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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Fondazione IRCCS Policlinico San Matteo
  Pavia, Lombardy, Italy Recruiting

Study contacts

• Study coordinator: Francesco Agustoni, MD
• Email: f.agustoni@smatteo.pv.it
• Phone: 0382501433

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.