Clinical trial NCT05735327: A Study of Brigatinib as Preferred First Therapy for Adults With Non-Small Cell Lung Cancer (NSCLC) ENTIRETY
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-small Cell Lung Cancer (NSCLC)
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2023-02-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants diagnosed with ALK positive NSCLC who received brigatinib in first-line treatment in Poland.

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.

Eligibility criteria: Inclusion Criteria

1. Adult (aged ≥18) ALK positive NSCLC participants receiving brigatinib as a first-line treatment in the scope of NDP.
2. Participants willing to participate in the study and signed ICF.

Exclusion Criteria

1. Current or planned participation in an interventional clinical trial for ALK positive non-small cell lung cancer (NSCLC).
2. Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Primary outcomes:
measure: Real-World Progression Free Survival (rwPFS)
timeFrame: Up to 33 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 33 months
measure: Real-World Overall Response Rate (rwORR)
timeFrame: Up to 33 months
measure: Time to Discontinuation (TTD)
timeFrame: Up to 33 months
Other outcomes:
Locations:
city: Wroclaw
country: Poland
facility: Dolnoslskie Centrum Onkologii, Pulmonologii i Hematologii
state: Dolnoslskie
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im.Prof. F. Lukaszczyka w Bydgoszczy
state: Kujawsko-Pomorskie
city: Lodz
country: Poland
facility: SPZOZ Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej Akademii Medycznej Uniwersytetu Medycznego w Lodzi Centralny Szpital Weteranow
state: Lodzkie
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
state: Lubelskie
city: Krakow
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie- Panstwowy Instytut Badawczy Oddzial w Krakowie
state: Malopolskie
city: Krakow
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II w Krakowie
state: Malopolskie
city: Warszawa
country: Poland
facility: Instytut Gruzlicy i Chorob Pluc
state: Mazowieckie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie, Panstwowy Instytut Badawczy
state: Mazowieckie
city: Rzeszow
country: Poland
facility: Podkarpackie Centrum Chorob Pluc
state: Podkarpackie
city: Bystra
country: Poland
facility: Centrum Pulmonologii i Torakochirurgii w Bystrej
state: Slskie
city: Poznan
country: Poland
facility: Szpital Kliniczny im. Heliodora Swiecickiego UM wPoznaniu.
state: Wielkopolskie
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
state: Wielkopolskie
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: