783587 COMPLETED
Squamous Cell Carcinoma of the Head and Neck
Dana-Farber Cancer Institute
 2013-02 PHASE1
NCT02595840 TERMINATED
Non-small-cell Lung Cancer With Somatic EGFR Mutations
Universität Duisburg-Essen
 2015-11-25 PHASE2
NCT02145637 COMPLETED
NSCLC
Yonsei University
 2015-05-07 PHASE1
NCT01721525 COMPLETED
Head and Neck Cancer; Squamous Cell Cancer
Memorial Sloan Kettering Cancer Center
 2012-11 PHASE1
NCT02369484 COMPLETED
NSCLC
ETOP IBCSG Partners Foundation
 2015-09-16 PHASE2
NCT02876081 WITHDRAWN
SMALL CELL LUNG CARCINOMA
Fondation Hôpital Saint-Joseph
 2017-09-01 PHASE2
NCT02271906 TERMINATED
Lung Cancer
M.D. Anderson Cancer Center
 2015-07-01 PHASE2
NCT02511847 UNKNOWN
Triple Negative Breast Cancer
National Taiwan University Hospital
 2015-08 PHASE2
NCT02208843 COMPLETED
Carcinoma, Non-Small-Cell Lung
Boehringer Ingelheim
 2014-10-02 PHASE4
NCT01999985 COMPLETED
Lung Cancer; Non-small Cell Lung Cancer (NSCLC)
H. Lee Moffitt Cancer Center and Research Institute
 2013-12-31 PHASE1
NCT01271725 COMPLETED
Breast Neoplasms
Boehringer Ingelheim
 2011-05-24 PHASE2
NCT01728818 UNKNOWN
Focus of Study Instead
PD Dr. med. Volker Heinemann
 2013-04 PHASE2
NCT01732640 TERMINATED
Squamous Cell Carcinoma of the Head and Neck
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 2012-12 PHASE1; PHASE2
NCT01345669 TERMINATED
Head and Neck Neoplasms
Boehringer Ingelheim
 2011-10-17 PHASE3
NCT02695290 TERMINATED
Carcinoma, Non-Small-Cell Lung; ErbB Receptors
Boehringer Ingelheim
 2016-03-17 PHASE4
NCT02131155 TERMINATED
Head and Neck Neoplasms
Boehringer Ingelheim
 2014-07-17 PHASE3
NCT01649271 COMPLETED
Breast Neoplasms; Stomach Neoplasms
Boehringer Ingelheim
 2012-07-23 PHASE1
NCT01466660 COMPLETED
Lung Neoplasms
Boehringer Ingelheim
 2011-12-13 PHASE2
NCT02044380 COMPLETED
Carcinoma, Non-Small-Cell Lung
Boehringer Ingelheim
 2014-03 PHASE3
NCT01824823 TERMINATED
Head and Neck Squamous Cell Carcinoma
ECOG-ACRIN Cancer Research Group
 2014-06-30 PHASE2
NCT01919879 COMPLETED
Metastatic Colorectal Cancer
UNICANCER
 2012-10 PHASE2
NCT01647711 COMPLETED
Carcinoma, Non-Small-Cell Lung
Boehringer Ingelheim
 2012-07 PHASE1
NCT02274012 WITHDRAWN
HER-2 Positive Gastric Cancer; Gastrooesophageal Cancer; Esophageal Cancer
Columbia University
 2014-05-29 PHASE2
NCT01538381 COMPLETED
Carcinoma, Squamous Cell of Head and Neck
European Organisation for Research and Treatment of Cancer - EORTC
 2012-07 PHASE2
NCT01415011 COMPLETED
Carcinoma, Non-Small-Cell Lung
University College, London
 2012-12 PHASE2
NCT02216617 COMPLETED
HNSCC
Groupe Oncologie Radiotherapie Tete et Cou
 2014-08-06 PHASE1
NCT01814553 COMPLETED
Carcinoma, Non-Small-Cell Lung
Boehringer Ingelheim
 2013-04 PHASE3
NCT01861223 UNKNOWN
NSCLC
Samsung Medical Center
 2013-05 PHASE1; PHASE2
NCT01836341 WITHDRAWN
Non-small Cell Lung Cancer
Memorial Sloan Kettering Cancer Center
 2013-04 PHASE1
NCT01932229 UNKNOWN
NSCLC
Sheba Medical Center
 2013-02 PHASE2
NCT02020577 COMPLETED
Neoplasms
Boehringer Ingelheim
 2013-12 PHASE1
NCT02747953 COMPLETED
Non-small Cell Lung Cancer
Samsung Medical Center
 2011-07 PHASE2
NCT02096718 COMPLETED
Renal Insufficiency
Boehringer Ingelheim
 2014-05 PHASE1
NCT01325428 COMPLETED
Breast Neoplasms
Boehringer Ingelheim
 2011-08 PHASE2
NCT02625168 COMPLETED
Lung Cancer
The University of Hong Kong
 2013-01 PHASE2
NCT01776684 UNKNOWN
EGFR Mutation Positive Non-small Cell Lung Cancer
Samsung Medical Center
 2012-06
NCT01345682 COMPLETED
Head and Neck Neoplasms; Carcinoma, Squamous Cell
Boehringer Ingelheim
 2012-01-05 PHASE3
NCT01594177 COMPLETED
Unilateral HER2 Positive Breast Cancer
GBG Forschungs GmbH
 2012-05 PHASE2
NCT01441596 COMPLETED
Breast Neoplasms; Neoplasm Metastasis
Boehringer Ingelheim
 2011-10 PHASE2
NCT01523587 COMPLETED
Carcinoma, Non-Small-Cell Lung
Boehringer Ingelheim
 2012-03-05 PHASE3
NCT01531764 TERMINATED
Carcinoma Breast Stage IV
University of Magdeburg
 2012-07 PHASE2
NCT01214616 COMPLETED
Neoplasms
Boehringer Ingelheim
 2010-10-01 PHASE1
NCT01320280 TERMINATED
Refractory Cancer
Universitätsklinikum Hamburg-Eppendorf
 2011-05 PHASE2
NCT01480141 WITHDRAWN
Lung Cancer
Medical University of South Carolina
 2012-01 PHASE2
NCT01298063 COMPLETED
Liver Diseases; Healthy
Boehringer Ingelheim
 2011-02 PHASE1
NCT01426958 COMPLETED
Healthy
Boehringer Ingelheim
 2011-08 PHASE1
NCT01003899 COMPLETED
Carcinoma, Non-Small-Cell Lung
Boehringer Ingelheim
 2009-10 PHASE2
NCT01396265 COMPLETED
Healthy
Boehringer Ingelheim
 2011-07 PHASE1
NCT00727506 COMPLETED
Glioma
Boehringer Ingelheim
 2008-07-14 PHASE2
NCT00748709 TERMINATED
Neoplasms
Boehringer Ingelheim
 2008-10-01 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-09-01)

Check the Afatinib (BIBW2992) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Afatinib irreversibly binds to epidermal growth factor receptor (EGFR/ErbB1), ErbB2 (HER2), and ErbB4 (HER4) tyrosine kinases, effectively blocking receptor autophosphorylation and downstream pro-survival cell signaling to inhibit cell proliferation and induce autophagy and apoptosis. This comprehensive catalytic blockade drives substantial tumor regression, establishing its clinical relevance in targeting non-small cell lung cancer, head and neck squamous cell carcinoma, and advanced refractory solid tumors in clinical trials.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.