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Clinical Trials in Italy / NCT07190677
Recruiting Observational

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

NCT07190677 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Phase
Observational
Started
2025-01-17
Last updated
2025-09-24

Condition(s) studied

Non Small Cell Lung Cancer Metastatic

Study 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

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • to estimate OS and PFS — January 2022 - December 2025
    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

Trial sites (1)

FacilityCityRegionStatus
Fondazione IRCCS Policlinico San Matteo Pavia Lombardy Recruiting

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07190677 on ClinicalTrials.gov ↗ ← All trials in Italy