[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638941":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":11,"centralContacts":25,"locations":11,"responsibleParty":31,"collaborators":11,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":11,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":42,"enrollmentInfo":43,"targetDuration":11,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":11,"overallStatus":52,"whyStopped":11,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":11},{"fullName":5,"class":6},"Everest Medicines (China) Co.,Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"EVM14 at Dose Escalation Level plus +Ivonescimab Administered 200mg Q3W","EXPERIMENTAL",null,[13,14],"Biological: EVM14","Biological: Ivonescimab",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":11},"BIOLOGICAL","EVM14","Cancer Vaccine, Intramuscular (IM) injection at escalating dose levels, administered once every 3 weeks (Q3W)",[9],{"type":17,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"Ivonescimab","Anti PD 1\u002FVEGF bispecific antibody, administered intravenously at a dose of 200 mg once every 3 weeks",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":11,"email":30},"Everest Clinical Trial Information Center","CONTACT","+86 21 8012 5712","ctinfo.center@everestmedicines.com",{"type":32,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100638941","phase-1-evaluate-the-safety-tolerability-and-preliminary-efficacy-of-evm14-in-combination-with-ivonescimab-in-sq-nsclc-patients-100638941",false,"NCT07614646","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","Inclusion Criteria:\n\n1. Pathologically confirmed locally advanced (Stage IIIB\u002FIIIC) or metastatic (Stage IV) squamous non-small-cell lung cancer (sq-NSCLC), which is unresectable or not curable by definitive concurrent\u002Fsequential chemoradiotherapy.\n2. Known positive PD-L1 expression in tumor tissue prior to enrollment, with Tumor Proportion Score (TPS) ≥ 1% assessed via the 22C3 assay.\n3. No prior systemic anti-tumor therapy. Neoadjuvant\u002Fadjuvant systemic chemoradiotherapy for curative intent in non-metastatic disease, or definitive concurrent\u002Fsequential chemoradiotherapy for locally advanced disease, are permitted, provided disease progression occurs ≥ 6 months after the last treatment.\n4. Patients with at least 1 measurable lesion as defined per RECIST v1.1.\n5. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.\n6. Life expectancy ≥ 6 months.\n7. Patients must have adequate organ function.\n\nExclusion Criteria:\n\n1. Has disease that is suitable for local treatment administered with curative intent.\n2. Cannot provide sufficient tumor slides for biomarker testing.\n3. Has a diagnosed and\u002For 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.\n4. Active central nervous system (CNS) metastases. Patients with clinically stable brain metastases are eligible for enrollment.\n5. 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.\n6. Has received prior systemic anti-angiogenic therapy or any tumor-directed immunotherapy\n7. The left ventricular ejection fraction (LVEF) \\\u003C 50% during the screening period.\n8. Patients known to be human immunodeficiency virus (HIV)-positive.","ALL","18 Years","99 Years",{"count":44,"type":45},13,"ESTIMATED","INTERVENTIONAL",[48],"PHASE1","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.",[51],"Squamous Non-Small Cell Lung Cancer sqNSCLC","NOT_YET_RECRUITING","2026-05-28",{"date":55,"type":56},"2026-05-29","ACTUAL",{"date":58,"type":45},"2026-07",{"date":60,"type":45},"2028-07",{"name":62,"class":6},"Everest Medicines (Beijing) Co., Ltd."]