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NCT Number: NCT06095505

A Study of Alisertib in Patients With Extensive Stage 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/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.

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Key information

Conditions

Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Southern Cancer Center, Daphne, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alisertib

Drug

Alisertib enteric-coated tablets

Other names: PB-8237, MLN8237

Primary outcomes

  1. 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

    Objective response rate is defined as the percentage of participants demonstrating a confirmed objective response during the study

  2. 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

    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.

  3. 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

    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.

  4. 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

    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.

  5. Overall Survival (OS) within biomarker-defined subgroup

    Time frame: 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.

Secondary outcomes

  1. Objective response rate (ORR) in the enrolled patient population

    Time frame: 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.

  2. Duration of response (DOR) in the enrolled patient population

    Time frame: 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.

  3. Disease Control Rate (DCR) in the enrolled patient population

    Time frame: 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.

  4. Progression Free Survival (PFS) in the enrolled patient population

    Time frame: 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.

  5. Overall Survival (OS) in the enrolled patient population

    Time frame: 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.

  6. Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) in the enrolled patient population

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Puma Biotechnology, Inc. Clinical Operations Senior Director

CONTACT

[email protected]

(424) 248-6500

Sponsors and collaborators

Lead sponsor

Puma Biotechnology, Inc.

Industry

Registry information

Official study title

A Phase 2 Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer

Acronym: ALISCA-Lung1

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Oct 23, 2023
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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