An Observational Study to Assess the Effectiveness and Safety of a Cemiplimab in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) in Routine Clinical Practice Settings in Europe

Launched by REGENERON PHARMACEUTICALS · May 2, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a medication called cemiplimab (also known as Libtayo®) for adults with advanced non-small cell lung cancer (NSCLC). The researchers want to understand how well this treatment works in everyday clinical settings across Europe. If you or a loved one is at least 18 years old and has been diagnosed with NSCLC, you might be eligible to participate, especially if your doctor has already prescribed cemiplimab as part of your treatment plan.

Participants in this study can expect to complete some questionnaires about their experience with the treatment. It's important to note that individuals who have already received cemiplimab, have certain uncontrolled health issues, or are involved in other clinical trials may not be eligible. Overall, this study aims to gather valuable information that can help improve care for patients with NSCLC.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. At least 18 years of age at the time of cemiplimab treatment initiation
• • 2. Has been diagnosed with histologically or cytologically documented squamous or non-squamous NSCLC
• • 3. Prescribed a cemiplimab-based regimen as part of routine clinical practice as determined by the treating physician per standard of care and in accordance with the Summary of Product Characteristics (SmPC).
• • 4. Can understand and complete the study-related questionnaires
• • 5. Must be legally capable of providing written consent for participation in the study and have signed informed consent prior to any study activities
• Key Exclusion Criteria:
• • 1. Has received cemiplimab prior to enrollment
• • 2. Has uncontrolled autoimmune disease
• • 3. Has a contraindication to cemiplimab as noted in the local SmPC
• • 4. Is concurrently participating in any other study of an investigational drug or procedure
• • 5. Has cognitive impairment or other medical condition that, in the opinion of the investigator, would interfere with the ability to complete the study-related questionnaires
• • NOTE: Other protocol-defined inclusion/exclusion criteria apply