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

Last updated: August 19, 2025
Sponsor: Takeda
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

No intervention

Clinical Study ID

NCT05735327
Brigatinib-4004
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: No intervention
Phase:
Study Start date:
May 22, 2023
Estimated Completion Date:
June 01, 2027

Study 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.

Connect with a study center

  • Dolnoslskie Centrum Onkologii, Pulmonologii i Hematologii

    Wroclaw, Dolnoslskie 53-413
    Poland

    Site Not Available

  • Dolnoslskie Centrum Onkologii, Pulmonologii i Hematologii

    Wroclaw 3081368, Dolnoslskie 53-413
    Poland

    Active - Recruiting

  • Szpital Kliniczny im. Heliodora Swiecickiego UM wPoznaniu.

    Poznan 3088171, Greater Poland Voivodeship 3337498 60-355
    Poland

    Active - Recruiting

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

    Poznan 3088171, Greater Poland Voivodeship 3337498 60-569
    Poland

    Active - Recruiting

  • Centrum Onkologii im.Prof. F. Lukaszczyka w Bydgoszczy

    Bydgoszcz, Kujawsko-Pomorskie 85-796
    Poland

    Site Not Available

  • Centrum Onkologii im.Prof. F. Lukaszczyka w Bydgoszczy

    Bydgoszcz 3102014, Kuyavian-Pomeranian Voivodeship 3337500 85-796
    Poland

    Active - Recruiting

  • Krakowski Szpital Specjalistyczny im. Jana Pawla II w Krakowie

    Krakow 3094802, Lesser Poland Voivodeship 858786 31-202
    Poland

    Active - Recruiting

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

    Krakow 3094802, Lesser Poland Voivodeship 858786 31-115
    Poland

    Site Not Available

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

    Lodz, Lodzkie 90-549
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

    Lublin, Lubelskie 20-954
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

    Lublin 765876, Lublin Voivodeship 858785 20-954
    Poland

    Active - Recruiting

  • Krakowski Szpital Specjalistyczny im. Jana Pawla II w Krakowie

    Krakow, Malopolskie 31-202
    Poland

    Site Not Available

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

    Krakow, Malopolskie 31-115
    Poland

    Site Not Available

  • Instytut Gruzlicy i Chorob Pluc

    Warsaw 756135, Masovian Voivodeship 858787 01-138
    Poland

    Active - Recruiting

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

    Warsaw 756135, Masovian Voivodeship 858787 02-781
    Poland

    Active - Recruiting

  • Instytut Gruzlicy i Chorob Pluc

    Warszawa, Mazowieckie 01-138
    Poland

    Site Not Available

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

    Warszawa, Mazowieckie 02-781
    Poland

    Active - Recruiting

  • Podkarpackie Centrum Chorob Pluc

    Rzeszow, Podkarpackie 35-241
    Poland

    Site Not Available

  • Podkarpackie Centrum Chorob Pluc

    Rzeszów 759734, Podkarpackie Voivodeship 858788 35-241
    Poland

    Site Not Available

  • Centrum Pulmonologii i Torakochirurgii w Bystrej

    Bystra, Slskie 43-360
    Poland

    Site Not Available

  • Centrum Pulmonologii i Torakochirurgii w Bystrej

    Bystra 3101987, Slskie 43-360
    Poland

    Site Not Available

  • Szpital Kliniczny im. Heliodora Swiecickiego UM wPoznaniu.

    Poznan, Wielkopolskie 60-355
    Poland

    Site Not Available

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

    Poznan, Wielkopolskie 60-569
    Poland

    Active - Recruiting

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

    Lodz 3093133, Łódź Voivodeship 3337493 90-549
    Poland

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne Gdansk

    Gdansk, 80-952
    Poland

    Site Not Available

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

    Warszawa, 02-781
    Poland

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.