Safety and effectiveness of LORLAtinib as a FIRST-line treatment in an ALK-positive Advanced Non-Small Cell Lung Cancer Spanish population. (LORLA-FIRST).

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Evaluation of patient-reported outcomes

  Other
• If ‘other’, further details on the scope of the study:
  Evaluate the real-world safety and effectiveness of Lorlatinib
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• 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

  Non-small cell lung cancer stage IV

Population studied

• Short description of the study population:
  Patients in 20 Spanish hospitals (clinics, or and primary care centers) must have a confirmed diagnosis of locally advanced and/or metastatic NSCLC with an ALK rearrangement identified by an approved diagnostic test, be older or equal than 18 years and have initiated first-line therapy with lorlatinib at least 7 days and up to 28 days prior to enrolment in the study according to routine clinical practice. ; They must also sign an informed consent and have a minimum of predetermined data recorded in their medical records. Socio demographic data about the patient's gender, age, height, weight at the treatment initiation will be collected. ; Additional socio demographic data will be collected: race, along with details regarding their smoking habits, as well as exposure to asbestos and previous personal and family history of cancer, particularly in first-degree relatives. ; Patients included in clinical trials are also excluded.
• Age groups:
  Adults (18 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:
  116

Study design details

• Study design:
  The study is an observational, non-interventional, prospective and multicenter trial that evaluates the real-world safety and effectiveness of lorlatinib as a first-line treatment in patients with ALK-positive advanced NSCLC in Spain.
• Main study objective:
  To describe all the spectrum of the adverse events (AEs) of Lorlatinib Common terminology criteria for adverse events (CTCAE v6.0) and its mitigation strategies, with special interest in CNS (Central Nervous system) AEs.
• Setting:
  The study population includes adult patients aged 18 years or older diagnosed with non-small cell lung cancer who are carriers of the ALK gene rearrangement recruited in an 18-month estimated period from 20 high specialized hospitals at the country level who have started first-line therapy with lorlatinib according to label prescription, with treatment duration of at least 7 days and up to 28 days.
• Data analysis plan:
  The safety assessment will be based primarily on the frequency and severity of AEs. ; AEs will be summarized by presenting the number and percentage of these figures in the total number of patients. ; The absolute and variable frequencies of each AE with respect to the total number of reported AEs will also be presented.; Descriptive analyses will be carried out to evaluate the objectives of the study. ; Categorical variables are described by their absolute and relative frequency. ; Continuous variables are described with total n, valid n, n unavailable, means, standard deviation, quartiles, minimum and maximum.; Survival analysis will be performed using Kaplan Meier method. ; A Cox regression model will be carried out to find independent variables associated with overall survival or time until disease progression.