A Study of Usage of Brigatinib in the Treatment of Adult Participants for Approved Indications In South Korea

NCT04592523 | Recruiting FDA Drug

• 2 other identifiers: Brigatinib-5005U1111-1257-0204
• Study Type: observational
• Target: 257
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to estimate the proportion of all adverse events (AEs) including serious adverse events (SAEs) occurring with the use of brigatinib among adult participants who have been administered brigatinib as per the approved indications.

Conditions

Carcinoma, Non-Small-Cell Lung; Anaplastic Lymphoma Kinase

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with AEs and SAEs

  Up to 30 days after the end of treatment (up to 24 months)

Secondary Outcomes (3)

• Objective Response Rate (ORR)

  Up to 24 months

• Duration of Response (DOR)

  Up to 24 months

• Progression Free Survival (PFS)

  From first administration of study drug to the date of disease progression or death due to any cause (up to 24 months)

Study Arms (1)

All Participants

Participants diagnosed with anaplastic lymphoma kinase (ALK)-positive advanced or metastatic non-small cell lung cancer (NSCLC) who initiate treatment for the first time with brigatinib in a routine clinical practical setting will be observed prospectively for up to 24 month-surveillance period.

Other: No Intervention

Interventions

No Intervention OTHER

This is a non-interventional study.

All Participants

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with ALK-positive advanced or metasatatic NSCLC who initiate treatment for the first time with brigatinib in a routine clinical practical setting will be observed prospectively.

You may qualify if:

• With ALK-positive advanced or metastatic NSCLC.
• Who initiate brigatinib for the first time.

You may not qualify if:

• Treated with brigatinib outside of the locally approved label in Korea.
• Whom brigatinib is contraindicated as per product label.
• Participating in other clinical trials of NSCLC treatment.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Pusan National University Hospital

Busan, 49241, South Korea

RECRUITING

Related Links

• Click here for more information about this trial in easy-to-understand language.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 19, 2020
• Study Start: September 5, 2019
• Primary Completion (Estimated): August 26, 2026
• Study Completion (Estimated): August 26, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

KR (1)