Actively Recruiting
Post-Marketing Surveillance of Brigatinib for Adult Patients with ALK-Positive Non-Small Cell Lung Cancer in South Korea
Led by Takeda · Updated on 2025-12-24
257
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a prospective observational study to monitor adult participants with ALK-positive advanced or metastatic non-small cell lung cancer (NSCLC) who start treatment with brigatinib for the first time. The study aims to assess the safety and effectiveness of brigatinib when used in routine clinical practice for its approved indications. This post-marketing surveillance study is sponsored by Takeda and takes place in South Korea. All participants will be observed as a single group without any intervention by the study team, reflecting real-world usage of brigatinib. The observation period for each participant will last up to 24 months from the start of treatment, during which data will be collected from routine and emergency clinical visits. Approximately 257 participants will be enrolled at multiple centers. Participants will have their health monitored through regularly scheduled visits, with data recorded in electronic case report forms. Researchers will track adverse events (AEs), including serious adverse events (SAEs), and evaluate treatment outcomes such as objective response rate, duration of response, and progression-free survival over the 24-month period. Safety assessments will continue up to 30 days after treatment ends, encompassing the full study duration of about six years.
CONDITIONS
Brief Title
A Study of Usage of Brigatinib in the Treatment of Adult Participants for Approved Indications In South Korea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 19 years or older
- Diagnosed with ALK-positive advanced or metastatic non-small cell lung cancer
- Starting brigatinib treatment for the first time
You will not qualify if you...
- Treated with brigatinib outside of the locally approved label in Korea
- Brigatinib is contraindicated as per product label
- Currently participating in other clinical trials for non-small cell lung cancer treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants diagnosed with ALK-positive advanced or metastatic non-small cell lung cancer who initiate treatment for the first time with brigatinib in a routine clinical practical setting will be observed prospectively.
Visits scheduled routinely and during emergencies as part of clinical care
Trial Site Locations
Total: 1 location
1
Pusan National University Hospital
Busan, South Korea, 49241
Actively Recruiting
Research Team
T
Takeda Contact
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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