Clinical trial · Observational
First-line Therapy With Nivolumab Plus Ipilimumab in Combination With Chemotherapy for Metatastatic NSCLC (NICReWo Trial)
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- to estimate OS and PFS
- timeFrame
- January 2022 - December 2025
- description
- 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 (4)
- measure
- to estimate OS and PFS under real-life conditions in Italy considering subgroups
- timeFrame
- January 2022 - December 2025
- description
- 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)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available