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NCT05100069 Clinical Trial

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

Non-small Cell Lung Cancer (NSCLC) Clinical Trial

Official title:
General Use-results Survey of Alunbrig Tablets "Non-small Cell Lung Cancer"

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05100069
Other study ID # C25026
Secondary ID jRCT2031210404
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2021
Est. completion date May 31, 2026

Study information
Verified date October 2023
Source Takeda
Contact Takeda Contact
Phone +1-877-825-3327
Email medinfoUS@takeda.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date May 31, 2026
Est. primary completion date May 31, 2026
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Brigatinib
Brigatinib Tablets

Locations
Country Name City State
Japan Takeda Selected Site Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants with Adverse Events Related to Interstitial Lung Disease An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. Up to 1 year
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