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Trial Title:
A Study to Learn About Brigatinib Treatment Information Available in Chinese Participants With Non-Small-cell Lung Cancer (NSCLC)
NCT ID:
NCT05721950
Condition:
Non-small Cell Lung Cancer (NSCLC)
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
Drug Therapy
Real-world Data
Anaplastic Lymphoma Kinase Tyrosine Kinase Inhibitors
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Drug
Intervention name:
Brigatinib
Description:
Brigatinib Tablets
Arm group label:
Brigatinib 90 mg/180mg
Other name:
Alunbrig
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 and December 31, 2023.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 the
study is approved before December 2023 or it will have retrospective data collection if
the study is approved after December 2023.
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 52 months.
Criteria for eligibility:
Study pop:
Participants diagnosed with ALK positive locally advanced or metastatic NSCLC who
received/will receive brigatinib in first line treatment between September 1, 2022 and
December 31, 2026 in China.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria
1. Age ≥ 18 years.
2. Participant with histologically/cytologically confirmed locally advanced or
metastatic NSCLC.
3. Participants with ALK gene rearrangement confirmed by local hospital medical
records.
4. During the period from September 1, 2022 to December 31, 2023, participants who
received brigatinib as first line treatment confirmed by medical records.
5. Participants who have at least one medical record after the start of brigatinib
treatment.
Exclusion Criteria
1. Participants participated in NSCLC-related interventional clinical trials after
locally advanced or metastatic NSCLC diagnosis and during brigatinib treatment.
2. Previously received any other TKIs, including ALK-targeted TKIs.
3. Previously received more than 1 regimen of systemic anticancer therapy for locally
advanced or metastatic disease.
4. Participants have been diagnosed as malignancies (excluding completely resected
basal cell carcinoma, bladder carcinoma in situ, cervical carcinoma in situ) in
addition to NSCLC within the past 5 years.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Oncology, Shanghai pulmonary hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Recruiting
Contact:
Last name:
Caicun Zhou
Phone:
+86 13301825532
Email:
caicunzhoudr@163.com
Start date:
January 17, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Takeda
Agency class:
Industry
Source:
Takeda
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05721950
https://clinicaltrials.takeda.com/study-detail/a4a0ed12fe314db1?idFilter=%5B%22Brigatinib-4002%22%5D
