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
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