Trial Title:
A Post Approval Commitment Study on Tabrecta® (Capmatinib) in South Korea
NCT ID:
NCT05703516
Condition:
Non-Small-Cell Lung Carcinoma
Conditions: Official terms:
Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: 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
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Capmatinib
Description:
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
Arm group label:
Capmatinib
Other name:
Tabrecta
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.
Criteria for eligibility:
Study pop:
Patients who receive Tabrecta® (Capmatinib) as per locally approved label.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Novartis Investigative Site
Address:
City:
Daegu
Zip:
42602
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Suwon
Zip:
443380
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Seoul
Zip:
02447
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Seoul
Zip:
06591
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Busan
Zip:
602-030
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Daejeon
Zip:
302-241
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Incheon
Zip:
405 760
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Jeollanam
Zip:
519763
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Seoul
Zip:
02841
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Seoul
Zip:
06273
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Start date:
June 12, 2023
Completion date:
October 31, 2024
Lead sponsor:
Agency:
Novartis Pharmaceuticals
Agency class:
Industry
Source:
Novartis
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05703516
