[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597660":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":27,"locations":33,"responsibleParty":54,"collaborators":56,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":10,"enrollmentInfo":88,"targetDuration":10,"studyType":91,"phases":10,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"IRCCS San Raffaele","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort A: patient treated with chemo-ICI regimen as first line therapy",null,"Cohort A: Carboplatin\u002FCisplatin+Pemetrexed+Pembrolizumab\u002FCemiplimab (Keynote 189, EmpowerLung 3) for 4 cycles and then maintenance with Pemetrexed+Pembrolizumab\u002FCemiplimab up to 2 years or disease progression or unacceptable toxicity",[13],"Drug: Carboplatin\u002FCisplatin+Pemetrexed+Pembrolizumab\u002FCemiplimab for 4 cycles and then maintenance with Pemetrexed+Pembrolizumab\u002FCemiplimab up to 2 years or disease progression or unacceptable toxicity",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort B: patient treated with double ICI-chemo regimen as first line therapy","Cohort B:\n\nCarboplatin\u002FCisplatin+Pemetrexed+Nivolumab+Ipilimumab (CheckMate9LA) for 2 cycles and then maintenance with Nivolumab q21 and Ipilimumab q42 up to 2 years or disease progression or unacceptable toxicity",[18],"Drug: Carboplatin\u002FCisplatin+Pemetrexed+Nivolumab+Ipilimumab for 2 cycles and then maintenance with Nivolumab q21 and Ipilimumab q42 up to 2 years or disease progression or unacceptable toxicity",[20,24],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":10},"DRUG","Carboplatin\u002FCisplatin+Pemetrexed+Pembrolizumab\u002FCemiplimab for 4 cycles and then maintenance with Pemetrexed+Pembrolizumab\u002FCemiplimab up to 2 years or disease progression or unacceptable toxicity",[9],{"type":21,"name":25,"description":16,"armGroupLabels":26,"otherNames":10},"Carboplatin\u002FCisplatin+Pemetrexed+Nivolumab+Ipilimumab for 2 cycles and then maintenance with Nivolumab q21 and Ipilimumab q42 up to 2 years or disease progression or unacceptable toxicity",[15],[28],{"name":29,"role":30,"phone":31,"phoneExt":10,"email":32},"Sara Oresti, Medical Oncologist","CONTACT","+39 022643 8195","oresti.sara@hsr.it",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":38,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"IRCCS Ospedale San Raffaele","RECRUITING","Milan","Italy","20132","IT",{"type":42,"coordinates":43},"Point",[44,45],12.59836,42.78235,{"lat":45,"lon":44},[48,51],{"name":29,"role":30,"phone":49,"phoneExt":50,"email":32},"026438195","+ 39",{"name":52,"role":53,"phone":10,"phoneExt":10,"email":10},"Sara Oresti","PRINCIPAL_INVESTIGATOR",{"type":53,"investigatorFullName":52,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"MD",[57,60,62,64,66,68,70,72,74,76],{"name":58,"class":59},"AOU Città della Salute e della Scienza di Torino - Presidio Molinette","UNKNOWN",{"name":61,"class":59},"Fondazione Policlinico Campus Bio-Medico",{"name":63,"class":59},"ASST Lariana, Como",{"name":65,"class":59},"IRCCS Istituto Nazionale dei Tumori",{"name":67,"class":6},"ASST Grande Ospedale Metropolitano Niguarda",{"name":69,"class":59},"IRCCS San Gerardo dei Tintori, Monza",{"name":71,"class":6},"Asst Degli Spedali Civili Di Brescia",{"name":73,"class":59},"Policlinico San Matteo Pavia",{"name":75,"class":6},"Humanitas Research Hospital IRCCS, Rozzano-Milan",{"name":77,"class":59},"Ospedale Vincenzo Monaldi","100597660","patient-reported-outcome-measurements-proms-impact-on-clinical-outcome-in-first-line-setting-non--small-cell-lung-cancer-nsclc-according-to-chemo--immunotherapy-regimen-100597660",false,"NCT07061379","Patient Reported Outcome Measurements (PROMs) Impact on Clinical Outcome in firsT Line settIng Non- Small-Cell Lung Cancer (NSCLC) According to Chemo- Immunotherapy reGimen","Patient Reported Outcome Measurements (PROMs) Impact on Clinical Outcome in firsT Line settIng Non- Small-Cell Lung Cancer (NSCLC) According to Chemo- Immunotherapy reGimen (PROMOTING)","PROMOTING","Inclusion Criteria:\n\n* Age \\> 18 years\n* Diagnosis of Stage IV NSCLC with PD-L1 \\\u003C50%, without actionable genomic alterations\n* Signed Informed Consent Form (ICF) to the study\n* Patients eligible to receive first line treatment with combo chemo-immuno treatments as standard of care\n\nExclusion Criteria:\n\n\\- Patients unable to fill the questionnaires due to neurological comorbidities","ALL","18 Years",{"count":89,"type":90},144,"ESTIMATED","OBSERVATIONAL","A multicenter, national pharmacological observational study that has as its overall goal to implement a set of validated and agreed upon European-wide questionnaires (PROMs - patient's reported outcomes) to assess patients' perceptions of aspects of their lives based on the treatment they are receiving.\n\nSpecifically, with the research we present here, we aim to obtain data on patients' health and condition, including quality of life, symptom status, physical function, mental health (anxiety and depression), sleep quality, and sexuality as useful indicators not only of patient well-being but also of the effectiveness of the treatment itself.\n\nThe study involves the following: patients will be asked to complete online questionnaires at the following timepoints: before the start of treatment, after 4 and 8 treatment cycles, and at disease progression.\n\nData will also be collected regarding the patient's oncological medical history, treatment performed, response to treatment at CT\u002FPET reevaluations, any toxicities that arose during treatment.",[94],"PROMs",[96,97],"NSCLC","immunotherapy","2025-08-31",{"date":100,"type":101},"2025-09-03","ACTUAL",{"date":103,"type":101},"2025-07-24",{"date":105,"type":90},"2031-06",{"name":5,"class":6},1]