An observational study in Carcinoma, Non-Small-Cell Lung and Anaplastic Lymphoma Kinase, sponsored by Takeda. Completed at 1 site in Argentina. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-18.
Sponsored by Takeda · Observational
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.
This is a prospective, observational post-marketing surveillance study of brigatinib in participants with advanced or metastatic NSCLC. This study will assess the safety, efficacy and effectiveness of brigatinib for its approved indications in a routine clinical practice setting under real world use.
The study will enroll approximately 37 participants. The data will be collected both prospectively and/or retrospectively at the specialized centers and outpatient oncology clinics and will be recorded by the investigator in the electronic Case Report Form (eCRF) based on the routine medical care data that is collected in the medical records. All the participants will be assigned to a single observational cohort:
This multi-center study will be conducted in Argentina. The overall duration of the study will be approximately 52 weeks. Data collection will be based on 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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 39 is below the median of 136 across 625 observational studies indexed under Lymphoma.
Browse Lymphoma studies →Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult participants with a diagnosis of ALK positive metastatic NSCLC that are treated with brigatinib.
Exclusion Criteria:
Note: There are no specific exclusion criteria.
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.
Other: No Intervention
This is a non-interventional study.
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.
Time frame: Up to 24 week
Number of Participants Reporting One or More AEs
Time frame: Up to 24 week
Number of Participants Reporting One or More Serious Adverse Events (SAEs)
Time frame: Up to 24 week
Number of Participants Reporting One or More Non-serious Adverse Events (Non-SAEs)
Time frame: Up to 24 week
Objective Response Rate (ORR)
ORR will be evaluated by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. ORR is defined as the percentage of participants who achieved a best response of a complete response (CR) or partial response (PR). CR: defined as disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.
Time frame: Up to 24 week
Central Nervous System Objective Response Rate (CNS-ORR)
CNS-ORR will be evaluated by the investigator judgement based on usual clinical practice guided by RECIST version1.1 in all participants with evaluable CNS metastases.
Time frame: Up to 24 week
Progression-Free Survival (PFS)
PFS will be evaluated by treating physicians according to RECIST version 1.1. PFS is defined as the time from the date of randomization to the date of first documentation of progressive disease or death due to any cause, whichever occurs first.
Time frame: 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)
OS is defined as the time interval from the date of the first dose of the study treatment until death due to any cause.
Time frame: From first administration of study drug to death (up to 24 week)
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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