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This observational study evaluates the real-world safety and effectiveness of repotrectinib in Korean participants with locally advanced or metastatic ROS1-positive non-small cell lung cancer or solid tumors harboring neurotrophic tyrosine receptor kinase (NTRK) gene fusions. Participants receiving repotrectinib in routine clinical practice will be followed for up to 12 months or until the end of the 2-year surveillance period, whichever occurs first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ROS1-Positive NSCLC Cohort | Participants ≥19 years with histologically or cytologically confirmed locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) |
| |
| NTRK Gene Fusion Solid Tumor Cohort | Participants ≥12 years with solid tumors harboring NTRK gene fusions that are locally advanced, metastatic, or likely to cause severe morbidity if surgically resected |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repotrectinib | Drug | As per product label |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants experiencing adverse events | Adverse events include: adverse drug reaction (ADR), serious adverse event (SAE), serious adverse drug reaction (SADR), unexpected adverse event (AE), unexpected ADR, unexpected SAE or SADR and adverse events of special interest (AESI) | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants achieving objective tumor response according to RECIST version 1.1 | Up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Korean participants with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) or solid tumors harboring Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusions who are prescribed repotrectinib in routine clinical practice.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Clinical Trials Contact Center www.BMSClinicalTrials.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bristol Myers Squibb Pharmaceutical Korea Ltd | Seoul | South Korea |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000708510 | repotrectinib |
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