Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Brigatinib
- description
- 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.
- interventionNames
- Drug: No intervention
Primary outcomes (1)
- measure
- Real-World Progression Free Survival (rwPFS)
- timeFrame
- Up to 33 months
- description
- 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.
Secondary outcomes (3)
- measure
- Overall Survival (OS)
- timeFrame
- Up to 33 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available