A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
A Phase 2 Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
Puma Biotechnology, Inc.
80 participants
Feb 8, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria1
- Prior treatment with an AURKA specific-targeted or pan-Aurora-targeted agent, including alisertib in any setting
Interventions
Alisertib enteric-coated tablets
Locations(30)
View Full Details on ClinicalTrials.gov
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NCT06095505