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

May 28, 2026 updated by: Novartis Pharmaceuticals

A Post Approval Commitment Study on Tabrecta® (Capmatinib) in South Korea; Open Label, Prospective, Multicenter, Post Approval Surveillance

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals

Study Locations

  • South Korea
      • Busan, South Korea, 602-030
        • Recruiting
        • Novartis Investigative Site
      • Daejeon, South Korea, 302-241
        • Recruiting
        • Novartis Investigative Site
      • Jeollanam, South Korea, 519763
        • Recruiting
        • Novartis Investigative Site
      • Seoul, South Korea, 05505
        • Recruiting
        • Novartis Investigative Site
      • Seoul, South Korea, 06591
        • Recruiting
        • Novartis Investigative Site
    • Dalseo gu
      • Daegu, Dalseo gu, South Korea, 42602
        • Recruiting
        • Novartis Investigative Site
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, South Korea, 16499
        • Recruiting
        • Novartis Investigative Site
    • Korea
      • Incheon, Korea, South Korea, 405 760
        • Recruiting
        • Novartis Investigative Site
      • Seoul, Korea, South Korea, 02447
        • Recruiting
        • Novartis Investigative Site
    • Seoul
      • Seoul, Seoul, South Korea, 06351
        • Recruiting
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who receive Tabrecta® (Capmatinib) as per locally approved label.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Capmatinib
Participants will be treated with capmatinib as per locally approved label
Other: Capmatinib
There is no treatment allocation. Capmatinib will be prescribed by the physician as per locally approved label. Treatment duration depends on the decision of treating physician. No drug will be dispensed from Novartis
Other Names:
  • Tabrecta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events (AEs) and serious adverse events (SAEs).
Time Frame: 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
From date of first study dose to end of study, assessed up to approximately 28 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rates (ORRs) assessed by investigator
Time Frame: 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.
Up to 24 weeks
Progression Free Survival (PFS)
Time Frame: 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.
Up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2023

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

January 19, 2023

First Submitted That Met QC Criteria

January 19, 2023

First Posted (Actual)

January 30, 2023

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CINC280AKR01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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