[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602375":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":44,"locations":50,"responsibleParty":74,"collaborators":29,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":29,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":29,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":29,"overallStatus":53,"whyStopped":29,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Innovent Biologics (Suzhou) Co. Ltd.","INDUSTRY",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"IBI363","EXPERIMENTAL","Neoadjuvant Treatment period: up to 3 cycles of IBI363 plus platinum-based chemotherapy prior to surgery.",[13,14,15,16],"Drug: Pemetrexed","Drug: Cisplatin","Drug: IBI363","Drug: Carboplatin",{"label":18,"type":19,"description":20,"interventionNames":21},"Keytruda","ACTIVE_COMPARATOR","Neoadjuvant Treatment period: up to 3 cycles of Keytruda plus platinum-based chemotherapy prior to surgery.",[13,14,16,22],"Drug: Keytruda",[24,30,34,37,41],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Pemetrexed","500 mg\u002Fm2 D1 IV Q3W",[9,18],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Cisplatin","75 mg\u002Fm2 D1 IV Q3W",[9,18],{"type":25,"name":9,"description":35,"armGroupLabels":36,"otherNames":29},"1.5 mg\u002Fkg D1 IV Q3W",[9],{"type":25,"name":38,"description":39,"armGroupLabels":40,"otherNames":29},"Carboplatin","AUC 5 mg\u002Fml\u002Fmin D1 IV Q3W",[9,18],{"type":25,"name":18,"description":42,"armGroupLabels":43,"otherNames":29},"200mg D1 IV Q3W",[18],[45],{"name":46,"role":47,"phone":48,"phoneExt":29,"email":49},"wei zhang","CONTACT","15005136320","wei.zhang02@innoventbio.com",[51],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Liaoning Cancer Hospital and Institute","RECRUITING","Shenyang","Liaoning","110000","China","CN",{"type":60,"coordinates":61},"Point",[62,63],123.43278,41.79222,{"lat":63,"lon":62},[66,70,73],{"name":67,"role":47,"phone":68,"phoneExt":29,"email":69},"Hongxu Liu","024-81916272","hongxuliu@qq.com",{"name":71,"role":72,"phone":29,"phoneExt":29,"email":29},"Jianxing He","PRINCIPAL_INVESTIGATOR",{"name":67,"role":72,"phone":29,"phoneExt":29,"email":29},{"type":75,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","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":87,"type":88},170,"ESTIMATED","INTERVENTIONAL",[91],"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.",[94],"Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer","2025-09-28",{"date":97,"type":98},"2025-09-30","ACTUAL",{"date":100,"type":98},"2025-08-26",{"date":102,"type":88},"2030-04-30",{"name":5,"class":6},1]