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OncoMatch/Clinical Trials/NCT06095505

A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer

Is NCT06095505 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Alisertib for small cell lung cancer.

Phase 2RecruitingPuma Biotechnology, Inc.NCT06095505Data as of May 2026

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.

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Extracted eligibility criteria

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

Max 2 prior lines
Min 2 prior lines

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 →

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