About this trial
This study is focused on patients with non-small cell lung cancer (NSCLC) and have been prescribed a cemiplimab (Libtayo®) based treatment regimen under standard care.
The goal of this study is to learn more about the use, benefits, and safety of cemiplimab based treatment regimens in participants with NSCLC.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At least 18 years of age at the time of cemiplimab treatment initiation
Has been diagnosed with histologically or cytologically documented squamous or non-squamous NSCLC
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).
Can understand and complete the study-related questionnaires
Disqualifiers
Has received cemiplimab prior to enrollment
Has uncontrolled autoimmune disease
Has a contraindication to cemiplimab as noted in the local SmPC
Is concurrently participating in any other study of an investigational drug or procedure
Trial population
The source population for this study will be patients with either locally advanced NSCLC not suitable for definitive chemoradiation or metastatic NSCLC and who are initiating a cemiplimab-based regimen of treatment as part of routine clinical practice at the time of study enrollment. The study will aim to enroll approximately 500 adult patients from up to 50 sites across Europe.
Trial design
Cohort
Prospective
Treatments tested in this trial
Cemiplimab
Drugsolution for injection via intravenous (IV) infusion
Platinum-based chemotherapy
DrugIV administration
Treatment groups
Trial outcomes
Primary outcomes
Overall survival (OS)
Date and primary cause of death
Secondary outcomes
Overall Response Rate (ORR)
Defined as the proportion of patients with a complete response or partial as the physician-reported best overall response.
Duration of Response (DoR)
Defined among responders (patients with a complete response or partial response) as the time from the date of the first response after cemiplimab treatment initiation until the first date of disease progression or death due to any cause.
Time to Response (TTR)
Defined as the time from the first cemiplimab dose until the date of first response observed for that patient. Patients who die during the study will be censored using the date of the last valid disease assessment).
Progression-Free Survival (PFS)
Defined as the time from the first dose of cemiplimab until the date of the first documented tumour progression or death due to any cause.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.