Real World Evaluation of Sotorasib among Chinese Non-Small Cell Lung Cancer Patients (20240175)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Evaluation of patient-reported outcomes

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Retrospective medical chart review study.

Study drug and medical condition

• Name of medicine, other:
  LUMAKRAS® (sotorasib)
• Medical condition to be studied:
  Non-small cell lung cancer

Population studied

• Short description of the study population:
  Adult participants with KRAS p.G12C-mutated locally advanced or metastatic NSCLC and previously treated with at least 1 prior systemic therapy that have received sotorasib treatment in either location of BOAO Pilot Zone and Hong Kong Special Administrative Region (SAR).
• 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:
  115

Study design details

• Study design:
  This is a retrospective medical chart review study of Chinese participants treated with sotorasib in real-world and clinical settings in BOAO Pilot Zone and Hong Kong SAR.
• Main study objective:
  The main objective of the study is to characterize the safety profile of sotorasib.
• Setting:
  Two regions will be included in the study, ie, BOAO Pilot Zone and Hong Kong SAR. Until data cut-off date, approximately 100 sotorasib treated participants in Hainan BOAO Pilot Zone, and about 15 participants in Hong Kong SAR, will be eligible for medical chart review.
• Outcomes:
  Primary outcomes; 1. Number of participants experiencing adverse events (AE) after sotorasib initiation; ; Secondary outcomes ; 1. Overall survival (OS) from initial date of sotorasib use to date of death; ; Exploratory; · Describe real-world PFS of sotorasib; · Describe any reported quality of life scores or lung cancer-related respiratory symptom scores before and after treatment of sotorasib
• Data analysis plan:
  The analyses of all objectives will be performed using descriptive statistical methods. No hypotheses testing is planned.