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



The goal of this clinical study is to learn more about the study drug, sacituzumab govitecan-hziy (SG), and its dosing in combination with pembrolizumab or pembrolizumab and a platinum agent (carboplatin or cisplatin), in participants with advanced or metastatic (cancer that has spread) non-small-cell lung cancer (NSCLC).

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


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


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.


  • UC Irvine Health
    Orange California 92868 United States
  • USC/Norris Comprehensive Cancer Center
    Los Angeles California 90033 United States


in progress, not accepting new patients
Start Date
Completion Date
Gilead Sciences
Gilead Clinical Trials Website
Phase 2 research study
Study Type
About 193 people participating
Last Updated