Status:
RECRUITING
First-line Therapy With Nivolumab Plus Ipilimumab in Combination With Chemotherapy for Metatastatic NSCLC (NICReWo Trial)
Lead Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Conditions:
Non Small Cell Lung Cancer Metastatic
Eligibility:
All Genders
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 plu...
Detailed Description
The major parameters collected are: patient characteristics (age, sex, ECOG, performance status, smoking status, comorbidities), disease characteristics (NSCLC histology, metastatic sites, molecular p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 17 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT07190677
Start Date
January 17 2025
End Date
December 31 2027
Last Update
September 24 2025
Active Locations (1)
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1
Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, Italy, 27100