A Study of Brigatinib to Treat Adults With Anaplastic Lymphoma Kinase (ALK) Positive Metastatic Non Small Cell Lung Cancer (NSCLC)

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04887519
• Other study ID #: Brigatinib-5008
• Status: Completed
• Start date: December 30, 2020
• Est. completion date: March 31, 2023

Study information

• Verified date: April 2023
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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:

• All Participants

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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.

Exclusion Criteria:

Note: There are no specific exclusion criteria.

Related Conditions & MeSH terms

• Anaplastic Lymphoma Kinase
• Carcinoma, Non-Small-Cell Lung
• Lymphoma

Intervention

Other:
• No Intervention
This is a non-interventional study.

Locations

Country	Name	City	State
Argentina	IC Projects	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of Participants Reporting One or More AEs		Up to 24 week
Primary	Number of Participants Reporting One or More Serious Adverse Events (SAEs)		Up to 24 week
Primary	Number of Participants Reporting One or More Non-serious Adverse Events (Non-SAEs)		Up to 24 week
Secondary	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.	Up to 24 week
Secondary	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.	Up to 24 week
Secondary	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.	From first administration of study drug to the date of disease progression or death due to any cause (up to 24 week)
Secondary	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.	From first administration of study drug to death (up to 24 week)

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