RecruitingPhase 2NCT06095505

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

A Phase 2 Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer

Sponsor

Puma Biotechnology, Inc.

Enrollment

80 participants

Start Date

Feb 8, 2024

Study Type

INTERVENTIONAL

Conditions

Small Cell Lung Cancer

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 immunotherapy agent. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior lines of therapy. 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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing alisertib, a targeted therapy that blocks a protein called Aurora A kinase, in patients with extensive-stage small cell lung cancer (SCLC) — an aggressive form of lung cancer — whose disease came back after initial treatment. The study focuses on patients who have received prior platinum chemotherapy and immunotherapy. **You may be eligible if...** - You are 18 or older with confirmed small cell lung cancer (extensive stage) - You previously received platinum-based chemotherapy and an anti-PD-L1 immunotherapy - You have received at most two prior lines of treatment in total - You are in adequate health to tolerate treatment **You may NOT be eligible if...** - You have previously been treated with alisertib or any other Aurora kinase inhibitor - You have conditions making you unable to tolerate the study drug - There are additional criteria the study center will assess Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAlisertib

Alisertib enteric-coated tablets

Locations(30)

Southern Cancer Center

Daphne, Alabama, United States

The Oncology Institute of Hope and Innovation

Long Beach, California, United States

Rocky Mountain Cancer Centers

Lone Tree, Colorado, United States

Georgetown Lombardi Cancer Center

Washington D.C., District of Columbia, United States

Clermont Oncology Center

Clermont, Florida, United States

The Oncology Institute of Hope and Innovation

Fort Lauderdale, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Illinois Cancer Specialists

Niles, Illinois, United States

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States

University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

Minnesota Oncology Hematology

Burnsville, Minnesota, United States

Nebraska Cancer Specialists

Grand Island, Nebraska, United States

Oncology Hematology Care Clinical Trials

Cincinnati, Ohio, United States

University Hospital - Cleveland Medical Center

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Zangmeister Cancer Center

Columbus, Ohio, United States

Oncology Associates of Oregon

Eugene, Oregon, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina Hollings Cancer Center

Charleston, South Carolina, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dallas, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Oncology & Hematology Associates of Southwest Virginia

Blacksburg, Virginia, United States

Universtity of Virginia Health System

Charlottesville, Virginia, United States

Virginia Cancer Specialists Research Institute

Fairfax, Virginia, United States

Northwest Cancer Specialists

Vancouver, Washington, United States

Marshfield Medical Center

Marshfield, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT06095505

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