Actively Recruiting
First-line Therapy With Nivolumab Plus Ipilimumab in Combination With Chemotherapy for Metatastatic NSCLC (NICReWo Trial)
Led by Fondazione IRCCS Policlinico San Matteo di Pavia · Updated on 2025-09-24
300
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
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).
CONDITIONS
Official Title
First-line Therapy With Nivolumab Plus Ipilimumab in Combination With Chemotherapy for Metatastatic NSCLC (NICReWo Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of stage IV or recurrent NSCLC confirmed by tissue or cell analysis
- Decision to start first-line treatment with nivolumab plus ipilimumab and 2 cycles of platinum-based chemotherapy per Italian guidelines
- Tumors must not have sensitising EGFR mutation or ALK translocation
- Patient is at least 18 years old at treatment decision
- Patient has provided written informed consent to join the study
You will not qualify if you...
- Current diagnosis of another primary cancer requiring systemic or other treatment
- Previous treatment with nivolumab and/or ipilimumab
- Already enrolled in another interventional clinical trial for advanced or recurrent NSCLC
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, Italy, 27100
Actively Recruiting
Research Team
F
Francesco Agustoni, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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