Last updated on June 2019

A Study of Brigatinib in Participants With Anaplastic Lymphoma Kinase-Positive (ALK+) Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib


Brief description of study

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.

Detailed Study Description

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.

This multicenter trial will be conducted worldwide. The overall time to participate in this study is approximately 5 years, but the total sample size and study duration may be adjusted according to preliminary data from interim analysis. Participants will make multiple visits to the clinic, and 30 days after last dose of study drug for a follow-up assessment.

Clinical Study Identifier: NCT03535740

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Recruitment Status: Open


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