Study of Sacituzumab Govitecan Combinations in First-line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC)

Not Recruiting

Trial ID: NCT05186974


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

Stanford Investigator(s)

Joel Neal, MD, PhD
Joel Neal, MD, PhD

Associate Professor of Medicine (Oncology)


Key Inclusion Criteria:

   - 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

Key Exclusion Criteria:

   - 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

   - Is currently participating in or has participated in a study of an investigational

   - 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.


drug: Sacituzumab Govitecan-hziy (SG)

drug: Pembrolizumab

drug: Carboplatin

drug: Cisplatin

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Monica Loza

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