This is one randomized, double-blind, placebo-controlled, multi-center, phase III clinical study to evaluate the efficacy and safety of Toripalimab injection (JS001) or placebo combined with standard 1st-line chemotherapy in treatment-naïve advanced non-small cell lung cancer (NSCLC); and evaluate the population with the best predictive biomarkers, i.e., positive diagnosis population. About 450 subjects with advanced non-small cell lung cancer without activated EGFR mutation (exon 19 deletion, or exon 21 L858R, exon 21 L861Q, exon 18 G719X or exon 20 S768I mutations) and ALK fusion will be 2:1 randomized into two groups, JS001 combined with the standard 1st-line chemotherapy will be given in the study group whereas placebo combined with standard 1st-line chemotherapy will be given in the control group. The stratification will be based on the following factors: PD-L1 expression (TC≥1% vs TC\<1%); Smoking state (often smoking vs no smoking or infrequent smoking); Pathological type (squamous cell carcinoma vs non-squamous cell carcinoma).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
465
TORIPALIMAB INJECTION(JS001 ) or Placebo ,240mg/6ml/vial, Q3W,up to 2 years of treatment.
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
PFS
Progression free survival (PFS) evaluated by investigators according to the response evaluation criteria in solid tumors (RECIST 1.1)
Time frame: Up to 2 approximately years
OS
Overall survival (OS)
Time frame: Up to 2 approximately years
PFS
PFS evaluated by the Blinded Individual Review Committee (BIRC) based on RECIST1.1 criteria
Time frame: Up to 2 approximately years
ORR
Objective response rate (ORR) evaluated by investigators and BIRC based on RECIST1.1
Time frame: Up to 2 approximately years
DOR
Duration of response (DOR) evaluated by investigators and BIRC based on RECIST1.1
Time frame: Up to 2 approximately years
DCR
Disease control rate (DCR) evaluated by investigators and BIRC based on RECIST1.1
Time frame: Up to 2 approximately years
TTR
Time to response (TTR) evaluated by investigators and BIRC based on RECIST1.1
Time frame: Up to 2 approximately years
Incidence of AEs/SAEs
Overall incidence of adverse events (AEs); incidence of grade 3 and above AEs; incidence of serious adverse events (SAEs); incidence of AEs leading to termination of the investigational drug; incidence of AEs interruption of the investigational drug
Time frame: From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years
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