GioTag: Real-world data study on sequential therapy with Gi(l)otrif®/ afatinib as first-line treatment followed by osimertinib in patients with EGFR mutation positive advanced non-small cell lung cancer

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Observational study designed to provide information on treatment efficacy or possible benefit on the targeted population.
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

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

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

Population studied

• Short description of the study population:
  Patients with EGFR mutation-positive Non-small cell lung cancer (NSCLC).
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Non-small cell lung cancer patients
• Estimated number of subjects:
  190

Study design details

• Main study objective:
  Primary:To determine the time on treatment of afatinib (Gi(l)otrif®) as first-line therapy in patients with EGFR mutation-positive NSCLC followed by osimertinib in case the T790M resistance mutation was developed in real-world setting. Secondary:To collect data on acquired resistance mechanism to osimertinib.
• Outcomes:
  Time on treatment with afatinib (Gi(l)otrif®) followed by osimertinib. Type and proportion of acquired resistance mutations after osimertinib.
• Data analysis plan:
  The primary endpoint is time on treatment which will be analyzed using Kaplan-Meier method, and the median along with two-sided 90% confidence interval will be displayed (use the Greenwood’s formula for estimation of standard errors).In the analyses of time-to-event endpoint, missing or incomplete data are managed by standard survival analysis techniques. For patient still on treatment, time on treatment will be censored at the date of data collection. The secondary endpoint is the different types of resistance mutations identified at the time of discontinuation of osimertinib treatment will be systematically reviewed and categorized. The proportion of patients with different types of mutations after categorization will be summarized descriptively. Baseline conditions and demographics will be analyzed with descriptive statistics. The frequency of treatment interruption and dose reduction of both afatinib (Gi(l)otrif®) and osimertinib will be summarized through descriptive statistics.