A Study of Alisertib for Extensive Stage Small Cell Lung Cancer
This study is testing a drug called alisertib in people with extensive stage small cell lung cancer (SCLC). You may be able to join if you are at least 18 years old, have SCLC that has been confirmed by a doctor, and have already received one platinum-based chemotherapy and an anti-PD-L1/PD-1 immunotherapy (a type of treatment that uses your body's immune system to fight cancer). You might also have had up to one additional cancer treatment. The researchers want to see how well alisertib works, if it is safe, and if certain biomarkers (biological signs in your body) can help predict who will benefit most from the treatment. This study is currently unclear on its recruitment status and plans to enroll 120 participants.
- Study design
- This is a Phase 2 study, meaning it's in an earlier stage of testing a new treatment. It is designed to evaluate alisertib monotherapy in participants who have already received certain prior treatments.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track how well the treatment works for up to 36 months after your first dose.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
At a glance
Conditions
Where it's being run
30 sites across 21 statesStudy leadership
- Chief Scientific Officer · STUDY_DIRECTOR · Puma Biotechnology, Inc.
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Objective response rate (ORR) within biomarker-defined subgroupFrom 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 subgroupFrom 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 subgroupFrom 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 subgroupFrom 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 subgroupFrom 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.