RecruitingPhase IIEN originalLung cancerMetastatic / advanced

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Wiek co najmniej 18 lat
  • Potwierdzony rozpoznaniem raka płuca z małymi komórkami
  • Poprzednia chemioterapia zawierająca sole platyny oraz immunoterapia
  • Możliwość włączenia do pięciu wcześniejszych sposobów leczenia

✗ Disqualifies

  • Poprzednia terapia innymi lekami skierowanymi na białko AURKA lub lekami typu Aurora-targeted, w tym alisertib

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
August 17, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (30)

Southern Cancer Center

Daphne, United States

The Oncology Institute of Hope and Innovation

Long Beach, United States

Rocky Mountain Cancer Centers

Lone Tree, United States

Georgetown Lombardi Cancer Center

Washington D.C., United States

Clermont Oncology Center

Clermont, United States

The Oncology Institute of Hope and Innovation

Fort Lauderdale, United States

Moffitt Cancer Center

Tampa, United States

Illinois Cancer Specialists

Niles, United States

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, United States

University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, United States

Beth Israel Deaconess Medical Center

Boston, United States

Dana Farber Cancer Institute

Boston, United States

Henry Ford Hospital

Detroit, United States

Minnesota Oncology Hematology

Burnsville, United States

Nebraska Cancer Specialists

Grand Island, United States

Oncology Hematology Care Clinical Trials

Cincinnati, United States

University Hospital - Cleveland Medical Center

Cleveland, United States

Cleveland Clinic

Cleveland, United States

Zangmeister Cancer Center

Columbus, United States

Oncology Associates of Oregon

Eugene, United States

UPMC Hillman Cancer Center

Pittsburgh, United States

Medical University of South Carolina Hollings Cancer Center

Charleston, United States

SCRI Oncology Partners

Nashville, United States

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dallas, United States

University of Texas Southwestern Medical Center

Dallas, United States

Oncology & Hematology Associates of Southwest Virginia

Blacksburg, United States

Universtity of Virginia Health System

Charlottesville, United States

Virginia Cancer Specialists Research Institute

Fairfax, United States

Northwest Cancer Specialists

Vancouver, United States

Marshfield Medical Center

Marshfield, United States

Trial contact

Puma Biotechnology, Inc. Clinical Operations Senior Director

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/18/2026.

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