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

Trial ID or NCT#

NCT05186974

Status

not recruiting iconNOT RECRUITING

Purpose

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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
    1. Key
Exclusion Criteria:
  1. * 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
    1. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Investigator(s)

Joel Neal, MD, PhD
Joel Neal, MD, PhD
Medical oncologist, Thoracic specialist
Associate Professor of Medicine (Oncology)

Contact us to find out if this trial is right for you.

Contact

Monica Loza
lozam@stanford.edu

View on ClinicalTrials.gov