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

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.

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