A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer (ALISCA-Lung1)

June 3, 2026 updated by: Puma Biotechnology, Inc.

A Phase 2 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Daphne, Alabama, United States, 36526
        • Recruiting
        • Southern Cancer Center
    • California
      • Long Beach, California, United States, 90805
        • Recruiting
        • The Oncology Institute of Hope and Innovation
    • Colorado
      • Lone Tree, Colorado, United States, 80124
        • Recruiting
        • Rocky Mountain Cancer Centers
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20057
        • Recruiting
        • Georgetown Lombardi Cancer Center
    • Florida
      • Clermont, Florida, United States, 64711
        • Recruiting
        • Clermont Oncology Center
      • Fort Lauderdale, Florida, United States, 33316
        • Recruiting
        • The Oncology Institute of Hope and Innovation
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
    • Illinois
      • Niles, Illinois, United States, 60714
        • Recruiting
        • Illinois Cancer Specialists
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Melvin and Bren Simon Comprehensive Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland Greenebaum Comprehensive Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Recruiting
        • Minnesota Oncology Hematology
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • Recruiting
        • Nebraska Cancer Specialists
    • Ohio
      • Cincinnati, Ohio, United States, 45226
        • Recruiting
        • Oncology Hematology Care Clinical Trials
      • Cleveland, Ohio, United States, 44195
        • Active, not recruiting
        • Cleveland Clinic
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospital - Cleveland Medical Center
      • Columbus, Ohio, United States, 43219
        • Recruiting
        • Zangmeister Cancer Center
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Oncology Associates of Oregon
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Withdrawn
        • UPMC Hillman Cancer Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina Hollings Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • SCRI Oncology Partners
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern Medical Center
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Texas Oncology-Baylor Charles A. Sammons Cancer Center
    • Virginia
      • Blacksburg, Virginia, United States, 24073
        • Recruiting
        • Oncology & Hematology Associates of Southwest Virginia
      • Charlottesville, Virginia, United States, 22908
        • Completed
        • Universtity of Virginia Health System
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Virginia Cancer Specialists Research Institute
    • Washington
      • Vancouver, Washington, United States, 98686
        • Recruiting
        • Northwest Cancer Specialists
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Recruiting
        • Marshfield Medical Center

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: Alisertib
Alisertib enteric-coated tablets
Other Names:
  • MLN8237
  • PB-8237

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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.
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
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.
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
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.
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
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.
From date of first dose to death, assessed up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months
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.
From start date of response (after date of first dose) to first PD, assessed up to 36 months
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.
From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months
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.
From date of first dose to date of recurrence, progression or death, assessed up to 36 months
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.
From date of first dose to death, assessed up to 36 months
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.
From date of first dose through last dose plus 28 days, assessed up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Puma Biotechnology, Inc.

Investigators

  • Study Director: Chief Scientific Officer, Puma Biotechnology, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2024

Primary Completion (Estimated)

October 30, 2027

Study Completion (Estimated)

April 30, 2028

Study Registration Dates

First Submitted

September 27, 2023

First Submitted That Met QC Criteria

October 18, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMA-ALI-4201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge.

In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings.

Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information.

Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.

IPD Sharing Time Frame

Clinical study documents and clinical trial data may be requested by qualified researchers and study participants for studies that have been completed for at least 18 months, and for which the indication of the drug has been approved in the US and/or EU, as applicable. Requests will be accepted for up to 24 months after the criteria described in this section are met.

IPD Sharing Access Criteria

Requestors must provide organizational contact information; a detailed research plan, including outcomes; timeline for completion of the research; qualifications of the research team; funding source; and potential conflicts of interest.

Puma will not provide access to patient-level data if there is a reasonable likelihood that individual patients could be identified, or in cases where confidentiality or consent provisions prohibit transfer of data or information to third parties. Additionally, Puma will not disclose information that jeopardizes intellectual property rights or divulges confidential commercial information.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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