NCT06095505Phase 2Recruiting

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

Study sponsor: Puma Biotechnology, Inc. · PBYI

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2027-10-30Estimated

Enrollment · participants120Estimated

Source updated2026-08-17Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-06-05 · 2 fields changed

Planned enrollment increased by 40 participants

− Before

~~80 participants (planned)~~

+ After

120 participants (planned)

Primary completion date changed

− Before

~~30 Apr 2027~~

+ After

30 Oct 2027

Check registry source

Study details

Conditions studied

Small Cell Lung Cancer

Treatments or interventions studied

AlisertibDrugAlso known as PB-8237, MLN8237

Primary outcomes · main study measures

Read the study measures

measure: Objective response rate (ORR) within biomarker-defined subgroup; description: Objective response rate is defined as the percentage of participants demonstrating a confirmed objective response during the study; timeFrame: From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months; measure: Duration of response (DOR) within biomarker-defined subgroup; description: 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.; timeFrame: From start date of response (after date of first dose) to first PD, assessed up to 36 months; measure: Disease Control Rate (DCR) within biomarker-defined subgroup; description: 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.; timeFrame: From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months; measure: Progression Free Survival (PFS) within biomarker-defined subgroup; description: 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.; timeFrame: From date of first dose to date of recurrence, progression or death, assessed up to 36 months; measure: Overall Survival (OS) within biomarker-defined subgroup; description: 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.; timeFrame: From date of first dose to death, assessed up to 36 months

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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