Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients

Inclusion Criteria:

• Age ≥ 18 years old at the time of enrollment

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

• Expected life expectancy ≥ 3 months

• Metastatic (Stage IV) NSCLC

• Histologically or cytologically confirmed squamous or non-squamous NSCLC

• Recorded measurement of the Tumor Proportion Score (TPS) for PD-L1 expression,irrespective of the PD-L1 expression, prior to randomization

• 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

• Known actionable genomic alterations (EGFR, ALK, ROS1, and BRAF V600E) or genes forwhich first-line approved therapies are available.

• For non-squamous histology patients, actionable driver mutation testing resultsare required before randomization.

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

• Tumor invasion, encasement of organs (e.g. heart, trachea, esophagus, centralbronchi), or major blood vessels (e.g aorta, central veins), if poses a significantincreased risk of bleeding.