[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623240":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":47,"responsibleParty":71,"collaborators":10,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":10,"enrollmentInfo":85,"targetDuration":88,"studyType":89,"phases":10,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":50,"whyStopped":10,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Gazi University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Chemo + Pembrolizumab",null,"Patients receiving platinum-based chemotherapy combined with pembrolizumab as part of routine care.",[13],"Drug: Pembrolizumab",{"label":15,"type":10,"description":16,"interventionNames":17},"Nivolumab + Ipilimumab + Chemotherapy","Patients receiving nivolumab plus ipilimumab in combination with platinum-based chemotherapy as part of routine care.",[18,19],"Drug: Nivolumab","Drug: Ipilimumab (1mg\u002Fkg)",[21,26,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"DRUG","Pembrolizumab","Pembrolizumab administered as part of routine clinical care in combination with platinum-based chemotherapy, according to standard clinical practice. Treatment selection, dosing, and scheduling are determined by the treating physician and are not protocol-mandated.",[9],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"Nivolumab","Nivolumab administered as part of routine clinical care in combination with ipilimumab and platinum-based chemotherapy, according to standard clinical practice. Treatment selection, dosing, scheduling, and duration are determined by the treating physician and are not protocol-mandated.",[15],{"type":22,"name":31,"description":32,"armGroupLabels":33,"otherNames":10},"Ipilimumab (1mg\u002Fkg)","Ipilimumab administered as part of routine clinical care in combination with nivolumab and platinum-based chemotherapy, according to standard clinical practice. Treatment selection, dosing, scheduling, and duration are determined by the treating physician and are not protocol-mandated.",[15],[35],{"name":36,"affiliation":5,"role":37},"Ozan Yazıcı, MD","STUDY_CHAIR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":10,"email":43},"Orhun Akdogan, MD","CONTACT","+905375831594","orhun.akdogan@gazi.edu.tr",{"name":45,"role":41,"phone":10,"phoneExt":10,"email":46},"Osman Sutcuoglu, MD","sutcuogluo@gmail.com",[48,64],{"facility":49,"status":50,"city":51,"state":10,"zip":10,"country":52,"countryCode":10,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Ankara Etlik City Hospital","RECRUITING","Ankara","Turkey (Türkiye)",{"type":54,"coordinates":55},"Point",[56,57],32.85427,39.91987,{"lat":57,"lon":56},[60],{"name":61,"role":41,"phone":62,"phoneExt":10,"email":63},"Enes Yeşilbaş, MD","+905321795590","yesilbas126@gmail.com",{"facility":65,"status":50,"city":51,"state":10,"zip":10,"country":52,"countryCode":10,"cosmosGeoPoint":66,"geoPoint":68,"contacts":69},"Gazi University Faculty of Medicine, Department of Medical Oncology",{"type":54,"coordinates":67},[56,57],{"lat":57,"lon":56},[70],{"name":40,"role":41,"phone":42,"phoneExt":10,"email":43},{"type":72,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Orhun Akdoğan","Medical Oncologist","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":86,"type":87},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.",[92,93],"Nonsmall Cell Lung Cancer, Stage IV","Metastatic Nonsmall Cell Lung Cancer",[95,96,97,98,99,100,101,102],"NSCLC","Metastatic Lung Cancer","Chemo-Immunotherapy","PD-L1","Progression-Free Survival","Overall Survival","Quality of Life","Patient-Reported Outcomes","2026-05-14",{"date":105,"type":106},"2026-05-18","ACTUAL",{"date":108,"type":106},"2026-02-01",{"date":110,"type":87},"2028-02",{"name":5,"class":6},2]