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
Description
Brief Summary
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).
Phase
N/AInclusion and Exclusion 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
- 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.
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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