[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612663":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":47,"locations":29,"responsibleParty":53,"collaborators":29,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":29,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":29,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":29,"overallStatus":74,"whyStopped":29,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":80,"leadSponsor":82,"locationsCount":29},{"fullName":5,"class":6},"CSPC Megalith Biopharmaceutical Co.,Ltd.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"SYS6010 + Osimertinib","EXPERIMENTAL","Neoadjuvant Therapy: SYS6010 + Osimertinib Adjuvant Therapy: Osimertinib + Pemetrexed + Cisplatin or Carboplatin",[13,14],"Drug: SYS6010","Drug: Osimertinib",{"label":16,"type":17,"description":18,"interventionNames":19},"Osimertinib","ACTIVE_COMPARATOR","Neoadjuvant Therapy: Osimertinib Adjuvant Therapy: Osimertinib + Pemetrexed + Cisplatin or Carboplatin",[14,20,21,22],"Drug: Pemetrexed","Drug: Cisplatin","Drug: Carboplatin",[24,30,35,39,43],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","SYS6010","SYS6010 by intravenous (IV) infusion",[9],null,{"type":25,"name":16,"description":31,"armGroupLabels":32,"otherNames":33},"Osimertinib, oral",[16,9],[34],"Osimertinib Mesylate Tablets",{"type":25,"name":36,"description":37,"armGroupLabels":38,"otherNames":29},"Pemetrexed","500 mg\u002Fm\\^2 by IV infusion, Q3W",[16],{"type":25,"name":40,"description":41,"armGroupLabels":42,"otherNames":29},"Cisplatin","75 mg\u002Fm\\^2 by IV infusion, Q3W",[16],{"type":25,"name":44,"description":45,"armGroupLabels":46,"otherNames":29},"Carboplatin","AUC 5 mg\u002FmL•min by IV infusion, Q3W",[16],[48],{"name":49,"role":50,"phone":51,"phoneExt":29,"email":52},"Clinical Trials Information Group officer","CONTACT","+86-0311-69085587","ctr-contact@cspc.cn",{"type":54,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100612663","phase-2-a-study-of-sys6010-combined-with-osimertinib-versus-osimertinib-alone-as-neoadjuvant-therapy-for-patients-with-egfr-mutation-positive-resectable-non-squamous-non-small-cell-lung-cancer-100612663",false,"NCT07256509","A Study of SYS6010 Combined With Osimertinib Versus Osimertinib Alone as Neoadjuvant Therapy for Patients With EGFR Mutation-positive Resectable Non-squamous Non-small Cell Lung Cancer","A Phase II Study to Evaluate the Safety and Efficacy of SYS6010 Combined With Osimertinib Versus Osimertinib as Neoadjuvant Therapy in Participants With Resectable Stage II-IIIB Non-squamous Non-small Cell Lung Cancer With EGFR Mutation Positive","Inclusion Criteria:\n\n1. Able to understand and voluntarily sign the written informed consent form (ICF);\n2. Age 18-75 years, regardless of sex;\n3. Histologically or cytologically confirmed non-squamous non-small cell lung cancer, staged as resectable or potentially resectable Stage II-IIIB disease according to the International Association for the Study of Lung Cancer (IASLC) 8th Edition TNM staging criteria;\n4. Must be eligible for complete surgical resection of the primary tumor;\n5. Nodal status must be evaluated by whole-body FDG-PET and contrast-enhanced CT;\n6. Confirmed presence of an EGFR-sensitizing mutation (exon 19 deletion or exon 21 L858R mutation, co-mutation with other EGFR sites is allowed), as tested by a central laboratory or local testing facility;\n7. No prior systemic anti-tumor therapy (including chemotherapy, biotherapy, targeted therapy, immunotherapy);\n8. At least one measurable lesion at baseline as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;\n9. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;\n10. Life expectancy ≥6 months;\n11. Adequate major organ and bone marrow function;\n12. Women or men of childbearing potential must use highly effective contraception.\n\n1\\. Able to understand and voluntarily sign the written informed consent form (ICF); 2. Age 18-75 years, regardless of sex; 3. Histologically or cytologically confirmed non-squamous non-small cell lung cancer, staged as resectable or potentially resectable Stage II-IIIB disease according to the International Association for the Study of Lung Cancer (IASLC) 8th Edition TNM staging criteria; 4. Must be eligible for complete surgical resection of the primary tumor; 5. Nodal status must be evaluated by whole-body FDG-PET and contrast-enhanced CT; 6. Confirmed presence of an EGFR-sensitizing mutation (exon 19 deletion or exon 21 L858R mutation, co-mutation with other EGFR sites is allowed), as tested by a central laboratory or local testing facility; 7. No prior systemic anti-tumor therapy (including chemotherapy, biotherapy, targeted therapy, immunotherapy); 8. At least one measurable lesion at baseline as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; 9. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; 10. Life expectancy ≥6 months; 11. Adequate major organ and bone marrow function; 12. Women or men of childbearing potential must use highly effective contraception.\n\nExclusion Criteria:\n\n1. Diagnosis of Stage I, Stage IIIB with N3, and Stage IIIC, IVA, and IVB non-small cell lung cancer;\n2. Multiple primary malignancies (refer to exclusion criterion #8 for synchronous primary lung cancer) OR a mixed histology of SCLC and NSCLC;\n3. T4 stage lung cancer due to invasion of the great vessels, carina, trachea, esophagus, heart, or vertebral body; and\u002For bulky N2 disease;\n4. Eligible only for segmentectomy or wedge resection;\n5. Receipt of Chinese patent medicine preparations indicated for the treatment of lung cancer within 1 week before randomization;\n6. Major surgery or severe traumatic injury within 4 weeks before the first study treatment, or expected to undergo major surgery during the study period;\n7. History of other primary malignant tumor (including any known or suspected concurrent primary lung cancer);\n8. History of autoimmune disease, immunodeficiency, or organ transplant (except for corneal transplant);\n9. Refractory nausea, vomiting, chronic gastrointestinal disease, inability to swallow drugs orally;\n10. Evidence of severe or uncontrolled medical conditions (including uncontrolled hypertension, diabetes mellitus, etc,);\n11. Active or prior history of interstitial lung disease (ILD)\u002Fpneumonitis;\n12. Expected to receive live vaccine therapy within 30 days after randomization;\n13. History of a definite neurological or mental disorder; known allergy, hypersensitivity, or intolerance to the study drugs or any of their excipients;\n14. Pregnant or lactating women;","ALL","18 Years","75 Years",{"count":66,"type":67},120,"ESTIMATED","INTERVENTIONAL",[70],"PHASE2","To evaluate the safety and efficacy of SYS6010 combined with osimertinib as neoadjuvant therapy for patients with resectable EGFR mutation non-squamous non-small cell lung cancer.",[73],"Non-Small Cell Lung Cancer","NOT_YET_RECRUITING","2025-11-30",{"date":77,"type":78},"2025-12-05","ACTUAL",{"date":75,"type":67},{"date":81,"type":67},"2032-06-30",{"name":5,"class":6}]