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

PUMA-ALI-4201 is a Phase 2 study evaluating alisertib in patients with pathologically-confirmed extensive-stage small cell lung cancer (ES-SCLC) following progression on or after first-line treatment with platinum-based chemotherapy along with an anti-PDL-1 immunotherapy agent. This study is intended to evaluate the efficacy, safety, and pharmacokinetics of alisertib and to identify the biomarker-defined subgroup(s) that may benefit most from alisertib treatment.

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 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 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) 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) 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.

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 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 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) 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) 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.

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

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.

Inclusion Criteria: Aged ≥18 years at signing of informed consent Pathologically confirmed ES-SCLC Progression on or after first-line platinum-based chemotherapy. Patients must have also received a prior anti-PDL-1 immunotherapy agent 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.

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.

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.

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.