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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04592523
• Other study ID #: Brigatinib-5005
• Secondary ID: U1111-1257-0204
• Status: Recruiting
• Start date: September 5, 2019
• Est. completion date: August 26, 2026

Study information

• Verified date: October 2023
• Source: Takeda
• Contact: Takeda Contact
• Phone: +1-877-825-3327
• Email: medinfoUS[@]takeda.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 600 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 616
• Est. completion date: August 26, 2026
• Est. primary completion date: August 26, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• No Intervention
This is a non-interventional study.

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with AEs and SAEs		Up to 30 days after the end of treatment (up to 24 months)
Secondary	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
Secondary	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
Secondary	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)