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.
Data 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).
Diagnosis of stage IV or recurrent NSCLC (histologically or cytologically confirmed stage);
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;
Patient is at least 18 years of age at time of treatment decision;
Patient provided written informed consent to participate in the study.
Current primary diagnosis of a cancer other than NSCLC that requires systemic or other treatment;
Previous treatment with nivolumab and/or ipilimumab;
Patient already included in an interventional clinical trial for their advanced or recurrent NSCLC.