NCT05721950

A Study to Learn About Brigatinib Treatment Information Available in Chinese Participants With Non-Small-cell Lung Cancer (NSCLC)

A Real-World Study to Evaluate the Effectiveness and Safety of Brigatinib in First Line in Patients With ALK Positive Locally Advanced or Metastatic NSCLC in China: An Ambispective, Non-interventional, Observational, Multi-center Study.

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 154 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main aim of this study is to learn about the time between the start and stop of treatment with brigatinib in Chinese participants with non-small-cell lung cancer (NSCLC) and who have been positively diagnosed with having the anaplastic lymphoma kinase (ALK) gene. Other study aims are to learn about the progression of NSCLC and participants' response to treatment with brigatinib.

Detailed description

This is a non-interventional, ambispective (retrospective + prospective) study of Chinese participants with ALK-positive locally advanced or metastatic NSCLC receiving brigatinib as their first line of treatment from September 1, 2022.This study will evaluate the time-to-treatment discontinuation and other efficacy outcomes of brigatinib in participants with NSCLC in real-world settings. This study will enroll approximately 200 participants in the following cohort: • Brigatinib 90 mg/180mg This study is an ambispective study that will have prospective data collection if participants enrolled after the study initiation or it will have retrospective data collection if the participants have already started receiving brigatinib as first line treatment before study initiation. This multi-center trial will be conducted in China. Participants will be followed up for safety from signing informed consent until 36 months after the last dose of treatment or until death of the last participant. The overall time for data collection is approximately 8 years.

Conditions

• Non-small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	Brigatinib	Brigatinib Tablets

Timeline

• Start date: 2024-01-17
• Primary completion: 2028-03-20
• Completion: 2028-12-30
• First posted: 2023-02-10
• Last updated: 2026-02-18

Locations

1 site across 1 country: China