Observational study on the use of Tabrecta® for lung cancer in South Korea
A Post Approval Commitment Study on Tabrecta® (Capmatinib) in South Korea; Open Label, Prospective, Multicenter, Post Approval Surveillance
This study is testing how safe and effective Tabrecta® is for people with non-small-cell lung cancer in South Korea in real-life situations.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Novartis Industry-sponsored |
| Drugs / interventions | Capmatinib |
| Locations | 12 sites (Daegu, Dalseo Gu and 11 other locations) |
| Trial ID | NCT05703516 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with exon 14 skipping mutated NSCLC who plan to receive Tabrecta® as per the approved label.
Not a fit: Patients with contraindications to Tabrecta® or those whose medical records are not accessible may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness and safety of Tabrecta® for patients with NSCLC.
How similar studies have performed: Other studies on the effectiveness of targeted therapies in NSCLC have shown promising results, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Daegu, Dalseo Gu and 11 other locations
- Novartis Investigative Site — Daegu, Dalseo Gu, South Korea (Recruiting)
- Novartis Investigative Site — Suwon, Gyeonggi-do, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, Korea, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, Seocho Gu, South Korea (Recruiting)
- Novartis Investigative Site — Busan, South Korea (Recruiting)
- Novartis Investigative Site — Daejeon, South Korea (Recruiting)
- Novartis Investigative Site — Incheon, South Korea (Recruiting)
- Novartis Investigative Site — Jeollanam, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: +41613241111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.