A Post Approval Commitment Study on Tabrecta® (Capmatinib) in South Korea
ConditionNon-Small-Cell Lung Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Capmatinib
Treatment groups
44 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov