Non-small Cell Lung Cancer (NSCLC) Clinical Trial
— BrilliantOfficial title:
A Real-World Study to Evaluate the Effectiveness and Safety of Brigatinib in First Line in Patients With ALK Positive Locally Advanced or Metastatic NSCLC in China: An Ambispective, Non-interventional, Observational, Multi-center Study.
Verified date | March 2024 |
Source | Takeda |
Contact | Takeda Contact |
Phone | +1-877-825-3327 |
medinfoUS[@]takeda.com | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Department of Oncology, Shanghai pulmonary hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Takeda |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Up to 52 months | |
Secondary | 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. | Up to 52 months | |
Secondary | 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. | Up to 52 months | |
Secondary | 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. | Up to 52 months | |
Secondary | 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. | Up to 52 months | |
Secondary | 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. | Up to 52 months |
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