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).
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.
Study Type
OBSERVATIONAL
Enrollment
50
As this is an observational study, no intervention will be administered.
Dolnoslskie Centrum Onkologii, Pulmonologii i Hematologii
Wroclaw, Dolnoslskie, Poland
RECRUITINGSzpital Kliniczny im. Heliodora Swiecickiego UM wPoznaniu.
Poznan, Greater Poland Voivodeship, Poland
RECRUITINGWielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
Poznan, Greater Poland Voivodeship, Poland
RECRUITINGCentrum Onkologii im.Prof. F. Lukaszczyka w Bydgoszczy
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
RECRUITINGNarodowy Instytut Onkologii im. Marii Sklodowskiej-Curie- Panstwowy Instytut Badawczy Oddzial w Krakowie
Krakow, Lesser Poland Voivodeship, Poland
NOT_YET_RECRUITINGKrakowski Szpital Specjalistyczny im. Jana Pawla II w Krakowie
Krakow, Lesser Poland Voivodeship, Poland
RECRUITINGSamodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
Lublin, Lublin Voivodeship, Poland
RECRUITINGInstytut Gruzlicy i Chorob Pluc
Warsaw, Masovian Voivodeship, Poland
RECRUITINGNarodowy Instytut Onkologii im. Marii Sklodowskiej-Curie, Panstwowy Instytut Badawczy
Warsaw, Masovian Voivodeship, Poland
RECRUITINGPodkarpackie Centrum Chorob Pluc
Rzeszów, Podkarpackie Voivodeship, Poland
NOT_YET_RECRUITING...and 2 more locations
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.
Time frame: Up to 33 months
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 33 months
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