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

Launched by BRISTOL-MYERS SQUIBB · Jul 2, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the effectiveness and safety of a combination treatment using two medications, ipilimumab and nivolumab, for patients with advanced forms of non-small cell lung cancer (NSCLC). Specifically, the study focuses on individuals in Italy who are starting this treatment for the first time. Researchers want to gather real-world information about how well this treatment works, the characteristics of the patients receiving it, and any side effects that may occur.

To be eligible for this study, participants must be at least 18 years old and have been diagnosed with stage IV or recurrent NSCLC, which has been confirmed through medical tests. Importantly, they should not have certain genetic changes (known as EGFR or ALK alterations) and must not have received this combination treatment before. Participants will receive the treatment as part of their regular care, and they will be monitored throughout the study to track their health and any effects from the medications. This trial aims to provide valuable insights that could help improve treatment options for future patients with NSCLC.

Gender

ALL

Eligibility criteria

• 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)