[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Anhui Chest Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":42},{"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":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100596120","oral-metronomic-vinorelbine-and-pd-1-inhibitors-in-elderly-non-small-cell-lung-cancer-100596120",false,"NCT07041320","Oral Metronomic Vinorelbine and PD-1 Inhibitors in Elderly Non-small Cell Lung Cancer","Effect and Safety of Oral Metronomic Vinorelbine and PD-1 Inhibitors in Elderly Patients With Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* 1\\) All patients are histologically or cytologically confirmed non-small cell lung cancer. Genetic testing identifies no driver gene mutations.\n\n  2\\) Male or female, age ≥ 65 years 3) Patients had not received first-line treatment. 4) KPS score ≥ 70 points (ECOG score 0-1 points), the expected survival ≥3 months; 5) No dysfunction of major organs. EcG, liver function, renal function, and blood count tests before treatment are normal or basically normal, but must meet the following experimental results:\n  1. Blood routine test:\n\n     Leukocyte WBC≥3.5×109\u002FL; Neutrophil count (ANC) ≥ 1.5×109\u002FL; Platelet (PLT) ≥ 80×109\u002FL;\n  2. Blood biochemical test:\n\n     Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal values; Alanine aminotransferase (ALT\u002FSGPT) and alanine transaminases (AST\u002FSGOT) ≤ 2.5 times the normal high value (ULN), or ≤ 5 times the upper limit of normal value in patients with liver metastases; Serum creatinine (Cr) ≤ 1.5 times the upper limit of normal values;\n  3. Cardiac function test: 50% of the left ventricular ejection function of the heart \\>; 6) The subject has good compliance, and can cooperates with follow-up.\n\n     Exclusion Criteria:\n* previously treated","ALL","65 Years",{"count":19,"type":20},40,"ESTIMATED","2 Years","OBSERVATIONAL","The goal of this observational study is to evaluate the efficacy and safety of oral metronomic vinorelbine and PD-1 inhibitors in elderly patients with unoperable, locally advanced or metastatic non-small-cell lung cancer. The primary end point was objective response rate (ORR), and the second end points included disease control rate (DCR), progression-free survival (PFS), and safety. Participants over 65 years old, received oral metronomic vinorelbine 40mg every week (20mg for patients over 80 years old), combined with PD-1 inhibitors every 3 weeks.",[25,26],"Lung Cancer (NSCLC)","Elderly (People Aged 65 or More)",[28,29],"Oral metronomic vinorelbine","PD-1 inhibitors","RECRUITING","2025-06-19",{"date":33,"type":34},"2025-06-27","ACTUAL",{"date":36,"type":34},"2023-06-15",{"date":38,"type":20},"2026-12-31",{"name":40,"class":41},"Anhui Chest Hospital","OTHER",""]