A Randomized, Double-blinded, Multiregional Phase 3 Study of Ivonescimab Versus Pembrolizumab for the First-line Treatment of Metastatic Non-small Cell Lung Cancer in Patients Whose Tumors Demonstrate High PD-L1 Expression

Inclusion Criteria: - 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 - Histologically or cytologically confirmed squamous or non-squamous NSCLC - Tumor demonstrates high PD-L1 expression ( TPS>50%) based on a 22C3 immunohistochemistry ( IHC) clinical assay approved / cleared by local health authorities. - At least one measurable noncerebral lesion according to RECIST 1.1 - No prior systemic treatment for metastatic NSCLC. Exclusion Criteria: - 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 - Symptomatic CNS metastases, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to randomization, potential need for CNS radiation within the first cycle, or leptomeningeal disease - Other prior malignancy (including previously treated NSCLC) unless the patient has undergone curative therapy with no evidence of recurrence of the disease for 3 years prior to randomization - Active autoimmune or lung disease requiring systemic therapy - Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE version 5 - Severe infection within 4 weeks prior to randomization - Major surgical procedures or serious trauma within 4 weeks prior to randomization - History of noninfectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease