Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT05721950
Brief Summary:
The main aim of this study is to learn about the time between the start and stop of treatment with brigatinib in Chinese participants with non-small-cell lung cancer (NSCLC) and who have been positively diagnosed with having the anaplastic lymphoma kinase (ALK) gene. Other study aims are to learn about the progression of NSCLC and participants' response to treatment with brigatinib.
Detailed Description:
This is a non-interventional, ambispective (retrospective + prospective) study of Chinese participants with ALK-positive locally advanced or metastatic NSCLC receiving brigatinib as their first line of treatment from September 1, 2022.This study will evaluate the time-to-treatment discontinuation and other efficacy outcomes of brigatinib in participants with NSCLC in real-world settings.
This study will enroll approximately 200 participants in the following cohort:
• Brigatinib 90 mg/180mg
This study is an ambispective study that will have prospective data collection if participants enrolled after the study initiation or it will have retrospective data collection if the participants have already started receiving brigatinib as first line treatment before study initiation.
This multi-center trial will be conducted in China. Participants will be followed up for safety from signing informed consent until 36 months after the last dose of treatment or until death of the last participant. The overall time for data collection is approximately 8 years.
Study:
NCT05721950
Study Brief:
Protocol Section:
NCT05721950