First-line Therapy With Nivolumab Plus Ipilimumab in Combination With Chemotherapy for Metatastatic NSCLC (NICReWo Trial)
Recruiting now
Conditions studied: Non Small Cell Lung Cancer Metastatic
In brief
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).
Key facts
- Study ID
- NCT07190677
- Run by
- Fondazione IRCCS Policlinico San Matteo di Pavia
- People needed
- 300
- Starts
- 2025-01-17
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2025-09-24
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
- Fondazione IRCCS Policlinico San Matteo — Pavia, Lombardy, Italy (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.