NCT05703516 A Post Approval Commitment Study on Tabrecta® (Capmatinib) in South Korea
| NCT ID | NCT05703516 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Non-Small-Cell Lung Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 44 participants |
| Start Date | 2023-06-12 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 44 participants in total. It began in 2023-06-12 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Novartis Pharmaceuticals
STUDY DIRECTOR
Novartis Pharmaceuticals
Frequently Asked Questions
Who can join the NCT05703516 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Non-Small-Cell Lung Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05703516 currently recruiting?
Yes, NCT05703516 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT05703516 trial being conducted?
This trial is being conducted at Daegu, South Korea, Suwon, South Korea, Incheon, South Korea, Seoul, South Korea and 6 additional locations.
Who is sponsoring the NCT05703516 clinical trial?
NCT05703516 is sponsored by Novartis Pharmaceuticals. The principal investigator is Novartis Pharmaceuticals at Novartis Pharmaceuticals. The trial plans to enroll 44 participants.