This is a Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Study to evaluate the efficacy and safety of Toripalimab injection (JS001) or placebo combined with chemotherapy in Advanced Non-small Cell Lung Cancer (NSCLC) Participants with TKI-resistant EGFR-mutated Tumors; and evaluate the population with the best predictive biomarkers, i.e., positive diagnosis population. About 440 subjects with advanced non-small cell lung cancer with activated EGFR mutation will be 1:1 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: The history of the previous lines of EGFR-TKI treament ( 1st or 2nd generation of TKI vs. 3rd generation of TKI vs. 1st or 2nd generation of TKI + 3rd generation of TKI) ; Disease stage (IIIB-C vs. IV);
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
440
TORIPALIMAB INJECTION(JS001 ) or Placebo, 240mg/6ml/vial, Q3W,up to 2 years of treatment.
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGPeking University Shenzhen Hospital
Shenzhen, China
RECRUITINGOS
Overall survival,It's suitable for all subjects.
Time frame: Approximately 5 years
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 4 years
ORR (Objective Response Rate)
Objective response rate (ORR) evaluated by investigators based on RECIST1.1;
Time frame: Approximately 4 years
DOR (Duration of Response)
Duration of response (DOR) evaluated by investigators and BIRC based on RECIST1.1;
Time frame: Approximately 4 years
DCR (Disease of Response)
Disease control rate (DCR) evaluated by investigators based on RECIST1.1;
Time frame: Approximately 4 years
TTR (Time to Response)
Time to response (TTR) evaluated by investigators based on RECIST1.1;
Time frame: Approximately 4 years
Incidence of AEs/SAEs
Adverse events (AEs) study drug related; serious adverse events (SAEs)study drug related; abnormal value of Lab test according to NCI-CTCAE V5.0
Time frame: Approximately 5 years
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