NCT07190677Recruiting
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)
Source: ClinicalTrials.gov · Last updated 24 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 15 Sept 2025
- Start date
- 17 Jan 2025
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Diseases
- Lung cancer, Childhood cancers
- NCT number
- NCT07190677
What you commit to
- Study type: Observational
- Planned participants: 300
- From 17 Jan 2025 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with nivolumab and/or ipilimumab;
Other illness
- Current primary diagnosis of a cancer other than NSCLC that requires systemic or other treatment;
Other
- Patient already included in an interventional clinical trial for their advanced or recurrent NSCLC.
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.