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.
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 Type
OBSERVATIONAL
Enrollment
154
Brigatinib Tablets
Department of Oncology, Shanghai pulmonary hospital
Shanghai, Shanghai Municipality, China
Real-World Time-to-Treatment Discontinuation (rwTDD)
rwTTD is defined as the time from initiation of brigatinib to discontinuation of treatment for any reason, including disease progression, death, serious adverse events, or participant preference.
Time frame: Up to 8 years
Real-World Progression-Free Survival (rwPFS)
rwPFS is defined as the time from initiation of brigatinib to disease progression or death from any cause, or the time of the last confirmed survival.
Time frame: Up to 8 years
Real-World Progression-Free Survival at Years 1, 2 and 3
rwPFS at years 1,2 and 3 is defined as the probability of progression-free survival/ survival over one year; the probability of progression-free survival/survival over two years; the probability of progression-free survival/survival over three years.
Time frame: Up to 8 years
Real-World Overall Survival (rwOS) at Years 1, 2 and 3
rwOS is defined as the time from initiation of brigatinib to death from any cause, or the time of the last confirmed survival.
Time frame: Up to 8 years
Real-World Objective Response Rate (rwORR)
rwORR is defined as the percentage of participants who are confirmed to achieved complete response (CR) or partial response (PR) after receiving brigatinib.
Time frame: Up to 8 years
Real-World Duration of Response (rwDOR)
rwDOR is defined as the time from the first assessment of CR or PR after receiving first line treatment with brigatinib to progression or death.
Time frame: Up to 8 years
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