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

Non-small Cell Lung Cancer (NSCLC) Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05735327
• Other study ID #: Brigatinib-4004
• Status: Recruiting
• Start date: May 22, 2023
• Est. completion date: June 1, 2027

Study information

• Verified date: August 2023
• Source: Takeda
• Contact: Takeda Contact
• Phone: +1-877-825-3327
• Email: medinfoUS[@]takeda.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2027
• Est. primary completion date: June 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer (NSCLC)

Intervention

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

Locations

Country	Name	City	State
Poland	Centrum Onkologii im.Prof. F. Lukaszczyka w Bydgoszczy	Bydgoszcz	Kujawsko-Pomorskie
Poland	Centrum Pulmonologii i Torakochirurgii w Bystrej	Bystra	Slskie
Poland	Krakowski Szpital Specjalistyczny im. Jana Pawla II w Krakowie	Krakow	Malopolskie
Poland	Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie- Panstwowy Instytut Badawczy Oddzial w Krakowie	Krakow	Malopolskie
Poland	SPZOZ Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej Akademii Medycznej Uniwersytetu Medycznego w Lodzi Centralny Szpital Weteranow	Lodz	Lodzkie
Poland	Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie	Lublin	Lubelskie
Poland	Szpital Kliniczny im. Heliodora Swiecickiego UM wPoznaniu.	Poznan	Wielkopolskie
Poland	Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu	Poznan	Wielkopolskie
Poland	Podkarpackie Centrum Chorob Pluc	Rzeszow	Podkarpackie
Poland	Instytut Gruzlicy i Chorob Pluc	Warszawa	Mazowieckie
Poland	Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie, Panstwowy Instytut Badawczy	Warszawa	Mazowieckie
Poland	Dolnoslskie Centrum Onkologii, Pulmonologii i Hematologii	Wroclaw	Dolnoslskie

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Real-World Progression Free Survival (rwPFS)	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.	Up to 33 months
Secondary	Overall Survival (OS)	OS is defined as the time from starting treatment with brigatinib until death due to any cause or loss to follow-up.	Up to 33 months
Secondary	Real-World Overall Response Rate (rwORR)	rwORR (including intracranial response) is defined as the sum of the partial and complete response according to RECIST version 1.1. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm.	Up to 33 months
Secondary	Time to Discontinuation (TTD)	TTD is defined as the time from starting treatment to the time to treatment discontinuation due to any cause.	Up to 33 months

External Links

•   To obtain more information on the study, click here/on this link.