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

Phase 2

Recruiting

• Conditions: Small Cell Lung Cancer
• Interventions: Drug: Alisertib

• Registration Number: NCT06095505
• Lead Sponsor: Puma Biotechnology, Inc.

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-27
• Study First Submitted QC: 2023-10-18
• Study First Posted: 2023-10-23
• Study Start: 2024-02-08
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-26
• Last Update Posted: 2025-07-01
• Primary Completion: 2027-04-30
• Study Completion: 2027-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Alisertib	Alisertib	50 mg (Prior to Amendment 2) or 60 mg (Amendment 2) of alisertib PO BID on days 1-7 of each 21-day cycle
Alisertib	Alisertib	50 mg of alisertib PO BID on days 1-7 of each 21-day cycle

Primary Outcome Measures

Name	Time	Method
Disease Control Rate (DCR) within biomarker-defined subgroup	From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months	Disease control rate is the proportion of patients who achieve overall tumor response (confirmed CR or PR) or SD lasting for at least 8 weeks from first dose of investigational product.
Progression Free Survival (PFS) within biomarker-defined subgroup	From date of first dose to date of recurrence, progression or death, assessed up to 36 months	Progression Free Survival (PFS) is measured in months and based on the local tumor assessment. The time interval from the date of first dose until the first date on which recurrence, progression, or death due to any cause, is documented.
Overall Survival (OS) within biomarker-defined subgroup	From date of first dose to death, assessed up to 36 months	Overall survival (OS) is defined as the time from date of first dose to death due to any cause, censored at the last date known alive on or prior to the data cutoff employed for the analysis, whichever was earlier.
Objective response rate (ORR) within biomarker-defined subgroup	From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months	Objective response rate is defined as the percentage of participants demonstrating a confirmed objective response during the study
Duration of response (DOR) within biomarker-defined subgroup	From start date of response (after date of first dose) to first PD, assessed up to 36 months	Duration of response is measured from the time at which measurement criteria are first met for CR or PR (whichever status is recorded first) until the first date of recurrence or progressive disease (PD) or death is objectively documented.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS) in the enrolled patient population	From date of first dose to date of recurrence, progression or death, assessed up to 36 months	Progression Free Survival (PFS) is measured in months and based on the local tumor assessment. The time interval from the date of first dose until the first date on which recurrence, progression, or death due to any cause, is documented.
Overall Survival (OS) in the enrolled patient population	From date of first dose to death, assessed up to 36 months	Overall survival (OS) is defined as the time from date of first dose to death due to any cause, censored at the last date known alive on or prior to the data cutoff employed for the analysis, whichever was earlier.
Objective response rate (ORR) in the enrolled patient population	From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months	Objective response rate is defined as the percentage of participants demonstrating a confirmed objective response during the study.
Duration of response (DOR) in the enrolled patient population	From start date of response (after date of first dose) to first PD, assessed up to 36 months	Duration of response is measured from the time at which measurement criteria are first met for CR or PR (whichever status is recorded first) until the first date of recurrence or progressive disease (PD) or death is objectively documented.
Disease Control Rate (DCR) in the enrolled patient population	From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months	Disease control rate is the proportion of patients who achieve overall tumor response (confirmed CR or PR) or SD lasting for at least 8 weeks from first dose of investigational product.
Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) in the enrolled patient population	From date of first dose through last dose plus 28 days, assessed up to 36 months	Treatment emergent adverse events are those events reported on or after the first dose of investigational product and up to 28 days after last dose.

Trial Locations

Locations (26)

Southern Cancer Center; 🇺🇸 Daphne, Alabama, United States

The Oncology Institute of Hope and Innovation; 🇺🇸 Fort Lauderdale, Florida, United States

Rocky Mountain Cancer Centers; 🇺🇸 Lone Tree, Colorado, United States

Georgetown Lombardi Cancer Center; 🇺🇸 Washington, District of Columbia, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

Illinois Cancer Specialists; 🇺🇸 Niles, Illinois, United States

University of Maryland Greenebaum Comprehensive Cancer Center; 🇺🇸 Baltimore, Maryland, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

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