NCT05703516

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Jun 2023

Typical duration for all trials

Geographic Reach
1 country

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Jun 2023Oct 2026

First Submitted

Initial submission to the registry

January 19, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 30, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

June 12, 2023

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

January 14, 2025

Status Verified

January 1, 2025

Enrollment Period

3.4 years

First QC Date

January 19, 2023

Last Update Submit

January 12, 2025

Conditions

Non-Small-Cell Lung Carcinoma

Keywords

Non Small Cell LungNon Small Cell Lung CancerNon-small cell lung cancerNSCLCINC280Non-small cell lung carcinoma (NSCLC)lung cancerlung adenocarcinomaNon small cell lung carcinomaMET exon 14 deletionMETex14delMET exon 14 skippingMET exon 14 mutationMET mutationMET amplificationMET inhibitorMET dysregulationMET activationMET signalingMET pathway

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events (AEs) and serious adverse events (SAEs).

    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 Outcomes (2)

  • Objective response rates (ORRs) assessed by investigator

    Up to 24 weeks

  • Progression Free Survival (PFS)

    Up to 24 weeks

Study Arms (1)

Capmatinib

Participants will be treated with capmatinib as per locally approved label

Other: Capmatinib

Interventions

CapmatinibOTHER

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

Also known as: Tabrecta
Capmatinib

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Novartis Investigative Site

Daegu, Dalseo Gu, 42602, South Korea

RECRUITING

Novartis Investigative Site

Suwon, Gyeonggi-do, 16499, South Korea

RECRUITING

Novartis Investigative Site

Seoul, Korea, 02447, South Korea

RECRUITING

Novartis Investigative Site

Seoul, Seocho Gu, 06591, South Korea

RECRUITING

Novartis Investigative Site

Busan, 602-030, South Korea

RECRUITING

Novartis Investigative Site

Daejeon, 302-241, South Korea

RECRUITING

Novartis Investigative Site

Incheon, 405 760, South Korea

RECRUITING

Novartis Investigative Site

Jeollanam, 519763, South Korea

RECRUITING

Novartis Investigative Site

Seoul, 02841, South Korea

RECRUITING

Novartis Investigative Site

Seoul, 05505, South Korea

RECRUITING

Novartis Investigative Site

Seoul, 06273, South Korea

RECRUITING

Novartis Investigative Site

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung NeoplasmsAdenocarcinoma of Lung

Interventions

capmatinib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2023

First Posted

January 30, 2023

Study Start

June 12, 2023

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

January 14, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(12)