Comparative Effectiveness of Sotorasib Versus Docetaxel Monotherapy in Second Line and Beyond (2L+) Among Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) in the Cancer Analysis System Database in England (20240164)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Comparative, retrospective, new-user cohort study

Study drug and medical condition

• Name of medicine:
  LUMYKRAS
• Study drug International non-proprietary name (INN) or common name:
  DOCETAXEL

  SOTORASIB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01CD02) docetaxel

  docetaxel

  (L01XX73) sotorasib

  sotorasib

Population studied

• Short description of the study population:
  Patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who had received at least 1 prior systemic therapy;
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
• Estimated number of subjects:
  1290

Study design details

• Study design:
  Comparative, retrospective, new-user cohort study using secondary real-world data to generate evidence on the comparative effectiveness of sotorasib versus docetaxel monotherapy in 2L+.
• Main study objective:
  To compare overall survival in patients with locally advanced or metastatic NSCLC who initiated treatment with sotorasib monotherapy versus docetaxel monotherapy in 2L+.
• Comparators:
  Docetaxel
• Outcomes:
  The outcome variables to be assessed are overall survival (OS), time to next treatment or death (TTNTD), time to treatment discontinuation or death (TTDD)
• Data analysis plan:
  The study will describe baseline demographics, clinical and tumor characteristics. ; Propensity score-based weighting will account for baseline confounding, with covariate balance assessed using standardized mean differences (SMDs). ; Kaplan-Meier methods and Cox proportional hazards regression will evaluate treatment effectiveness, reporting median survival times, confidence intervals, and hazard ratios (HRs), with unadjusted and adjusted HRs provided based on propensity score weighting, prior therapies, and molecular variables for the overall population and stratified by treatment group.