Evaluate the Safety, Tolerability, and Preliminary Efficacy of EVM14 in Combination With Ivonescimab in Sq-NSCLC Patients
A Phase Ia Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of EVM14 Combined With Ivonescimab in Patients With Squamous Non-Small Cell Lung Cancer
Sponsor: Everest Medicines (Beijing) Co., Ltd.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Incidence of dose-limiting toxicity (DLT)
Time frame: 21days since the 1st EVM14 dose
Incidence and severity of TEAE, TRAE, SAEs, and adverse events (AEs) of Grade ≥ 3
Time frame: From first dose until 30±7 days post-last dose
Secondary Endpoints
Objective Response Rate(ORR)
Duration of Response(DOR)
Disease Control Rate(DCR)
Eligibility Criteria
Inclusion Criteria: 1. 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. 2. Known positive PD-L1 expression in tumor tissue prior to enrollment, with Tumor Proportion Score (TPS) ≥ 1% assessed via the 22C3 assay. 3. 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. 4. Patients with at least 1 measurable lesion as defined per RECIST v1.1. 5. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1. 6. Life expectancy ≥ 6 months. 7. Patients must have adequate organ function. Exclusion Criteria: 1. Has disease that is suitable for local treatment ad…
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