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

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• 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

You cannot join if

• 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.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

alisertib. A second-generation, orally bioavailable, highly selective small molecule inhibitor of the serine/threonine protein kinase Aurora A kinase with potential antineoplastic activity. Alisertib binds to and inhibits Aurora A kinase, which may result in disruption of the assembly of the mitotic spindle apparatus, disruption of chromosome segregation, and inhibition of cell proliferation. Aurora A kinase localizes to the spindle poles and to spindle microtubules during mitosis, and is thought to regulate spindle assembly. Aberrant expression of Aurora kinases occurs in a wide variety of cancers, including colon and breast cancers. NCI Drug Dictionary

Treatments listed in the registry

• Alisertib (Drug): Alisertib enteric-coated tablets

Na · Single Group · masking: None

Main goals

• Objective response rate (ORR) within biomarker-defined subgroup (From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months)
• Duration of response (DOR) within biomarker-defined subgroup (From start date of response (after date of first dose) to first PD, assessed up to 36 months)
• Disease Control Rate (DCR) within biomarker-defined subgroup (From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months)
• Progression Free Survival (PFS) within biomarker-defined subgroup (From date of first dose to date of recurrence, progression or death, assessed up to 36 months)
• Overall Survival (OS) within biomarker-defined subgroup (From date of first dose to death, assessed up to 36 months)

Other goals

• Objective response rate (ORR) in the enrolled patient population
• Duration of response (DOR) in the enrolled patient population
• Disease Control Rate (DCR) in the enrolled patient population
• Progression Free Survival (PFS) in the enrolled patient population
• Overall Survival (OS) in the enrolled patient population
• Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) in the enrolled patient population

Planned enrollment: 120 (estimated).

• Southern Cancer Center, Daphne, Alabama
• The Oncology Institute of Hope and Innovation, Long Beach, California
• Rocky Mountain Cancer Centers, Lone Tree, Colorado
• Georgetown Lombardi Cancer Center, Washington D.C., District of Columbia
• Clermont Oncology Center, Clermont, Florida
• The Oncology Institute of Hope and Innovation, Fort Lauderdale, Florida
• Moffitt Cancer Center, Tampa, Florida
• Illinois Cancer Specialists, Niles, Illinois
• Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, Indiana
• University of Maryland Greenebaum Comprehensive Cancer Center, Baltimore, Maryland
• Beth Israel Deaconess Medical Center, Boston, Massachusetts
• Dana Farber Cancer Institute, Boston, Massachusetts
• Minnesota Oncology Hematology, Burnsville, Minnesota
• Nebraska Cancer Specialists, Grand Island, Nebraska
• Oncology Hematology Care Clinical Trials, Cincinnati, Ohio
• University Hospital - Cleveland Medical Center, Cleveland, Ohio
• Zangmeister Cancer Center, Columbus, Ohio
• Oncology Associates of Oregon, Eugene, Oregon
• Medical University of South Carolina Hollings Cancer Center, Charleston, South Carolina
• SCRI Oncology Partners, Nashville, Tennessee
• Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, Texas
• University of Texas Southwestern Medical Center, Dallas, Texas
• Oncology & Hematology Associates of Southwest Virginia, Blacksburg, Virginia
• Virginia Cancer Specialists Research Institute, Fairfax, Virginia
• Northwest Cancer Specialists, Vancouver, Washington
• Marshfield Medical Center, Marshfield, Wisconsin

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT06095505
• NCI Drug Dictionary: C71717

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Aug 16, 2026. Public record; not medical advice.