The anti-tumor activity of anti-PD-1 therapy and VEGF inhibitor in TKI-resistant EGFR-mutated non-squamous NSCLC Chinese patients will be investigated in this clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
492
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
PFS (Progression Free Survival)
Time frame: Time from randomization to first documented disease progression (radiographic) assessed by Independent Imaging Assessment Committee (IRRC) or death due to any cause. up to 24month
OS (Overall Survival)
Time frame: Time from randomization to the death of the subject due to any cause assessed up to 36 months.
ORR (overall response rate)
Time frame: The proportion of subjects who have a complete response (CR) or a partial response (PR) assessed up to 24 months.
PFS (Progression Free Survival)
Time frame: Time from randomization to first documented disease progression (radiographic) assessed by investigator or death due to any cause up to 24 month.
DCR(Disease control rate )
Time frame: The proportion of subjects in the analysis population who had a complete response (CR) or partial response (PR) or stable disease (SD) up to 24 month.
TTR(Time to objective response )
Time frame: For subjects with CR or PR, defined as the time from randomization to the first documented CR or PR up to 24 month.
DOR(Duration of response)
Time frame: For subjects with CR or PR, defined as the time from the first documented CR or PR to disease progression or death up to 24 month.
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75mg/m2 IV Q3W
Placebo1 IV Q3W
Placebo2 IV Q3W