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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- to estimate OS and PFS
Study Overview
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).
Detailed Description
The major parameters collected are: patient characteristics (age, sex, ECOG, performance status, smoking status, comorbidities), disease characteristics (NSCLC histology, metastatic sites, molecular profile), treatment timeline (date of starting therapy, number of administered cycles, date and reason of end of therapy, best response, subsequent therapies after disease progression), survival outcomes [PFS (defined as the time from the starting therapy to disease progression or death from any cause) and OS (defined as the time from the starting therapy to death from any cause)]. Data about adverse drug reactions are collected according to the Common Terminology Criteria Adverse Events v5.0. Data collection includes patients treated starting from January 2022 until December, 31 2025, with a 2-years period of follow-up time.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
to estimate OS and PFS
Time Frame: 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
Secondary Outcomes
- 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)
Investigators
Francesco Agustoni
MD
Fondazione IRCCS Policlinico San Matteo di Pavia