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

Takeda

Status: Enrolling

Conditions: Carcinoma, Non-Small-Cell Lung; Anaplastic Lymphoma Kinase

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT04592523

U1111-1257-0204 (Registry Identifier)

Brigatinib-5005

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 257 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

257 participants in 1 patient group

All Participants

Description:

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.

Treatment:

Other: No Intervention