RecruitingNCT05703516

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


Sponsor

Novartis Pharmaceuticals

Enrollment

250 participants

Start Date

Jun 12, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This is a post-approval monitoring study in South Korea tracking how well capmatinib (brand name Tabrecta) works in real-world clinical settings. Capmatinib is a targeted therapy approved for a specific type of lung cancer with a mutation called MET exon 14 skipping. **You may be eligible if...** - You have been diagnosed with non-small cell lung cancer (NSCLC) with a MET exon 14 skipping mutation (confirmed by tumor tissue or blood test) - Your doctor has prescribed capmatinib (Tabrecta) as part of your standard treatment - You have signed informed consent **You may NOT be eligible if...** - You have a medical reason why capmatinib is contraindicated for you - Your medical records cannot be accessed for the study - You are unwilling to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERCapmatinib

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

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NCT05703516


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