The primary purpose of this study is to determine the efficacy of brigatinib by confirmed
objective response rate (ORR) by response evaluation criteria in solid tumors (Response
Evaluation Criteria in Solid Tumors [RECIST]), in participants with ALK+ locally advanced
or metastatic NSCLC whose disease has progressed on therapy with alectinib or ceritinib.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03535740.
The drug being tested in this study is called brigatinib (AP26113). Brigatinib is being
tested to treat people who have anaplastic lymphoma kinase-positive (ALK+), advanced
non-small-cell lung cancer (NSCLC).
The study will enroll approximately 103 patients. Participants will be assigned to the
treatment group:
• Brigatinib
All participants will be asked to take brigatinib 90 mg tablet in lead-in period for 7
days, followed by brigatinib 180 mg at the same time each day throughout the study.
Participants with progressive disease had an option to receive an escalated dose of
brigatinib 240 mg as per investigator's discretion in case no toxicities (greater than
grade 2) are experienced.
This multicenter trial will be conducted worldwide. The overall time to participate in
this study is approximately 3 years. Participants will make multiple visits to the
clinic, and 30 days after last dose of study drug for a follow-up assessment.
Lead OrganizationARIAD Pharmaceuticals