Trial Title:
A Study of Brigatinib as Preferred First Therapy for Adults With Non-Small Cell Lung Cancer (NSCLC) ENTIRETY
NCT ID:
NCT05735327
Condition:
Non-small Cell Lung Cancer (NSCLC)
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
Drug Therapy
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
No intervention
Description:
As this is an observational study, no intervention will be administered.
Arm group label:
Brigatinib
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.
Criteria for eligibility:
Study pop:
Participants diagnosed with ALK positive NSCLC who received brigatinib in first-line
treatment in Poland.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Dolnoslskie Centrum Onkologii, Pulmonologii i Hematologii
Address:
City:
Wroclaw
Zip:
53-413
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Site Contact
Phone:
+48 71 33 49 400
Email:
dcchp@dcchp.pl
Investigator:
Last name:
Joanna Luboch-Kowal
Email:
Principal Investigator
Facility:
Name:
Centrum Onkologii im.Prof. F. Lukaszczyka w Bydgoszczy
Address:
City:
Bydgoszcz
Zip:
85-796
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Site Contact
Phone:
+48 52 374 33 44
Email:
co@co.bydgoszcz.pl
Investigator:
Last name:
Adrianna Makarewicz
Email:
Principal Investigator
Facility:
Name:
SPZOZ Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej Akademii Medycznej Uniwersytetu Medycznego w Lodzi Centralny Szpital Weteranow
Address:
City:
Lodz
Zip:
90-549
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Site Contact
Phone:
+48 42 6393 606
Email:
z.pulmonologia.s@skwam.lodz.pl
Investigator:
Last name:
Adam Antczak
Email:
Principal Investigator
Facility:
Name:
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
Address:
City:
Lublin
Zip:
20-954
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Site Contact
Phone:
48 81 724 42 26
Email:
szpital@spsk4.lublin.pl
Investigator:
Last name:
Tomasz Jankowski
Email:
Principal Investigator
Facility:
Name:
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie- Panstwowy Instytut Badawczy Oddzial w Krakowie
Address:
City:
Krakow
Zip:
31-115
Country:
Poland
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
48 12 63 48 268
Email:
kontakt@krakow.nio.gov.pl
Investigator:
Last name:
Aleksandra Drosik-Kwasniewska
Email:
Principal Investigator
Facility:
Name:
Krakowski Szpital Specjalistyczny im. Jana Pawla II w Krakowie
Address:
City:
Krakow
Zip:
31-202
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Site Contact
Phone:
+48 12 614 34 54
Email:
chemioterapia@szpitaljp2.krakow.pl
Investigator:
Last name:
Grzegorz Czyzewicz
Email:
Principal Investigator
Facility:
Name:
Instytut Gruzlicy i Chorob Pluc
Address:
City:
Warszawa
Zip:
01-138
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Site Contact
Phone:
+48 22 43 12 144
Email:
2klinika@igichp.edu.pl
Investigator:
Last name:
Pawel Sliwinski
Email:
Principal Investigator
Facility:
Name:
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie, Panstwowy Instytut Badawczy
Address:
City:
Warszawa
Zip:
02-781
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Site Contact
Phone:
+48 22 5462169
Email:
sekretariat4@pib-nio.pl
Investigator:
Last name:
Dariusz Kowalski
Email:
Principal Investigator
Facility:
Name:
Podkarpackie Centrum Chorob Pluc
Address:
City:
Rzeszow
Zip:
35-241
Country:
Poland
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
+48 17 86 11 479
Email:
szpital@pcchp.pl
Investigator:
Last name:
Aleksandra Stryjkowska-Gora
Email:
Principal Investigator
Facility:
Name:
Centrum Pulmonologii i Torakochirurgii w Bystrej
Address:
City:
Bystra
Zip:
43-360
Country:
Poland
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
+48 33 4991 801
Email:
sekretariat@szpitalbystra.pl
Investigator:
Last name:
Brygida Brudny-Borowska
Email:
Principal Investigator
Facility:
Name:
Szpital Kliniczny im. Heliodora Swiecickiego UM wPoznaniu.
Address:
City:
Poznan
Zip:
60-355
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Site Contact
Phone:
+48 61 854 90 38
Email:
szpital@spsk2.pl
Investigator:
Last name:
Rodryg Ramlau
Email:
Principal Investigator
Facility:
Name:
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
Address:
City:
Poznan
Zip:
60-569
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Site Contact
Phone:
+48 61 6654200
Email:
sekretariat@wcpit.org
Investigator:
Last name:
Katarzyna Stencel
Email:
Principal Investigator
Start date:
May 22, 2023
Completion date:
June 1, 2027
Lead sponsor:
Agency:
Takeda
Agency class:
Industry
Source:
Takeda
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05735327
https://clinicaltrials.takeda.com/study-detail/f64756166dc44be0?idFilter=%5B%22Brigatinib-4004%22%5D
