First-line Therapy With Nivolumab Plus Ipilimumab in Combination With Chemotherapy for Metatastatic NSCLC (NICReWo Trial)

Plain-language summary

This study evaluates first-line treatment with Nivolumab plus Ipilimumab combined with chemotherapy in metastatic non-small cell lung cancer (NSCLC). Adults aged 18 and older with stage IV or recurrent NSCLC whose tumors have no sensitizing EGFR mutation or ALK translocation may take part. The study does not use a clinical phase and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Recruiting

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Start date

1/17/2025

Estimated completion

12/31/2027

Countries

Italy

Related genes

Locations

• Pavia, Italy

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.