This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of Serplulimab + chemotherapy+ concurrent radiotherapy vs chemotherapy+ concurrent radiotherapy in subjects with Limited-Stage Small Cell Lung Cancer.
Eligible subjects in this study will be randomized to Arm A or Arm B at 1:1 ratio. Arm A (Serplulimab arm): Serplulimab + chemotherapy(Carboplatin/Cisplatin-Etoposide)+concurrent radiotherapy; Arm B (placebo arm): Placebo + chemotherapy(Carboplatin/Cisplatin-Etoposide)+concurrent radiotherapy; The 4 stratification factors for randomization include: ECOG PS (0 or 1), staging (I/II or III), radiation fraction (bid or qd), and region (Asia or non-Asia).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
511
Serplulimab is an innovative monoclonal antibody targeting PD-1,developed by Shanghai Henlius Biotech, Inc. 300mg Q3W
Etoposide: 100 mg/m2, IV, on Days 1, 2, and 3 of each cycle. Carboplatin: AUC = 5, IV, on Day 1 of each cycle up to a dose of 750 mg. investigator's choice. Cisplatin: 75mg/m2, IV, on Days 1 of each cycle. investigator's choice.
Standard Thoracic Radiotherapy
Progression-free survival (PFS)
PFS, assessed by the Blinded Independent Central Review (BICR) as per RECIST v1.1
Time frame: up to approximately 24months
Overall survival (OS)
the time from randomization to death due to any cause
Time frame: up to 36 months
Progression-free survival
PFS, assessed by the investigator as per RECIST v1.1
Time frame: up to approximately 24months
Objective response rate (ORR)
ORR, assessed by the BICR and investigator as per RECIST 1.1
Time frame: up to approximately 24months
Duration of remission (DOR)
DOR, assessed by the BICR and investigator as per RECIST 1.1
Time frame: up to approximately 24months
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Placebo Q3W
PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.
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