A regulatory requirement post-marketing surveillance study to monitor the safety and efficacy of GIOTRIF®(afatinib dimaleate, 20mg, 30mg, 40mg, q.d) in Korean patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) mutation(s) (GIOTRIF rPMS in Korean patients with NSCLC)

Study type

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

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  GIOTRIF
• 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)
• Estimated number of subjects:
  3000

Study design details

• Main study objective:
  The main objective is to monitor the safety profile and efficacy of GIOTRIF®(afatinib dimaleate, q.d) in Korean patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).
• Outcomes:
  to monitor the safety profile of GIOTRIF, to evaluate the tolerability and efficacy of GIOTRIF
• Data analysis plan:
  Safety analysis will be based on all patients treated. In accordance with local regulation, interim analyses are planned biannually for the initial two years and annually thereafter.