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Evaluating alisertib for extensive stage small cell lung cancer

A Phase 2 Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer

Phase 2 Interventional Puma Biotechnology, Inc. · NCT06095505

This study is testing whether a drug called alisertib can help people with advanced small cell lung cancer who have already tried other treatments.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment80 (estimated)
Ages18 Years and up
SexAll
SponsorPuma Biotechnology, Inc. Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy
Locations30 sites (Daphne, Alabama and 29 other locations)
Trial IDNCT06095505 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with pathologically confirmed extensive stage small cell lung cancer who have received prior treatment with platinum-based chemotherapy and anti-PD-L1 immunotherapy.

Not a fit: Patients who have previously been treated with alisertib or other AURKA specific-targeted agents may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced small cell lung cancer who have limited treatment alternatives.

How similar studies have performed: While there have been studies on various treatments for small cell lung cancer, the specific use of alisertib in this context is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Daphne, Alabama and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Small Cell Lung CancerAlisertibSCLC
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.