Actively Recruiting

Age: 18Years - 100Years
All Genders
NCT05703516

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

Led by Novartis Pharmaceuticals · Updated on 2025-01-14

250

Participants Needed

12

Research Sites

176 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent obtained before joining the study
  • Diagnosed with exon 14 skipping mutated NSCLC confirmed by tissue or plasma (ctDNA) analysis by treating physician
  • Planning to receive Tabrecta4 (Capmatinib) according to the locally approved label
Not Eligible

You will not qualify if you...

  • Contraindications to Tabrecta4 (Capmatinib) as per the locally approved label
  • Medical records not accessible
  • Unwilling to provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 12 locations

1

Novartis Investigative Site

Daegu, Dalseo Gu, South Korea, 42602

Actively Recruiting

2

Novartis Investigative Site

Suwon, Gyeonggi-do, South Korea, 16499

Actively Recruiting

3

Novartis Investigative Site

Seoul, Korea, South Korea, 02447

Actively Recruiting

4

Novartis Investigative Site

Seoul, Seocho Gu, South Korea, 06591

Actively Recruiting

5

Novartis Investigative Site

Busan, South Korea, 602-030

Actively Recruiting

6

Novartis Investigative Site

Daejeon, South Korea, 302-241

Actively Recruiting

7

Novartis Investigative Site

Incheon, South Korea, 405 760

Actively Recruiting

8

Novartis Investigative Site

Jeollanam, South Korea, 519763

Actively Recruiting

9

Novartis Investigative Site

Seoul, South Korea, 02841

Actively Recruiting

10

Novartis Investigative Site

Seoul, South Korea, 05505

Actively Recruiting

11

Novartis Investigative Site

Seoul, South Korea, 06273

Actively Recruiting

12

Novartis Investigative Site

Seoul, South Korea, 06351

Actively Recruiting

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Research Team

N

Novartis Pharmaceuticals

CONTACT

N

Novartis Pharmaceuticals

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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