Non-small Cell Lung Cancer (NSCLC)
Conditions
Keywords
Drug Therapy, Real-world Data, Anaplastic Lymphoma Kinase Tyrosine Kinase Inhibitors
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.
Interventions
DRUGBrigatinib
Brigatinib Tablets
Sponsors
Takeda
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. Participants who received brigatinib since September 1, 2022 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Real-World Time-to-Treatment Discontinuation (rwTDD) | Up to 8 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Real-World Progression-Free Survival (rwPFS) | Up to 8 years | 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. |
| Real-World Progression-Free Survival at Years 1, 2 and 3 | Up to 8 years | 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. |
| Real-World Overall Survival (rwOS) at Years 1, 2 and 3 | Up to 8 years | rwOS is defined as the time from initiation of brigatinib to death from any cause, or the time of the last confirmed survival. |
| Real-World Objective Response Rate (rwORR) | Up to 8 years | rwORR is defined as the percentage of participants who are confirmed to achieved complete response (CR) or partial response (PR) after receiving brigatinib. |
| Real-World Duration of Response (rwDOR) | Up to 8 years | 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. |
Countries
China
Contacts
STUDY_DIRECTORStudy Director
Takeda
Outcome results
None listed