Survey of Brigatinib Used To Treat People With Non-Small Cell Lung Cancer

Takeda

Status: Enrolling

Conditions: Non-small Cell Lung Cancer (NSCLC)

Treatments: Drug: Brigatinib

Study type: Observational

Funder types: Industry

Identifiers

NCT05100069

C25026

jRCT2031210404 (Registry Identifier)

Details and patient eligibility

About

This study is a survey in Japan of Brigatinib tablets used to treat Japanese people with non-small cell lung cancer. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

The main aim of the study is to check for side effects related to lung disease from Brigatinib. During the study, participants with non-small cell lung cancer will take Brigatinib tablets according to their clinic's standard practice. The study doctors will check for side effects from Brigatinib for 1 year.

Enrollment: 500 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria Participants with unresectable advanced/recurrent ALK fusion gene-positive non-small cell lung cancer.

Exclusion criteria Participants who has a history of hypersensitivity to any component of birigatinib.

Trial design

500 participants in 1 patient group

Brigatinib Tablets

Description:

Brigatinib 90 milligrams (mg), tablet, orally, once daily for up to 7 days, followed by 180 mg, tablets, once daily for 51 weeks. Participants received interventions as part of routine medical care.

Treatment:

Drug: Brigatinib