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

Recruiting now · Phase 2

Conditions studied: Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT06095505

Run by

Puma Biotechnology, Inc.

People needed

120

Starts

2024-02-08

Expected to finish

2028-04-30

Last updated by the study team

2026-06-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Marshfield Medical Center — Marshfield, Wisconsin, United States (enrolling)
• The Oncology Institute of Hope and Innovation — Long Beach, California, United States (enrolling)
• Rocky Mountain Cancer Centers — Lone Tree, Colorado, United States (enrolling)
• Georgetown Lombardi Cancer Center — Washington D.C., District of Columbia, United States (enrolling)
• Clermont Oncology Center — Clermont, Florida, United States (enrolling)
• The Oncology Institute of Hope and Innovation — Fort Lauderdale, Florida, United States (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• Illinois Cancer Specialists — Niles, Illinois, United States (enrolling)
• Indiana University Melvin and Bren Simon Comprehensive Cancer Center — Indianapolis, Indiana, United States (enrolling)
• University of Maryland Greenebaum Comprehensive Cancer Center — Baltimore, Maryland, United States (enrolling)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Henry Ford Hospital — Detroit, Michigan, United States (enrolling)
• Minnesota Oncology Hematology — Burnsville, Minnesota, United States (enrolling)
• Nebraska Cancer Specialists — Grand Island, Nebraska, United States (enrolling)
• Oncology Hematology Care Clinical Trials — Cincinnati, Ohio, United States (enrolling)
• University Hospital - Cleveland Medical Center — Cleveland, Ohio, United States (enrolling)
• Virginia Cancer Specialists Research Institute — Fairfax, Virginia, United States (enrolling)
• Northwest Cancer Specialists — Vancouver, Washington, United States (enrolling)
• Southern Cancer Center — Daphne, Alabama, United States (enrolling)
• Zangmeister Cancer Center — Columbus, Ohio, United States (enrolling)
• Oncology Associates of Oregon — Eugene, Oregon, United States (enrolling)
• Medical University of South Carolina Hollings Cancer Center — Charleston, South Carolina, United States (enrolling)
• SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
• Texas Oncology-Baylor Charles A. Sammons Cancer Center — Dallas, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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