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

Sponsor
Takeda (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05100069
Collaborator
(none)
500
1
54.9
9.1

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

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
General Use-results Survey of Arumbrig Tablets "Non-small Cell Lung Cancer"
Actual Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
May 31, 2026
Anticipated Study Completion Date :
May 31, 2026

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:
  • Alunbrig Tablets
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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.
    Responsible Party:
    Takeda
    ClinicalTrials.gov Identifier:
    NCT05100069
    Other Study ID Numbers:
    • C25026
    • jRCT2031210404
    First Posted:
    Oct 29, 2021
    Last Update Posted:
    Nov 3, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 3, 2021