[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607601":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":7,"centralContacts":8,"locations":14,"responsibleParty":32,"collaborators":7,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":42,"eligibilityCriteria":43,"healthyVolunteers":38,"sex":44,"minAge":7,"maxAge":7,"enrollmentInfo":45,"targetDuration":7,"studyType":48,"phases":7,"briefSummary":49,"conditions":50,"keywords":52,"overallStatus":17,"whyStopped":7,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},{"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,"countryCode":22,"cosmosGeoPoint":23,"geoPoint":28,"contacts":29},"Fondazione IRCCS Policlinico San Matteo","RECRUITING","Pavia","Lombardy","27100","Italy","IT",{"type":24,"coordinates":25},"Point",[26,27],9.15917,45.19205,{"lat":27,"lon":26},[30],{"name":31,"role":11,"phone":12,"phoneExt":7,"email":13},"Francesco Augustoni",{"type":33,"investigatorFullName":34,"investigatorTitle":35,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"PRINCIPAL_INVESTIGATOR","Francesco Agustoni","MD","100607601","first-line-therapy-with-nivolumab-plus-ipilimumab-in-combination-with-chemotherapy-for-metatastatic-nsclc-nicrewo-trial-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":46,"type":47},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).",[51],"Non Small Cell Lung Cancer Metastatic",[53,54,55],"Nivolumab","Ipilimumab","Real world","2025-09-20",{"date":58,"type":59},"2025-09-24","ACTUAL",{"date":61,"type":59},"2025-01-17",{"date":63,"type":47},"2027-12-31",{"name":5,"class":6},1]