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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
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
Stanford Investigator(s)
Joel Neal, MD, PhD
Associate Professor of Medicine (Oncology)
Eligibility
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 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.
Intervention(s):
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
lozam@stanford.edu