[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nonsmall-cell-lung-cancer-stage-iv\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nonsmall-cell-lung-cancer-stage-iv":26},{"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":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100623240","real-world-comparison-of-chemo-immunotherapy-regimens-in-metastatic-nsclc-with-pd-l1-50-alcg-01-100623240",false,"NCT07394062","Real-World Comparison of Chemo-Immunotherapy Regimens in Metastatic NSCLC With PD-L1 \u003C50% (ALCG-01)","A Prospective Observational Study Comparing Chemotherapy Plus Pembrolizumab Versus Nivolumab Plus Ipilimumab With Chemotherapy in Patients With Metastatic Non-Small Cell Lung Cancer and PD-L1 Expression Below 50%","ALCG-01","Inclusion Criteria:\n\n* Age ≥18 years.\n* Histologically or cytologically confirmed non-small cell lung cancer.\n* Metastatic (stage IV) disease at the time of study entry.\n* Tumor PD-L1 expression \\\u003C50%.\n* Initiation of first-line systemic treatment with either chemotherapy plus pembrolizumab or nivolumab plus ipilimumab in combination with chemotherapy, according to routine clinical practice.\n* Ability to provide informed consent.\n\nExclusion Criteria:\n\n* Prior systemic therapy for metastatic non-small cell lung cancer.\n* Participation in an interventional clinical trial that mandates treatment assignment.\n* Presence of another active malignancy requiring systemic treatment.\n* Inability to comply with routine clinical follow-up or data collection.","ALL","18 Years",{"count":20,"type":21},400,"ESTIMATED","18 Months","OBSERVATIONAL","Patients with metastatic non-small cell lung cancer (NSCLC) and programmed death-ligand 1 (PD-L1) expression below 50% are commonly treated with different chemo-immunotherapy regimens in routine clinical practice. Although these regimens are widely used, comparative real-world data on survival outcomes and patient-reported quality of life are limited.\n\nThis prospective observational study aims to compare two commonly used treatment approaches in patients with metastatic NSCLC and PD-L1 expression \\\u003C50%: chemotherapy plus pembrolizumab versus nivolumab plus ipilimumab combined with chemotherapy. Patients will receive treatment according to routine clinical decisions made by their treating physicians; no treatment assignment or intervention will be performed as part of the study.\n\nThe primary outcomes of the study are progression-free survival and overall survival. In addition, health-related quality of life will be assessed using validated patient-reported outcome questionnaires during routine follow-up.\n\nExploratory analyses will examine treatment outcomes in relation to selected clinical and patient-related factors, such as biological age, antibiotic exposure, and dietary patterns, in subsets of patients with available data.\n\nThe results of this study are expected to provide real-world evidence on survival and quality of life outcomes associated with commonly used chemo-immunotherapy strategies in metastatic NSCLC.",[26,27],"Nonsmall Cell Lung Cancer, Stage IV","Metastatic Nonsmall Cell Lung Cancer",[29,30,31,32,33,34,35,36],"NSCLC","Metastatic Lung Cancer","Chemo-Immunotherapy","PD-L1","Progression-Free Survival","Overall Survival","Quality of Life","Patient-Reported Outcomes","RECRUITING","2026-05-14",{"date":40,"type":41},"2026-05-18","ACTUAL",{"date":43,"type":41},"2026-02-01",{"date":45,"type":21},"2028-02",{"name":47,"class":48},"Gazi University","OTHER",2]