[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573230":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":75,"collaborators":21,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":21,"enrollmentInfo":87,"targetDuration":21,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":98,"overallStatus":43,"whyStopped":21,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Centre hospitalier de l'Université de Montréal (CHUM)","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Neoadjuvant cemiplimab and dupilumab combination therapy","EXPERIMENTAL","Neoadjuvant immunotherapy administered prior to thoracic surgery",[13,14],"Drug: Cemiplimab","Drug: Dupilumab",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Cemiplimab","Cemiplimab 350 mg administered intravenously on day 1",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Dupilumab","Dupilumab 600 mg administered subcutaneously on day 1",[9],[27],{"name":28,"affiliation":29,"role":30},"Antoine Desilets, MD, MSc","CHUM","PRINCIPAL_INVESTIGATOR",[32,36],{"name":28,"role":33,"phone":34,"phoneExt":21,"email":35},"CONTACT","514-890-8444","antoine.desilets.med@ssss.gouv.qc.ca",{"name":37,"role":33,"phone":38,"phoneExt":39,"email":40},"Wiam Belkaid, PhD","514-836-3273","23242","wiam.belkaid.chum@ssss.gouv.qc.ca",[42,62],{"facility":29,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Montreal","Quebec","H2X 0A9","Canada","CA",{"type":50,"coordinates":51},"Point",[52,53],-73.58781,45.50884,{"lat":53,"lon":52},[56,61],{"name":57,"role":33,"phone":58,"phoneExt":59,"email":60},"Anna Perez","5148908000","31326","anna.perez.chum@ssss.gouv.qc.ca",{"name":28,"role":30,"phone":21,"phoneExt":21,"email":21},{"facility":5,"status":63,"city":44,"state":45,"zip":64,"country":47,"countryCode":48,"cosmosGeoPoint":65,"geoPoint":67,"contacts":68},"NOT_YET_RECRUITING","H2X 3E4",{"type":50,"coordinates":66},[52,53],{"lat":53,"lon":52},[69,70,71,72],{"name":28,"role":33,"phone":34,"phoneExt":21,"email":35},{"name":37,"role":33,"phone":38,"phoneExt":39,"email":40},{"name":28,"role":30,"phone":21,"phoneExt":21,"email":21},{"name":73,"role":74,"phone":21,"phoneExt":21,"email":21},"Moishe Liberman, MD, PhD","SUB_INVESTIGATOR",{"type":76,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100573230","phase-iii-study-of-neoadjuvant-cemiplimab-and-dupilumab-in-early-stage-non-small-cell-lung-cancer-100573230",false,"NCT06743581","Study of Neoadjuvant Cemiplimab and Dupilumab in Early-Stage Non-Small Cell Lung Cancer","Phase I\u002FII Study of Combined Treatment With Cemiplimab (Anti-PD-1) and Dupilumab (Anti-IL-4R) in Patients With Early-stage, Resectable NSCLC","Dupi-Cemi","Inclusion Criteria:\n\n* Histological confirmation of NSCLC is required before treatment (however, patients with a smoking history and radiographic findings suggestive of NSCLC may consent prior to biopsy to combine research and diagnostic procedures.\n* Age ≥ 18 years.\n* ECOG performance status 0-1\n* Determined to be a surgical candidate for tumor resection by a multidisciplinary team.\n* Women of childbearing potential and men must use approved contraception during the study and for 4 months post-treatment. Pregnancy or suspected pregnancy must be reported immediately.\n* Adequate organ and marrow function.\n* Pre-treatment biopsies are mandatory, and tumors must be T1b or larger (\\>1cm) and amenable to biopsy as determined by a multidisciplinary team.\n* Patients must consent to provide blood at designated study time points.\n* Patients must consent to core needle biopsies (at least 3 samples, as deemed safe by the performing surgeon\u002Fradiologist) prior to treatment initiation\n\nExclusion Criteria:\n\n* History of autoimmune disorders or use of immunomodulatory drugs (including dupilumab) within 2 months prior to treatment initiation.\n* Active autoimmune disease requiring systemic treatment in the past year, excluding replacement therapies like thyroxine or insulin.\n* Use of immunosuppressive drugs or systemic steroids within 7 days prior to treatment, except chronic steroids ≤10mg prednisone or equivalent.\n* No smoking history or confirmed tissue or ctDNA evidence of actionable driver alterations (e.g. EGFR mutation, ALK, or ROS1 rearrangements)\n* Prior chemotherapy or radiotherapy for another primary tumor, or prior locoregional therapy to the target lesion. Therapy for a different cancer is acceptable.\n* Metastatic disease where surgery would not have curative intent.\n* Uncontrolled illness, including active infections requiring antibiotics, symptomatic heart failure, unstable angina, or psychiatric\u002Fsocial conditions impeding study compliance.\n* Pregnancy or nursing, due to potential harm to the fetus or infant.\n* Progressive malignancy requiring active treatment, except for certain stable cancers treated with curative intent\n* HIV infection with detectable viral load or not on a stable HAART regimen\n* Active Hepatitis B or C (PCR-detectable)\n* History of allogeneic hematopoietic or solid organ transplantation.\n* Documented hypersensitivity to protein therapeutics.\n* Any condition, therapy, or abnormality that may interfere with trial results, patient participation, or their best interest as per the investigator's judgment.","ALL","18 Years",{"count":88,"type":89},24,"ESTIMATED","INTERVENTIONAL",[92],"NA","This phase 1b\u002F2a study evaluates the safety, feasibility, and efficacy of combining dupilumab (anti-IL-4Rα) and cemiplimab (anti-PD-1) in patients with early-stage, resectable NSCLC. Phase 1b focuses on safety and feasibility, using a 3+3 design to monitor dose-limiting toxicities (DLTs), while Phase 2a assesses the major pathological response (MPR) rate with a Simon's two-stage minimax design. Secondary endpoints include event-free survival, overall survival, and translational objectives such as deep immune monitoring from patient samples, with the trial expected to enroll 24 patients at CHUM over five years.",[95,96,97],"Non-Small Cell Lung Cancer","Immunotherapy","Neoadjuvant Therapy",[99,100,18,23],"NSCLC","Neoadjuvant immunotherapy","2026-08-13",{"date":103,"type":104},"2026-08-17","ACTUAL",{"date":106,"type":104},"2025-08-19",{"date":108,"type":89},"2030-02",{"name":5,"class":6},2]