This is a Phase 3 Randomized, double-blind, Multiregional Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer. The primary endpoint is overall survival and progression free survival assessed by investigator. The key secondary endpoints include response and safety.
This study consists of two distinct NSCLC histology cohorts: squamous (N=600) and non-squamous (N=1000), approximately 1600 patients in total. Within each cohort, subjects are randomized in a 1:1 ratio into one of two treatment groups, receiving either ivonescimab or pembrolizumab combined with platinum-doublet chemotherapy. The two histology cohorts will be analyzed independently
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,600
Subject will receive ivonescimab and chemotherapy as an IV injection
Subject will receive pembrolizumab and chemotherapy as an IV injection
Overall Survival (OS)
Overall Survival (OS) in the ITT population
Time frame: approximately 4 years
Progression Free Survival (PFS)
Progression Free Survival (PFS) assessed by investigator based on RECIST V1.1
Time frame: approximately 3 years
Adverse Event (AE)
incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results
Time frame: From the subject signs the ICF to 30 days (AE) and 90 days (SAE related to ivonescimab/pembrolizumab ) after the last dose of study treatment or initiation of other anticancer therapy, whichever occurs first, up to 2 years.
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