A Post Approval Commitment Study on Tabrecta® (Capmatinib) in South Korea
About the study
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).
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Non-Small-Cell Lung Carcinoma
Age (in years)
18+
Participants needed
250
Est. Completion Date
Oct 31, 2024
Treatment type
Observational
Sponsor
Novartis
ClinicalTrials.gov identifier
NCT05703516
Study number
CINC280AKR01
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