First-line nivolumab plus ipilimumab with short-course chemotherapy for metastatic non-small cell lung cancer

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)

This project will collect real-world data to see if nivolumab plus ipilimumab combined with a short course of platinum chemotherapy works well as first-line treatment for adults with metastatic non-small cell lung cancer who do not have EGFR or ALK alterations.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Sex: All
• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia (other)
• Drugs / interventions: nivolumab, ipilimumab, chemotherapy
• Locations: 1 site (Pavia, Lombardy)
• Trial ID: NCT07190677 on ClinicalTrials.gov

What this trial studies

NICReWo is an Italy-wide, multicenter ambispective observational program that retrospectively collects data from January 2022 and prospectively through December 31, 2025. The co-primary outcomes are progression-free survival and overall survival measured in a routine clinical setting, with secondary endpoints including overall response rate, treatment duration, and incidence of treatment-related adverse events. Clinical and disease characteristics, treatment timelines, response, subsequent therapies, and adverse events (graded by CTCAE v5.0) are captured in electronic case report forms using a REDCap EDC system. Patients will have up to two years of follow-up after treatment initiation to capture survival and safety outcomes.

Who should consider this trial

Good fit: Adults (≥18) with histologically or cytologically confirmed stage IV or recurrent NSCLC who are starting first-line nivolumab plus ipilimumab with two cycles of platinum-based chemotherapy per the Italian label, have no sensitizing EGFR mutation or ALK translocation, and provide informed consent.

Not a fit: Patients with prior treatment with nivolumab and/or ipilimumab, an active primary cancer other than NSCLC requiring treatment, enrollment in an interventional NSCLC trial, or tumors with EGFR or ALK driver alterations are unlikely to be included or to benefit from this real-world data collection.

Why it matters

Potential benefit: If successful, the results could give doctors and patients clearer real-world information about how effective and tolerable the nivolumab-plus-ipilimumab-plus-chemotherapy approach is outside clinical trials.

How similar studies have performed: Randomized trials of nivolumab plus ipilimumab with limited chemotherapy (for example CheckMate 9LA) have shown improved overall survival, but prospective real-world evidence specifically on this combination remains limited.

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.

Where this trial is running

Pavia, Lombardy

• Fondazione IRCCS Policlinico San Matteo — Pavia, Lombardy, Italy (RECRUITING)

Study contacts

• Study coordinator: Francesco Agustoni, MD

Conditions: Non Small Cell Lung Cancer Metastatic, Nivolumab, Ipilimumab, Real world