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

Study Overview
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Brief Summary
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Primary Objective: Describe the overall survival rate (OS) rate in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice. Secondary Objectives: To describe the following in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice: Objective response rate (ORR) Time to response (TTR) Time to progression Time to first subsequent anti-NSCLC treatment (TTST) Duration of response (DoR) Progression-free Survival (PFS) Incidence and severity of adverse events (AEs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice

Detailed Description
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Originally registered as OBS17104 by Sanofi; transitioned to REGN 05Jul2023. The recruitment period will be 36 months. Data will be collected during routine clinical visits approximately every three months while the patient is on cemiplimab treatment and then approximately every six months for up to 36 months after cemiplimab discontinuation. Patients will be followed from cemiplimab treatment initiation until death, loss to follow-up, study withdrawal, or to the end of the study period (72 months after study launch), whichever occurs first.

Official Title
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An Observational Study to Assess the Effectiveness and Safety of Cemiplimab in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) in Routine Clinical Practice Settings in Europe (CEMI-LUNG)

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Cemiplimab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Treated with a cemiplimab-based regimen as part of routine clinical practice as determined by the treating physician (independent of the study) and in accordance with approved prescribing information, as follows: Initiating treatment within the eligibility period after the study launch and site initiation Or Has received one or two doses of cemiplimab within the eligibility period prior to the study launch and site initiation Can understand and complete the study-related questionnaires Must have given signed informed consent prior to any study activities Exclusion Criteria: Has received more than two doses of cemiplimab prior to enrolment Has uncontrolled autoimmune disease Is receiving cemiplimab for an indication other than advanced NSCLC Has a contraindication to cemiplimab as noted in the local summary of product characteristics Presence of estimated glomerular filtration rate (EGFR), anaplastic lymphoma receptor (ALK), or c-ros oncogene 1 (ROS1) driver mutations Is concurrently participating in any other study of an investigational drug or procedure The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Patients who have initiated cemiplimab therapy for NSCLC under standard of care | Drug: Cemiplimab<br>* solution for injection via intravenous (IV) infusion<br>* Other names: SAR439684- Libtayo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Date and primary cause of death | Up to 72 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate | Defined as the proportion of patients with a complete response or partial as the physician-reported best overall response. | Up to 72 months | 
| Time to Response | 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). | Up to 72 months | 
| Time to Progression | Defined as the time from first dose of cemiplimab until the date of the first clinician-documented tumour progression. | Up to 72 months | 
| Time to first subsequent anti-NSCLC treatment | Defined as the time from the first cemiplimab dose until the date of the first subsequent anti-NSCLC treatment.. | Up to 72 months | 
| Duration of Response | 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. | Up to 72 months | 
| Progression-Free Survival | 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. | Up to 72 months | 
| Incidence and severity of adverse events (AEs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice | Number of patients with serious and non-serious adverse events occurring during treatment | Up to 72 months |