This randomized, double-blinded, placebo-controlled phase III, multicenter study is designed to evaluate the safety and efficacy of SHR-1316 in combination with carboplatin plus (+) etoposide compared with treatment with placebo + carboplatin + etoposide in chemotherapy-naive participants with ES-SCLC.
Participants will be randomized in a 1:1 ratio to receive either SHR-1316 + carboplatin + etoposide or placebo + carboplatin + etoposide for 4-6 cycles in the induction phase followed by maintenance with SHR-1316 or placebo until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or or unacceptable toxicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
462
SHR-1316 intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6) and maintenance phase.
Carboplatin intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).
Etoposide intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Jilin Cancer Hospital
Jilin City, Changchun, China
Duration of Overall Survival (OS)
Baseline until death from any cause
Time frame: up to approximately 31 months
Duration of Progression-Free Survival (PFS) as Assessed Using RECIST v1.1
Time frame: up to approximately 6 months
Percentage of Participants With Objective Response (OR) as Assessed by the Investigator Using RECIST v1.1
Baseline until partial response (PR) or complete response (CR), whichever occurs first
Time frame: up to approximately 31 months
Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1
First occurrence of PR or CR until PD or death, whichever occurs first
Time frame: up to approximately 31 months
Percentage of Participants Alive and Without PD, as Assessed by the Investigator Using RECIST v1.1, at 6 Months and 1 Year
Time frame: 6 months, 1 year
Percentage of Participants Alive at 1 Year and 2 Years
Time frame: 1 year, 2 years
Percentage of Participants with Adverse Events Or Serious Adverse Events.
Time frame: up to approximately 31 months
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Placebo intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6) and maintenance phase.