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)

Investigating Survival Rates in Advanced Non-Small Cell Lung Cancer (NSCLC) with Investigational Medication

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

Updated on 10 Feb 2025. Study ID: NCT05363319

This study investigates the survival rates of patients with advanced non-small cell lung cancer (NSCLC) who are treated with an investigational medication regimen in regular clinical settings. Non-small cell lung cancer is a type of lung cancer that includes several subtypes such as squamous cell carcinoma and adenocarcinoma. The purpose of this study is to understand how well patients survive over time when treated with this regimen in a real-world context.

Participants in this study will undergo regular clinical visits where various aspects of their health will be monitored. These include tracking how well the cancer responds to the treatment, the time it takes for the cancer to progress, and the occurrence of any side effects. The study will also look at how long it takes for patients to need additional treatments and how long any positive effects of the treatment last.

  • Who can participate: Adults aged 18 and older who have been diagnosed with advanced NSCLC and are beginning or have recently begun treatment with an investigational medication are eligible. Participants should not have received more than two doses prior to enrollment and must not have certain genetic mutations or uncontrolled autoimmune diseases.
  • Study details: Participants will receive an investigational medication as part of their regular clinical care. They will be monitored to assess their response to treatment and any side effects they may experience. Follow-up will track the progression of their cancer and any additional treatments required.
  • Study Timelines: The study will last 72 months.

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