Lung Cancer Clinical Trial
A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
Summary
PUMA-ALI-4201 is a Phase 2 study evaluating alisertib in patients with pathologically-confirmed extensive-stage small cell lung cancer (ES-SCLC) following progression on or after first-line treatment with platinum-based chemotherapy along with an anti-PDL-1 immunotherapy agent. This study is intended to evaluate the efficacy, safety, and pharmacokinetics of alisertib and to identify the biomarker-defined subgroup(s) that may benefit most from alisertib treatment.
Eligibility Criteria
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.
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There are 19 Locations for this study
Daphne Alabama, 36526, United States
Lone Tree Colorado, 80124, United States
Washington District of Columbia, 20057, United States
Niles Illinois, 60714, United States
Detroit Michigan, 48202, United States
Burnsville Minnesota, 55337, United States
Cincinnati Ohio, 45226, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43219, United States
Eugene Oregon, 97401, United States
Pittsburgh Pennsylvania, 15232, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75390, United States
Blacksburg Virginia, 24073, United States
Charlottesville Virginia, 22908, United States
Fairfax Virginia, 22031, United States
Vancouver Washington, 98686, United States
Marshfield Wisconsin, 54449, United States
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