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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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).

Who May Be Eligible (Plain English)

Who May Qualify: - Signed willing to sign a consent form 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 Who Should NOT Join This Trial: - Subject with contraindication according to the locally approved label - Subject whose medical record is not accessible - Subject who are not willing to provide willing to sign a consent form Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

OTHER

Capmatinib

There is no treatment allocation. Capmatinib will be prescribed by the physician as per locally approved label. Treatment duration depends on the decision of treating physician. No drug will be dispensed from Novartis

Locations (12)

Novartis Investigative Site
Daegu, Dalseo Gu, South Korea
Novartis Investigative Site
Suwon, Gyeonggi-do, South Korea
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Seoul, Seocho Gu, South Korea
Novartis Investigative Site
Busan, South Korea
Novartis Investigative Site
Daejeon, South Korea
Novartis Investigative Site
Incheon, South Korea
Novartis Investigative Site
Jeollanam, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea