START: Real-world study on sequential therapy with afatinib as first-line treatment in patients with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer (NSCLC)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)

  Other

  Safety study (incl. comparative)
• If ‘other’, further details on the scope of the study:
  Treatment pattern

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Non-interventional, prospective study based on newly-collected data

Study drug and medical condition

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

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

  Non-small cell lung cancer metastatic

  Non-small cell lung cancer stage IV

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:
  750

Study design details

• Main study objective:
  To determine in Chinese patients in real-world setting with EGFR mutation-positive non-small cell lung cancer (NSCLC) the time on treatment (TOT) of afatinib as first-line treatment followed by 3rd generation EGFR-TKI in the event that T790M resistance mutation was developed
• Outcomes:
  TOT with afatinib as first-line treatment followed by 3rd generation EGFR-TKI in the event of the T790M resistance mutation is developed in patients with EGFR mutation-positive NSCLC. This will be assessed as the time from the start of afatinib as first-line treatment until the last dose of 3rd generation EGFR-TKI. 1.TOT with afatinib as first-line treatment followed by investigator’s choice treatment in event of the T790M negative status in real-world setting2.OS from the start of afatinib until the date of death 3.PFS as judged by an investigator with afatinib in first-line treatment 4.ORR OR is defined as best overall response of CR and PR according to RECIST 1.1 with afatinib in first-line tre...
• Data analysis plan:
  TOT will be analysed using Kaplan-Meier method, and the median TOT along with two-sided 90% confidence interval (CI) will be calculated. PFS and OS will be analysed similarly. ORR, DCR, and acquired resistance mutation type, and AEs will be summarised descriptively by frequency and proportions.