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Active, not recruiting Observational

A Study to Evaluate First-line Ipilimumab + Nivolumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT06487156 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2023-10-11
Last updated
2026-01-27

Condition(s) studied

Non-small Cell Lung Cancer (NSCLC)

Investigational drug(s) / intervention(s)

Nivolumab + ipilimumabAll Nivolumab trials (280) →All Ipilimumab trials (137) →

Nivolumab + ipilimumab: As per product label

Study summary

The purpose of this study is to collect and evaluate real-world data to describe the outcomes, patient characteristics, safety profile and treatment patterns of first-line nivolumab plus ipilimumab treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) in Italy

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Diagnosis of stage IV or recurrent NSCLC (histologically or cytologically confirmed stage), without known EGFR- or ALK-alterations * Decision to initiate a first-line treatment with nivolumab plus ipilimumab for the treatment of NSCLC according to the Italy label has been made independently of the study * 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 * Patients with known EGFR- or ALK-alterations * Previous treatment with nivolumab and/or ipilimumab * Patient already included in an interventional clinical trial for their advanced or recurrent NSCLC (but: Patients who have completed their participation in an interventional trial, who are not receiving study drug any more, and who are only followed-up for OS, can be enrolled)

Primary outcome measure(s)

  • Overall survival (OS) — Up to 5 years

Trial sites (1)

FacilityCityRegionStatus
Local Institution - 0001 Naples Italy
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06487156 on ClinicalTrials.gov ↗ ← All trials in Italy