JRCT ID: jRCT2031210404
Registered date:01/11/2021
Survey of Brigatinib Used To Treat People With Non-Small Cell Lung Cancer
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Non-small cell lung cancer |
Date of first enrollment | 01/11/2021 |
Target sample size | 500 |
Countries of recruitment | |
Study type | Observational |
Intervention(s) |
Outcome(s)
Primary Outcome | Number of Participants with Adverse Events Related to Interstitial Lung Disease Time Frame; 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. |
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Secondary Outcome | None |
Key inclusion & exclusion criteria
Age minimum | Not applicable |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | Participants with unresectable advanced/recurrent ALK fusion gene-positive non-small cell lung cancer. |
Exclude criteria | Participants who has a history of hypersensitivity to any component of brigatinib. |
Related Information
Primary Sponsor | Contact for Clinical Trial Information |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Trial Information Contact for Clinical |
Address | 1-1, Doshomachi 4-chome, Chuo-ku, Osaka Osaka Japan 540-8645 |
Telephone | +81-6-6204-2111 |
smb.Japanclinicalstudydisclosure@takeda.com | |
Affiliation | Takeda Pharmaceutical Company Limited |
Scientific contact | |
Name | Trial Information Contact for Clinical |
Address | 1-1, Doshomachi 4-chome, Chuo-ku, Osaka Osaka Japan 540-8645 |
Telephone | +81-6-6204-2111 |
smb.Japanclinicalstudydisclosure@takeda.com | |
Affiliation | Takeda Pharmaceutical Company Limited |