Lung Cancer Clinical Trial

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

Summary

PUMA-ALI-4201 is a Phase 2 study evaluating alisertib in patients with pathologically-confirmed extensive-stage small cell lung cancer (ES-SCLC) following progression on or after first-line treatment with platinum-based chemotherapy along with an anti-PDL-1 immunotherapy agent. This study is intended to evaluate the efficacy, safety, and pharmacokinetics of alisertib and to identify the biomarker-defined subgroup(s) that may benefit most from alisertib treatment.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Aged ≥18 years at signing of informed consent
Pathologically confirmed ES-SCLC
Progression on or after first-line platinum-based chemotherapy. Patients must have also received a prior anti-PDL-1 immunotherapy agent

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.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

60

Study ID:

NCT06095505

Recruitment Status:

Recruiting

Sponsor:

Puma Biotechnology, Inc.

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There are 14 Locations for this study

See Locations Near You

Southern Cancer Center
Daphne Alabama, 36526, United States
Rocky Mountain Cancer Centers
Lone Tree Colorado, 80124, United States
Georgetown Lombardi Cancer Center
Washington District of Columbia, 20057, United States
Illinois Cancer Specialists
Niles Illinois, 60714, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Oncology Hematology Care Clinical Trials
Cincinnati Ohio, 45226, United States
University Hospital - Cleveland Medical Center
Cleveland Ohio, 44106, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Oncology Associates of Oregon
Eugene Oregon, 97401, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
Oncology & Hematology Associates of Southwest Virginia
Blacksburg Virginia, 24073, United States
Universtity of Virginia Health System
Charlottesville Virginia, 22908, United States
Virginia Cancer Specialists Research Institute
Fairfax Virginia, 22031, United States
Northwest Cancer Specialists
Vancouver Washington, 98686, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

60

Study ID:

NCT06095505

Recruitment Status:

Recruiting

Sponsor:


Puma Biotechnology, Inc.

How clear is this clinincal trial information?

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