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

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Poland
Centrum Onkologii im.Prof. F. Lukaszczyka w Bydgoszczy
RECRUITING
Bydgoszcz
Centrum Pulmonologii i Torakochirurgii w Bystrej
NOT_YET_RECRUITING
Bystra
Krakowski Szpital Specjalistyczny im. Jana Pawla II w Krakowie
RECRUITING
Krakow
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie- Panstwowy Instytut Badawczy Oddzial w Krakowie
NOT_YET_RECRUITING
Krakow
SPZOZ Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej Akademii Medycznej Uniwersytetu Medycznego w Lodzi Centralny Szpital Weteranow
RECRUITING
Lodz
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
RECRUITING
Lublin
Szpital Kliniczny im. Heliodora Swiecickiego UM wPoznaniu.
RECRUITING
Poznan
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
RECRUITING
Poznan
Podkarpackie Centrum Chorob Pluc
NOT_YET_RECRUITING
Rzeszów
Instytut Gruzlicy i Chorob Pluc
RECRUITING
Warsaw
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie, Panstwowy Instytut Badawczy
RECRUITING
Warsaw
Dolnoslskie Centrum Onkologii, Pulmonologii i Hematologii
RECRUITING
Wroclaw
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date: 2023-05-22
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 50
Treatments
Brigatinib
Participants receiving Brigatinib as part of their first-line treatment in scope of their routine clinical practice within the frames of National Drug Program (NDP) will be observed at baseline, and every 3 months (± 1 month) at routine follow-up for up to 33 months.
Sponsors
Leads: Takeda

This content was sourced from clinicaltrials.gov