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

Active, not recruiting

• Conditions: Non-small Cell Lung Cancer (NSCLC)
• Interventions: Drug: Brigatinib

• Registration Number: NCT05721950
• Lead Sponsor: Takeda

Brief 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.

Study Timeline

• Study First Submitted: 2023-02-01
• Study First Submitted QC: 2023-02-01
• Study First Posted: 2023-02-10
• Study Start: 2024-01-17
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Primary Completion: 2028-03-20
• Study Completion: 2028-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Brigatinib 90 mg/180mg	Brigatinib	Participants with ALK positive locally advanced or metastatic NSCLC will be observed ambispectively (retrospective plus prospective) after receiving recommended dose of brigatinib, 90 mg orally once daily for first 7 days followed by 180 mg once daily for up to 36 months as their first line of treatment as part of routine medical care. Data will be collected every 3 months after their first dose until the 36 month or participant death, loss to follow-up, or withdrawal from the study for any reason in the real-world setting from September 1, 2022.

Primary Outcome Measures

Name	Time	Method
Real-World Time-to-Treatment Discontinuation (rwTDD)	Up to 8 years	rwTTD is defined as the time from initiation of brigatinib to discontinuation of treatment for any reason, including disease progression, death, serious adverse events, or participant preference.

Secondary Outcome Measures

Name	Time	Method
Real-World Progression-Free Survival at Years 1, 2 and 3	Up to 8 years	rwPFS at years 1,2 and 3 is defined as the probability of progression-free survival/ survival over one year; the probability of progression-free survival/survival over two years; the probability of progression-free survival/survival over three years.
Real-World Overall Survival (rwOS) at Years 1, 2 and 3	Up to 8 years	rwOS is defined as the time from initiation of brigatinib to death from any cause, or the time of the last confirmed survival.
Real-World Progression-Free Survival (rwPFS)	Up to 8 years	rwPFS is defined as the time from initiation of brigatinib to disease progression or death from any cause, or the time of the last confirmed survival.
Real-World Objective Response Rate (rwORR)	Up to 8 years	rwORR is defined as the percentage of participants who are confirmed to achieved complete response (CR) or partial response (PR) after receiving brigatinib.
Real-World Duration of Response (rwDOR)	Up to 8 years	rwDOR is defined as the time from the first assessment of CR or PR after receiving first line treatment with brigatinib to progression or death.

Trial Locations

Locations (1)

Department of Oncology, Shanghai pulmonary hospital; 🇨🇳 Shanghai, Shanghai, China