[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572284":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":167,"centralContacts":172,"locations":178,"responsibleParty":206,"collaborators":209,"id":213,"slug":214,"hasResults":215,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":91,"eligibilityCriteria":219,"healthyVolunteers":215,"sex":220,"minAge":221,"maxAge":91,"enrollmentInfo":222,"targetDuration":91,"studyType":225,"phases":226,"briefSummary":228,"conditions":229,"keywords":91,"overallStatus":181,"whyStopped":91,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":243},{"fullName":5,"class":6},"Emory University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment (diclofenac, immunotherapy)","EXPERIMENTAL","Patients receive diclofenac PO BID and standard of care immunotherapy with pembrolizumab, atezolizumab, nivolumab or cemiplimab on day 1 of each cycle. Cycles repeat every 21 or 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and CT, PET, or MRI on study.",[13,14,15,16,17,18,19,20,21,22],"Biological: Atezolizumab","Procedure: Biospecimen Collection","Biological: Cemiplimab","Procedure: Computed Tomography","Drug: Diclofenac Potassium","Other: Electronic Health Record Review","Procedure: Magnetic Resonance Imaging","Biological: Nivolumab","Biological: Pembrolizumab","Procedure: Positron Emission Tomography",[24,42,51,62,77,87,92,112,134,154],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"BIOLOGICAL","Atezolizumab","Given atezolizumab",[9],[30,31,32,33,34,35,36,37,38,39,40,41],"MPDL 3280A","MPDL 328OA","MPDL-3280A","MPDL3280A","MPDL328OA","RG 7446","RG-7446","RG7446","RO 5541267","RO-5541267","RO5541267","Tecentriq",{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"PROCEDURE","Biospecimen Collection","Undergo blood sample collection",[9],[48,49,50],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",{"type":25,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"Cemiplimab","Given cemiplimab",[9],[56,57,58,59,60,61],"Cemiplimab RWLC","Cemiplimab-rwlc","Libtayo","REGN 2810","REGN-2810","REGN2810",{"type":43,"name":63,"description":64,"armGroupLabels":65,"otherNames":66},"Computed Tomography","Undergo CT",[9],[67,68,69,70,71,72,73,74,75,76],"CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan","tomography",{"type":78,"name":79,"description":80,"armGroupLabels":81,"otherNames":82},"DRUG","Diclofenac Potassium","Given PO",[9],[83,84,85,86],"Cambia","Cataflam","CGP 45840B","Zipsor",{"type":6,"name":88,"description":89,"armGroupLabels":90,"otherNames":91},"Electronic Health Record Review","Ancillary studies",[9],null,{"type":43,"name":93,"description":94,"armGroupLabels":95,"otherNames":96},"Magnetic Resonance Imaging","Undergo MRI",[9],[97,98,99,100,101,102,103,104,105,106,107,108,109,110,111],"Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging","sMRI","Structural MRI",{"type":25,"name":113,"description":114,"armGroupLabels":115,"otherNames":116},"Nivolumab","Given nivolumab",[9],[117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133],"ABP 206","BCD-263","BMS 936558","BMS-936558","BMS936558","CMAB819","MDX 1106","MDX-1106","MDX1106","NIVO","Nivolumab Biosimilar ABP 206","Nivolumab Biosimilar BCD-263","Nivolumab Biosimilar CMAB819","ONO 4538","ONO-4538","ONO4538","Opdivo",{"type":25,"name":135,"description":136,"armGroupLabels":137,"otherNames":138},"Pembrolizumab","Given pembrolizumab",[9],[139,140,141,142,143,144,145,146,147,148,149,150,151,152,153],"BCD-201","GME 751","GME751","Keytruda","Lambrolizumab","MK 3475","MK-3475","MK3475","Pembrolizumab Biosimilar BCD-201","Pembrolizumab Biosimilar GME751","Pembrolizumab Biosimilar QL2107","QL2107","SCH 900475","SCH-900475","SCH900475",{"type":43,"name":155,"description":156,"armGroupLabels":157,"otherNames":158},"Positron Emission Tomography","Undergo PET",[9],[159,160,161,162,163,164,165,166],"Medical Imaging, Positron Emission Tomography","PET","PET Scan","Positron emission tomography (procedure)","Positron Emission Tomography Scan","Positron-Emission Tomography","proton magnetic resonance spectroscopic imaging","PT",[168],{"name":169,"affiliation":170,"role":171},"Jennifer W Carlisle","Emory University Hospital\u002FWinship Cancer Institute","PRINCIPAL_INVESTIGATOR",[173],{"name":174,"role":175,"phone":176,"phoneExt":91,"email":177},"Kajona McCall","CONTACT","404-778-5087","kajohna.mccall@emory.edu",[179,197],{"facility":180,"status":181,"city":182,"state":183,"zip":184,"country":185,"countryCode":186,"cosmosGeoPoint":187,"geoPoint":192,"contacts":193},"Emory University Hospital Midtown","RECRUITING","Atlanta","Georgia","30308","United States","US",{"type":188,"coordinates":189},"Point",[190,191],-84.38798,33.749,{"lat":191,"lon":190},[194],{"name":169,"role":175,"phone":195,"phoneExt":91,"email":196},"404-778-2304","Jennifer.W.Carlisle@emory.edu",{"facility":170,"status":181,"city":182,"state":183,"zip":198,"country":185,"countryCode":186,"cosmosGeoPoint":199,"geoPoint":201,"contacts":202},"30322",{"type":188,"coordinates":200},[190,191],{"lat":191,"lon":190},[203,205],{"name":204,"role":175,"phone":195,"phoneExt":91,"email":196},"Jennifer W. Carlisle",{"name":204,"role":171,"phone":91,"phoneExt":91,"email":91},{"type":171,"investigatorFullName":207,"investigatorTitle":208,"investigatorAffiliation":5,"oldNameTitle":91,"oldOrganization":91},"Jennifer Carlisle","Principal Investigator",[210],{"name":211,"class":212},"National Cancer Institute (NCI)","NIH","100572284","phase-2-diclofenac-for-the-treatment-of-patients-with-metastatic-non-small-cell-lung-cancer-on-single-agent-immunotherapy-100572284",false,"NCT06731270","Diclofenac for the Treatment of Patients With Metastatic Non-small Cell Lung Cancer on Single Agent Immunotherapy","Phase II Study of Diclofenac Salvage in Patients Metastatic Non-Small Cell Lung Cancer With Early Signs of Progression on Single Agent PD(L)-1 Blockade","Inclusion Criteria:\n\n* Capable of signing informed consent\n* Age ≥ 18 years at time of study entry\n* Stage III or IV pathologically proven NSCLC with advanced or metastatic disease, currently on treatment with an Food and Drug Administration (FDA) approved single agent monoclonal antibody inhibiting the PD(L)-1 pathway (pembrolizumab, atezolizumab, nivolumab, or cemiplimab) for a minimum of 12 weeks\n\n  * May include frontline single agent immune checkpoint inhibitors (ICI), maintenance single agent ICI after chemo-ICI, or subsequent line therapy\n* Radiographic evidence of clinical progression as determined by the treating physician, not warranting immediate change of therapy. Progressive disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria is not required. This can include mixed response, will need at least one growing lesion. Exposure to PD1 inhibitor for at least 12 weeks will minimize the risk of pseudo-progression\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Life expectancy of ≥ 26 weeks\n* Absolute neutrophil count (ANC) ≥ 1,000 cell\u002Fmm\\^3\n* Platelets ≥ 100,000 cells\u002Fmm\\^3\n* Hemoglobin ≥ 8 gm\u002FdL\n* Creatinine clearance ≥ 45 ml\u002Fml\n* Bilirubin ≤ 1.5 x institutional upper limit of normal\n\n  * Bilirubin must be ≤ 3 x institutional upper limit of normal in patients with documented Gilbert's syndrome\n* Serum glutamic oxaloacetic transaminase (SGOT) \u002F serum gluatmic pyruvic transaminase (SGPT) ≤ 2.5 x institutional upper limit of normal\n* Ability to take oral medications\n* Willingness 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\nExclusion Criteria:\n\n* Concurrent enrollment in another clinical study, unless it is non-therapeutic\n* Prophylactic or therapeutic anticoagulation therapy including but not limited to: warfarin, heparin, low molecular weight heparin, or direct oral anticoagulants, including: dabigatran (Pradaxa), rivaroxaban (Xarelto), apixaban (Eliquis), edoxaban (Savaysa), and betrixaban (Bevyxxa)\n* Treatment within the previous 6 weeks or planned initiation of bevacizumab\n* Abnormal markers of coagulation as measured by international normalized ratio (INR) \\> 2\n* Contraindication for NSAID therapy including: chronic aspirin therapy for coronary artery disease (CAD), cerebrovascular accident (CVA), or other indication, uncontrolled gastrointestinal ulcerative disease, known bleeding diathesis, known allergy or hypersensitivity to NSAIDS, advanced renal disease, uncontrolled hypertension, known seizure disorder or others\n* Female of childbearing potential unwilling or unable to use 2 methods of contraception, detailed in protocol\n* Uncontrolled intercurrent illness\n* History of another primary malignancy with exceptions noted in protocol\n* History of active primary immunodeficiency or active infection including tuberculosis, hepatitis B, hepatitis C\n* Current or prior use of immunosuppressive medication within 14 days before the first dose of diclofenac. There are exceptions to this criterion\n* Receipt of live attenuated vaccine within 30 days prior to the first dose of study medications\n* Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements","ALL","18 Years",{"count":223,"type":224},20,"ESTIMATED","INTERVENTIONAL",[227],"PHASE2","This phase II trial tests how well diclofenac works in treating patients non-small cell lung cancer (NSCLC) that may have spread from where it first started (primary site) to other places in the body (metastatic) on single agent immunotherapy. Diclofenac, a type of non-steroidal anti-inflammatory (NSAID), blocks the body's production of a substance that causes inflammation and may decrease tumor growth and improve the effectiveness of immunotherapy. Immunotherapy with pembrolizumab, atezolizumab, nivolumab or cemiplimab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving diclofenac may kill more tumor cells in patients with metastatic NSCLC on single agent immunotherapy.",[230,231,232,233],"Advanced Lung Non-Small Cell Carcinoma","Metastatic Lung Non-Small Cell Carcinoma","Stage III Lung Cancer AJCC v8","Stage IV Lung Cancer AJCC v8","2026-02-10",{"date":236,"type":237},"2026-02-12","ACTUAL",{"date":239,"type":237},"2025-04-09",{"date":241,"type":224},"2028-01-01",{"name":5,"class":6},2]