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RECRUITING Phase 2

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

NCT06095505 · View on ClinicalTrials.gov ↗

Study Summary

PUMA-ALI-4201 is a Phase 2 study evaluating alisertib monotherapy in patients with pathologically-confirmed small cell lung cancer (SCLC) following progression on or after treatment with one platinum-based chemotherapy and anti-PD-L1 immunotherapy agent. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior lines of therapy. This study is intended to identify the biomarker-defined subgroup(s) that may benefit most from alisertib treatment and to evaluate the efficacy, safety, and pharmacokinetics of alisertib.

Conditions Studied

Interventions

  • DRUG Alisertib

Study Locations (20)

Ohio

  • Oncology Hematology Care Clinical Trials — Cincinnati
  • University Hospital - Cleveland Medical Center — Cleveland
  • Cleveland Clinic — Cleveland
  • Zangmeister Cancer Center — Columbus

Florida

  • Clermont Oncology Center — Clermont
  • The Oncology Institute of Hope and Innovation — Fort Lauderdale
  • Moffitt Cancer Center — Tampa

Massachusetts

  • Beth Israel Deaconess Medical Center — Boston
  • Dana Farber Cancer Institute — Boston

Alabama

  • Southern Cancer Center — Daphne

California

  • The Oncology Institute of Hope and Innovation — Long Beach

Colorado

  • Rocky Mountain Cancer Centers — Lone Tree

District of Columbia

  • Georgetown Lombardi Cancer Center — Washington D.C.

Illinois

  • Illinois Cancer Specialists — Niles

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2024-02-08
Est. Completion 2027-10-31
Phase Phase 2

Sponsor

Puma Biotechnology

6 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06095505

The ClinicalTrials.gov registry entry for NCT06095505 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Puma Biotechnology, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention — of which Alisertib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06095505 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Ohio, Florida, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06095505 about?

NCT06095505 is a clinical study titled "A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer". PUMA-ALI-4201 is a Phase 2 study evaluating alisertib monotherapy in patients with pathologically-confirmed small cell lung cancer (SCLC) following progression on or after treatment with one platinum-based chemotherapy and anti-PD-L1 immunotherapy agent. Up to one additional systemic anti-cancer the...

What is the current status of trial NCT06095505?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2024-02-08. Estimated completion is 2027-10-31.

What conditions does trial NCT06095505 study?

This clinical trial studies the following conditions: Small Cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06095505?

The interventions under investigation include: Alisertib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06095505?

This trial is sponsored by Puma Biotechnology, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06095505 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial