NCT06095505RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 17 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 27 Sept 2023
- Start date
- 8 Feb 2024
- Primary completion date
- 30 Oct 2027
- Lead sponsor
- Puma Biotechnology, Inc.
- Diseases
- Lung cancer
- NCT number
- NCT06095505
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 120
- From 8 Feb 2024 to the primary completion date, 30 Oct 2027
- 30 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (30)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Maryland Greenebaum Comprehensive Cancer Center Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Oncology & Hematology Associates of Southwest Virginia Coordinator of this site? Confirm its status | Blacksburg | United States | Recruiting |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Minnesota Oncology Hematology Coordinator of this site? Confirm its status | Burnsville | United States | Recruiting |
| Medical University of South Carolina - Hollings Cancer Center Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| Universtity of Virginia Health System Coordinator of this site? Confirm its status | Charlottesville | United States | Completed |
| Oncology Hematology Care Clinical Trials Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Clermont Oncology Center Coordinator of this site? Confirm its status | Clermont | United States | Recruiting |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Active, not recruiting |
| University Hospital Cleveland Medical Center Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Zangmeister Cancer Center Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Texas Oncology - Baylor Charles A. Sammons Cancer Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Southern Cancer Center Coordinator of this site? Confirm its status | Daphne | United States | Recruiting |
| Henry Ford Hospital Coordinator of this site? Confirm its status | Detroit | United States | Completed |
| Oncology Associates of Oregon Coordinator of this site? Confirm its status | Eugene | United States | Recruiting |
| Virginia Cancer Specialists Research Institute Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| The Oncology Institute of Hope and Innovation Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Recruiting |
| Nebraska Cancer Specialists Coordinator of this site? Confirm its status | Grand Island | United States | Recruiting |
| Indiana University Melvin and Bren Simon Comprehensive Cancer Center Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| Rocky Mountain Cancer Centers Coordinator of this site? Confirm its status | Lone Tree | United States | Recruiting |
| The Oncology Institute of Hope and Innovation Coordinator of this site? Confirm its status | Long Beach | United States | Recruiting |
| Marshfield Medical Center Coordinator of this site? Confirm its status | Marshfield | United States | Recruiting |
| SCRI Oncology Partners Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Illinois Cancer Specialists Coordinator of this site? Confirm its status | Niles | United States | Recruiting |
| UPMC Hillman Cancer Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Withdrawn |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Northwest Cancer Specialists Coordinator of this site? Confirm its status | Vancouver | United States | Recruiting |
| Georgetown Lombardi Cancer Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.