Puma Biotechnology Initiates ALISCA®-Lung2, a Phase II Trial of Alisertib in Combination with Paclitaxel for the Treatment of Patients with Advanced Small Cell Lung Cancer
Puma Biotechnology initiated ALISCA-Lung2, a Phase II trial (PUMA-ALI-4202; NCT07465757) of alisertib in combination with paclitaxel, enrolling approximately 50 patients with advanced small cell lung cancer who progressed on or after platinum-based chemotherapy and immunotherapy. The trial's primary endpoint is safety and tolerability of the combination, with secondary endpoints including objective response rate, duration of response, disease control rate, progression-free survival and overall survival, along with biomarker analysis to identify responsive patient subsets.
Key figures
- Drug Name
- alisertib in combination with paclitaxel
- Phase Of Trial
- Phase II
- Trial Id
- PUMA-ALI-4202
- Nct Number
- NCT07465757
- Enrollment
- approximately 50 patients
- Indication
- advanced small cell lung cancer after platinum-based chemotherapy and immunotherapy
- Primary Endpoint
- safety and tolerability
- Secondary Endpoints
- objective response rate, duration of response, disease control rate, progression-free survival, overall survival, biomarkers
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