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A Post Approval Commitment Study on Tabrecta® (Capmatinib) in South Korea

RecruitingN/A

Sponsor: Novartis Pharmaceuticals

Conditions: Non-Small-Cell Lung Carcinoma

Interventions: Capmatinib

Countries: South Korea

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

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. 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

Locations (10)

Daegu, Dalseo gu, South Korea
Suwon, Gyeonggi-do, South Korea
Incheon, Korea, South Korea
Seoul, Korea, South Korea
Seoul, Seoul, South Korea
Busan, South Korea
Daejeon, South Korea
Jeollanam, South Korea
Seoul, South Korea
Seoul, South Korea