RecruitingNCT04592523

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


Sponsor

Takeda

Enrollment

257 participants

Start Date

Sep 5, 2019

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This observational study tracks real-world outcomes of brigatinib — a targeted therapy already approved in South Korea — for people with advanced or metastatic non-small cell lung cancer (NSCLC) driven by a specific gene abnormality called an ALK rearrangement. ALK-positive lung cancer tends to respond well to targeted drugs, and this study collects safety and effectiveness data from everyday clinical use outside of controlled trial conditions. **You may be eligible if...** - You have ALK-positive advanced or metastatic non-small cell lung cancer - You are starting brigatinib treatment for the first time in South Korea - Your doctor has prescribed brigatinib within the locally approved label guidelines **You may NOT be eligible if...** - You are using brigatinib outside the approved Korean prescribing guidelines - You have a health condition that makes brigatinib unsafe according to its product label - You are already enrolled in another lung cancer clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNo Intervention

This is a non-interventional study.


Locations(1)

Pusan National University Hospital

Busan, South Korea

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NCT04592523


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