NCT06095505 · Puma Biotechnology, Inc.
A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
(ALISCA-Lung1)
What this study is about
PUMA-ALI-4201 is a Phase 2 study evaluating alisertib treatment given alone 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.
View original scientific description
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.
Interventions
DRUG
Alisertib
Alisertib enteric-coated tablets
Primary outcome measures
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
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.
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.
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Daphne, Alabama
- Long Beach, California
- Lone Tree, Colorado
- Washington D.C., District of Columbia
- Clermont, Florida
- Fort Lauderdale, Florida
- Tampa, Florida
- Niles, Illinois
- Indianapolis, Indiana
- Baltimore, Maryland
- Boston, Massachusetts
- Detroit, Michigan
And 15 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 5, 2026 · Source of record for eligibility and locations