Actively Recruiting
A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
Led by Puma Biotechnology, Inc. · Updated on 2026-02-17
80
Participants Needed
30
Research Sites
194 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older at signing of informed consent
- Pathologically confirmed small cell lung cancer
- Prior treatment with one platinum-based chemotherapy and an anti-PD-L1 immunotherapy
- Up to one additional systemic anti-cancer therapy for small cell lung cancer is allowed, for a total of up to two prior lines of therapy
You will not qualify if you...
- Prior treatment with an AURKA specific-targeted or pan-Aurora-targeted agent, including alisertib in any setting
- Additional inclusion and exclusion criteria assessed by the study center
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 30 locations
1
Southern Cancer Center
Daphne, Alabama, United States, 36526
Actively Recruiting
2
The Oncology Institute of Hope and Innovation
Long Beach, California, United States, 90805
Actively Recruiting
3
Rocky Mountain Cancer Centers
Lone Tree, Colorado, United States, 80124
Actively Recruiting
4
Georgetown Lombardi Cancer Center
Washington D.C., District of Columbia, United States, 20057
Actively Recruiting
5
Clermont Oncology Center
Clermont, Florida, United States, 64711
Actively Recruiting
6
The Oncology Institute of Hope and Innovation
Fort Lauderdale, Florida, United States, 33316
Actively Recruiting
7
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
8
Illinois Cancer Specialists
Niles, Illinois, United States, 60714
Actively Recruiting
9
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
10
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
11
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
12
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
13
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
14
Minnesota Oncology Hematology
Burnsville, Minnesota, United States, 55337
Actively Recruiting
15
Nebraska Cancer Specialists
Grand Island, Nebraska, United States, 68803
Actively Recruiting
16
Oncology Hematology Care Clinical Trials
Cincinnati, Ohio, United States, 45226
Actively Recruiting
17
University Hospital - Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
18
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Active, Not Recruiting
19
Zangmeister Cancer Center
Columbus, Ohio, United States, 43219
Actively Recruiting
20
Oncology Associates of Oregon
Eugene, Oregon, United States, 97401
Actively Recruiting
21
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Withdrawn
22
Medical University of South Carolina Hollings Cancer Center
Charleston, South Carolina, United States, 29425
Actively Recruiting
23
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
24
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
Actively Recruiting
25
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
26
Oncology & Hematology Associates of Southwest Virginia
Blacksburg, Virginia, United States, 24073
Actively Recruiting
27
Universtity of Virginia Health System
Charlottesville, Virginia, United States, 22908
Completed
28
Virginia Cancer Specialists Research Institute
Fairfax, Virginia, United States, 22031
Actively Recruiting
29
Northwest Cancer Specialists
Vancouver, Washington, United States, 98686
Actively Recruiting
30
Marshfield Medical Center
Marshfield, Wisconsin, United States, 54449
Actively Recruiting
Research Team
P
Puma Biotechnology, Inc. Clinical Operations Senior Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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