Actively Recruiting
First-line Therapy With Nivolumab Plus Ipilimumab in Combination With Chemotherapy for Metastatic Non-small Cell Lung Cancer: an Ambispective, Observational, Italian, Multicenter, Real World Study (NICReWo Trial)
Led by Fondazione IRCCS Policlinico San Matteo di Pavia · Updated on 2025-09-24
300
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are collecting real-life data on the use of nivolumab plus ipilimumab combined with chemotherapy as a first-line treatment for metastatic non-small cell lung cancer (NSCLC). This study is observational and ambispective, meaning it includes both retrospective data from January 2022 and prospective data collection continuing until December 31, 2025. The main goals are to evaluate progression-free survival (PFS) and overall survival (OS) in a real-world patient population, along with secondary outcomes such as response rates, treatment duration, and treatment-related adverse events. The study gathers detailed information on patient characteristics like age, sex, smoking status, and comorbidities, as well as disease features including NSCLC type, metastatic sites, and molecular profile. Treatment timelines, such as therapy start dates, number of cycles, reasons for ending therapy, and responses to treatment, are also recorded. Adverse drug reactions are monitored using established criteria, and data collection is maintained through an electronic data capture system. After December 2025, participants will be followed for two additional years to track long-term outcomes. Participants provide informed consent and are observed during their routine treatment with nivolumab plus ipilimumab and chemotherapy. Researchers review survival outcomes from therapy initiation to disease progression or death, as well as the overall response and safety of treatment. The study aims to reflect the effectiveness and risks of this therapy in everyday clinical practice. Data collection will continue until the end of 2025 with follow-up extending for two years to monitor patient outcomes comprehensively.
CONDITIONS
Brief Title
First-line Therapy With Nivolumab Plus Ipilimumab in Combination With Chemotherapy for Metatastatic NSCLC (NICReWo Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of stage IV or recurrent NSCLC confirmed by histology or cytology
- Decision to start first-line treatment with nivolumab plus ipilimumab combined with 2 cycles of platinum-based chemotherapy as per Italian label
- Patient is at least 18 years old at the time of treatment decision
- Patient has provided written informed consent to participate in the study
You will not qualify if you...
- Current primary diagnosis of cancer other than NSCLC requiring systemic or other treatment
- Previous treatment with nivolumab and/or ipilimumab
- Patient already enrolled in an interventional clinical trial for advanced or recurrent NSCLC
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From start of treatment in January 2022 through December 2025
Participants who undergo routine care for metastatic NSCLC are observed to collect data on treatment timelines, response, adverse events, and survival outcomes.
Visits as per routine clinical practice
Duration - Up to 2 years after treatment completion
Participants are followed for up to 2 years after end of treatment to assess survival outcomes and safety.
Follow-up visits as per routine clinical practice
Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, Italy, 27100
Actively Recruiting
Research Team
F
Francesco Agustoni, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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