RecruitingSmall Cell Lung Cancer

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

Eligible age

18+ yrs

Accepts

All genders

Locations

21 states

Healthy volunteers

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About this study

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.

Sponsor: Puma Biotechnology, Inc.

You may qualify if…

✓ 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 SCLC is allowed, for a total of up to two prior treatment regimens

You may not qualify if…

✕ 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.