NCT05735327

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

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: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	No intervention	As this is an observational study, no intervention will be administered.

Timeline

• Start date: 2023-05-22
• Primary completion: 2027-04-26
• Completion: 2027-04-26
• First posted: 2023-02-21
• Last updated: 2026-04-13

Locations

12 sites across 1 country: Poland