This is a randomized, open-label study of Serplulimab plus chemotherapy (Carboplatin-Etoposide) in comparison with Atezolizumab plus chemotherapy in previously untreated US patients with ES-SCLC. Subjects in this study will be randomized to arm A or B at 1:1 ratio as follows: * Arm A (Serplulimab): Serplulimab + chemotherapy (carboplatin-etoposide) * Arm B (control): Atezolizumab + chemotherapy (carboplatin-etoposide)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Drug: Serplulimab is an innovative monoclonal antibody targeting PD-1,developed by Shanghai Henlius Biotech, Inc. Drug: carboplatin and etoposide chemotherapeutics
Drug: Atezolizumab is a monoclonal antibody targeting PD-L1,developed by Roche Pharma AG. Drug: carboplatin and etoposide chemotherapeutics
OS
Overall assessment
Time frame: A period from randomization through death regardless of causality (approximately up to 24 months).
ORR
Objective response rate
Time frame: approximately up to 14 months
PFS
Progression-free survival
Time frame: approximately up to 24 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Adverse events are described and graded using the grading categories defined in CTCAE, Version 5.0
Time frame: approximately up to 24 months
Maximum Plasma Concentration (Cmax)
The maximum concentration (Cmax) of Serplulimab will be measured
Time frame: approximately up to 24 months
Minimum Plasma Concentration (Cmin)
The minimum concentration (Cmin) of Serplulimab will be measured
Time frame: approximately up to 24 months
Average Plasma Concentration (Cavg)
The average Plasma Concentration (Cavg) of Serplulimab will be measured
Time frame: approximately up to 24 months
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...and 57 more locations