RecruitingNCT07190677

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)


Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Enrollment

300 participants

Start Date

Jan 17, 2025

Study Type

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

Simplified for easier understanding

This study is collecting real-world data on patients in Italy who are receiving a combination of two immunotherapy drugs (nivolumab and ipilimumab) plus a short course of chemotherapy as their first treatment for advanced non-small cell lung cancer (NSCLC). The goal is to observe how this treatment works outside of clinical trial settings. **You may be eligible if...** - You have been diagnosed with stage IV or recurrent non-small cell lung cancer (confirmed by biopsy or lab test) - Your doctor has already decided to treat you with nivolumab plus ipilimumab and 2 rounds of platinum-based chemotherapy as your first treatment — independent of this study - Your tumor does not have EGFR mutations or ALK rearrangements - You are 18 or older and have given written consent **You may NOT be eligible if...** - You have another active cancer requiring systemic treatment - You have previously received nivolumab or ipilimumab - You are already enrolled in another interventional clinical trial for your lung cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.


Locations(1)

Fondazione IRCCS Policlinico San Matteo

Pavia, Lombardy, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07190677


Related Trials