Status:
RECRUITING
A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
Lead Sponsor:
Puma Biotechnology, Inc.
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
PUMA-ALI-4201 is a Phase 2 study evaluating alisertib monotherapy in patients with pathologically-confirmed small cell lung cancer (SCLC) following progression on or after treatment with one platinum-...
Eligibility Criteria
Inclusion
- Aged ≥18 years at signing of informed consent
- Pathologically confirmed SCLC
- Prior treatment with one platinum-based chemotherapy and an anti-PD-L1 immunotherapy. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior lines of therapy
Exclusion
- Prior treatment with an AURKA specific-targeted or pan-Aurora-targeted agent, including alisertib in any setting
- Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.
Key Trial Info
Start Date :
February 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06095505
Start Date
February 8 2024
End Date
October 31 2027
Last Update
November 12 2025
Active Locations (30)
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1
Southern Cancer Center
Daphne, Alabama, United States, 36526
2
The Oncology Institute of Hope and Innovation
Long Beach, California, United States, 90805
3
Rocky Mountain Cancer Centers
Lone Tree, Colorado, United States, 80124
4
Georgetown Lombardi Cancer Center
Washington D.C., District of Columbia, United States, 20057