[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595587":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":49,"collaborators":11,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":11,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":11,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":11,"overallStatus":34,"whyStopped":11,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"China Medical University, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"denosumab combined chemotherapy plus anti-PD-1\u002FPD-L1 inhibitor","EXPERIMENTAL",null,[13],"Drug: denosumab combined anti-PD-1 inhibitor with chemotherapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"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",[9],[21],{"name":22,"affiliation":23,"role":24},"Qu chief physician","First Hospital of China Medical University","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":11,"email":30},"Zhang Chief Physician","CONTACT","15909881516","zhangly1105@126.com",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"The First Affiliated Hospital of China Medical University","RECRUITING","Shenyang","Liaoning","110000","China","CN",{"type":41,"coordinates":42},"Point",[43,44],123.43278,41.79222,{"lat":44,"lon":43},[47],{"name":48,"role":28,"phone":29,"phoneExt":11,"email":30},"Zhang chief physician",{"type":24,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Xiujuan Qu","Chief Physician","100595587","phase-2-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-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":63,"type":64},40,"ESTIMATED","INTERVENTIONAL",[67],"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.",[70],"Non-Small Cell Lung Cancer","2025-06-22",{"date":73,"type":74},"2025-06-24","ACTUAL",{"date":76,"type":74},"2025-05-12",{"date":78,"type":64},"2027-10-31",{"name":5,"class":6},1]