Evaluate the Safety, Tolerability, and Preliminary Efficacy of EVM14 in Combination With Ivonescimab in Sq-NSCLC Patients

Inclusion criteria

• Pathologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) squamous non-small-cell lung cancer (sq-NSCLC), which is unresectable or not curable by definitive concurrent/sequential chemoradiotherapy.
• Known positive PD-L1 expression in tumor tissue prior to enrollment, with Tumor Proportion Score (TPS) ≥ 1% assessed via the 22C3 assay.
• No prior systemic anti-tumor therapy. Neoadjuvant/adjuvant systemic chemoradiotherapy for curative intent in non-metastatic disease, or definitive concurrent/sequential chemoradiotherapy for locally advanced disease, are permitted, provided disease progression occurs ≥ 6 months after the last treatment.
• Patients with at least 1 measurable lesion as defined per RECIST v1.1.
• Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.
• Life expectancy ≥ 6 months.
• Patients must have adequate organ function.

Exclusion criteria

• Has disease that is suitable for local treatment administered with curative intent.
• Cannot provide sufficient tumor slides for biomarker testing.
• Has a diagnosed and/or treated additional malignancy within 5 years prior to the first dose of study treatment except for: curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, and curatively resected in situ breast, cervical cancer, and prostate cancer.
• Active central nervous system (CNS) metastases. Patients with clinically stable brain metastases are eligible for enrollment.
• Has active autoimmune disease that has required systemic treatment in past 2 years or history of autoimmune disease that has possibility of relapse or at risk of having these conditions.
• Has received prior systemic anti-angiogenic therapy or any tumor-directed immunotherapy
• The left ventricular ejection fraction (LVEF) < 50% during the screening period.
• Patients known to be human immunodeficiency virus (HIV)-positive.