Brigatinib has been evaluated in numerous clinical trials ranging from Phase 1 to Phase 3 in adult and pediatric populations, as well as safety and bioavailability studies in healthy volunteers. These trials target non-small cell lung cancer, ALK-positive anaplastic large cell lymphoma, ROS1-rearranged lung malignancies, inflammatory myofibroblastic tumors, and central nervous system metastases. Sponsored by commercial pharmaceutical companies like Takeda and Ariad alongside academic institutions such as the National Cancer Institute, the body of research encompasses completed, active recruiting, non-recruiting, and withdrawn or terminated studies.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT04925609 | RECRUITING | Anaplastic Large Cell Lymphoma, ALK-Positive; Inflammatory Myofibroblastic Tumor; Other Solid Tumor |
Princess Maxima Center for Pediatric Oncology |
2022-08-18 | PHASE1; PHASE2 |
| NCT06620835 | RECRUITING | NSCLC |
Groupe Francais De Pneumo-Cancerologie |
2025-06-19 | PHASE2 |
| NCT04374305 | RECRUITING | Neurofibromatosis Type 2; Vestibular Schwannoma; Non-vestibular Schwannoma; Meningioma; Ependymoma |
Scott R. Plotkin, MD, PhD |
2020-06-20 | PHASE2 |
| NCT06813079 | RECRUITING | Pancreatic Ductal Carcinoma; Advanced Cancer; Epithelial Tumor |
University Health Network, Toronto |
2025-04-07 | PHASE2 |
| NCT04227028 | ACTIVE_NOT_RECRUITING | Locally Advanced Lung Non-Small Cell Carcinoma; Metastatic Lung Non-Small Cell Carcinoma; Recurrent Lung Non-Small Cell Carcinoma; Stage III Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8 |
City of Hope Medical Center |
2020-03-09 | PHASE1 |
| NCT04223596 | ACTIVE_NOT_RECRUITING | Lung Cancer; NSCLC; NSCLC Stage IIIB; NSCLC Stage IV |
Fundación GECP |
2020-05-04 | PHASE2 |
| NCT04318938 | COMPLETED | NSCLC |
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest |
2020-03-30 | PHASE2 |
| NCT03707938 | ACTIVE_NOT_RECRUITING | Advanced Lung Carcinoma; ALK Gene Rearrangement; Lung Non-Small Cell Carcinoma; Recurrent Lung Non-Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8 |
M.D. Anderson Cancer Center |
2018-12-18 | PHASE1 |
| NCT05200481 | ACTIVE_NOT_RECRUITING | Non Small Cell Lung Cancer; ALK Gene Mutation |
Intergroupe Francophone de Cancerologie Thoracique |
2022-05-18 | PHASE2 |
| NCT06522360 | WITHDRAWN | Non-small Cell Lung Cancer |
M.D. Anderson Cancer Center |
2024-12-11 | PHASE2 |
| NCT04074993 | UNKNOWN | Non Small Cell Lung Cancer |
JI-YOUN HAN |
2020-05-15 | PHASE2 |
| NCT04591431 | UNKNOWN | Breast Cancer; Gastrointestinal Cancer; Non Small Cell Lung Cancer; Other Cancer |
Fondazione per la Medicina Personalizzata |
2020-10-07 | PHASE2 |
| NCT05718297 | WITHDRAWN | NSCLC, Stage III; ALK-rearrangement |
ETOP IBCSG Partners Foundation |
2024-06-07 | PHASE2 |
| NCT05361564 | UNKNOWN | Non-small Cell Lung Cancer |
Yonsei University |
2022-06 | PHASE2 |
| NCT03596866 | COMPLETED | ALK+ Advanced NSCLC |
Takeda |
2019-04-19 | PHASE3 |
| NCT06132867 | COMPLETED | Healthy Volunteers |
Takeda |
2023-12-20 | PHASE1 |
| NCT06132867 | Completed | Healthy Volunteers |
Takeda |
2024-01-17 | Phase 1 |
| NCT04260009 | WITHDRAWN | Anaplastic Lymphoma Kinase Positive (ALK +) Anaplastic Large Cell Lymphoma; Inflammatory Myofibroblastic Tumors; Solid Tumors |
Takeda |
2020-09-01 | PHASE1; PHASE2 |
| NCT04005144 | TERMINATED | ALK Gene Rearrangement; Lung Non-Small Cell Carcinoma; Progressive Disease; ROS1 Gene Rearrangement; Stage IIIB Lung Cancer; Stage IIIC Lung Cancer; Stage IV Lung Cancer; Stage IVA Lung Cancer; Stage IVB Lung Cancer |
University of California, San Francisco |
2020-02-25 | PHASE1 |
| NCT04925609 | Recruiting | Anaplastic Large Cell Lymphoma ALK-Positive|Inflammatory Myofibroblastic Tumor|Other Solid Tumor |
Princess Maxima Center for Pediatric Oncology|Takeda |
2022-08-18 | Phase 1|Phase 2 |
| NCT04634110 | TERMINATED | Brain Metastases; Lung Cancer |
University of Colorado, Denver |
2020-11-17 | PHASE2 |
| NCT03737994 | TERMINATED | Lung Non-Squamous Non-Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8 |
National Cancer Institute (NCI) |
2019-07-25 | PHASE2 |
| NCT04718012 | Completed | Lung Cancer ROS Translocated |
Centre Hospitalier Intercommunal Creteil |
2021-03-17 | -- |
| NCT03868423 | WITHDRAWN | Advanced Malignant Neoplasm; ALK Fusion Protein Expression; ALK Gene Amplification; ALK Gene Mutation; Locally Advanced Malignant Solid Neoplasm; Metastatic Malignant Neoplasm in the Brain; Metastatic Malignant Neoplasm in the Central Nervous System; Metastatic Malignant Solid Neoplasm; ROS1 Fusion Positive; ROS1 Gene Amplification; ROS1 Gene Mutation |
Sameek Roychowdhury |
2019-03-20 | PHASE2 |
| NCT04634110 | Terminated | Brain Metastases|Lung Cancer |
University of Colorado Denver|National Cancer Institute (NCI) |
2020-11-17 | Phase 2 |
| NCT02706626 | TERMINATED | Non-Small Cell Lung Cancer |
Criterium, Inc. |
2017-03-09 | PHASE2 |
| NCT03535740 | COMPLETED | ALK-positive Advanced NSCLC |
Ariad Pharmaceuticals |
2019-01-31 | PHASE2 |
| NCT03410108 | COMPLETED | ALK-positive Advanced NSCLC |
Takeda |
2018-01-29 | PHASE2 |
| NCT04260009 | Withdrawn | Anaplastic Lymphoma Kinase Positive (ALK +) Anaplastic Large Cell Lymphoma|Inflammatory Myofibroblastic Tumors|Solid Tumors |
Takeda |
2020-09-01 | Phase 1|Phase 2 |
| NCT04111705 | Active not recruiting | Non Small Cell Lung Cancer Metastatic |
Intergroupe Francophone de Cancerologie Thoracique |
2020-08-05 | Phase 2 |
| NCT02737501 | COMPLETED | Non-small Cell Lung Cancer; Lung Cancer; Advanced Malignancies; Carcinoma |
Ariad Pharmaceuticals |
2016-05-26 | PHASE3 |
| NCT03420742 | COMPLETED | Carcinoma, Advanced ALK+ or ROS1+Non-Small-Cell Lung, Neoplasm, Advanced ALK+ or ROS1+Solid Tumors |
Takeda |
2019-06-26 | PHASE1 |
| NCT03719898 | WITHDRAWN | Anaplastic Large Cell Lymphoma, ALK-Positive |
Fox Chase Cancer Center |
2018-12-06 | PHASE2 |
| NCT02094573 | COMPLETED | Carcinoma, Non-Small-Cell Lung |
Ariad Pharmaceuticals |
2014-06-04 | PHASE2 |
| NCT01449461 | COMPLETED | Lymphoma, Large-Cell, Anaplastic; Carcinoma, Non-Small-Cell Lung |
Ariad Pharmaceuticals |
2011-09-20 | PHASE1; PHASE2 |
(data from https://clinicaltrials.gov, updated on 2025-12-05)
Check the
Brigatinib
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
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>).
Note: Technical data last updated: Sep 1, 2026.