[{"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":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100602375","phase-2-ibi363-combined-with-chemotherapy-or-pembrolizumab-combined-with-chemotherapy-as-neoadjuvant-therapy-in-resectable-stage-ib-iii-non-squamous-non-small-cell-lung-cancer-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":20,"type":21},170,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer","RECRUITING","2025-09-28",{"date":31,"type":32},"2025-09-30","ACTUAL",{"date":34,"type":32},"2025-08-26",{"date":36,"type":21},"2030-04-30",{"name":38,"class":39},"Innovent Biologics (Suzhou) Co. Ltd.","INDUSTRY"]