Actively Recruiting
A Phase 2 Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
Led by Puma Biotechnology, Inc. · Updated on 2026-06-05
120
Participants Needed
30
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating alisertib as a single treatment in patients with small cell lung cancer (SCLC) that has progressed after prior therapies. This Phase 2 study focuses on patients who have already received at least one platinum-based chemotherapy and an anti-PD-L1/PD-1 immunotherapy, with allowance for up to two prior treatment regimens in total. The study aims to identify specific biomarker groups that may respond best to alisertib and to assess its effectiveness, safety, and how the body processes the drug. Participants will receive alisertib tablets orally in doses of 50 mg, 60 mg, or 70 mg twice daily for seven days within each 21-day treatment cycle. The dosing amount depends on protocol amendments and is given on a schedule of days 1 to 7 of each cycle. This treatment continues under close monitoring to evaluate patient response and side effects. During the study, participants will be regularly evaluated for response to treatment, including measures such as tumor shrinkage and disease control, lasting up to 36 months after the first dose. Researchers will also assess progression-free survival and overall survival within biomarker-defined groups and the overall enrolled population. Safety is monitored by tracking adverse events from the start of treatment through 28 days after the last dose. Patients will be followed for up to three years to gather comprehensive data on treatment outcomes and safety.
CONDITIONS
Brief 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/PD-1 immunotherapy
- Up to one additional systemic anti-cancer therapy for small cell lung cancer allowed, for a total of up to two prior treatment regimens
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 determined by the study center
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive alisertib tablets by mouth twice daily on days 1 to 7 of each 21-day cycle.
Visits every cycle for treatment administration and assessments
Duration - Up to 36 months after first dose
Participants are monitored for safety and overall survival after treatment ends.
Periodic follow-up visits as scheduled by the study team
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here