First-line Therapy With Nivolumab Plus Ipilimumab in Combination With Chemotherapy for Metatastatic NSCLC (NICReWo Trial)

NCT07190677 | Recruiting

• 1 other identifier: NICReWo
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Non Small Cell Lung Cancer Metastatic

Keywords

Nivolumab; Ipilimumab; Real world

Outcome Measures

Primary Outcomes (1)

• to estimate OS and PFS

  to estimate the overall OS and the PFS after 24 months from start of therapy among patients with stage IV or recurrent NSCLC treated with nivolumab plus ipilimumab in combination with 2 cycles of platinum-based chemotherapy

  January 2022 - December 2025

Secondary Outcomes (4)

• to estimate OS and PFS under real-life conditions in Italy considering subgroups

  January 2022 - December 2025

• to evaluate overall response rates by histology type, other subgroups of interest and treatment characteristics

  January 2022 - December 2025

• to assess the overall duration of treatment and subdivide it according to histology types and other subgroups of interest

  January 2022 - December 2025

• to understand the safety of treatment by examining the frequency and severity of adverse events and identifying toxicity

  January 2022 - December 2025

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with stage IV or recurrent NSCLC treated with nivolumab plus ipilimumab in combination with 2 cycles of platinum-based chemotherapy, according to local clinical practice.

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.

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, Lombardy, 27100, Italy

RECRUITING

Central Study Contacts

Francesco Agustoni, MD

CONTACT

0382501433; f.agustoni@smatteo.pv.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 24, 2025
• Study Start: January 17, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 24, 2025

Record last verified: 2025-09

Locations

IT (1)