Survey of Brigatinib Used To Treat People With Non-Small Cell Lung Cancer
- Registration Number
- NCT05100069
- Lead Sponsor
- Takeda
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Brigatinib Tablets Brigatinib 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.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Takeda Selected Site
🇯🇵Tokyo, Japan