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.
Small Cell Lung Cancer
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.
A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
-
Southern Cancer Center, Daphne, Alabama, United States, 36526
The Oncology Institute of Hope and Innovation, Long Beach, California, United States, 90805
Rocky Mountain Cancer Centers, Lone Tree, Colorado, United States, 80124
Georgetown Lombardi Cancer Center, Washington, District of Columbia, United States, 20057
The Oncology Institute of Hope and Innovation, Fort Lauderdale, Florida, United States, 33316
Moffitt Cancer Center, Tampa, Florida, United States, 33612
Illinois Cancer Specialists, Niles, Illinois, United States, 60714
University of Maryland Greenebaum Comprehensive Cancer Center, Baltimore, Maryland, United States, 21201
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States, 02215
Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
18 Years to
ALL
No
Puma Biotechnology, Inc.,
Chief Scientific Officer, STUDY_DIRECTOR, Puma Biotechnology, Inc.
2026-01-31