[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607601":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":7,"centralContacts":8,"locations":14,"responsibleParty":31,"collaborators":7,"id":35,"slug":7,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":39,"acronym":40,"eligibilityCriteria":41,"healthyVolunteers":36,"sex":42,"minAge":7,"maxAge":7,"enrollmentInfo":43,"targetDuration":7,"studyType":46,"phases":7,"briefSummary":47,"conditions":48,"keywords":50,"overallStatus":17,"whyStopped":7,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},{"fullName":5,"class":6},"Fondazione IRCCS Policlinico San Matteo di Pavia","OTHER",null,[9],{"name":10,"role":11,"phone":12,"phoneExt":7,"email":13},"Francesco Agustoni, MD","CONTACT","0382501433","f.agustoni@smatteo.pv.it",[15],{"facility":16,"status":17,"city":18,"state":19,"zip":20,"country":21,"cosmosGeoPoint":22,"geoPoint":27,"contacts":28},"Fondazione IRCCS Policlinico San Matteo","RECRUITING","Pavia","Lombardy","27100","Italy",{"type":23,"coordinates":24},"Point",[25,26],9.15917,45.19205,{"lat":26,"lon":25},[29],{"name":30,"role":11,"phone":12,"phoneExt":7,"email":13},"Francesco Augustoni",{"type":32,"investigatorFullName":33,"investigatorTitle":34,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"PRINCIPAL_INVESTIGATOR","Francesco Agustoni","MD","100607601",false,"NCT07190677","First-line Therapy With Nivolumab Plus Ipilimumab in Combination With Chemotherapy for Metatastatic NSCLC (NICReWo Trial)","First-line Therapy With Nivolumab Plus Ipilimumab in Combination With Chemotherapy for Metatastatic Non-small Cell Lung Cancer: an Ambispective, Observational, Italian, Multicenter, Real World Study (NICReWo Trial)","NICReWo","Inclusion Criteria:\n\n* Diagnosis of stage IV or recurrent NSCLC (histologically or cytologically confirmed stage);\n* Decision to initiate a first-line treatment with nivolumab plus ipilimumab in combination with 2 cycles of platinum-based chemotherapy for the treatment of NSCLC according to the Italian label, independently of the study, in patients whose tumors have no sensitising EGFR mutation or ALK translocation;\n* Patient is at least 18 years of age at time of treatment decision;\n* Patient provided written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Current primary diagnosis of a cancer other than NSCLC that requires systemic or other treatment;\n* Previous treatment with nivolumab and\u002For ipilimumab;\n* Patient already included in an interventional clinical trial for their advanced or recurrent NSCLC.","ALL",{"count":44,"type":45},300,"ESTIMATED","OBSERVATIONAL","NICReWo is an Italy-wide, multicenter, observational, ambispective study, designed to collect real-life data during the early post-market authorization approval period of the combination nivolumab plus ipilimumab plus chemotherapy.\n\nData are retrospectively collected starting from January 2022 and will be prospectively collected until 31 December 2025, co-primary endpoints are to evaluate progression-free survival (PFS) and overall survival (OS) in a real world patient population. Secondary endpoints are overall response rate (ORR), duration of treatment and incidence of treatment-related adverse events (AEs). All data obtained for this study are recorded with an Electronic Data Capture (EDC) system using eCRFs (RedCap platform).",[49],"Non Small Cell Lung Cancer Metastatic",[51,52,53],"Nivolumab","Ipilimumab","Real world","2025-09-20",{"date":56,"type":57},"2025-09-24","ACTUAL",{"date":59,"type":57},"2025-01-17",{"date":61,"type":45},"2027-12-31",{"name":5,"class":6},1]