NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedNon-small cell lung cancer
Date of first enrollment01/11/2021
Target sample size500
Countries of recruitment
Study typeObservational
Intervention(s)

Outcome(s)

Primary OutcomeNumber 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.
Secondary OutcomeNone

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
GenderBoth
Include criteriaParticipants with unresectable advanced/recurrent ALK fusion gene-positive non-small cell lung cancer.
Exclude criteriaParticipants who has a history of hypersensitivity to any component of brigatinib.

Related Information

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
E-mail 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
E-mail smb.Japanclinicalstudydisclosure@takeda.com
Affiliation Takeda Pharmaceutical Company Limited