A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer

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-based chemotherapy and anti-PD-L1/PD-1 immunotherapy agent. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior treatment regimens. This study is intended to identify the biomarker-defined subgroup(s) that may benefit most from alisertib treatment and to evaluate the efficacy, safety, and pharmacokinetics of alisertib.

Trial Details

NCT ID
NCT06095505
Phase
PHASE2
Sponsor
Puma Biotechnology, Inc.
Status
RECRUITING
Cancer Type
Small Cell (SCLC) Lung Cancer
Interventions
  • Alisertib
Locations (sample)
  • Daphne, Alabama, United States|30.60353,-87.9036
  • Long Beach, California, United States|33.76696,-118.18923
  • Lone Tree, Colorado, United States|39.55171,-104.8863
  • Washington D.C., District of Columbia, United States|38.89511,-77.03637
  • Clermont, Florida, United States|28.54944,-81.77285

Key Eligibility Criteria

  • Aged ≥18 years at signing of informed consent
  • Pathologically confirmed SCLC
  • Prior treatment with one platinum-based chemotherapy and an anti-PD-L1/PD-1 immunotherapy. Up to one additional systemic anti-cancer therapy for SC…

For full eligibility, visit ClinicalTrials.gov.

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