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NCT06095505RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 17 Aug 2026

Brief summary (registry, in English)

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/PD-1 immunotherapy agent. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior treatment regimens. 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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
120 (estimated)
First submitted
27 Sept 2023
Start date
8 Feb 2024
Primary completion date
30 Oct 2027
Lead sponsor
Puma Biotechnology, Inc.
Diseases
Lung cancer
NCT number
NCT06095505

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 120
  • From 8 Feb 2024 to the primary completion date, 30 Oct 2027
  • 30 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Who the study is looking for

  • Aged ≥18 years at signing of informed consent
  • Pathologically confirmed SCLC
  • Prior treatment with one platinum-based chemotherapy and an anti-PD-L1/PD-1 immunotherapy. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior treatment regimens

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (30)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Maryland Greenebaum Comprehensive Cancer Center
Coordinator of this site? Confirm its status
BaltimoreUnited StatesRecruiting
Oncology & Hematology Associates of Southwest Virginia
Coordinator of this site? Confirm its status
BlacksburgUnited StatesRecruiting
Dana-Farber Cancer Institute
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Beth Israel Deaconess Medical Center
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Minnesota Oncology Hematology
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BurnsvilleUnited StatesRecruiting
Medical University of South Carolina - Hollings Cancer Center
Coordinator of this site? Confirm its status
CharlestonUnited StatesRecruiting
Universtity of Virginia Health System
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CharlottesvilleUnited StatesCompleted
Oncology Hematology Care Clinical Trials
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CincinnatiUnited StatesRecruiting
Clermont Oncology Center
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ClermontUnited StatesRecruiting
Cleveland Clinic
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ClevelandUnited StatesActive, not recruiting
University Hospital Cleveland Medical Center
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ClevelandUnited StatesRecruiting
Zangmeister Cancer Center
Coordinator of this site? Confirm its status
ColumbusUnited StatesRecruiting
Texas Oncology - Baylor Charles A. Sammons Cancer Center
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DallasUnited StatesRecruiting
University of Texas Southwestern Medical Center
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DallasUnited StatesRecruiting
Southern Cancer Center
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DaphneUnited StatesRecruiting
Henry Ford Hospital
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DetroitUnited StatesCompleted
Oncology Associates of Oregon
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EugeneUnited StatesRecruiting
Virginia Cancer Specialists Research Institute
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FairfaxUnited StatesRecruiting
The Oncology Institute of Hope and Innovation
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Fort LauderdaleUnited StatesRecruiting
Nebraska Cancer Specialists
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Grand IslandUnited StatesRecruiting
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
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IndianapolisUnited StatesRecruiting
Rocky Mountain Cancer Centers
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Lone TreeUnited StatesRecruiting
The Oncology Institute of Hope and Innovation
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Long BeachUnited StatesRecruiting
Marshfield Medical Center
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MarshfieldUnited StatesRecruiting
SCRI Oncology Partners
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NashvilleUnited StatesRecruiting
Illinois Cancer Specialists
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NilesUnited StatesRecruiting
UPMC Hillman Cancer Center
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PittsburghUnited StatesWithdrawn
Moffitt Cancer Center
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TampaUnited StatesRecruiting
Northwest Cancer Specialists
Coordinator of this site? Confirm its status
VancouverUnited StatesRecruiting
Georgetown Lombardi Cancer Center
Coordinator of this site? Confirm its status
Washington D.C.United StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.