A Study of Usage of Brigatinib in the Treatment of Adult Participants for Approved Indications In South Korea
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorTakeda
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
With ALK-positive advanced or metastatic NSCLC.
Who initiate brigatinib for the first time.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No Intervention
Other interventionThis is a non-interventional study.
Treatment groups
257 Participants
are divided into 1 treatment groupGroup A: All Participants1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Participants with AEs and SAEs
Time frame
Up to 30 days after the end of treatment (up to 24 months)Secondary outcomes
1
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.
Time frame
Up to 24 months2
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.
Time frame
Up to 24 months3
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.
Time frame
From first administration of study drug to the date of disease progression or death due to any cause (up to 24 months) Source ClinicalTrials.gov