[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-nonsmall-cell-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-nonsmall-cell-lung-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"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":5},"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",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100533643","phase-1-molecularly-targeted-radionuclide-therapy-via-the-integrin-alphavbeta6-100533643","NCT06228482","Molecularly Targeted Radionuclide Therapy Via the Integrin Alphavbeta6","Inclusion Criteria:\n\n\\[68Ga\\]Ga DOTA-5G PET\u002FCT Inclusion Criteria:\n\n1. Ability to understand and willingness to sign a written informed consent document.\n2. Age 18 or more years\n3. Pathologically confirmed NSCLC with metastatic disease and measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion \\> 1 cm or lymph node \\> 1.5 cm in short axis)\n4. Participant must have documented tumor progression for metastatic disease during or following at least one prior FDA approved systemic regimen as established by diagnostic imaging.\n5. Available archival tumor tissue (excisional, core, or FNA is acceptable). Tissue from a metastatic site is preferred when available.\n6. Eastern Cooperative Oncology Group Performance Status ≤ 2\n7. Participant must have completed prior systemic therapy at least 2 weeks (washout period) prior to \\[68Ga\\]Ga DOTA-5G PET scan. Any clinically significant toxicity (with the exceptions of hair loss and sensory neuropathy) related to prior therapy resolved to Grade 1 or baseline.\n8. Hematologic parameters defined as:\n\n   Absolute neutrophil count (ANC) ≥ 1000 cells\u002Fmm3 Platelet count ≥ 100,000\u002Fmm3 Hemoglobin ≥ 8 g\u002FdL\n9. Blood chemistry levels defined as:\n\n   AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN) Total bilirubin ≤ 2 times ULN Creatinine ≤ 2 times ULN\n10. Anticipated life expectancy ≥ 3 months\n11. Able to remain motionless for up to 30-60 minutes per scan\n\n\\[177Lu\\]Lu DOTA-ABM-5G therapy Inclusion Criteria:\n\n1. Completion of entry into \\[68Ga\\]Ga DOTA-5G PET study and completion of scan\n2. The presence of at least one measurable disease by \\[68Ga\\]Ga DOTA-5G PET\u002FCT (SUVmax\\>2-fold above normal bone, brain, lung or liver and identified on standard of care diagnostic imaging) Patients with a history of brain metastases and or any clinical concern for brain metastases will be evaluated with brain MRI as per standard of care for patients with metastatic NSCLC.\n\nExclusion Criteria:\n\n\\[68Ga\\]Ga DOTA-5G and \\[177Lu\\]Lu DOTA-ABM-5G therapy Exclusion Criteria:\n\n1. Participants with Class 3 or 4 NYHA Congestive Heart Failure\n2. Clinically significant bleeding within two weeks prior to trial. entry (e.g. gastrointestinal bleeding, intracranial bleeding)\n3. Pregnant or lactating women\n4. Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of a central venous access, percutaneous feeding tube, or biopsy) within 28 days prior to study day 1 or anticipated surgery within the subsequent 6 weeks\n5. Has an additional active malignancy requiring therapy within the past 2 years (other than early stage, surgically managed basal and squamous skin cancer and in situ malignancies of the breast and cervix)\n6. Active, uncontrolled bacterial, viral, or fungal infection(s) despite systemic therapy\n7. Psychiatric illness\u002Fsocial situations that would interfere with compliance with study requirements\n8. Cannot undergo PET\u002FCT or SPECT\u002FCT scanning because of weight limits (350 lbs.)\n9. Known interstitial lung disease or pre-existing pulmonary fibrosis\n10. INR \\>2.0: PTT\\>15 seconds above ULN",{"count":56,"type":21},40,"INTERVENTIONAL",[59],"PHASE1","This is a Phase I study to evaluate the safety and efficacy of the \\[68Ga\\]Ga DOTA-5G and \\[177Lu\\]Lu DOTA-ABM-5G theranostics pair in patients with metastatic non small cell lung cancer (NSCLC).",[27],[63,64,65,66],"integrin","metastatic NSCLC","PET","theranostic","2026-02-23",{"date":69,"type":41},"2026-02-27",{"date":71,"type":41},"2024-01-22",{"date":73,"type":21},"2027-01",{"name":75,"class":48},"University of California, Davis",1]