Clinical Trial

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

Study acronym: ALISCA-Lung1
Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 3 changes
notable Enrollment increased: 80 -> 120 participants 2026-06-06
notable Primary completion pushed: 2027-04-30 -> 2027-10-30 2026-06-06
minor Completion pushed: 2027-10-31 -> 2028-04-30 2026-06-06
Trial Details
NCT Number NCT06095505
Lead Sponsor Puma Biotechnology, Inc.
Conditions Small Cell Lung Cancer
Enrollment 120 participants
Start Date 2024-02-08
Primary Completion 2027-10-30 (estimated)
Study Completion 2028-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-05