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

Recruitingn/aAges 18 Years - 100 YearsAllNovartis Pharmaceuticals
NCT05703516 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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
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What it tests

  • Capmatinib
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Where

10 sites
Novartis Investigative Site
Daegu, South Korea
Novartis Investigative Site
Suwon, South Korea
Novartis Investigative Site
Incheon, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Busan, South Korea
Novartis Investigative Site
Daejeon, South Korea
Novartis Investigative Site
Jeollanam, South Korea

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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