Clinical trial · Observational
A Post Approval Commitment Study on Tabrecta® (Capmatinib) in South Korea
A Post Approval Commitment Study on Tabrecta® (Capmatinib) in South Korea; Open Label, Prospective, Multicenter, Post Approval Surveillance
- 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)
This is an open label, prospective, multicenter, non-comparative study to assess the safety and effectiveness of Tabrecta® (Capmatinib) in real world setting. Also, this study is to fulfill the regulatory requirements as part of the RMP (Risk Management Plan) for Tabrecta® (Capmatinib), as requested by Korea Health Authority, MFDS (Ministry of Food and Drug Safety).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small-Cell Lung Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capmatinib | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Capmatinib
- description
- Participants will be treated with capmatinib as per locally approved label
- interventionNames
- Other: Capmatinib
Primary outcomes (1)
- measure
- Number of participants with adverse events (AEs) and serious adverse events (SAEs).
- timeFrame
- From date of first study dose to end of study, assessed up to approximately 28 weeks
- description
- The number of participants with AEs and SAEs will be assessed
Secondary outcomes (2)
- measure
- Objective response rates (ORRs) assessed by investigator
- timeFrame
- Up to 24 weeks
- description
- ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 and as assessed by the investigator.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. * Subject who are diagnosed as exon 14 skipping mutated NSCLC from tissue or plasma(ctDNA) sample analysis by treating physician (i.e. Any kind of diagnostic methods the institution currently has. Diagnostic modalities for research purpose would be also allowable.) * Subject who plan to receive Tabrecta® (Capmatinib) as per locally approved label Exclusion Criteria: * Subject with contraindication according to the locally approved label * Subject whose medical record is not accessible * Subject who are not willing to provide informed consent
References
Publications (0)
Data not yet available