[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"resectable-stage-ib-iii-non-squamous-non-small-cell-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:resectable-stage-ib-iii-non-squamous-non-small-cell-lung-cancer":39},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":5},"100602375",false,"NCT07122687","IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer","A Phase II Study Evaluating the Efficacy and Safety of IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Males and Females, age ≥18 years and ≤75 years;\n2. Histologically or cytologically confirmed primary non-squamous NSCLC:\n\n   * Stage IB, II, IIIA or IIIB (N2) NSCLC (per AJCC8);\n   * No administration of any anti-NSCLC therapy in the pre-operative period;\n   * Be able to undergo the radical resection; Pulmonary function capacity capable of tolerating the proposed lung resection according to the surgeon.\n3. Participants without EGFR mutations or ALK translocation;\n4. At least 1 measurable lesion per RECISIT v1.1;\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;\n6. Adequate organ function confirmed at screening period.\n\nExclusion Criteria:\n\n1. Histologically confirmed the presence of small cell lung cancer, neuroendocrine carcinoma, sarcoma, salivary gland tumor, and mesenchymal tumor components, or mixed NSCLC with predominant squamous cell carcinoma features;\n2. Tumor invasion of surrounding important structures, which is symptomatic or medical intervention indicated;\n3. Pancoast tumor;\n4. Malignant tumor nodule in the contralateral lung lobe;\n5. Participants with known or suspected brain metastases or other distant metastases;\n6. Participants who received Chinese herbal medicines, proprietary Chinese medicines with anti-tumor indications, or immunomodulatory drugs within 2 weeks prior to the first dose of the study drug;\n7. Participants with a condition requiring systemic treatment with corticosteroids or is receiving any other form of immunosuppressive therapy within 7 days prior the first dose of the study drug;\n8. History of any arterial thromboembolic event within 6 months prior to the first dose of the study drug;\n9. History of deep vein thrombosis, pulmonary embolism, or any other serious venous thromboembolism within 3 months prior to the first dose of study drug;\n10. History of pneumonitis requiring corticosteroid therapy, or history of clinically significant lung diseases or who are suspected to have these diseases by imaging during the screening period;\n11. Active or uncontrolled diseases or conditions;\n12. History of immunodeficiency disease;\n13. Participants with active autoimmune disease requiring systemic treatment within 2 years prior to the first dose of the study drug.","ALL","18 Years","75 Years",{"count":19,"type":20},170,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study is a randomized, open-label Phase 2 study to compare the efficacy and safety of IBI363 Combined with Chemotherapy or Pembrolizumab Combined with Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer.",[26],"Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer","RECRUITING","2025-09-28",{"date":30,"type":31},"2025-09-30","ACTUAL",{"date":33,"type":31},"2025-08-26",{"date":35,"type":20},"2030-04-30",{"name":37,"class":38},"Innovent Biologics (Suzhou) Co. Ltd.","INDUSTRY",""]