This is a phase III, multicenter, double-blinded, placebo-controlled study of platinum(Cisplatin or Carboplatin) plus etoposide with or without toripalimab as first Line therapy in patients with extensive stage small cell lung cancer. The purpose of this study is to evaluate the safety and efficacy of toriplimab in combination with platinum(Cisplatin or Carboplatin) plus etoposide in treatment naive extensive stage small cell lung cancer. Participants will receive asigned study treatment until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
442
TORIPALIMAB INJECTION(JS001 ) or Placebo combined with chemotherapy, 240mg/6ml/vial, Q3W,up to 2 years of treatment.
Ying Cheng
Changchun, China
PFS (Progression Free Survival) by investigator
Progression free survival (PFS) evaluated by investigators according to the response evaluation criteria in solid tumors (RECIST 1.1)
Time frame: Approximately 2 years
Overall suvival (OS)
Overall suvival (OS)
Time frame: Approximately 2.8 years
PFS (Progression Free Survival) per RECIST1.1 as Assessed by BIRC (Blinded Independent Review Board)
PFS evaluated by the Blinded Individual Review Committee (BIRC) based on RECIST1.1 criteria;
Time frame: Approximately 2 years
ORR (Objective Response Rate)
Objective response rate (ORR) evaluated by investigators and BIRC based on RECIST1.1;
Time frame: Approximately 2 years
DOR (Duration of Response)
Duration of response (DOR) evaluated by investigators and BIRC based on RECIST1.1;
Time frame: Approximately 2 years
DCR (Disease of Response)
Disease control rate (DCR) evaluated by investigators and BIRC based on RECIST1.1;
Time frame: Approximately 2 years
TTR (Time to Response)
Time to response (TTR) evaluated by investigators and BIRC based on RECIST1.1;
Time frame: Approximately 2 years
OS (Overall Survival) rate
OS rates at 1 and 2 years
Time frame: Approximately 2 years
Incidence of AEs/SAEs
Adverse events (AEs) ; serious adverse events (SAEs); abnormal value of Lab test according to NCI-CTCAE V5.0
Time frame: Approximately 2 years
PFS (Progression Free Survival) Rate
PFS rates at 6-month(inestigators and BICR) and at 1-year
Time frame: Approximately 1year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.