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

• Status: Recruiting
• Trial end date: 2026-01-31
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Puma Biotechnology, Inc.

Criteria

Inclusion Criteria:

• Aged ≥18 years at signing of informed consent

• Pathologically confirmed SCLC

• Prior treatment with one platinum-based chemotherapy and an anti-PD-L1 immunotherapy. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior lines of therapy

Exclusion Criteria:

• 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.