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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAlisertib

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC) · PD-L1

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 17, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 2

Interventional

Where is it offered?30 U.S. locations

Locations may change over time.

Who runs it?Puma Biotechnology, Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Puma Biotechnology, Inc.
Interventions being studied: Drug: Alisertib

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Small cell lung cancer (SCLC)→

Biomarkers

PD-L1→

Treatment approach

Immunotherapy→Chemotherapy→

Study topics

After prior treatment→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion criteria

Prior treatment with an AURKA specific-targeted or pan-Aurora-targeted agent, including alisertib in any setting Note: There are additional inclusion and

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

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.

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