Comparative effectiveness of sotorasib versus docetaxel in second line and beyond (2L+) among patients with advanced non-small cell lung cancer (NSCLC) in the Flatiron Health (FH) Enhanced Datamart (EDM)

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:
  Cohort

Study drug and medical condition

• Name of medicine:
  DOCETAXEL
• Name of medicine, other:
  LUMAKRAS® (sotorasib); Drug 1: sotorasib; Drug 2: docetaxel;
• Study drug International non-proprietary name (INN) or common name:
  DOCETAXEL

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

  docetaxel

  (L01XX73) sotorasib

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

Population studied

• Short description of the study population:
  • Patients with advanced NSCLC will be identified from the Flatiron Health EDM ; • Flatiron Health EDM includes over 280 community oncology practices and several academic centers throughout the US;
• Age groups:
  Adult and elderly population (≥18 years)

  Adults (18 to < 65 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  471

Study design details

• Study design:
  This study will comprise of two cohorts: Sotorasib cohort: KRAS p.G12C-mutated advanced NSCLC patients who initiated sotorasib monotherapy in 2L/2L+ between 28 May 2021 (date of US FDA approval) and 30 Sep 2022; Docetaxel cohort: KRAS p.G12C-mutated advanced NSCLC patients who initiated docetaxel.
• Main study objective:
  To compare overall survival in KRAS p.G12C-mutated advanced NSCLC patients initiating treatment with sotorasib monotherapy versus docetaxel monotherapy or combination therapy in second line (2L) setting, within the US FH EDM.
• Setting:
  Community oncology practices and several academic centers throughout the US.
• Comparators:
  Docetaxel monotherapy or combination therapy in 2L+ setting.
• Outcomes:
  Primary Outcome:; • Overall survival (OS) of participants treated with sotorasib monotherapy versus docetaxel monotherapy or combination therapy in 2L setting.; Secondary Outcome:; • OS of participants treated with sotorasib monotherapy versus docetaxel monotherapy or combination therapy in 2L+ setting.;
• Data analysis plan:
  Nonparametric methods will be used to estimate OS. Median OS and corresponding 95% confidence intervals (CIs) will be calculated using Kaplan-Meier estimates. The estimated survival probabilities for OS and corresponding 95% CIs will be presented for patients at 6- and 12-months.