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

Carcinoma, Non-Small-Cell Lung Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 600 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT04592523
• Study type: Observational
• Source: Takeda
• Contact: Takeda Contact
• Phone: +1-877-825-3327
• Email: medinfoUS@takeda.com
• Status: Recruiting
• Start date: September 5, 2019
• Completion date: August 26, 2026