A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
Status:
Recruiting
Trial end date:
2026-01-31
Target enrollment:
Participant gender:
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-based chemotherapy and anti-PD-L1 immunotherapy agent. Up to one
additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior
lines of therapy. 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.