A Study of Brigatinib as Preferred First Therapy for Adults With Non-Small Cell Lung Cancer (NSCLC) ENTIRETY

Study Overview
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Brief Summary
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This is a study of brigatinib in adults with Non-Small Cell Lung Cancer (NSCLC). The main aim of this study is to learn about the time period in which the condition does not worsen after the participant has received brigatinib. Another aim is to learn about the overall rate of participants who respond to the treatment with brigatinib. Participants will receive brigatinib as part of their normal clinical practice. Data will be collected during regular visits to the hospital (a total of up to 12 visits is planned throughout study duration).

Detailed Description
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This is a non-interventional, prospective study of Polish participants with ALK positive NSCLC receiving Brigatinib as their first line of treatment in the scope of routine clinical practice within the frames of National Drug Program (NDP). This study will evaluate progression-free survival (from the time of the first dose of brigatinib). This study will enrol approximately 50 participants. Participants will be enrolled in the following cohort to be observed at baseline, and every 3 months up to 33 months: • Brigatinib This multi-center trial will be conducted in Poland. The overall duration of the study will include approximately 18 months of enrolment and approximately 33 months of data collection and follow-up.

Official Title
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Effectiveness and Safety of Brigatinib Treatment as First-line Therapy Administered to ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients. Prospective, Multicenter, Observational Study

Conditions
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Non-small Cell Lung Cancer (NSCLC)

Intervention / Treatment
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* Drug: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Adult (aged ≥18) ALK positive NSCLC participants receiving brigatinib as a first-line treatment in the scope of NDP. Participants willing to participate in the study and signed ICF. Exclusion Criteria Current or planned participation in an interventional clinical trial for ALK positive non-small cell lung cancer (NSCLC). Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Brigatinib<br>Participants receiving Brigatinib as part of their first-line treatment in scope of their routine clinical practice within the frames of National Drug Program (NDP) will be observed at baseline, and every 3 months (± 1 month) at routine follow-up for up to 33 months. | Drug: No intervention<br>* As this is an observational study, no intervention will be administered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real-World Progression Free Survival (rwPFS) | rwPFS is defined as the time from starting treatment to the time of radiographic progression according to Response evaluation criteria in solid tumors (RECIST) v1.1 criteria. | Up to 33 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | OS is defined as the time from starting treatment with brigatinib until death due to any cause or loss to follow-up. | Up to 33 months | 
| Real-World Overall Response Rate (rwORR) | rwORR (including intracranial response) is defined as the sum of the partial and complete response according to RECIST version 1.1. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. | Up to 33 months | 
| Time to Discontinuation (TTD) | TTD is defined as the time from starting treatment to the time to treatment discontinuation due to any cause. | Up to 33 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Therapy