Evaluating alisertib for extensive stage small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 study investigates the efficacy and safety of alisertib monotherapy in patients with extensive stage small cell lung cancer (SCLC) who have previously undergone treatment with platinum-based chemotherapy and anti-PD-L1 immunotherapy. The trial aims to identify specific biomarker-defined subgroups that may benefit most from alisertib treatment. Participants may have received up to two prior lines of systemic anti-cancer therapy. The study will also assess the pharmacokinetics of alisertib in this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Southern Cancer Center
  Daphne, Alabama, United States Recruiting
• The Oncology Institute of Hope and Innovation
  Long Beach, California, United States Recruiting
• Rocky Mountain Cancer Centers
  Lone Tree, Colorado, United States Recruiting
• Georgetown Lombardi Cancer Center
  Washington D.C., District of Columbia, United States Recruiting
• Clermont Oncology Center
  Clermont, Florida, United States Recruiting
• The Oncology Institute of Hope and Innovation
  Fort Lauderdale, Florida, United States Recruiting

Study contacts

• Study coordinator: Puma Biotechnology, Inc. Clinical Operations Senior Director
• Email: ClinicalTrials@pumabiotechnology.com
• Phone: (424) 248-6500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.