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).
Name: TORIPALIMAB INJECTION (JS001 ) combine with chemotherapy
Description: TORIPALIMAB INJECTION(JS001 ) or Placebo ,240mg/6ml/vial, Q3W,up to 2 years of treatment.Type: DrugGroup TORIPALIMAB combined with standard chemotherapy Group Placebo combined with standard chemotherapy
Description: Progression free survival (PFS) evaluated by investigators according to the response evaluation criteria in solid tumors (RECIST 1.1)
Measure: PFS Time: Up to 2 approximately yearsDescription: Overall survival (OS)
Measure: OS Time: Up to 2 approximately yearsDescription: PFS evaluated by the Blinded Individual Review Committee (BIRC) based on RECIST1.1 criteria
Measure: PFS Time: Up to 2 approximately yearsDescription: Objective response rate (ORR) evaluated by investigators and BIRC based on RECIST1.1
Measure: ORR Time: Up to 2 approximately yearsDescription: Duration of response (DOR) evaluated by investigators and BIRC based on RECIST1.1
Measure: DOR Time: Up to 2 approximately yearsDescription: Disease control rate (DCR) evaluated by investigators and BIRC based on RECIST1.1
Measure: DCR Time: Up to 2 approximately yearsDescription: Time to response (TTR) evaluated by investigators and BIRC based on RECIST1.1
Measure: TTR Time: Up to 2 approximately yearsDescription: 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
Measure: Incidence of AEs/SAEs Time: From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately yearsAllocation: Randomized
Crossover Assignment
There are 3 SNPs
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. --- L858R ---
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. --- L858R --- --- L861Q ---
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. --- L858R --- --- L861Q --- --- S768I ---