RecruitingNCT05735327

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

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

Sponsor

Takeda

Enrollment

50 participants

Start Date

May 22, 2023

Study Type

OBSERVATIONAL

Conditions

Non-small Cell Lung Cancer (NSCLC)

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).

Eligibility

Min Age: 18 Years

Inclusion Criteria2

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 Criteria2

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.

Interventions

DRUGNo intervention

As this is an observational study, no intervention will be administered.

Locations(12)

Dolnoslskie Centrum Onkologii, Pulmonologii i Hematologii

Wroclaw, Dolnoslskie, Poland

Szpital Kliniczny im. Heliodora Swiecickiego UM wPoznaniu.

Poznan, Greater Poland Voivodeship, Poland

Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

Poznan, Greater Poland Voivodeship, Poland

Centrum Onkologii im.Prof. F. Lukaszczyka w Bydgoszczy

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie- Panstwowy Instytut Badawczy Oddzial w Krakowie

Krakow, Lesser Poland Voivodeship, Poland

Krakowski Szpital Specjalistyczny im. Jana Pawla II w Krakowie

Krakow, Lesser Poland Voivodeship, Poland

Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

Lublin, Lublin Voivodeship, Poland

Instytut Gruzlicy i Chorob Pluc

Warsaw, Masovian Voivodeship, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie, Panstwowy Instytut Badawczy

Warsaw, Masovian Voivodeship, Poland

Podkarpackie Centrum Chorob Pluc

Rzeszów, Podkarpackie Voivodeship, Poland

Centrum Pulmonologii i Torakochirurgii w Bystrej

Bystra, Slskie, Poland

SPZOZ Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej Akademii Medycznej Uniwersytetu Medycznego w Lodzi Centralny Szpital Weteranow

Lodz, Łódź Voivodeship, Poland

View Full Details on ClinicalTrials.gov

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NCT05735327

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