Status:
RECRUITING
A Study to Evaluate First-line Ipilimumab + Nivolumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Non-small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18+ years
Brief 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 tr...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 11 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 11 2030
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06487156
Start Date
October 11 2023
End Date
October 11 2030
Last Update
July 5 2024
Active Locations (1)
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1
Istituto Nazionale Tumori - IRCCS Fondazione G.Pascale
Napoli, Italy, 80131