The study aims to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab versus chemotherapy in combination with pembrolizumab in the first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC with PD-L1 negative.
This is a randomized, open-label, multicenter, Phase 3 study to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab versus chemotherapy in combination with pembrolizumab in the first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC with PD-L1 negative.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
432
IV Infusion
IV Infusion
IV Infusion
IV Infusion
Shanghai Oriental Hospital
Shanghai, China
RECRUITINGProgression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first.
Time frame: Randomization up to approximately 28 months
Overall Survival (OS)
OS is defined as the time from randomization until the date of death due to any cause.
Time frame: Randomization up to approximately 43 months
Progression-Free Survival (PFS) assessed by Investigator
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator or death due to any cause, whichever occurs first.
Time frame: Randomization up to approximately 28 months
Objective Response Rate (ORR)
ORR is defined as the percentage of patients who achieve complete response(CR) or partial response (PR), as assessed by BICR/investigator per RECIST 1.1
Time frame: Randomization up to approximately 28 months
Disease control rate (DCR)
DCR is defined as the percentage of patients who achieve CR, PR or stable disease (SD), as assessed by BICR/ investigator per RECIST 1.1
Time frame: Randomization up to approximately 28 months
Duration of Response (DoR)
DoR is defined as the time from the date of first documented CR or PR until date of documented disease progression per RECIST 1.1, as assessed by BICR/investigator or death due to any cause, whichever occurs first.
Time frame: Randomization up to approximately 28 months
Time to Response (TTR)
TTR is defined as the time from the date of randomization until the first documentation of CR or PR as assessed by BICR/investigator per RECIST 1.1.
Time frame: Randomization up to approximately 28 months
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