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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
193
Administered intravenously
Administered intravenously
Administered intravenously
Objective Response Rate as Assessed by Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame: Up to 22 Months
Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) per Dose Level in the Safety Run-in Cohorts
Time frame: First dose date up to 21 days
Progression-free Survival as Assessed by IRC per RECIST Version 1.1
Time frame: Up to 24 Months
Overall Survival
Time frame: Up to 24 Months
Duration of Response as Assessed by IRC per RECIST Version 1.1
Time frame: Up to 24 Months
Disease Control Rate as Assessed by IRC per RECIST Version 1.1
Time frame: Up to 24 Months
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: First dose date up to 24 Months plus 30 days
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Time frame: First dose date up to 24 Months plus 30 days
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Administered intravenously
Alaska Oncology and Hematology, LLC.
Anchorage, Alaska, United States
Beverly Hills Cancer Center
Beverly Hills, California, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
UCLA Hematology/Oncology - Santa Monica
Los Angeles, California, United States
UC Irvine Health
Orange, California, United States
Stanford Cancer Institute
Stanford, California, United States
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora, Colorado, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Moffitt Cancer Center
Tampa, Florida, United States
Northside Hospital Central Research Department
Atlanta, Georgia, United States
...and 91 more locations