A Study of Brigatinib to Treat Adults With Anaplastic Lymphoma Kinase (ALK) Positive Metastatic Non Small Cell Lung Cancer (NSCLC)
Post Authorization Study to Monitor Efficacy, Effectiveness and Safety of Brigatinib (Alunbrig®) in Anaplastic Lymphoma Kinase (ALK) Positive Metastatic Non Small Cell Lung Cancer (NSCLC) in Argentina
1 other identifier
observational
39
1 country
1
Brief Summary
The aims of the study are to assess the safety profile of brigatinib and the clinical response rates in adults with Anaplastic Lymphoma Kinase (ALK)-Positive Metastatic Non Small Cell Lung Cancer (NSCLC). Treatment with brigatinib and follow-up will be according to routine clinical practice. Study doctors will review the participants' medical records at the start of the study, then at 12 and 24 weeks after treatment starts.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 30, 2020
CompletedFirst Submitted
Initial submission to the registry
May 13, 2021
CompletedFirst Posted
Study publicly available on registry
May 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2023
CompletedApril 18, 2023
April 1, 2023
2.2 years
May 13, 2021
April 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number of Participants Reporting One or More Adverse Events (AEs) of Special Interest
AEs of special interest includes Pneumonitis, interstitial lung disease, including early onset pulmonary events or symptoms; Hypertension; Bradycardia; Drug interactions with strong or moderate CYP3A inhibitors and inducers; hepatic toxicity; Myopathy, including elevation of creatine phosphokinase rhabdomyolysis and cardiomyopathy; Pancreatitis including elevation of lipase and amylase; Macular degeneration, retinopathy and visual disturbances and Embryo-fetal toxicity.
Up to 24 week
Number of Participants Reporting One or More AEs
Up to 24 week
Number of Participants Reporting One or More Serious Adverse Events (SAEs)
Up to 24 week
Number of Participants Reporting One or More Non-serious Adverse Events (Non-SAEs)
Up to 24 week
Secondary Outcomes (4)
Objective Response Rate (ORR)
Up to 24 week
Central Nervous System Objective Response Rate (CNS-ORR)
Up to 24 week
Progression-Free Survival (PFS)
From first administration of study drug to the date of disease progression or death due to any cause (up to 24 week)
Overall Survival (OS)
From first administration of study drug to death (up to 24 week)
Study Arms (1)
All Participants
Participants with advanced or metastatic ALK positive NSCLC who have been prescribed with brigatinib in real-world will be observed both prospectively and/or retrospectively at the local clinical practice setting and data will be taken from medical records of the routine visit after every 12 weeks from the start of treatment up to 24 weeks of follow up or death or cancer progression or treatment discontinuation, whichever occurs first.
Interventions
Eligibility Criteria
Adult participants with a diagnosis of ALK positive metastatic NSCLC that are treated with brigatinib.
You may qualify if:
- \. With either a diagnosis of ALK positive metastatic NSCLC previously treated with crizotinib OR a diagnosis of ALK positive metastatic NSCLC previously not treated with an ALK inhibitor. Have received at least one dose of brigatinib according to approved indications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (1)
IC Projects
Buenos Aires, C1055AAD, Argentina
Related Publications (1)
Martin C, Malcervelli GI, Martinengo GL, Levit P, Servienti P, Malaver E, Brion L, Patronella V, Zumarraga A, Zarba J. Safety and Effectiveness of Brigatinib in Anaplastic Lymphoma Kinase (ALK) Positive Metastatic Non-Small Cell Lung Cancer (NSCLC) in Argentina: A Post-Marketing Surveillance Study. Drugs Real World Outcomes. 2025 Jun;12(2):227-235. doi: 10.1007/s40801-025-00484-z. Epub 2025 Feb 26.
PMID: 40011377DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2021
First Posted
May 14, 2021
Study Start
December 30, 2020
Primary Completion
March 31, 2023
Study Completion
March 31, 2023
Last Updated
April 18, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.