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NCT06095505 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Small-cell Lung Cancer, sponsored by Puma Biotechnology.

Recruiting
Registry status
Phase 2
Development phase
80
Enrollment target
20
Study locations

NCT06095505 is a Phase 2 study of Small-cell Lung Cancer that is actively recruiting participants, run by Puma Biotechnology. The registered enrollment target is 80 participants, below the 231-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT06095505, a Phase 2 study of Small-cell Lung Cancer, is actively recruiting participants, sponsored by Puma Biotechnology.

RECRUITING
Registry status
Phase 2
Development phase
80 participants
Enrollment target
20
Study locations

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

Small-cell Lung Cancer

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

28 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, categorized as Phase 2. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 231-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (65% lower). The listed sponsor is Puma Biotechnology, which has 28 total studies on file at ClinicalTrials.gov.

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.

NCT06095505 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Ohio, Florida, Massachusetts.

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.

What interventions are being tested in trial NCT06095505?

The interventions under investigation include: Alisertib (DRUG).

Who is sponsoring clinical trial NCT06095505?

This trial is sponsored by Puma Biotechnology, which has 28 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.