Observational study on the use of Tabrecta® for lung cancer in South Korea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the safety and effectiveness of Tabrecta® (Capmatinib) in patients with non-small-cell lung carcinoma (NSCLC) in a real-world setting. It is a multicenter, open-label study that does not involve a comparator arm or blinding, focusing on post-approval surveillance as required by the Korea Health Authority. Treatment regimens will follow local approval and can be adjusted by the treating physician based on clinical judgment. The study will collect data for up to 24 weeks after enrollment or until the study drug is discontinued.

Why it matters

Who can join: the full rules

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

Where it's running

• Novartis Investigative Site
  Daegu, Dalseo gu, South Korea Recruiting
• Novartis Investigative Site
  Suwon, Gyeonggi-do, South Korea Recruiting
• Novartis Investigative Site
  Incheon, Korea, South Korea Recruiting
• Novartis Investigative Site
  Seoul, Korea, South Korea Recruiting
• Novartis Investigative Site
  Seoul, Seoul, South Korea Recruiting
• Novartis Investigative Site
  Busan, South Korea Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +41613241111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.