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This is a multicenter, non-interventional, observational real-world study to evaluate the efficacy and safety of Taletrectinib in ROS1-positive non-small cell lung cancer (NSCLC) with brain metastases. Patients deemed eligible for Taletrectinib by their physicians were enrolled after providing informed consent. Taletrectinib will be administered according to clinical practice and data on treatment patterns, clinical outcomes, and safety will be collected during routine evaluations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cohort 1 | ROS1 fusion positive NSCLC patients with brain metastases who received taletrecitnib |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taletrectinib | Drug | Taletrectinib, 600mg, QD |
|
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| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate | 6 months |
| iORR | Intracranial objective response rate | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression free survival | 25 months |
| DoR | Duration of response | 25 months |
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Inclusion Criteria:
Patients must meet all of the following criteria to be eligible for enrollment into the study:
Exclusion Criteria:
Patient presenting with any of the following criteria will not be included in the study:
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Patients with ROS1-positive non-small cell lung cancer (NSCLC) with brain metastasis
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 201107 | China |
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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 |
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| ID | Term |
|---|---|
| C000720459 | taletrectinib |
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| DCR | Disease control rate | 6 months |
| OS | Overall survival | 51 months |
| iPFS | Intracranial progress free survival | 25 months |
| iDoR | Intracranial duration of response | 6 months |
| iDCR | Intracranial disease control rate | 6 months |
| Adverse events | Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities, graded by the NCI CTCAE 5.0 | 25 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |