NCT03410108

Phase 2 Study of Brigatinib in Japanese Participants With Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer (NSCLC)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate efficacy and safety of brigatinib in Japanese participants with anaplastic lymphoma kinase (ALK)-positive NSCLC.

Detailed description

The drug being tested in this study is called brigatinib. Brigatinib is being tested in participants with ALK-positive NSCLC in order to evaluate efficacy and safety of oral doses of brigatinib in Japanese participants with ALK-positive NSCLC. The study will enroll approximately 110 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 53 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.

Conditions

• ALK-positive Advanced NSCLC

Interventions

Type	Name	Description
DRUG	Brigatinib	Brigatinib tablet

Timeline

• Start date: 2018-01-29
• Primary completion: 2020-09-29
• Completion: 2021-07-28
• First posted: 2018-01-25
• Last updated: 2024-05-08
• Results posted: 2021-12-14

Locations

33 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study