Clinical trial · Observational
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
NCT04592523CI-TRIAL-00118263completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anaplastic Lymphoma Kinase | — | UNRESOLVED | — |
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No Intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- All Participants
- description
- 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.
- interventionNames
- Other: No Intervention
Primary outcomes (1)
- measure
- Percentage of Participants with AEs and SAEs
- timeFrame
- Up to 30 days after the end of treatment (up to 24 months)
Secondary outcomes (3)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Up to 24 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.