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)
Fondazione IRCCS Policlinico San Matteo di Pavia
300 participants
Jan 17, 2025
OBSERVATIONAL
Conditions
Summary
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).
Eligibility
Plain Language Summary
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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07190677