Brigatinib-PASS

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