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 type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  Characterization of population receiving therapy
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Observational prospective product registry

Study drug and medical condition

• Medicinal product name:
  LIBTAYO
• Study drug International non-proprietary name (INN) or common name:
  CEMIPLIMAB
• Medical condition to be studied:
  Non-small cell lung cancer

Population studied

• Short description of the study 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.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  500

Study design details

• Study design:
  This is a non-interventional, longitudinal study of patients with advanced NSCLC treated with a cemiplimab-based regimen (cemiplimab monotherapy or cemiplimab in combination with platinum-based chemotherapy) in accordance with the SmPC, in routine clinical practice.
• Main study objective:
  The primary objective of the study is to describe OS in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice.
• Outcomes:
  • Overall survival (OS); • ORR, duration of response (DoR), time to response (TTR), PFS, and time to first subsequent anti-NSCLC treatment (TTST) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice; • Incidence and severity of treatment-related adverse events (TRAEs), treatment-related serious adverse events (TRSAEs), immune-mediated adverse events (imAEs), and infusion related reactions (IRRs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice
• Data analysis plan:
  Data collected in this registry will be analyzed descriptively.