NCT07190677 First-line Therapy With Nivolumab Plus Ipilimumab in Combination With Chemotherapy for Metatastatic NSCLC (NICReWo Trial)
| NCT ID | NCT07190677 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia |
| Condition | Non Small Cell Lung Cancer Metastatic |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-01-17 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2025-01-17 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07190677 clinical trial?
This trial is open to participants of all sexes, studying Non Small Cell Lung Cancer Metastatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07190677 currently recruiting?
Yes, NCT07190677 is actively recruiting participants. Contact the research team at f.agustoni@smatteo.pv.it for enrollment information.
Where is the NCT07190677 trial being conducted?
This trial is being conducted at Pavia, Italy.
Who is sponsoring the NCT07190677 clinical trial?
NCT07190677 is sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. The trial plans to enroll 300 participants.
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