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

Last updated: January 12, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Treatment

Capmatinib

Clinical Study ID

NCT05703516
CINC280AKR01
  • Ages 18-100
  • All Genders

Study 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

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 orplasma(ctDNA) sample analysis by treating physician (i.e. Any kind of diagnosticmethods the institution currently has. Diagnostic modalities for research purposewould be also allowable.)

  • Subject who plan to receive Tabrecta® (Capmatinib) as per locally approved label

Exclusion

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

Total Participants: 250
Treatment Group(s): 1
Primary Treatment: Capmatinib
Phase:
Study Start date:
June 12, 2023
Estimated Completion Date:
October 31, 2026

Study 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.

Connect with a study center

  • Novartis Investigative Site

    Daegu, Dalseo Gu 42602
    Korea, Republic of

    Active - Recruiting

  • Novartis Investigative Site

    Suwon si, Gyeonggi Do 16499
    Korea, Republic of

    Active - Recruiting

  • Novartis Investigative Site

    Suwon, Gyeonggi-do 443380
    Korea, Republic of

    Site Not Available

  • Novartis Investigative Site

    Busan, 602-030
    Korea, Republic of

    Active - Recruiting

  • Novartis Investigative Site

    Daejeon, 302-241
    Korea, Republic of

    Active - Recruiting

  • Novartis Investigative Site

    Incheon, 405 760
    Korea, Republic of

    Active - Recruiting

  • Novartis Investigative Site

    Jeollanam, 519763
    Korea, Republic of

    Active - Recruiting

  • Novartis Investigative Site

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

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