[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611533":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":11,"centralContacts":40,"locations":11,"responsibleParty":46,"collaborators":11,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":11,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":11,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":11,"overallStatus":70,"whyStopped":11,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":11},{"fullName":5,"class":6},"Peking University Cancer Hospital & Institute","OTHER",[8,14,19,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm1 PD-L1 TPS≥50%","EXPERIMENTAL",null,[13],"Combination Product: Ivonescimab\u002Fsurgery",{"label":15,"type":16,"description":11,"interventionNames":17},"Arm2 PD-L1 TPS≥50%","ACTIVE_COMPARATOR",[18],"Combination Product: Ivonescimab\u002Fchemotherapy\u002Fsurgery",{"label":20,"type":10,"description":11,"interventionNames":21},"Arm3 PD-L1 TPS\u003C50%",[18],{"label":23,"type":16,"description":11,"interventionNames":24},"Arm4 PD-L1 TPS\u003C50%",[18],[26,31,35,38],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":11},"COMBINATION_PRODUCT","Ivonescimab\u002Fsurgery","Ivonescimab monotherapy (4 cycles)→surgery→Ivonescimab(13 cycles)",[9],{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":11},"Ivonescimab\u002Fchemotherapy\u002Fsurgery","Ivonescimab + 1cycle of platinum-based chemotherapy followed by 3 cycles of Ivonescimab monotherapy→surgery→Ivonescimab(13 cycles)",[20],{"type":27,"name":32,"description":36,"armGroupLabels":37,"otherNames":11},"Ivonescimab + platinum-based chemotherapy (4 cycles)→surgery→Ivonescimab(13 cycles)",[15],{"type":27,"name":32,"description":36,"armGroupLabels":39,"otherNames":11},[23],[41],{"name":42,"role":43,"phone":44,"phoneExt":11,"email":45},"Nan Wu","CONTACT","+86139 1015 4426","nanwu@bjmu.edu.cn",{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Wu Nan","Professor","100611533","phase-2-ivonescimab-monotherapy-or-in-combination-with-chemotherapy-as-neoadjuvantadjuvant-therapy-for-resectable-non-small-cell-lung-cancer-100611533",false,"NCT07241819","Ivonescimab Monotherapy or in Combination With Chemotherapy as Neoadjuvant\u002FAdjuvant Therapy for Resectable Non-small Cell Lung Cancer","Evaluate the Efficacy and Safety of Ivonescimab Monotherapy or in Combination With Chemotherapy as Neoadjuvant\u002FAdjuvant Therapy for Resectable Non-small Cell Lung Cancer","Inclusion Criteria:\n\n1. Voluntarily sign a written informed consent form;\n2. Aged ≥ 18 years and ≤ 75 years , both males and females are eligible;\n3. ECOG PS score of 0 or 1;\n4. Patients with non-small cell lung cancer confirmed by histopathology or cytology, and with resectable clinical stage II-IIIB (T3N2) (according to the 8th edition of lung cancer TNM staging by the Union for International Cancer Control and the American Joint Committee on Cancer);\n5. No prior anti-tumor treatment has been received;\n6. No known EGFR sensitive mutations\u002FALK gene translocations;\n\nExclusion Criteria:\n\n1. Patients with large cell carcinoma, mixed-cell lung cancer, or those with small cell lung cancer components in the mixture;\n2. Presence of locally advanced unresectable or metastatic disease;\n3. Palliative local treatment for non-target lesions within 2 weeks before the first administration; receipt of non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, tumor necrosis factor, etc., excluding IL-11 used for the treatment of thrombocytopenia) within 2 weeks before the first administration; receipt of Chinese herbal medicines or proprietary Chinese medicines with anti-tumor indications within 1 week before the first administration.\n4. Severe infection occurred within 4 weeks before the first administration, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; active infection treated with systemic anti-infective therapy within 2 weeks before the first administration (excluding antiviral therapy for hepatitis B or hepatitis C);\n5. Major surgical operation or severe trauma occurred within 4 weeks before the first administration, or those with a plan for major surgical operation within 4 weeks after the first administration (determined by the researcher); minor local surgery performed within 3 days before the first administration (excluding peripherally inserted central catheterization and venous access port implantation);\n6. History of severe bleeding tendency or coagulation dysfunction; presence of clinically significant bleeding symptoms within 1 month before the first administration, including but not limited to gastrointestinal bleeding, hemoptysis (defined as coughing up or expectorating ≥ 1 teaspoon of fresh blood or small blood clots, or coughing up only blood without sputum; those with blood-tinged sputum are allowed to enroll), nasal bleeding (excluding epistaxis and retrograde epistaxis); receipt of continuous antiplatelet or anticoagulant therapy within 10 days before the first administration.","ALL","18 Years","75 Years",{"count":61,"type":62},66,"ESTIMATED","INTERVENTIONAL",[65],"PHASE2","This study is a prospective, II Phase clinical trial designed to evaluate the efficacy and safety of ivonescimab as monotherapy or in combination with platinum-based chemotherapy in the perioperative treatment of resectable non-small cell lung cancer (NSCLC).\n\nPatients are stratified by PD-L1 expression level (TPS ≥50% vs. \\\u003C50%) and randomized in a 2:1 ratio to differentiated neoadjuvant treatment arms: PD-L1≥50% subgroup: Ivonescimab monotherapy (4 cycles) vs. ivonescimab + platinum-based chemotherapy (4 cycles); PD-L1\\\u003C50% subgroup: Ivonescimab + 1 cycle of chemotherapy followed by 3 cycles of monotherapy vs. ivonescimab + platinum-based chemotherapy (4 cycles). All patients subsequently receive 13 cycles of ivonescimab as adjuvant maintenance therapy postoperatively.\n\nAs the first study to explore a PD-L1-directed chemotherapy de-escalation strategy, this trial aims to reduce treatment toxicity while maintaining efficacy, thereby providing a novel personalized precision therapy pathway for resectable NSCLC.",[68,69],"II-IIIB (T3N2) Resectable Non-small Cell Lung Cancer","Perioperative","NOT_YET_RECRUITING","2025-11-18",{"date":73,"type":74},"2025-11-21","ACTUAL",{"date":76,"type":62},"2025-11-30",{"date":78,"type":62},"2028-11-30",{"name":5,"class":6}]