A Global, Multicenter, Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Standard of Care (SOC) in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Gilead Sciences
Summary
The goal of this clinical study is to learn more about the study drug sacituzumab govitecan (SG; Trodelvy®; GS-0132; IMMU 132), versus standard of care (SOC) in participants with previously treated extensive stage small cell lung cancer (ES-SCLC). The primary objectives of this study are to compare the effect of SG to SOC on overall survival (OS).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Histologically confirmed diagnosis of SCLC. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by investigator per RECIST v1.1 criteria. * Documentation of radiological disease progression after 1 prior line of platinum-containing chemotherapy (defined as at least 2 cycles of treatment) with or without therapy directed against programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1; PD-1 and PD-L1 are hereafter referred…
Interventions
- DrugSacituzumab Govitecan (SG)
Administered intravenously
- DrugTopotecan
Administered intravenously
- DrugAmrubicin (Japan only)
Administered intravenously
- DrugLurbinectedin (regions/countries where approved and available)
Administered intravenously
Locations (205)
- Los Angeles Cancer NetworkAnaheim, California
- Boca Raton RegionalMiami, Florida
- Hope and Healing Cancer ServicesHinsdale, Illinois
- Southern Illinois University School of MedicineSpringfield, Illinois
- Springfield ClinicSpringfield, Illinois
- Parkview Research CenterFort Wayne, Indiana