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

RECRUITINGPhase 2Sponsored by Puma Biotechnology, Inc.
Actively Recruiting
PhasePhase 2
SponsorPuma Biotechnology, Inc.
Started2024-02-08
Est. completion2027-04-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations30 sites
View on ClinicalTrials.gov →

NCT06095505

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

Age: 18 Years+Healthy volunteers accepted
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.

Conditions3

CancerLung CancerSmall Cell Lung Cancer

Locations30 sites

Southern Cancer Center
Daphne, Alabama, 36526
The Oncology Institute of Hope and Innovation
Long Beach, California, 90805
Rocky Mountain Cancer Centers
Lone Tree, Colorado, 80124
Georgetown Lombardi Cancer Center
Washington D.C., District of Columbia, 20057
Clermont Oncology Center
Clermont, Florida, 64711

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