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
This trial does not accept healthy volunteersQualifiers
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 population
Patients who receive Tabrecta® (Capmatinib) as per locally approved label.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Capmatinib
Other interventionThere 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
Treatment groups
44 Participants
are divided into 1 treatment groupGroup A: Capmatinib1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with adverse events (AEs) and serious adverse events (SAEs).
The number of participants with AEs and SAEs will be assessed
Time frame
From date of first study dose to end of study, assessed up to approximately 28 weeksSecondary outcomes
1
Objective response rates (ORRs) assessed by investigator
ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 and as assessed by the investigator.
Time frame
Up to 24 weeks2
Progression Free Survival (PFS)
PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.
Time frame
Up to 24 weeksSponsors and contacts
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Source ClinicalTrials.gov