Recruiting
Phase 2

Alisertib

Sponsor:

Puma Biotechnology, Inc.

Code:

NCT06095505

Conditions

Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Alisertib

Study Details

Brief 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/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.

Conditions

Small Cell Lung Cancer

Study ID

NCT06095505

Start date

Feb 8, 2024

Status verified date

Aug, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Oct 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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/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

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 Design

Enrollment

120 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Alisertib

50 mg (Prior to Amendment 2) or 60 mg (Amendment 2) or 70 mg (Amendment 3 or later) of alisertib PO BID on days 1-7 of each 21-day cycle

Interventions

Alisertib

Alisertib enteric-coated tablets

Primary outcome measure

  • Objective response rate (ORR) within biomarker-defined subgroup [ Time Frame: From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months ]
  • Duration of response (DOR) within biomarker-defined subgroup [ Time Frame: From start date of response (after date of first dose) to first PD, assessed up to 36 months ]
  • Disease Control Rate (DCR) within biomarker-defined subgroup [ Time Frame: From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months ]
  • Progression Free Survival (PFS) within biomarker-defined subgroup [ Time Frame: From date of first dose to date of recurrence, progression or death, assessed up to 36 months ]
  • Overall Survival (OS) within biomarker-defined subgroup [ Time Frame: From date of first dose to death, assessed up to 36 months ]

Central Contacts and Locations

Central contacts

Puma Biotechnology, Inc. Clinical Operations Senior Director

(424) 248-6500ClinicalTrials@pumabiotechnology.com

Locations

Southern Cancer Center

Recruiting

Daphne, Alabama, United States, 36526

The Oncology Institute of Hope and Innovation

Recruiting

Long Beach, California, United States, 90805

Rocky Mountain Cancer Centers

Recruiting

Lone Tree, Colorado, United States, 80124

Georgetown Lombardi Cancer Center

Recruiting

Washington D.C., District of Columbia, United States, 20057

Clermont Oncology Center

Recruiting

Clermont, Florida, United States, 64711

The Oncology Institute of Hope and Innovation

Recruiting

Fort Lauderdale, Florida, United States, 33316

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Illinois Cancer Specialists

Recruiting

Niles, Illinois, United States, 60714

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Recruiting

Indianapolis, Indiana, United States, 46202

University of Maryland Greenebaum Comprehensive Cancer Center

Recruiting

Baltimore, Maryland, United States, 21201

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Minnesota Oncology Hematology

Recruiting

Burnsville, Minnesota, United States, 55337

Nebraska Cancer Specialists

Recruiting

Grand Island, Nebraska, United States, 68803

Oncology Hematology Care Clinical Trials

Recruiting

Cincinnati, Ohio, United States, 45226

University Hospital - Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Zangmeister Cancer Center

Recruiting

Columbus, Ohio, United States, 43219

Oncology Associates of Oregon

Recruiting

Eugene, Oregon, United States, 97401

Medical University of South Carolina Hollings Cancer Center

Recruiting

Charleston, South Carolina, United States, 29425

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Recruiting

Dallas, Texas, United States, 75246

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Oncology & Hematology Associates of Southwest Virginia

Recruiting

Blacksburg, Virginia, United States, 24073

Virginia Cancer Specialists Research Institute

Recruiting

Fairfax, Virginia, United States, 22031

Northwest Cancer Specialists

Recruiting

Vancouver, Washington, United States, 98686

Marshfield Medical Center

Recruiting

Marshfield, Wisconsin, United States, 54449

More Information

Sponsor

Puma Biotechnology, Inc.

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

  • Alisertib
  • SCLC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Puma Biotechnology, Inc. on 2026-08-17.