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

Recruiting

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Brigatinib	No intervention	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.

Primary Outcome Measures

Name	Time	Method
Real-World Progression Free Survival (rwPFS)	Up to 33 months	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.

Secondary Outcome Measures

Name	Time	Method
Real-World Overall Response Rate (rwORR)	Up to 33 months	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.
Time to Discontinuation (TTD)	Up to 33 months	TTD is defined as the time from starting treatment to the time to treatment discontinuation due to any cause.
Overall Survival (OS)	Up to 33 months	OS is defined as the time from starting treatment with brigatinib until death due to any cause or loss to follow-up.

Locations (12): Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
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Lublin, Lubelskie, Poland
Dolnoslskie Centrum Onkologii, Pulmonologii i Hematologii
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Wroclaw, Dolnoslskie, Poland
Szpital Kliniczny im. Heliodora Swiecickiego UM wPoznaniu.
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Poznan, Wielkopolskie, Poland
Centrum Onkologii im.Prof. F. Lukaszczyka w Bydgoszczy
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Bydgoszcz, Kujawsko-Pomorskie, Poland
Instytut Gruzlicy i Chorob Pluc
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Warszawa, Mazowieckie, Poland
SPZOZ Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej Akademii Medycznej Uniwersytetu Medycznego w Lodzi Centralny Szpital Weteranow
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Lodz, Lodzkie, Poland
Krakowski Szpital Specjalistyczny im. Jana Pawla II w Krakowie
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Krakow, Malopolskie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie- Panstwowy Instytut Badawczy Oddzial w Krakowie
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Krakow, Malopolskie, Poland
Centrum Pulmonologii i Torakochirurgii w Bystrej
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Bystra, Slskie, Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
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Poznan, Wielkopolskie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie, Panstwowy Instytut Badawczy
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Warszawa, Mazowieckie, Poland
Podkarpackie Centrum Chorob Pluc
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Rzeszow, Podkarpackie, Poland