Survey of Brigatinib Used To Treat People With Non-Small Cell Lung Cancer
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Brigatinib Tablets 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. |
Drug: Brigatinib
Brigatinib Tablets
Other Names:
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Outcome Measures
Primary Outcome Measures
- Number of Participants with Adverse Events Related to Interstitial Lung Disease [Up to 1 year]
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.
Eligibility Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Takeda Selected Site | Tokyo | Japan |
Sponsors and Collaborators
- Takeda
Investigators
- Study Director: Study Director, Takeda
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- C25026
- jRCT2031210404