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#
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).
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
- - 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
- - 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.
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