Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1

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 22C3immunohistochemistry ( IHC) clinical assay approved / cleared by local healthauthorities.

• 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 carcinomafor which first-line approved therapies are indicated. For patients withnon-squamous histology, actionable driver mutation testing results are requiredbefore randomization.

• Has received any prior therapy for NSCLC in the metastatic setting.

• Concurrent enrollment in another clinical study, unless patient is enrolled in anon-interventional clinical study or is completing survival follow -up.

• Known actionable genomic alterations for which first-line approved therapies areindicated

• Symptomatic CNS metastases, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 daysprior to randomization, potential need for CNS radiation within the first cycle, orleptomeningeal disease

• Other prior malignancy (including previously treated NSCLC) unless the patient hasundergone curative therapy with no evidence of recurrence of the disease for 3 yearsprior 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 currentinterstitial lung disease