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Completed

NCT Number: NCT04887519

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

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.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Anaplastic Lymphoma Kinase Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IC Projects

Buenos Aires, C1055AAD, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

No intervention

Other

This is a non-interventional study.

Primary outcomes

  1. Number of Participants Reporting One or More Adverse Events (AEs) of Special Interest

    Time frame: Up to 24 week

    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.

  2. Number of Participants Reporting One or More AEs

    Time frame: Up to 24 week

  3. Number of Participants Reporting One or More Serious Adverse Events (SAEs)

    Time frame: Up to 24 week

  4. Number of Participants Reporting One or More Non-serious Adverse Events (Non-SAEs)

    Time frame: Up to 24 week

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: Up to 24 week

    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.

  2. Central Nervous System Objective Response Rate (CNS-ORR)

    Time frame: Up to 24 week

    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.

  3. Progression-Free Survival (PFS)

    Time frame: From first administration of study drug to the date of disease progression or death due to any cause (up to 24 week)

    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.

  4. Overall Survival (OS)

    Time frame: From first administration of study drug to death (up to 24 week)

    OS is defined as the time interval from the date of the first dose of the study treatment until death due to any cause.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
May 14, 2021
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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