[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595587":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":16,"studyPopulation":16,"armGroups":32,"interventions":38,"overallOfficials":44,"centralContacts":49,"locations":55,"responsibleParty":73,"collaborators":16,"id":76,"slug":16,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":16,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":16,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":16,"overallStatus":58,"whyStopped":16,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"China Medical University, China","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"6-month PFS rate","6-month progression-free rate","6 months",[14,18,20,22,24],{"measure":15,"description":16,"timeFrame":17},"progression-free survival（PFS）",null,"24 months",{"measure":19,"description":16,"timeFrame":17},"overall survival (OS)",{"measure":21,"description":16,"timeFrame":12},"objective response rate (ORR)",{"measure":23,"description":16,"timeFrame":12},"disease control rate (DCR)",{"measure":25,"description":16,"timeFrame":17},"Number of participants with treatment-related adverse events as assessed by CTCAE v4.0",{"allocation":27,"interventionModel":28,"interventionModelDescription":16,"primaryPurpose":29,"observationalModel":16,"timePerspective":16,"maskingInfo":30},"NA","SINGLE_GROUP","TREATMENT",{"masking":31,"maskingDescription":16,"whoMasked":16},"NONE",[33],{"label":34,"type":35,"description":16,"interventionNames":36},"denosumab combined chemotherapy plus anti-PD-1\u002FPD-L1 inhibitor","EXPERIMENTAL",[37],"Drug: denosumab combined anti-PD-1 inhibitor with chemotherapy",[39],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":16},"DRUG","denosumab combined anti-PD-1 inhibitor with chemotherapy","120mg of denosumab，d1 in a 28-days cycle；200mg of anti-PD-1 inhibitor, d1 in a 21-days cycle；500mg\u002Fm2 of pemetrexed, d1 in a 21-days cycle; AUC4-5 of carboplatin, d1 in a 21-days cycle, for 4-6 cycle",[34],[45],{"name":46,"affiliation":47,"role":48},"Qu chief physician","First Hospital of China Medical University","PRINCIPAL_INVESTIGATOR",[50],{"name":51,"role":52,"phone":53,"phoneExt":16,"email":54},"Zhang Chief Physician","CONTACT","15909881516","zhangly1105@126.com",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"The First Affiliated Hospital of China Medical University","RECRUITING","Shenyang","Liaoning","110000","China","CN",{"type":65,"coordinates":66},"Point",[67,68],123.43278,41.79222,{"lat":68,"lon":67},[71],{"name":72,"role":52,"phone":53,"phoneExt":16,"email":54},"Zhang chief physician",{"type":48,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"Xiujuan Qu","Chief Physician","100595587",false,"NCT07034391","A Study Evaluating the Efficacy of PD-1 Inhibitor Combined With Denosumab and Chemotherapy in Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Patients With Driver Gene-Negative Status","A Phase II Single-Arm Study Evaluating the Efficacy of PD-1 Inhibitor Combined With Denosumab and Chemotherapy in Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Patients With Driver Gene-Negative Status","Inclusion Criteria:\n\n* Histologically or cytologically confirmed locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC)\n* Documented negative for EGFR\u002FALK\u002FROS1\u002FBRAFV600E\u002FRET\u002FMETex14 mutations by validated genomic testing, with no prior targeted therapy and no history of other malignancies\n* No previous systemic therapy for advanced\u002Fmetastatic disease\n* At least one measurable lesion per RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1\n* No use of parathyroid hormone\u002Fderivatives, calcitonin, osteoprotegerin, mithramycin, or potassium supplements within the past 6 months\n* Adequate organ and marrow function\n\nExclusion Criteria:\n\n* Histologically or cytologically confirmed combined small cell and non-small cell lung cancer (mixed histology)\n* Any previous systemic anticancer treatment for NSCLC, including chemotherapy, biologics, immunotherapy, or investigational agents\n* Prior use of denosumab or any bone-modifying agents (e.g., bisphosphonates)\n* Uncontrolled hypocalcemia or hypophosphatemia\n* History or current evidence of osteonecrosis of the jaw (ONJ) or osteomyelitis of the jaw","ALL","18 Years","75 Years",{"count":86,"type":87},40,"ESTIMATED","INTERVENTIONAL",[90],"PHASE2","This is an interventional study to explore the efficacy and safety of denosumab combined chemotherapy and anti-PD-1\u002FPD-L1 inhibitor in locally advanced or metastatic NSCLC.",[93],"Non-Small Cell Lung Cancer","2025-06-22",{"date":96,"type":97},"2025-06-24","ACTUAL",{"date":99,"type":97},"2025-05-12",{"date":101,"type":87},"2027-10-31",{"name":5,"class":6},1]