Non-Small-Cell Lung Carcinoma Clinical Trial
Official title:
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).
Status | Recruiting |
Enrollment | 250 |
Est. completion date | October 31, 2024 |
Est. primary completion date | October 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Novartis Investigative Site | Busan | |
Korea, Republic of | Novartis Investigative Site | Daegu | Dalseo Gu |
Korea, Republic of | Novartis Investigative Site | Daejeon | |
Korea, Republic of | Novartis Investigative Site | Incheon | |
Korea, Republic of | Novartis Investigative Site | Jeollanam | |
Korea, Republic of | Novartis Investigative Site | Seoul | |
Korea, Republic of | Novartis Investigative Site | Seoul | |
Korea, Republic of | Novartis Investigative Site | Seoul | |
Korea, Republic of | Novartis Investigative Site | Seoul | |
Korea, Republic of | Novartis Investigative Site | Seoul | Korea |
Korea, Republic of | Novartis Investigative Site | Seoul | Seocho Gu |
Korea, Republic of | Novartis Investigative Site | Suwon | Gyeonggi-do |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Objective response rates (ORRs) assessed by investigator | 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 | |
Secondary | Progression Free Survival (PFS) | 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 |
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