This is a Phase 3 Randomized, double-blind, Multicenter Study of Ivonescimab Combined with Docetaxel Versus Placebo Combined with Docetaxel in Patients with Locally advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) that has progressed on or after PD-(L)1 inhibitor-based therapy. The purpose of this study is to evaluate the efficacy and safety of ivonescimab versus placebo, combined with docetaxel in patients with advanced NSCLC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
536
Patients will receive ivonescimab and docetaxel as an IV injection
Patients will receive placebo and docetaxel as an IV injection
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGOverall Survival (OS)
Overall Survival (OS) in the FAS population
Time frame: approximately 5 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 patient signs the ICF to 30 days (AE) and 90 days (SAE) after the last dose of study treatment or initiation of other anticancer therapy, whichever occurs first
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