[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced-lung-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced-lung-carcinoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,72],{"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":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100521894","evaluation-of-anti-pd-1-therapy-by-monitoring-t-cell-responses-in-melanoma-lung-and-other-cancer-types-100521894",false,"NCT06075524","Evaluation of Anti-PD-1 Therapy by Monitoring T Cell Responses in Melanoma, Lung and Other Cancer Types","Maximizing Anti-PD-1 Therapy by Monitoring T Cell Responses in Melanoma, Lung and Other Cancer Types","Inclusion Criteria:\n\n* Are 18 years of age or older\n* Have histologic evidence of locally or regionally advanced or stage IV malignancy\n* Are considered appropriate for starting therapy with anti-PD-1\u002Fanti-PD-L1 monoclonal antibody by their treating physician (prior therapy with immune checkpoint inhibitor (ICI) is allowed)\n* Have an understanding of the protocol and its requirements, risks, and discomforts\n* Are willing to undergo peripheral blood collection at the time points mentioned in the protocol\n* Are able and willing to sign an informed consent\n\nExclusion Criteria:\n\n* Inability on the part of the patient to understand the informed consent or be compliant with the protocol\n* Patients receiving any concurrent anti-cancer therapy or investigational agents (with the exception of an anti-PD-1\u002Fanti-PD-L1 agent as mentioned above)\n* Patients who are pregnant, nursing, or are of childbearing potential and are unwilling to employ adequate contraception","ALL","18 Years",{"count":19,"type":20},500,"ESTIMATED","OBSERVATIONAL","This study explores the role of T cells in monitoring disease status and response during anti-PD-1\u002FPD-L1 treatment in patients with melanoma, lung and other cancer types. Measuring levels of specific targets such as Bim and soluble PD-L1 during therapy may help track treatment resistance and clinical outcomes. This information may also help researchers determine why some people with melanoma, lung and other cancer types respond to PD-1\u002FPD-L1 treatment and others do not.",[24,25,26,27,28,29,30,31,32,33],"Clinical Stage III Cutaneous Melanoma AJCC v8","Clinical Stage IV Cutaneous Melanoma AJCC v8","Locally Advanced Lung Carcinoma","Locally Advanced Malignant Solid Neoplasm","Locally Advanced Melanoma","Metastatic Lung Carcinoma","Metastatic Malignant Solid Neoplasm","Metastatic Melanoma","Stage III Lung Cancer AJCC v8","Stage IV Lung Cancer AJCC v8","RECRUITING","2026-06-16",{"date":37,"type":38},"2026-06-18","ACTUAL",{"date":40,"type":38},"2015-06-15",{"date":42,"type":20},"2028-12-31",{"name":44,"class":45},"Mayo Clinic","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":46},"100525366","phase-2-esomeprazole-and-radiation-induced-esophagitis-100525366","NCT06120803","Esomeprazole and Radiation Induced Esophagitis","Effect of Esomeprazole on Radiation Induced Esophagitis in Non-small Cell Lung Cancer (EERENs): A Phase II Single Arm Study","EERENs","Inclusion Criteria:\n\n* Patient is ≥ 18 years of age.\n* Patient or patient's legal representative is willing and able to provide written informed consent and HIPAA authorization prior to performance of any study related activity.\n* Patient is willing and able to comply with scheduled visits and treatment schedules.\n* Patient has histopathologically confirmed diagnosis of NSCLC clinical stage III (as per the 8th edition of American Joint Committee on Cancer Staging).\n* Patients will receive thoracic radiation with estimated maximum dose to esophagus of at least 30 Gy (EQD2) in combination with concomitant chemotherapy.\n* Patient has Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.\n* Women of childbearing potential (WOCBP) must have a negative pregnancy test (serum or urine HCG) within 2 weeks of enrollment).\n* Double inclusion in any ongoing trial (if the other trial permits) will be allowed.\n\nExclusion Criteria:\n\n* Patient has history of gastroesophageal junction or stomach cancer.\n* Patient has history of pre-existing severe or very severe dysphagia.\n* Patient has history of severe liver disease, acute or subacute systemic lupus erythematosus.\n* Patient has interstitial nephritis.\n* Patient has history of peptic ulcer disease.\n* Patient has prior history of upper gastrointestinal bleeding.\n* Patient has a history of thoracic radiotherapy within 2 years of enrollment.\n* Patient has known or suspected allergic response and prior adverse drug reaction with proton pump inhibitors.\n* Patient is currently on clopidogrel, nelfinavir, rilpivirine, methotrexate, rifampin, digoxin, tacrolimus, or phenytoin as these may have major drug interaction with esomeprazole.\n* Patients without concomitant chemoradiotherapy and with estimated maximum dose to esophagus of less than 30 Gy (EQD2).",{"count":56,"type":20},48,"INTERVENTIONAL",[59],"PHASE2","Thoracic radiation therapy combined with chemotherapy (with or without immunotherapy) is the cornerstone of management in patients with locally advanced non-small cell lung cancer (NSCLC).",[62,26],"Radiation Esophagitis","2025-04-09",{"date":65,"type":38},"2025-04-13",{"date":67,"type":38},"2024-03-01",{"date":69,"type":20},"2028-06-30",{"name":71,"class":45},"Rush University Medical Center",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100414727","using-microbiome-to-predict-durvalumab-toxicity-in-post--concurrent-chemoradiation-therapy-ccrt-nsclc-patients-100414727","NCT04680377","Using Microbiome to Predict Durvalumab Toxicity in Post- Concurrent Chemoradiation Therapy (CCRT) NSCLC Patients","Using Microbiome to Predict Durvalumab Toxicity in Post-CCRT NSCLC Patients (Microdurva)","Microdurva","Inclusion Criteria:\n\n* Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent\n* Participant is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up\n* Life expectancy ≥12 weeks\n* Males and females age ≥ 18 years\n* Allowable type and amount of prior therapy:\n\nParticipants must have received two or more cycles of platinum-based chemotherapy (containing etoposide, vinblastine, vinorelbine, a taxane \\[paclitaxel or docetaxel\\], or pemetrexed) concurrently with definitive radiation therapy (54-66 Gy)\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status = 0 or 1\n* Body weight \\>30 kg (66.14 lbs)\n* Participants must have histologically- or cytologically-documented NSCLC who present with locally advanced, unresectable (Stage III) disease\n* Participants must have not progressed following definitive, platinum-based, concurrent chemoradiation therapy\n* Adequate organ function based on laboratory results\n* Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence, or to use an acceptable form of contraception for the duration of study participation, and for the time specified following completion of therapy\n\nExclusion Criteria:\n\n* Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or if the participant is in the follow-up period of an interventional study\n* Participation in another clinical study with an investigational product during the last 4 weeks prior to enrollment on this study\n* Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment arm assignment\n* Mixed small cell and non-small cell lung cancer histology\n* Participants who receive sequential chemoradiation therapy for locally advanced NSCLC\n* Participants with locally advanced NSCLC who have progressed whilst definitive platinum based, concurrent chemoradiation therapy\n* Receipt of any investigational drug within 4 weeks prior to the first dose of durvalumab; and in the case of monoclonal antibodies (not immunotherapy) 6 weeks prior to the first dose of durvalumab\n* Participants who have received prior anti-programmed death (PD)-1, anti- programmed death ligand (PD-L)1 or anti- cytotoxic T-lymphocyte-associated protein (CTLA)-4\n* Participants who have received prior immunotherapy\n* Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product (IP). Note: Participants, if enrolled, should not receive live vaccine whilst receiving durvalumab and up to 30 days after the last dose of IP\n* Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab\n* Any unresolved toxicity CTCAE ≥ Grade 2 from the prior chemoradiation \u002F anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria\n* Any grade pneumonitis from prior chemoradiation therapy\n* Active infection\n* Recent major surgery within 28 days prior to the first dose of study therapy\n* Active or prior documented autoimmune or inflammatory disorders\n* History of primary immunodeficiency\n* History of another primary malignancy\n* History of allogenic organ transplantation\u002Forgan transplant that requires therapeutic immunosuppression\n* History of leptomeningeal carcinomatosis\n* Participants with active ventricular arrhythmia requiring medication\n* Uncontrolled intercurrent illness\n* Participants who have progressed following definitive, platinum-based, concurrent chemoradiation therapy\n* Known allergy or hypersensitivity to durvalumab or any of durvalumab's excipients\n* Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent",{"count":81,"type":20},44,"This phase IV study is hoping to determine if examining the microbiome in non-small cell lung cancer participants who will receive durvalumab can predict treatment toxicity.",[84,26],"NSCLC, Stage III","2024-05-06",{"date":87,"type":38},"2024-05-08",{"date":89,"type":38},"2021-04-12",{"date":91,"type":20},"2026-12",{"name":93,"class":45},"Jun Zhang, MD, PhD",2]