[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620871":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":23,"studyPopulation":24,"armGroups":20,"interventions":25,"overallOfficials":20,"centralContacts":30,"locations":39,"responsibleParty":329,"collaborators":20,"id":331,"slug":20,"hasResults":332,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":336,"eligibilityCriteria":337,"healthyVolunteers":332,"sex":338,"minAge":339,"maxAge":20,"enrollmentInfo":340,"targetDuration":20,"studyType":343,"phases":20,"briefSummary":344,"conditions":345,"keywords":347,"overallStatus":204,"whyStopped":20,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":359},{"fullName":5,"class":6},"Gruppo Oncologico Italiano di Ricerca Clinica","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":12,"otherOutcomes":20},[9],{"measure":10,"description":10,"timeFrame":11},"The primary endpoint of the study is the frequency of new variant(s) detected by Next Generation Sequencing (NGS) Panel at the time of recurrence to adjuvant osimertinib in tissue and\u002For liquid biopsy","3 years",[13,16,18],{"measure":14,"description":15,"timeFrame":11},"Secondary endpoint","• Frequency of new variant(s) in Next Generation Sequencing (NGS) Panel in tissue sample at the time of recurrence to adjuvant osimertinib compared to surgical\u002Fpre-osimertinib sample",{"measure":14,"description":17,"timeFrame":11},"• percent of treatment options at disease relapse",{"measure":14,"description":19,"timeFrame":11},"• Correlation of new variants in NGS and clinical features to the onset of recurrence (on treatment\u002Foff treatment)",null,{"allocation":20,"interventionModel":20,"interventionModelDescription":20,"primaryPurpose":20,"observationalModel":22,"timePerspective":6,"maskingInfo":20},"COHORT","This study will include patients\n\n1. who have already received adjuvant osimertinib and who relapsed at the end of the treatment (off-treatment recurrence) and patients\n2. who relapsed during the treatment (on-treatment recurrence). Patients could be enrolled at the time or after the recurrence. Data regarding clinical features for each patient, including demographics and comorbidities, and clinical outcomes of adjuvant osimertinib will be collected.\n\nNGS analysis will be centrally performed on tissue biopsy and\u002For liquid biopsy collected at the time of recurrence in EGFR-mutated NSCLC treated with adjuvant osimertinib. NGS will be also centrally performed on tissue samples collected at the time of surgery.","100 relapsed EGFR-mutated NSCLC patient receiving osimertinib in adjuvant setting and with tissue biopsy and\u002For liquid biopsy collected at the time of recurrence",[26],{"type":27,"name":28,"description":29,"armGroupLabels":20,"otherNames":20},"DRUG","Osimertinib","Characterization of the molecular mechanisms of recurrence to adjuvant osimertinib",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":20,"email":35},"Alessandro Leonetti, MD","CONTACT","+39 0521702682","aleonetti@ao.pr.it",{"name":37,"role":33,"phone":20,"phoneExt":20,"email":38},"Michele Tognetto","goirc-remain@goirc.org",[40,54,68,81,94,107,117,127,137,146,155,164,177,190,202,216,226,239,248,257,270,283,293,305,317],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":20},"IRCCS Oncologico Giovanni Paolo II","ACTIVE_NOT_RECRUITING","Bari","BA","70124","Italy","IT",{"type":49,"coordinates":50},"Point",[51,52],16.86982,41.12066,{"lat":52,"lon":51},{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":46,"countryCode":47,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Asst Papa Giovanni Xxiii Sc Oncologia","NOT_YET_RECRUITING","Bergamo","BG","24127",{"type":49,"coordinates":61},[62,63],9.66721,45.69601,{"lat":63,"lon":62},[66],{"name":67,"role":33,"phone":20,"phoneExt":20,"email":20},"Anna Bettini, MD",{"facility":69,"status":56,"city":70,"state":71,"zip":72,"country":46,"countryCode":47,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"UOC di Oncologia Medica IRCCS - Policlinico S. Orsola Malpighi","Bologna","BO","40138",{"type":49,"coordinates":74},[75,76],11.33875,44.49381,{"lat":76,"lon":75},[79],{"name":80,"role":33,"phone":20,"phoneExt":20,"email":20},"Andrea De Giglio, MD",{"facility":82,"status":56,"city":83,"state":84,"zip":85,"country":46,"countryCode":47,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Humanitas Istituto Clinico Catanese Contrada Cubba","Misterbianco","CT","95045",{"type":49,"coordinates":87},[88,89],15.00913,37.51803,{"lat":89,"lon":88},[92],{"name":93,"role":33,"phone":20,"phoneExt":20,"email":20},"Alessandro Russo, MD",{"facility":95,"status":56,"city":96,"state":97,"zip":98,"country":46,"countryCode":47,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"A.S.S.T - Monza Ospedale San Gerardo","Monza","MB","20900",{"type":49,"coordinates":100},[101,102],9.27246,45.58005,{"lat":102,"lon":101},[105],{"name":106,"role":33,"phone":20,"phoneExt":20,"email":20},"Diego Cortinovis, MD",{"facility":108,"status":42,"city":109,"state":110,"zip":111,"country":46,"countryCode":47,"cosmosGeoPoint":112,"geoPoint":116,"contacts":20},"Grande Ospedale Metropolitano Niguarda Ca' Granda","Milan","Michigan","20162",{"type":49,"coordinates":113},[114,115],12.59836,42.78235,{"lat":115,"lon":114},{"facility":118,"status":42,"city":119,"state":120,"zip":121,"country":46,"countryCode":47,"cosmosGeoPoint":122,"geoPoint":126,"contacts":20},"Dip Oncologia-Ematologia - UO Oncologia AOU Policlinico di Modena","Modena","Missouri","41124",{"type":49,"coordinates":123},[124,125],10.92539,44.64783,{"lat":125,"lon":124},{"facility":128,"status":56,"city":109,"state":129,"zip":130,"country":46,"countryCode":47,"cosmosGeoPoint":131,"geoPoint":133,"contacts":134},"Irccs Humanitas Research Hospital","MI","20089",{"type":49,"coordinates":132},[114,115],{"lat":115,"lon":114},[135],{"name":136,"role":33,"phone":20,"phoneExt":20,"email":20},"Luca Toschi, MD",{"facility":138,"status":56,"city":109,"state":129,"zip":139,"country":46,"countryCode":47,"cosmosGeoPoint":140,"geoPoint":142,"contacts":143},"Fondazione IRCCS Istituto Nazionale dei Tumori di Milano","20113",{"type":49,"coordinates":141},[114,115],{"lat":115,"lon":114},[144],{"name":145,"role":33,"phone":20,"phoneExt":20,"email":20},"Marta Brambilla, MD",{"facility":147,"status":56,"city":109,"state":129,"zip":148,"country":46,"countryCode":47,"cosmosGeoPoint":149,"geoPoint":151,"contacts":152},"Ospedale San Raffaele Dipartimento di Oncologia Medica","20132",{"type":49,"coordinates":150},[114,115],{"lat":115,"lon":114},[153],{"name":154,"role":33,"phone":20,"phoneExt":20,"email":20},"Alessandra Bulotta, MD",{"facility":156,"status":56,"city":109,"state":129,"zip":157,"country":46,"countryCode":47,"cosmosGeoPoint":158,"geoPoint":160,"contacts":161},"European Institute of Oncology IRCCS","20141",{"type":49,"coordinates":159},[114,115],{"lat":115,"lon":114},[162],{"name":163,"role":33,"phone":20,"phoneExt":20,"email":20},"Antonio Passaro, MD",{"facility":165,"status":56,"city":166,"state":167,"zip":168,"country":46,"countryCode":47,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"UOC di Oncologia Medica 2 - IOV Istituto Oncologico Veneto","Padova","PD","35128",{"type":49,"coordinates":170},[171,172],11.14261,44.38225,{"lat":172,"lon":171},[175],{"name":176,"role":33,"phone":20,"phoneExt":20,"email":20},"Giulia Pasello, MD",{"facility":178,"status":56,"city":179,"state":180,"zip":181,"country":46,"countryCode":47,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"S.O.C. di Oncologia Medica e dei Tumori Immuno-correlati, Centro di Riferimento Oncologico IRCCS","Aviano","PN","33081",{"type":49,"coordinates":183},[184,185],12.59472,46.07056,{"lat":185,"lon":184},[188],{"name":189,"role":33,"phone":20,"phoneExt":20,"email":20},"Martina Bortolot, MD",{"facility":191,"status":56,"city":192,"state":193,"zip":194,"country":46,"countryCode":47,"cosmosGeoPoint":195,"geoPoint":199,"contacts":200},"UOC di Oncologia Medica Azienda Ospedaliero-Universitaria di Parma","Parma","PR","43126",{"type":49,"coordinates":196},[197,198],10.32618,44.79935,{"lat":198,"lon":197},[201],{"name":32,"role":33,"phone":20,"phoneExt":20,"email":20},{"facility":203,"status":204,"city":205,"state":206,"zip":207,"country":46,"countryCode":47,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"U.O.C. Oncologia Medica Azienda Unità Sanitaria Locale della Romagna","RECRUITING","Ravenna","RA","48100",{"type":49,"coordinates":209},[210,211],12.20121,44.41344,{"lat":211,"lon":210},[214],{"name":215,"role":33,"phone":20,"phoneExt":20,"email":20},"Chiara Bennati, MD",{"facility":217,"status":42,"city":218,"state":219,"zip":220,"country":46,"countryCode":47,"cosmosGeoPoint":221,"geoPoint":225,"contacts":20},"S.C. Oncologia Provinciale, Azienda USL-IRCCS di Reggio Emilia","Reggio Emilia","RE","42123",{"type":49,"coordinates":222},[223,224],10.63125,44.69825,{"lat":224,"lon":223},{"facility":227,"status":56,"city":228,"state":229,"zip":230,"country":46,"countryCode":47,"cosmosGeoPoint":231,"geoPoint":235,"contacts":236},"Fondazione Policlinico Universitario Campus Bio-Medico","Roma","RM","00128",{"type":49,"coordinates":232},[233,234],11.10642,44.99364,{"lat":234,"lon":233},[237],{"name":238,"role":33,"phone":20,"phoneExt":20,"email":20},"Alessandro Cortellini, MD",{"facility":240,"status":56,"city":228,"state":229,"zip":241,"country":46,"countryCode":47,"cosmosGeoPoint":242,"geoPoint":244,"contacts":245},"Ifo-Istituto Regina Elena - Oncologia Medica 1","00144",{"type":49,"coordinates":243},[233,234],{"lat":234,"lon":233},[246],{"name":247,"role":33,"phone":20,"phoneExt":20,"email":20},"Fabiana Cecere, MD",{"facility":249,"status":56,"city":228,"state":229,"zip":250,"country":46,"countryCode":47,"cosmosGeoPoint":251,"geoPoint":253,"contacts":254},"Fondazione Policlinico Universitario 'Agostino Gemelli' IRCCS","00168",{"type":49,"coordinates":252},[233,234],{"lat":234,"lon":233},[255],{"name":256,"role":33,"phone":20,"phoneExt":20,"email":20},"Emilio Bria, MD",{"facility":258,"status":56,"city":259,"state":260,"zip":261,"country":46,"countryCode":47,"cosmosGeoPoint":262,"geoPoint":266,"contacts":267},"AOU San Luigi Gonzaga - SSD oncologia polmonare","Orbassano","TO","10043",{"type":49,"coordinates":263},[264,265],7.53813,45.00547,{"lat":265,"lon":264},[268],{"name":269,"role":33,"phone":20,"phoneExt":20,"email":20},"Silvia Novello, MD",{"facility":271,"status":56,"city":272,"state":273,"zip":274,"country":46,"countryCode":47,"cosmosGeoPoint":275,"geoPoint":279,"contacts":280},"SC Oncologia ASST Sette Laghi \"Ospedale di Circolo e Fondazione Macchi \"","Varese","VA","21100",{"type":49,"coordinates":276},[277,278],8.82511,45.82058,{"lat":278,"lon":277},[281],{"name":282,"role":33,"phone":20,"phoneExt":20,"email":20},"Francesco Grossi, MD",{"facility":284,"status":42,"city":285,"state":286,"zip":287,"country":46,"countryCode":47,"cosmosGeoPoint":288,"geoPoint":292,"contacts":20},"\"OSPEDALE P. PEDERZOLI\" Casa di Cura Privata S.p.A.","Peschiera del Garda","VR","37019",{"type":49,"coordinates":289},[290,291],10.68614,45.43912,{"lat":291,"lon":290},{"facility":294,"status":56,"city":295,"state":286,"zip":296,"country":46,"countryCode":47,"cosmosGeoPoint":297,"geoPoint":301,"contacts":302},"AOU Integrata di Verona - Ospedale Borgo Trento","Verona","37126",{"type":49,"coordinates":298},[299,300],10.9938,45.43854,{"lat":300,"lon":299},[303],{"name":304,"role":33,"phone":20,"phoneExt":20,"email":20},"Lorenzo Belluomini, MD",{"facility":306,"status":56,"city":307,"state":20,"zip":308,"country":46,"countryCode":47,"cosmosGeoPoint":309,"geoPoint":313,"contacts":314},"Oncologia Clinica Sperimentale Toraco-Polmonare, IRCCS Pascale di Napoli","Naples","80131",{"type":49,"coordinates":310},[311,312],14.26811,40.85216,{"lat":312,"lon":311},[315],{"name":316,"role":33,"phone":20,"phoneExt":20,"email":20},"Alessandro Morabito, MD",{"facility":318,"status":56,"city":319,"state":20,"zip":320,"country":46,"countryCode":47,"cosmosGeoPoint":321,"geoPoint":325,"contacts":326},"A.O.U. \"Maggiore della Carita'\"- S.C.D.U Oncologia","Novara","28100",{"type":49,"coordinates":322},[323,324],8.62118,45.44694,{"lat":324,"lon":323},[327],{"name":328,"role":33,"phone":20,"phoneExt":20,"email":20},"Gloria Borra, MD",{"type":330,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100620871",false,"NCT07363252","Investigation of REcurrence Mechanisms to Adjuvant osimertINib in Radically Resected EGFR-mutated NSCLC Patients","Investigation of REcurrence Mechanisms to Adjuvant osimertINib in Radically Resected EGFR-mutated NSCLC Patients - REMAIN Study","REMAIN","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of radically resected IB-IIIA NSCLC with EGFR activating mutation\n* Treatment with adjuvant osimertinib (starting from September 2022, date of approval) according to clinical practice\n* Recurrence of disease during or after adjuvant therapy with osimertinib received according to clinical practice\n* Availability of tissue and\u002For liquid biopsy sample collected at the time of recurrence\n* Signed informed consent.\n\n  * Exclusion Criteria:\n* Unavailability of tissue and\u002For liquid biopsy sample collected at the time of recurrence\n* Concomitant synchronous malignancies aside from NSCLC or any concurrent and\u002For active malignancy that has required treatment within 2 years\n* Involvement in the planning and\u002For conduct of the study (applies to both investigator staff and\u002For staff at the study site).","ALL","18 Years",{"count":341,"type":342},100,"ESTIMATED","OBSERVATIONAL","Retrospective-prospective observational multicentric study including radically resected EGFR-mutated NSCLC patients relapsed during or after adjuvant osimertinib, received according to clinical practice",[346],"EGFR-mutated NSCLC",[346,348,349],"adjuvant osimertinib","Recurrence","2026-04-17",{"date":352,"type":353},"2026-04-22","ACTUAL",{"date":355,"type":353},"2026-04-14",{"date":357,"type":342},"2028-12",{"name":5,"class":6},25]