First-line Therapy With Nivolumab Plus Ipilimumab in Combination With Chemotherapy for Metatastatic NSCLC (NICReWo Trial)
Recruiting · NCT07190677 · Observational (researchers observe without assigning treatment) · Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
View the official record on ClinicalTrials.gov →What this trial is about
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).
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
1 location listed.
- Fondazione IRCCS Policlinico San Matteo - Pavia, Lombardy, Italy