A Post Approval Commitment Study on Tabrecta® (Capmatinib) in South Korea
Recruiting
Observational Study
Non-Small-Cell Lung Carcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 – 100
- Sex
- Any
- Study type
- Observational
- Participants needed
- 44 (estimated)
- Sponsor
- Novartis Pharmaceuticals · Industry
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About This Trial
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).
Trial Locations
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Eligibility 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. Di…
Contacts
Novartis Pharmaceuticals
CONTACT