A Retrospective Cohort Study to Characterize Patient Characteristics and Treatment Outcomes Among Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) in the French Epidemiological Strategy and Medical Economics Advanced or Metastatic Lung Cancer (ESME-AMLC) Database (20190402)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Non-small cell lung cancer

Population studied

• 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:
  45178

Study design details

• Main study objective:
  The main objective of this study is to estimate overall survival (OS) and real-world progression-free survival (rwPFS) of patients with KRAS G12C-mutated locally advanced or metastatic NSCLC.
• Outcomes:
  • Overall survival (OS) of patients with KRAS G12C-mutated locally advanced or metastatic NSCLC ; • Real world progression-free survival (rwPFS) of patients with KRAS G12C-mutated locally advanced or metastatic NSCLC; • OS and rwPFS of patients with locally advanced or metastatic NSCLC, overall and by biomarker status ; • Biomarker testing rates ; • Prevalence of KRAS G12C mutation ; • Demographics ; • Medical history ; • Clinical characteristics ; • Tumor characteristics ; • Treatment patterns ; • Concomitant medications ; • Genetic mutation profile
• Data analysis plan:
  There are no formal hypotheses for the study. Descriptive analyses will be performed. For continuous variables, descriptive statistics will be presented. ; For categorical variables, the number and percentage of patients in each category will be reported with 95% two-sided CIs. ; To describe time-to-event, Kaplan-Meier (KM) curves will be plotted, and KM estimates will be calculated.