Last updated on November 2018

Phase 2 Study of Brigatinib in Japanese Patients With ALK-Positive Non-Small Cell Lung Cancer (NSCLC)


Brief description of study

The purpose of this study is to evaluate efficacy and safety of Brigatinib in Japanese patients with anaplastic lymphoma kinase (ALK)-positive NSCLC that has progressed after 1 or 2 lines of prior ALK inhibitor therapy.

Detailed Study Description

The drug being tested in this study is called Brigatinib. Brigatinib is being tested in patients with ALK-positive NSCLC in order to evaluate efficacy and safety of oral doses of Brigatinib in Japanese patients with ALK-positive NSCLC.

The study will enroll approximately 80 participants. Participants will be enrolled in non-randomized and opened manner:

  • Brigatinib 90 mg for the first 7 days, followed by Brigatinib 180 mg of Brigatinib tablets, once daily in a 28-days cycle.

All participants will be asked to take tablets of Brigatinib once daily with or without food throughout the study.

This multi-center trial will be conducted in Japan. The overall time to participate in this study is approximately 41 months. Participants will make multiple visits to the clinic during the treatment period, and posttreatment period including a follow-up assessment after last dose of study drug.

Clinical Study Identifier: NCT03410108

Contact Investigators or Research Sites near you

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Takeda Study Registration Call Center

Iwate Medical University Hospital
Morioka, Japan
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