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).
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.
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.
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.
Cohort
Cross-sectional
Not listed
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
to estimate OS and PFS under real-life conditions in Italy considering subgroups
To estimate OS and PFS according to subgroups of interest: - ECOG Performance Status (PS): ECOG PS 0-1 and 2; - Presence of brain metastases; - Mediastinal lymph nodes staging: N0, N1, N2, N3; - Presence of extra-thoracic lymph node metastases; - Age \>75 years; - Pre-existing autoimmune disorders; - Development of immune-related adverse events (AEs); - PD-L1 negative status; - Genetic mutations and co-mutations (KRAS, MET, BRAF or ROS1 genes or with resistance-conferring mutations in the STK11, KEAP1 and TP53 genes)
to evaluate overall response rates by histology type, other subgroups of interest and treatment characteristics
To estimate the intermediate endpoints of response rates overall and according to histology types, other subgroups of interest and treatment characteristics with 24 months from start of therapy: - Overall response rate \[ORR = Complete Response + Partial Response\]; - Best overall response rate \[BORR\]
to assess the overall duration of treatment and subdivide it according to histology types and other subgroups of interest
To estimate duration of treatment overall and according to histology types and other subgroups of interest
to understand the safety of treatment by examining the frequency and severity of adverse events and identifying toxicity
To describe the frequency, severity, and management of following types of adverse events (AEs) to estimate toxicity up to 24 months from start of therapy: * Selected immune-related AEs (immune-related pneumonitis, colitis, hepatitis, nephritis/renal dysfunction, endocrinopathies, and rash); * Other immune-related AEs (severe infusion reactions, uveitis, pancreatitis, demyelination, Guillain-Barre Syndrome, myasthenic syndrome, encephalitis, toxic epidermal necrolysis
Click on the lead sponsor to view all of their trials.
