The purpose of this clinical trial is to evaluate the safety, tolerability, preliminary efficacy, and immunogenicity of EVM14 administered intramuscularly (IM) combination with Ivonescimab in patients with sq-NSCLC.
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.
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.
Sequential
EVM14
Biological/VaccineCancer Vaccine, Intramuscular (IM) injection at escalating dose levels, administered once every 3 weeks (Q3W)
Ivonescimab
Biological/VaccineAnti PD 1/VEGF bispecific antibody, administered intravenously at a dose of 200 mg once every 3 weeks
Incidence of dose-limiting toxicity (DLT)
Incidence and severity of TEAE, TRAE, SAEs, and adverse events (AEs) of Grade ≥ 3
Objective Response Rate(ORR)
Duration of Response(DOR)
Disease Control Rate(DCR)
Progression-Free Survival(PFS)
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