Observational study to investigate safety and effectiveness of lorlatinib as first line treatment for ALK-gene rearranged unresectable advanced/recurrent NSCLC patients in Japan clinical setting

Study type

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

  Safety study (incl. comparative)

Study drug and medical condition

• Name of medicine:
  LORVIQUA
• Name of medicine, other:
  LORBRENA
• Study drug International non-proprietary name (INN) or common name:
  LORLATINIB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01ED05) lorlatinib

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

  ALK gene rearrangement positive

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:
  75

Study design details

• Study design:
  This is a multicenter, non-interventional study for patients with ALK-positive unresectable advanced/recurrent NSCLC treated with lorlatinib as first line treatment in Japan. The patients will be enrolled both retrospectively and prospectively based on the study initiation date.
• Main study objective:
  The primary objectives are: ; 1. To characterize Adverse Events of special interests (AESIs: CNS AE, Hyperlipidemia, Edema) for patients treated with lorlatinib. ; 2. To investigate dose modifications, interruption, or discontinuation (if any), with related timing and reason. ; 3. To investigate time-to-treatment discontinuation (TTD) of lorlatinib.