OncoMatch/Clinical Trials/NCT06095505
A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
Is NCT06095505 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Alisertib for small cell lung cancer.
Treatment: Alisertib — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Small Cell Lung Cancer
Disease stage
Required: Stage IV
A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
Prior therapy
Must have received: platinum-based chemotherapy
Prior treatment with one platinum-based chemotherapy
Must have received: anti-PD-L1 therapy
Prior treatment with...an anti-PD-L1 immunotherapy
Cannot have received: AURKA specific-targeted or pan-Aurora-targeted agent (alisertib)
Prior treatment with an AURKA specific-targeted or pan-Aurora-targeted agent, including alisertib in any setting
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Southern Cancer Center · Daphne, Alabama
- The Oncology Institute of Hope and Innovation · Long Beach, California
- Rocky Mountain Cancer Centers · Lone Tree, Colorado
- Georgetown Lombardi Cancer Center · Washington D.C., District of Columbia
- Clermont Oncology Center · Clermont, Florida
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06095505 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior AURKA specific-targeted or pan-Aurora-targeted agent disqualifies patients from enrollment.
What disease stage is eligible?
Stage IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages