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A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer (ALISCA-Lung1)

Puma Biotechnology logo

Puma Biotechnology

Status and phase

Enrolling
Phase 2

Conditions

Small Cell Lung Cancer

Treatments

Drug: Alisertib

Study type

Interventional

Funder types

Industry

Identifiers

NCT06095505
PUMA-ALI-4201

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

Alisertib
Experimental group
Description:
50 mg of alisertib PO BID on days 1-7 of each 21-day cycle
Treatment:
Drug: Alisertib

Trial contacts and locations

19

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Central trial contact

Puma Biotechnology, Inc. Clinical Operations Senior Director

Data sourced from clinicaltrials.gov

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