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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

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No. of patients

2 / 120


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


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


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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