Observational Study on the Safety and Effectiveness of Sotorasib in South Korea (20200009)

Study type

• Study topic:
  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:
  Safety Reporting

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective and Prospective, observational Study

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

Population studied

• Age groups:
  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)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  25

Study design details

• Main study objective:
  To describe the safety of sotorosib in post-marketing clinical practice within the approved indication.
• Outcomes:
  Incidence of adverse events, serious adverse events, adverse drug reactions, serious adverse drug reactions, unexpected adverse drug reactions, unexpected serious adverse drug reactions, adverse events leading to sotorasib discontinuation and fatal events. Overall Response Rate (ORR) and clinical outcome measure by the Investigator.
• Data analysis plan:
  The data will be summarized descriptively. The incidence of adverse events will be summarized to include all treatment-emergent adverse events recorded from the start of sotorasib on this study or any worsening of medical conditions initially experienced before initiation of this study. ; All adverse events will be graded using the most recent Common Terminology Criteria for Adverse Events (CTCAE) version. The 6-month cumulative incidence of adverse events will be presented as frequency and percentage, and the 95% CI for the incidence estimate using an exact method will be provided. The Full Effectiveness Analysis Set will include all subjects from the Safety Analysis Set who also have at least 1 follow-up tumor assessment to estimate the ORR after initiation of sotorasib.