Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion

Description

Summary

The primary objectives of the study are to assess the objective response rate (ORR) and to determine the recommended Phase 2 dose (RP2D) of SG in combination with pembrolizumab or pembrolizumab and a platinum agent (carboplatin or cisplatin) in participants with advanced or metastatic non-small-cell lung cancer (NSCLC) without actionable genomic alterations.

Official Title

An Open-label, Multicenter, Phase 2 Study of Sacituzumab Govitecan Combinations in First-line Treatment of Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) Without Actionable Genomic Alterations

Keywords

Non-small Cell Lung Cancer, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Cisplatin, Carboplatin, Pembrolizumab, Sacituzumab Govitecan-hziy (SG), SG + Pembrolizumab + Carboplatin Safety Run-in, SG + Pembrolizumab + Cisplatin Safety Run-in (Optional)

Eligibility

You can join if…

Open to people ages 18 years and up

  • Individuals with pathologically documented evidence of Stage IV non-small cell lung Cancer (NSCLC) disease at the time of enrollment
  • Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per RECIST Version 1.1 criteria by investigator
  • No prior systemic treatment for metastatic NSCLC
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Adequate hematologic counts
  • Adequate hepatic function

You CAN'T join if...

  • Mixed SCLC and NSCLC histology
  • Active second malignancy
  • NSCLC that is eligible for definitive local therapy alone
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
  • Has had an allogenic tissue/solid organ transplant.
  • Has severe (≥ Grade 3) hypersensitivity to SG, pembrolizumab, carboplatin, or cisplatin, their metabolites, or formulation excipient
  • Has received radiation therapy to the lung
  • Individuals may not have received systemic anticancer treatment within the previous 6 months
  • Is currently participating in or has participated in a study of an investigational agent
  • Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
  • Known active central nervous system (CNS) metastases
  • History of cardiac disease
  • Active chronic inflammatory bowel disease
  • Active serious infection requiring antibiotics
  • Active or chronic hepatitis B infection
  • Positive hepatitis C antibody
  • Positive serum pregnancy test or women who are lactating

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

  • UC Irvine Medical Center accepting new patients
    Orange California 92868 United States
  • USC/Norris Comprehensive Cancer Center accepting new patients
    Los Angeles California 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
Links
Gilead Clinical Trials Website
ID
NCT05186974
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 164 study participants
Last Updated