A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
Sponsor: Puma Biotechnology, Inc.
ClinicalTrials ID:NCT06095505
The PUMA-ALI-4201 Phase 2 trial assesses alisertib monotherapy in patients with SCLC who have progressed after platinum-based chemotherapy and anti-PD-L1 therapy, allowing one additional prior systemic treatment. Participants must be 18 or older with confirmed SCLC. The study aims to identify responsive biomarker subgroups and evaluate alisertib's efficacy, safety, and pharmacokinetics using enteric-coated tablets.
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Program Overview
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.
Eligibility 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.
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