Non-small Cell Lung Cancer (NSCLC)BrilliantNCT05721950
A Study to Learn About Brigatinib Treatment Information Available in Chinese Participants With Non-Small-cell Lung Cancer (NSCLC)
An observational study of Non-small Cell Lung Cancer (NSCLC), run by Takeda at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- Brigatinib
- Type of treatment
- Pill or oral medicine
- How many people
- 154 participants
- Where
- 1 siteChina
- Study dates
- 17 Jan 2024to 30 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants diagnosed with ALK positive locally advanced or metastatic NSCLC who received/will receive brigatinib in first line treatment since September 1, 2022 in China.
Who may be able to join
- Age ≥ 18 years.
- Participant with histologically/cytologically confirmed locally advanced or metastatic NSCLC.
- Participants with ALK gene rearrangement confirmed by local hospital medical records.
- Participants who received brigatinib since September 1, 2022 as first line treatment confirmed by medical records.
- Participants who have at least one medical record after the start of brigatinib treatment.
Who cannot join
- Participants participated in NSCLC-related interventional clinical trials after locally advanced or metastatic NSCLC diagnosis and during brigatinib treatment.
- Previously received any other TKIs, including ALK-targeted TKIs.
- Previously received more than 1 regimen of systemic anticancer therapy for locally advanced or metastatic disease.
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Oncology, Shanghai pulmonary hospital
Shanghai, Shanghai Municipality, 200433
About this study
Official 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.
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.
Read the 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.
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Being tested
- Brigatinib
- Keywords
- Drug Therapy, Real-world Data, Anaplastic Lymphoma Kinase Tyrosine Kinase Inhibitors
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrigatinibDrug
Also called Alunbrig
Brigatinib Tablets
| Study group | Role | What they receive |
|---|---|---|
| Brigatinib 90 mg/180mg | Participants with ALK positive locally advanced or metastatic NSCLC will be observed ambispectively (retrospective plus prospective) after receiving recommended dose of brigatinib, 90 mg orally once daily for first 7 days followed by 180 mg once daily for up to 36 months as their first line of treatment as part of routine medical care. Data will be collected every 3 months after their first dose until the 36 month or participant death, loss to follow-up, or withdrawal from the study for any reason in the real-world setting from September 1, 2022. Receives: Drug: Brigatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 8 years
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start17 Jan 2024
- Primary completion20 Mar 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721950
- Sponsor's protocol ID
- Brigatinib-4002
- Acronym
- Brilliant
- Status last verified
- Feb 2026
- First submitted
- 1 Feb 2023
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT05721950
- Acronym / sponsor ID
- Brilliant / Brigatinib-4002
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Keywords
- Drug Therapy, Real-world Data, Anaplastic Lymphoma Kinase Tyrosine Kinase Inhibitors
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 154 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 20 Mar 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brigatinib 90 mg/180mg | – | Drug: BrigatinibParticipants with ALK positive locally advanced or metastatic NSCLC will be observed ambispectively (retrospective plus prospective) after receiving recommended dose of brigatinib, 90 mg orally once daily for first 7 days followed by 180 mg once daily for up to 36 months as their first line of treatment as part of routine medical care. Data will be collected every 3 months after their first dose until the 36 month or participant death, loss to follow-up, or withdrawal from the study for any reason in the real-world setting from September 1, 2022. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants diagnosed with ALK positive locally advanced or metastatic NSCLC who received/will receive brigatinib in first line treatment since September 1, 2022 in China.
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Participant with histologically/cytologically confirmed locally advanced or metastatic NSCLC.
- Participants with ALK gene rearrangement confirmed by local hospital medical records.
- Participants who received brigatinib since September 1, 2022 as first line treatment confirmed by medical records.
- Participants who have at least one medical record after the start of brigatinib treatment.
Key exclusion criteria (4 listed)
- Participants participated in NSCLC-related interventional clinical trials after locally advanced or metastatic NSCLC diagnosis and during brigatinib treatment.
- Previously received any other TKIs, including ALK-targeted TKIs.
- Previously received more than 1 regimen of systemic anticancer therapy for locally advanced or metastatic disease.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrigatinibAlso: AlunbrigBrigatinib Tablets | Drug | Brigatinib 90 mg/180mg |
Primary outcome
Real-World Time-to-Treatment Discontinuation (rwTDD)
Time frame: 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.
5 secondary outcomes
Real-World Progression-Free Survival (rwPFS)
Time frame: Up to 8 years
Real-World Progression-Free Survival at Years 1, 2 and 3
Time frame: Up to 8 years
Real-World Overall Survival (rwOS) at Years 1, 2 and 3
Time frame: Up to 8 years
Real-World Objective Response Rate (rwORR)
Time frame: Up to 8 years
Real-World Duration of Response (rwDOR)
Time frame: Up to 8 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Click here for more information about this trial in easy-to-understand language.Link provided by the sponsor.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer (NSCLC), run by Takeda at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real-World Time-to-Treatment Discontinuation (rwTDD) (time frame: Up to 8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.