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

NCT ID: NCT04592523

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

257 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-05

Study Completion Date

2026-08-26

Brief Summary

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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.

Detailed Description

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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 257 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.

Conditions

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Carcinoma, Non-Small-Cell Lung Anaplastic Lymphoma Kinase

Keywords

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Drug Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All Participants

Participants diagnosed with anaplastic lymphoma kinase (ALK)-positive advanced or metastatic non-small cell lung cancer (NSCLC) who initiate treatment for the first time with brigatinib in a routine clinical practical setting will be observed prospectively for up to 24 month-surveillance period.

No Intervention

Intervention Type OTHER

This is a non-interventional study.

Interventions

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No Intervention

This is a non-interventional study.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. With ALK-positive advanced or metastatic NSCLC.
2. Who initiate brigatinib for the first time.

Exclusion Criteria

1. Treated with brigatinib outside of the locally approved label in Korea.
2. Whom brigatinib is contraindicated as per product label.
3. Participating in other clinical trials of NSCLC treatment.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Pusan National University Hospital

Busan, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Takeda Contact

Role: CONTACT

Phone: +1-877-825-3327

Email: [email protected]

Related Links

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https://clinicaltrials.takeda.com/study-detail/5f9465aa296beb001e63bfa6??page=1&idFilter=Brigatinib-5005

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Other Identifiers

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U1111-1257-0204

Identifier Type: REGISTRY

Identifier Source: secondary_id

Brigatinib-5005

Identifier Type: -

Identifier Source: org_study_id