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A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
Trial Status: active
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.
Inclusion Criteria
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 Criteria
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.
Additional locations may be listed on ClinicalTrials.gov for NCT06095505.
