Status:

RECRUITING

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

Lead Sponsor:

Puma Biotechnology, Inc.

Conditions:

Small Cell Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief 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-...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

February 8 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 31 2027

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT06095505

Start Date

February 8 2024

End Date

October 31 2027

Last Update

November 12 2025

Active Locations (30)

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Page 1 of 8 (30 locations)

1

Southern Cancer Center

Daphne, Alabama, United States, 36526

2

The Oncology Institute of Hope and Innovation

Long Beach, California, United States, 90805

3

Rocky Mountain Cancer Centers

Lone Tree, Colorado, United States, 80124

4

Georgetown Lombardi Cancer Center

Washington D.C., District of Columbia, United States, 20057