Clinical trial NCT05703516: A Post Approval Commitment Study on Tabrecta® (Capmatinib) in South Korea
Official title: A Post Approval Commitment Study on Tabrecta® (Capmatinib) in South Korea; Open Label, Prospective, Multicenter, Post Approval Surveillance
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-Small-Cell Lung Carcinoma
Keywords: Non Small Cell Lung
Non Small Cell Lung Cancer
Non-small cell lung cancer
NSCLC
INC280
Non-small cell lung carcinoma (NSCLC)
lung cancer
lung adenocarcinoma
Non small cell lung carcinoma
MET exon 14 deletion
METex14del
MET exon 14 skipping
MET exon 14 mutation
MET mutation
MET amplification
MET inhibitor
MET dysregulation
MET activation
MET signaling
MET pathway
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-01-30
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who receive Tabrecta® (Capmatinib) as per locally approved label.

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.

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

Primary outcomes:
measure: Number of participants with adverse events (AEs) and serious adverse events (SAEs).
timeFrame: From date of first study dose to end of study, assessed up to approximately 28 weeks
Secondary outcomes:
measure: Objective response rates (ORRs) assessed by investigator
timeFrame: Up to 24 weeks
measure: Progression Free Survival (PFS)
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Novartis Investigative Site
state: Dalseo Gu
city: Suwon si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi Do
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Seocho Gu
city: Busan
country: Korea, Republic of
facility: Novartis Investigative Site
city: Daejeon
country: Korea, Republic of
facility: Novartis Investigative Site
city: Incheon
country: Korea, Republic of
facility: Novartis Investigative Site
city: Jeollanam
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: