[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613291":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":32,"locations":38,"responsibleParty":63,"collaborators":31,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":31,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":31,"overallStatus":41,"whyStopped":31,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Fondazione Ricerca Traslazionale","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"A","ACTIVE_COMPARATOR","Cemiplimab 350 mg iv q21 single agent (squamous histology) or Cemiplimab 350 mg iv q21 plus pemetrexed 500mg\u002Fm2 q21 (non- squamous histology).",[13],"Drug: Cemiplimab",{"label":15,"type":16,"description":17,"interventionNames":18},"B","EXPERIMENTAL","Cemiplimab 350 mg iv q 21 plus OSE2101 (TEDOPI®). The OSE2101 (TEDOPI®) dose to be injected is of 1 mL (5 mg of drug product) by subcutaneousubcutaneous administration",[19],"Drug: Tedopi",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Tedopi","Cemiplimab + OSE2101 (TEDOPI®) (ARM B: experimental arm)",[15],[27],"Cemiplimab",{"type":22,"name":27,"description":29,"armGroupLabels":30,"otherNames":31},"Cemiplimab +\u002F-Pemetrexed (ARM A: standard arm)",[9],null,[33],{"name":34,"role":35,"phone":36,"phoneExt":31,"email":37},"Federico Cappuzzo, Medical Oncology","CONTACT","+390652665789","federico.cappuzzo@fondazionefort.org",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Istituti Fisioterapici Ospitalieri- Ifo - Istituto Regina Elena","RECRUITING","Roma","RM","00144","Italy","IT",{"type":48,"coordinates":49},"Point",[50,51],11.10642,44.99364,{"lat":51,"lon":50},[54,59],{"name":55,"role":35,"phone":56,"phoneExt":57,"email":58},"Federico Cappuzzo, MD","06.5266.5698","+39","federico.cappuzzo@ifo.it",{"name":60,"role":35,"phone":61,"phoneExt":57,"email":62},"Lorenza Landi, MD","3397728272","lorenza.landi@ifo.it",{"type":64,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100613291","phase-2-a-randomized-phase-ii-trial-of-cemiplimab-plus-ose2101--tedopi-as-maintenance-therapy-in-ctdna-positive-nscl-the-cemited-study-100613291",false,"NCT07264673","A Randomized Phase II Trial of Cemiplimab Plus OSE2101 ( TEDOPI®) as Maintenance Therapy in ctDNA Positive NSCL. The Cemited Study.","Cemited","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of non- oncogene addicted advanced, locally advanced (not suitable for definitive chemoradiation therapy) or metastatic non-small-cell lung cancer (NSCLC)\n* Any patient candidate for first line chemo-immunotherapy irrespective of PD-L1 levels\n* HLA-A2 positive\n* ECOG PS 0-1\n* Signed informed consent (IC) prior to any trial-specific procedures\n\nExclusion Criteria:\n\n* Patients not candidate for chemo-immunotherapy\n* HLA-A2 negative\n* Symptomatic or not previously treated and not stable brain metastases. Brain metastases are allowed if asymptomatic or pretreated\n* Tumor tissue not available (archive or collected before trial inclusion)\n* Evidence of EGFR mutations or ALK or ROS1 rearrangements\n* Performance status \\>1 (ECOG)\n* Diagnosis of another cancer in the last 3 years, except for in situ carcinoma of cervix, breast and bladder or skin carcinoma(squamous or basaloid)","ALL","18 Years","99 Years",{"count":76,"type":77},160,"ESTIMATED","INTERVENTIONAL",[80],"PHASE2","This is a phase II randomized study investigating whether a combination maintenance with Cemiplimab and OSE2101 (TEDOPI®) could increase ctDNA clearance rate versus standard maintenance therapy in HLA-A2 positive NSCLC patients not progressing after 4 cycles of chemo-immunotherapy.",[83],"NSCLC","2025-11-24",{"date":86,"type":87},"2025-12-04","ACTUAL",{"date":89,"type":87},"2025-04-17",{"date":91,"type":77},"2029-10",{"name":5,"class":6},1]