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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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06095505.
