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)

Investigation of Effectiveness and Safety of Investigational Medication in Advanced NSCLC in Routine Clinical Practice Settings in Europe

Recruiting
18 years or above
All
Phase N/A
300 participants needed

Study Overview

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

Study Details

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.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Non-small Cell Lung Cancer
  • Age: 18 years or above
  • Gender: All

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

This study investigates the effectiveness and safety of an investigational medication in patients with advanced non-small cell lung cancer (NSCLC) in routine clinical practice settings in Europe. The purpose of this study is to observe how patients with advanced NSCLC respond to the investigational medication over time without altering their treatment regimen.

Participants will receive the investigational medication as part of their routine care. Data will be collected during regular clinical visits to monitor the overall survival rate and other outcomes such as the objective response rate and progression-free survival. The study will also track the incidence and severity of any adverse events experienced by the participants.

  • Who can participate: Adults aged 18 and older who have been diagnosed with advanced NSCLC and are receiving the investigational medication as part of their routine treatment are eligible to participate. Key eligibility includes having histologically or cytologically documented NSCLC and being able to understand and complete study questionnaires.
  • Study details: Participants will receive the investigational medication during their routine care visits. They will not be subjected to any changes in their treatment plan, and their data will be collected through observation only. This is an observational study, meaning data is collected by observing participants receiving routine care without changing their treatment.
  • Study timelines: The study will last 72 months.
Updated on 10 Feb 2025. Study ID: NCT05363319

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