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 topic:
  Disease /health condition

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

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  GIOTRIF
• Study drug International non-proprietary name (INN) or common name:
  AFATINIB DIMALEATE
• Anatomical Therapeutic Chemical (ATC) code:
  (L01EB03) afatinib

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

Population studied

• Short description of the study population:
  Inclusion criteria:; • Patients who have been started on GIOTRIF® in accordance with the ; approved label in Korea; • Age ≥19 years at enrolment; • Patients who have signed on the data release consent form; Exclusion criteria:; • Known hypersensitivity to afatinib or any of its excipients; • Patients with rare hereditary conditions of galactose intolerance, the ; Lapp lactase deficiency or glucose-galactose malabsorption; • Patients for whom Afatinib is contraindicationed according local ; label of GIOTRIF®
• 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

• Study design:
  This was a single arm study with GIOTRIF®. GIOTRIF® was prescribed ; according to the local label and at the discretion of the treating physician. ; Since this was a non-interventional study, the drug was not be supplied by ; the sponsor.
• 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).
• Setting:
  Patients were managed according to the local practice guidelines. The choice of treatment was solely at the discretion of the participating physician. GIOTRIF® was administered according to the approved label in ; Korea.
• 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.