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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capmatinib | Participants will be treated with capmatinib as per locally approved label |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capmatinib | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who receive Tabrecta® (Capmatinib) as per locally approved label.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | +41613241111 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Recruiting | Daegu | Dalseo gu | 42602 | South Korea | |
| Novartis Investigative Site |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| D000077192 | Adenocarcinoma of Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| ID | Term |
|---|---|
| C000613976 | capmatinib |
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|
| 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 |
| Recruiting |
| Suwon |
| Gyeonggi-do |
| 16499 |
| South Korea |
| Novartis Investigative Site | Recruiting | Incheon | Korea | 405 760 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | Korea | 02447 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | Seoul | 06351 | South Korea |
| Novartis Investigative Site | Recruiting | Busan | 602-030 | South Korea |
| Novartis Investigative Site | Recruiting | Daejeon | 302-241 | South Korea |
| Novartis Investigative Site | Recruiting | Jeollanam | 519763 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | 05505 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | 06591 | South Korea |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |