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Active, not recruiting Observational

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

NCT05735327 · tracked via the Priya Life Science Poland tracker
Sponsor
Phase
Observational
Started
2023-05-22
Last updated
2026-04-13

Condition(s) studied

Non-small Cell Lung Cancer (NSCLC)

Investigational drug(s) / intervention(s)

No intervention

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

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • 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.

Trial sites (12)

FacilityCityRegionStatus
Dolnoslskie Centrum Onkologii, Pulmonologii i Hematologii Wroclaw Dolnoslskie
Szpital Kliniczny im. Heliodora Swiecickiego UM wPoznaniu. Poznan Greater Poland Voivodeship
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu Poznan Greater Poland Voivodeship
Centrum Onkologii im.Prof. F. Lukaszczyka w Bydgoszczy Bydgoszcz Kuyavian-Pomeranian Voivodeship
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie- Panstwowy Instytut Badawczy Oddzial w Krakowie Krakow Lesser Poland Voivodeship
Krakowski Szpital Specjalistyczny im. Jana Pawla II w Krakowie Krakow Lesser Poland Voivodeship
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie Lublin Lublin Voivodeship
Instytut Gruzlicy i Chorob Pluc Warsaw Masovian Voivodeship
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie, Panstwowy Instytut Badawczy Warsaw Masovian Voivodeship
Podkarpackie Centrum Chorob Pluc Rzeszów Podkarpackie Voivodeship
Centrum Pulmonologii i Torakochirurgii w Bystrej Bystra Slskie
SPZOZ Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej Akademii Medycznej Uniwersytetu Medycznego w Lodzi Centralny Szpital Weteranow Lodz Łódź Voivodeship
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05735327 on ClinicalTrials.gov ↗ ← All trials in Poland