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

Recruiting

• Conditions: Non-Small-Cell Lung Carcinoma
• Interventions: Other: Capmatinib

• Registration Number: NCT05703516
• Lead Sponsor: Novartis Pharmaceuticals

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).

Detailed Description

The study is a post approval surveillance so there will be no comparator arm/drug nor blinding process.

Dose/regimen should follow locally approved label and it could be adjusted as per the decision from treating physician during treatment period, under their routine clinical practice. Treatment duration is deemed to the decision from treating physician under their routine clinical practice, since this study is a post approval surveillance and to look for safety profiles happening under real world practice. There will be no intervention from Novartis regarding dose/regimen and treatment duration.

This study will be completed after data collection of the last subject during the follow up period. The follow up period is recommended for up to 24 weeks after enrollment or up to the time of discontinuation of study drug (in case of early discontinuation) as per linical judgement of treating physician.

Study Timeline

• Study First Submitted: 2023-01-19
• Study First Submitted QC: 2023-01-19
• Study First Posted: 2023-01-30
• Study Start: 2023-06-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-12
• Last Update Posted: 2025-01-14
• Primary Completion: 2026-10-31
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Capmatinib	Capmatinib	Participants will be treated with capmatinib as per locally approved label

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events (AEs) and serious adverse events (SAEs).	From date of first study dose to end of study, assessed up to approximately 28 weeks	The number of participants with AEs and SAEs will be assessed

Secondary Outcome Measures

Name	Time	Method
Objective response rates (ORRs) assessed by investigator	Up to 24 weeks	ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 and as assessed by the investigator.
Progression Free Survival (PFS)	Up to 24 weeks	PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇰🇷 Seoul, Korea, Republic of