UpSwinG: Real World study on TKI activity in Uncommon mutations and Sequencing Giotrif®

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  The study observes how long patients with non-small cell lung cancer (NSCLC) benefit from treatment with Epidermal Growth Factor Tyrosine Kinase Inhibitor (EGFR-TKI).

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Non-interventional, multi-country, multi-centre study based on existing data from medical records or electronic health records

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L01XE13) afatinib

  afatinib

  (L01XE02) gefitinib

  gefitinib

  (L01XE03) erlotinib

  erlotinib

  (L01XE35) osimertinib

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

Population studied

• 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:
  400

Study design details

• Main study objective:
  The study aims to describe the time on treatment until its end or death.
• Outcomes:
  Time on treatment with EGFR-TKI(s), Overall survival, ORR, methodology and material used for mutational testing. Uncommon cohort only: time on treatment until failure of second line (TTF2).
• Data analysis plan:
  The two cohorts will be analysed separately- Uncommon mutations- Sequencing of osimertinib after afatinibThe primary endpoint for both cohorts is time on treatment. Kaplan-Meier estimates will be calculated. In addition, the median will be tabulated along with the two-sided 95% confidence interval, using Greenwood’s variance estimate. The primary analysis will be repeated within subgroups. The following additional endpoints will be analyzed similarly to the primary endpoint.- overall survival- time on treatment until failure of second-line (uncommon cohort only)Patients who were not known to have discontinued treatment will be censored on the date they were last verified to have been on treatment.As an additional exploratory analysis, the data from the sequencing cohort of this study may be pooled with the previous GioTag study.