Status:
ACTIVE_NOT_RECRUITING
Study of Sacituzumab Govitecan Combinations in First-line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC)
Lead Sponsor:
Gilead Sciences
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 (carbopla...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
May 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2026
Estimated Enrollment :
193 Patients enrolled
Trial Details
Trial ID
NCT05186974
Start Date
May 30 2022
End Date
February 1 2026
Last Update
September 16 2025
Active Locations (101)
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1
Alaska Oncology and Hematology, LLC.
Anchorage, Alaska, United States, 99508
2
Beverly Hills Cancer Center
Beverly Hills, California, United States, 90211
3
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
4
UCLA Hematology/Oncology - Santa Monica
Los Angeles, California, United States, 90404