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

Study Overview
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Brief Summary
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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).

Detailed Description
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The study is a post approval surveillance so there will be no comparator arm/drug nor blinding process. Dose/regimen should follow locally approved label and it could be adjusted as per the decision from treating physician during treatment period, under their routine clinical practice. Treatment duration is deemed to the decision from treating physician under their routine clinical practice, since this study is a post approval surveillance and to look for safety profiles happening under real world practice. There will be no intervention from Novartis regarding dose/regimen and treatment duration. This study will be completed after data collection of the last subject during the follow up period. The follow up period is recommended for up to 24 weeks after enrollment or up to the time of discontinuation of study drug (in case of early discontinuation) as per linical judgement of treating physician.

Official Title
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A Post Approval Commitment Study on Tabrecta® (Capmatinib) in South Korea; Open Label, Prospective, Multicenter, Post Approval Surveillance

Conditions
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Non-Small-Cell Lung Carcinoma

Intervention / Treatment
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* Other: Capmatinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Capmatinib<br>Participants will be treated with capmatinib as per locally approved label | Other: Capmatinib<br>* 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<br>* Other names: Tabrecta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events (AEs) and serious adverse events (SAEs). | The number of participants with AEs and SAEs will be assessed | From date of first study dose to end of study, assessed up to approximately 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 24 weeks | 
| 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. | Up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non Small Cell Lung, Non Small Cell Lung Cancer, Non-small cell lung cancer, NSCLC, INC280, Non-small cell lung carcinoma (NSCLC), lung cancer, lung adenocarcinoma, Non small cell lung carcinoma, MET exon 14 deletion, METex14del, MET exon 14 skipping, MET exon 14 mutation, MET mutation, MET amplification, MET inhibitor, MET dysregulation, MET activation, MET signaling, MET pathway