NCT04592523

A Study of Usage of Brigatinib in the Treatment of Adult Participants for Approved Indications In South Korea

Post-Marketing Surveillance (Usage Results Study) of Brigatinib in the Treatment of Adult Patients for Approved Indications in South Korea

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 257 (estimated)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to estimate the proportion of all adverse events (AEs) including serious adverse events (SAEs) occurring with the use of brigatinib among adult participants who have been administered brigatinib as per the approved indications.

Detailed description

This is a prospective observational post-marketing surveillance study of participants with ALK-positive NSCLC who initiate treatment for the first time with brigatinib in a routine clinical practical setting. The study will characterize the safety and effectiveness of brigatinib for its approved indications under real world use. The study will enroll approximately 257 participants. The data will be prospectively collected, at the centers from routinely scheduled and emergency visits until end of follow up, and recorded into electronic case report forms (e-CRFs). All participants will be assigned to a single observational cohort. This multi-center study will be conducted in the South Korea. The overall duration of this study is approximately 6 years. Data will be collected over and up to a 24 month-surveillance period (per participant) once enrolled.

Conditions

• Carcinoma, Non-Small-Cell Lung
• Anaplastic Lymphoma Kinase

Interventions

Type	Name	Description
OTHER	No Intervention	This is a non-interventional study.

Timeline

• Start date: 2019-09-05
• Primary completion: 2026-08-26
• Completion: 2026-08-26
• First posted: 2020-10-19
• Last updated: 2025-12-24

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study