A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
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.
Checked against the public recordLast updated Aug 17, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Puma Biotechnology, Inc.
- Interventions being studied
- Drug: Alisertib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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/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 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Southern Cancer CenterDaphne, Alabama
- The Oncology Institute of Hope and InnovationLong Beach, California
- Rocky Mountain Cancer CentersLone Tree, Colorado
- Georgetown Lombardi Cancer CenterWashington D.C., District of Columbia
- Clermont Oncology CenterClermont, Florida
- The Oncology Institute of Hope and InnovationFort Lauderdale, Florida
- Moffitt Cancer CenterTampa, Florida
- Illinois Cancer SpecialistsNiles, Illinois
- Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolis, Indiana
- University of Maryland Greenebaum Comprehensive Cancer CenterBaltimore, Maryland
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Dana Farber Cancer InstituteBoston, Massachusetts
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 17, 2026. Always confirm current availability with the study team.