Brigatinib-5007: 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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/44170
• EU PAS number:
  EUPAS32383
• Study ID:
  44170
• Official title and acronym:
  Brigatinib-5007: 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
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Denmark

  Finland

  France

  Germany

  Ireland

  Netherlands

  Norway

  Sweden

  United Kingdom
• Study description:
  This is a multi-centre, prospective, single-arm cohort study. This study will characterize the occurrence and risk factors of Early-onset Pulmonary Event (EOPEs) and will assess the effectiveness of the brigatinib Patient Alert Card among Anaplastic Lymphoma Kinase-Positive (ALK+) advanced Non-small Cell Lung Cancer (NSCLC) patients newly treated with brigatinib. The investigators will collect the baseline information on patient's demographics, NSCLC clinical characteristics, medical history, prior and concurrent cancer therapies, recent or concurrent medications. In this study there are no additional diagnostics, procedures, or clinic visits, other than what a patient would receive as part of the routine standard of care. The data collection will be performed using electronic case report forms (eCRFs). The data is anticipated to be collected between April 2020 and October 2024. The study aims to enroll 120 patients who initiated treatment with brigatinib. The study is planned to be conducted in Austria, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, Sweden, and the United Kingdom. The overall duration of the study is 42 days. All patients will be contacted approximately 30 days after brigatinib initiation to complete the Patient Alert Card questionnaire. The patients will be contacted again up to 2 times in case of non-response, around Day 35 and Day 42.
• Study status:
  Finalised

Research institutions and networks

Institutions

Takeda

Millennium Pharmaceuticals

Study timelines

Date when funding contract was signed

Planned: 01/03/2020

Actual: 28/04/2020

Study start date

Planned: 28/02/2021

Actual: 15/01/2021

Data analysis start date

Planned: 31/03/2024

Actual: 14/05/2024

Date of final study report

Planned: 31/12/2024

Actual: 09/09/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda

Study protocol

Initial protocol

Brigatinib-5007 EU PASS-Protocol_v2_Redacted

Updated protocol

Brigatinib-5007 EU PASS-Protocol_v2_Redacted.pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)