Study identification

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
First published:
01/02/2024
Institution
Millennium Pharmaceuticals

Contact details

Jin-Liern Hong

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Takeda
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)