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

Post-Marketing Surveillance (Usage Results Study) of Brigatinib in the Treatment of Adult Patients for Approved Indications in South Korea

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.

Study Overview

• Status: Completed
• Conditions: Carcinoma, Non-Small-Cell Lung; Anaplastic Lymphoma Kinase
• Intervention / Treatment: Other: No Intervention

Detailed Description

This is a prospective observational post-marketing surveillance study of participants with ALK-positive NSCLC who initiate treatment for the first time with brigatinib in a routine clinical practical setting. The study will characterize the safety and effectiveness of brigatinib for its approved indications under real world use.

The study will enroll approximately 257 participants. The data will be prospectively collected, at the centers from routinely scheduled and emergency visits until end of follow up, and recorded into electronic case report forms (e-CRFs). All participants will be assigned to a single observational cohort.

This multi-center study will be conducted in the South Korea. The overall duration of this study is approximately 6 years. Data will be collected over and up to a 24 month-surveillance period (per participant) once enrolled.

• Study Type: Observational
• Enrollment (Actual): 271

Contacts and Locations

Study Locations

• South Korea
  • Busan, South Korea, 49241
    • Pusan National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; This is a non-interventional study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants with AEs and SAEs	Up to 30 days after the end of treatment (up to 24 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	ORR will be evaluated by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. ORR is defined as the percentage of participants who achieved a best response of a complete response (CR) or partial response (PR). CR: defined as disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.	Up to 24 months
Duration of Response (DOR)	DOR will be evaluated according to RECIST version 1.1. DOR is defined as duration from the point at CR or PR is reached first until the day the recurrence of cancer or disease progression is confirmed. CR: defined as disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions. Progressive disease (PD) is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.	Up to 24 months
Progression Free Survival (PFS)	PFS will be evaluated by treating physicians according to RECIST version 1.1. PFS is defined as the time from the date of first dose to the date of first documentation of disease progression or date of death from any cause, whichever occurs first. Progressive disease (PD) is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.	From first administration of study drug to the date of disease progression or death due to any cause (up to 24 months)

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

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

Study Major Dates

• Study Start (Actual): September 5, 2019
• Primary Completion (Actual): March 12, 2026
• Study Completion (Actual): March 12, 2026

Study Registration Dates

• First Submitted: October 14, 2020
• First Submitted That Met QC Criteria: October 14, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: Brigatinib-5005; U1111-1257-0204 (Registry Identifier: WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No