Clinical trial NCT04887519: A Study of Brigatinib to Treat Adults With Anaplastic Lymphoma Kinase (ALK) Positive Metastatic Non Small Cell Lung Cancer (NSCLC)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Non-Small-Cell Lung
Anaplastic Lymphoma Kinase
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-05-14
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with a diagnosis of ALK positive metastatic NSCLC that are treated with brigatinib.

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Reporting One or More Adverse Events (AEs) of Special Interest
timeFrame: Up to 24 week
measure: Number of Participants Reporting One or More AEs
timeFrame: Up to 24 week
measure: Number of Participants Reporting One or More Serious Adverse Events (SAEs)
timeFrame: Up to 24 week
measure: Number of Participants Reporting One or More Non-serious Adverse Events (Non-SAEs)
timeFrame: Up to 24 week
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to 24 week
measure: Central Nervous System Objective Response Rate (CNS-ORR)
timeFrame: Up to 24 week
measure: Progression-Free Survival (PFS)
timeFrame: From first administration of study drug to the date of disease progression or death due to any cause (up to 24 week)
measure: Overall Survival (OS)
timeFrame: From first administration of study drug to death (up to 24 week)
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: IC Projects
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: