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.