Brigatinib-PASS
A Cohort Study to Describe the Occurrence of Early-Onset Pulmonary Events in Patients with Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Treated with Brigatinib: A Post-Authorisation Safety Study
Enrollment
Recruiting
No. of patients
2 / 120
Population
Adults aged 18 years or older with ALK+ advanced (stage III or IV) NSCLC who are initiating monotherapy with brigatinib in accordance with approved indication
Design
Prospective, observational, multi-center, cohort study of ALK+ advanced NSCLC patients treated with brigatinib in real-world practice
Key outcome parameters
Primary endpoint:
- To describe the occurrence of EOPEs in ALK + advanced NSCLC patients treated with brigatinib in real-world practice
Secondary endpoint:
- To assess the effectiveness of the Patient Alert Card as a risk minimization measure
Intervention
All participating patients, including those with no pulmonary events reported, will be asked to participate in a telephone interview to collect information on the receipt, understanding and use of the brigatinib Patient Alert Card in the 30 days after brigatinib initiation
Key inclusion criteria
Inclusion criteria:
- Patients with ALK+ advanced (stage III or IV) NSCLC as determined by the healthcare professional who prescribes brigatinib
- Initiating monotherapy with brigatinib as per approved label
- Patients should be recruited on or before the day of the first dose of brigatinib
- Signed release form, by the patient or a legally acceptable representative, permitting abstraction of the patient’s medical records at baseline and during participation in the study
Key exclusion criteria
Exclusion criteria:
- The patient is currently participating in or did participate in any interventional clinical trial within the previous 6 months in which treatment regimen and/or monitoring is dictated by a protocol
- Patients who received treatment with brigatinib previously
- Patients who will receive brigatinib in combination with any systemic anticancer therapy
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