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)
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).
Arms & interventions
- DrugSacituzumab Govitecan (SG)
Administered intravenously
- DrugTopotecan
Administered intravenously
- DrugAmrubicin (Japan only)
Administered intravenously
- DrugLurbinectedin (regions/countries where approved and available)
Administered intravenously
Outcome measures
Primary
Overall Survival (OS)
OS is defined as length of time from randomization until the date of death from any cause.
Time frame: Up to 4.5 years
Secondary
Progression-free Survival (PFS)
Time frame: Up to 4.5 years
Objective Response Rate (ORR)
Time frame: Up to 4.5 years
Duration of Response (DOR)
Time frame: Up to 4.5 years
Time to First Deterioration in Shortness of Breath Domain
Time frame: Up to 4.5 years
Time to First Deterioration in Physical Functioning Domain
Time frame: Up to 4.5 years
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: First dose date up to 4.5 years
Percentage of Participants Experiencing Clinical Laboratory abnormalities
Time frame: First dose date up to 4.5 years
Eligibility criteria
Study locations (19)
Genesis Cancer and Blood Institute
Hot Springs, Arkansas, 71913
Los Angeles Cancer Network
Anaheim, California, 92801
Boca Raton Regional
Miami, Florida, 33143
Hope and Healing Cancer Services
Hinsdale, Illinois, 60521
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Springfield Clinic
Springfield, Illinois, 62702
Parkview Research Center
Fort Wayne, Indiana, 46845
IU Health Ball Memorial Hospital and Physicians - Cancer Center - Muncie
Muncie, Indiana, 47303
Northwest Cancer Centers
Dyer, Kentucky, 46311
St. Claire Regional Medical Ce
Morehead, Kentucky, 40351
New Mexico Oncology Hematology Consultants, Ltd
Albuquerque, New Mexico, 87109
University Hospitals Seidman Cancer Center
Sandusky, Ohio, 44870
Taylor Cancer Research Foundation
Toledo, Ohio, 43617
Spoknwrd Clinical Trials Inc.
Easton, Pennsylvania, 18045
Hendrick Health System
Abilene, Texas, 79601
MD Anderson Cancer Center
Houston, Texas, 77030
Texas Oncology - San Antonio
New Braunfels, Texas, 78130
The University of Texas Health Science Center at Tyler
Tyler, Texas, 75708
Gundersen Health System
West Salem, Wisconsin, 54601