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)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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).

Detailed description

The major parameters collected are: patient characteristics (age, sex, ECOG, performance status, smoking status, comorbidities), disease characteristics (NSCLC histology, metastatic sites, molecular profile), treatment timeline (date of starting therapy, number of administered cycles, date and reason of end of therapy, best response, subsequent therapies after disease progression), survival outcomes \[PFS (defined as the time from the starting therapy to disease progression or death from any cause) and OS (defined as the time from the starting therapy to death from any cause)\]. Data about adverse drug reactions are collected according to the Common Terminology Criteria Adverse Events v5.0. Data collection includes patients treated starting from January 2022 until December, 31 2025, with a 2-years period of follow-up time.

Conditions

• Non Small Cell Lung Cancer Metastatic

Timeline

• Start date: 2025-01-17
• Primary completion: 2025-12-31
• Completion: 2027-12-31
• First posted: 2025-09-24
• Last updated: 2025-09-24

Locations

1 site across 1 country: Italy