A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
NCT06095505
This study is recruiting at 26 US sites in 19 states, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Small Cell Lung Cancer
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 2
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Puma Biotechnology, Inc.
- Last updated on ClinicalTrials.gov
- August 17, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Alabama · 1
- Southern Cancer Center · Daphne, AL
California · 1
- The Oncology Institute of Hope and Innovation · Long Beach, CA
Colorado · 1
- Rocky Mountain Cancer Centers · Lone Tree, CO
District of Columbia · 1
- Georgetown Lombardi Cancer Center · Washington D.C., DC
Florida · 3
- Clermont Oncology Center · Clermont, FL
- The Oncology Institute of Hope and Innovation · Fort Lauderdale, FL
- Moffitt Cancer Center · Tampa, FL
Illinois · 1
- Illinois Cancer Specialists · Niles, IL
Indiana · 1
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center · Indianapolis, IN
Maryland · 1
- University of Maryland Greenebaum Comprehensive Cancer Center · Baltimore, MD
Massachusetts · 2
- Beth Israel Deaconess Medical Center · Boston, MA
- Dana Farber Cancer Institute · Boston, MA
Minnesota · 1
- Minnesota Oncology Hematology · Burnsville, MN
Nebraska · 1
- Nebraska Cancer Specialists · Grand Island, NE
Ohio · 3
- Oncology Hematology Care Clinical Trials · Cincinnati, OH
- University Hospital - Cleveland Medical Center · Cleveland, OH
- Zangmeister Cancer Center · Columbus, OH
Oregon · 1
- Oncology Associates of Oregon · Eugene, OR
South Carolina · 1
- Medical University of South Carolina Hollings Cancer Center · Charleston, SC
Tennessee · 1
- SCRI Oncology Partners · Nashville, TN
Texas · 2
- Texas Oncology-Baylor Charles A. Sammons Cancer Center · Dallas, TX
- University of Texas Southwestern Medical Center · Dallas, TX
Virginia · 2
- Oncology & Hematology Associates of Southwest Virginia · Blacksburg, VA
- Virginia Cancer Specialists Research Institute · Fairfax, VA
Washington · 1
- Northwest Cancer Specialists · Vancouver, WA
Wisconsin · 1
- Marshfield Medical Center · Marshfield, WI
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.