About this trial
Clinical study of ivonescimab for first-line treatment of metastatic NSCLC patients with high PD-L1. Evaluating overall survival and progression free survival.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years old at the time of enrollment
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1
Expected life expectancy ≥ 3 months
Metastatic (Stage IV) NSCLC
Disqualifiers
Histologic or cytopathologic evidence of the presence of small cell lung carcinoma for which first-line approved therapies are indicated. For patients with non-squamous histology, actionable driver mutation testing results are required before randomization.
Has received any prior therapy for NSCLC in the metastatic setting.
Concurrent enrollment in another clinical study, unless patient is enrolled in a non-interventional clinical study or is completing survival follow -up.
Known actionable genomic alterations for which first-line approved therapies are indicated
Trial design
Parallel
Treatments tested in this trial
Ivonescimab Injection
Biological/VaccineSubject will receive ivonescimab as an IV injection
Pembrolizumab Injection
Biological/VaccineSubject will receive Pembrolizumab as an IV injection
Treatment groups
Trial outcomes
Primary outcomes
Overall Survival (OS)
Progression free survival (PFS)
Secondary outcomes
Objective response rate (ORR)
Disease control rate ( DCR)
Duration of response (DoR)
Adverse Events (AE): incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results
Sponsors and contacts
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