Effectiveness of LORlatinib as a Real-World, first-line treatment in ALK-positive Advanced or Metastatic Non-Small Cell Lung Cancer Patients in Italy(LOR-ALK).

Study type

• Study topic:
  Disease /health condition

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

  Effectiveness study (incl. comparative)

  Evaluation of patient-reported outcomes

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

Non-interventional study

• Non-interventional study design:
  Case-control

Study drug and medical condition

• Medicinal product name, 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:
  Lung cancer metastatic

Population studied

• Short description of the study population:
  The study population includes adult patients aged 18 years or older diagnosed with NSCLC in Italy
• 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:
  80

Study design details

• Study design:
  This is an observational, non-interventional, prospective, multicenter, and international wide study with the category of a PASS, which primary endpoint will describe the effectiveness of Lorlatinib as real-world PFS, assessed by the physician.;
• Main study objective:
  • To describe the Progression Free Survival (PFS) rate: PFS rate at 18-months.; • To describe Time to the Next Treatment (TTNT) defined as the period from the start of the treatment to the start of the next line of treatment.;
• Setting:
  The study population includes adult patients aged 18 years or older diagnosed with NSCLC in Italy, who are carriers of the ALK gene rearrangement. Molecular diagnosis of ALK rearrangement is routinely performed in patients with NSCLC according to the diagnostic guidelines of the Italian Association of Medical Oncology (AIOM).
• Outcomes:
  (PFS, TTNT, ORR, DOR, DCR, IC-RR, time to brain radiation, duration of intracranial response, DOT, cumulative incidence of BM in patient population at 12 and 18 months, PFS2, IC-TTP, proportion of patients with extracranial progression and sites of progression, any resistance mechanism with testing (e.g. liquid biopsy) after disease progression as per clinical practice in each center., proportion of patients with oligoprogression, OS as well as PFS, ORR, and DOT for subsequent line after Lorlatinib), QoL and PRO (EORTC QLQ-C30, EORTC QLQ-LC13, WPAI:GH) and safety (AEs, SAEs, non-serious AEs). AE, serious adverse events (SAE), and scenarios involving: exposure during breast feeding, medication error, overdose, misuse, lack of efficacy; exposure during pregnancy (EDP), ; occupational/environmental exposure and treatment-associated mortality as well as time to onset and duration of AEs.