Special Drug Use-Results Surveillance (all-case) for sotorasib in patients with KRAS G12C-mutated, unresectable, advanced and/or recurrent non-small-cell lung cancer, that has progressed after systemic anticancer therapy in Japan (20210051)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  LUMYKRAS
• Name of medicine, other:
  LUMAKRAS
• Study drug International non-proprietary name (INN) or common name:
  SOTORASIB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01XX73) sotorasib

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

  Non-small cell lung cancer recurrent

  Non-small cell lung cancer stage III

  Non-small cell lung cancer stage IIIA

  Non-small cell lung cancer stage IIIB

  Non-small cell lung cancer stage IV
• Additional medical condition(s):
  KRAS G12C-mutated and/or Unresectable non-small cell lung cancer

Population studied

• Age groups:
  Adolescents (12 to < 18 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:
  300

Study design details

• Main study objective:
  The main objectives of this study are to describe the rate of hepatic impairment, to describe associations between clinical characteristics and hepatic impairment to potentially identify risk factors and to describe the rate of interstitial lung disease (ILD) in all patients treated with sotorasib in post-marketing clinical settings in Japan.
• Outcomes:
  • Patient incidence of hepatic impairment ; • Patient incidence of hepatic impairment by patient background ; • Patient incidence of ILD, ; • Patient incidence of ILD by patient background ; • Patient incidence of adverse events (AEs) ; • Patient incidence of serious AEs ; • Patient incidence of adverse drug reactions (ADRs) ; • Patient incidence of serious ADRs ; • Patient incidence of ADRs by patient background including hepatic impairment
• Data analysis plan:
  As the primary analysis, the patient incidences of hepatic impairment and IDL will be summarized. In addition, hepatic impairment will be tabulated by patient characteristics to describe associations between clinical characteristics and hepatic impairment to potentially identify risk factors. As a secondary analysis, ILD will be tabulated by patient characteristics to describe associations between clinical characteristics and ILD to potentially identify risk factors. In addition, the incidence of all AE and ADR will be tabulated in patients with hepatic impairment and all patients.