Carcinoma, Non-Small-Cell LungNCT04887519
A Study of Brigatinib to Treat Adults With Anaplastic Lymphoma Kinase (ALK) Positive Metastatic Non Small Cell Lung Cancer (NSCLC)
An observational study of Carcinoma, Non-Small-Cell Lung and Anaplastic Lymphoma Kinase, run by Takeda at 1 site in Argentina.
Trial summary
The aims of the study are to assess the safety profile of brigatinib and the clinical response rates in adults with Anaplastic Lymphoma Kinase (ALK)-Positive Metastatic Non Small Cell Lung Cancer (NSCLC). Treatment with brigatinib and follow-up will be according to routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Anaplastic Lymphoma Kinase
- How many people
- 39 participants
- Where
- 1 siteArgentina
- Study dates
- 30 Dec 2020to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Adult participants with a diagnosis of ALK positive metastatic NSCLC that are treated with brigatinib.
Who may be able to join
- 1. With either a diagnosis of ALK positive metastatic NSCLC previously treated with crizotinib OR a diagnosis of ALK positive metastatic NSCLC previously not treated with an ALK inhibitor. Have received at least one dose of brigatinib according to approved indications.
Who cannot join
- Note: There are no specific exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post Authorization Study to Monitor Efficacy, Effectiveness and Safety of Brigatinib (Alunbrig®) in Anaplastic Lymphoma Kinase (ALK) Positive Metastatic Non Small Cell Lung Cancer (NSCLC) in Argentina
The aims of the study are to assess the safety profile of brigatinib and the clinical response rates in adults with Anaplastic Lymphoma Kinase (ALK)-Positive Metastatic Non Small Cell Lung Cancer (NSCLC). Treatment with brigatinib and follow-up will be according to routine clinical practice.
Study doctors will review the participants' medical records at the start of the study, then at 12 and 24 weeks after treatment starts.
Read the detailed description
This is a prospective, observational post-marketing surveillance study of brigatinib in participants with advanced or metastatic NSCLC. This study will assess the safety, efficacy and effectiveness of brigatinib for its approved indications in a routine clinical practice setting under real world use.
The study will enroll approximately 37 participants. The data will be collected both prospectively and/or retrospectively at the specialized centers and outpatient oncology clinics and will be recorded by the investigator in the electronic Case Report Form (eCRF) based on the routine medical care data that is collected in the medical records. All the participants will be assigned to a single observational cohort:
- All Participants
This multi-center study will be conducted in Argentina. The overall duration of the study will be approximately 52 weeks. Data collection will be based on routine visit after every 12 weeks from the start of treatment up to 24 weeks of follow up or death or cancer progression or treatment discontinuation, whichever occurs first.
- Being tested
- No Intervention
- Keywords
- Drug Therapy
- 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.
No InterventionOther
This is a non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Participants with advanced or metastatic ALK positive NSCLC who have been prescribed with brigatinib in real-world will be observed both prospectively and/or retrospectively at the local clinical practice setting and data will be taken from medical records of the routine visit after every 12 weeks from the start of treatment up to 24 weeks of follow up or death or cancer progression or treatment discontinuation, whichever occurs first. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting One or More Adverse Events (AEs) of Special Interest
AEs of special interest includes Pneumonitis, interstitial lung disease, including early onset pulmonary events or symptoms; Hypertension; Bradycardia; Drug interactions with strong or moderate CYP3A inhibitors and inducers; hepatic toxicity; Myopathy, including elevation of creatine phosphokinase rhabdomyolysis and cardiomyopathy; Pancreatitis including elevation of lipase and amylase; Macular degeneration, retinopathy and visual disturbances and Embryo-fetal toxicity.
Measured: Up to 24 week
Number of Participants Reporting One or More AEs
Measured: Up to 24 week
Number of Participants Reporting One or More Serious Adverse Events (SAEs)
Measured: Up to 24 week
Number of Participants Reporting One or More Non-serious Adverse Events (Non-SAEs)
Measured: Up to 24 week
Secondary outcomes (4)
Objective Response Rate (ORR)
ORR will be evaluated by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. ORR is defined as the percentage of participants who achieved a best response of a complete response (CR) or partial response (PR). CR: defined as disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.
Measured: Up to 24 week
Central Nervous System Objective Response Rate (CNS-ORR)
CNS-ORR will be evaluated by the investigator judgement based on usual clinical practice guided by RECIST version1.1 in all participants with evaluable CNS metastases.
Measured: Up to 24 week
Progression-Free Survival (PFS)
PFS will be evaluated by treating physicians according to RECIST version 1.1. PFS is defined as the time from the date of randomization to the date of first documentation of progressive disease or death due to any cause, whichever occurs first.
Measured: From first administration of study drug to the date of disease progression or death due to any cause (up to 24 week)
Overall Survival (OS)
OS is defined as the time interval from the date of the first dose of the study treatment until death due to any cause.
Measured: From first administration of study drug to death (up to 24 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start30 Dec 2020
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 39 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
- NCT04887519
- Sponsor's protocol ID
- Brigatinib-5008
- Status last verified
- Apr 2023
- First submitted
- 13 May 2021
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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.
Publications
Martin C, Malcervelli GI, Martinengo GL, Levit P, Servienti P, Malaver E, Brion L, Patronella V, Zumarraga A, Zarba J. Safety and Effectiveness of Brigatinib in Anaplastic Lymphoma Kinase (ALK) Positive Metastatic Non-Small Cell Lung Cancer (NSCLC) in Argentina: A Post-Marketing Surveillance Study. Drugs Real World Outcomes. 2025 Jun;12(2):227-235. doi: 10.1007/s40801-025-00484-z. Epub 2025 Feb 26.
PubMed 40011377
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Authorization Study to Monitor Efficacy, Effectiveness and Safety of Brigatinib (Alunbrig®) in Anaplastic Lymphoma Kinase (ALK) Positive Metastatic Non Small Cell Lung Cancer (NSCLC) in Argentina
- ClinicalTrials.gov ID
- NCT04887519
- Acronym / sponsor ID
- Brigatinib-5008
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 14 May 2021 (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 aims of the study are to assess the safety profile of brigatinib and the clinical response rates in adults with Anaplastic Lymphoma Kinase (ALK)-Positive Metastatic Non Small Cell Lung Cancer (NSCLC). Treatment with brigatinib and follow-up will be according to routine clinical practice.
Study doctors will review the participants' medical records at the start of the study, then at 12 and 24 weeks after treatment starts.
Detailed description
This is a prospective, observational post-marketing surveillance study of brigatinib in participants with advanced or metastatic NSCLC. This study will assess the safety, efficacy and effectiveness of brigatinib for its approved indications in a routine clinical practice setting under real world use.
The study will enroll approximately 37 participants. The data will be collected both prospectively and/or retrospectively at the specialized centers and outpatient oncology clinics and will be recorded by the investigator in the electronic Case Report Form (eCRF) based on the routine medical care data that is collected in the medical records. All the participants will be assigned to a single observational cohort:
- All Participants
This multi-center study will be conducted in Argentina. The overall duration of the study will be approximately 52 weeks. Data collection will be based on routine visit after every 12 weeks from the start of treatment up to 24 weeks of follow up or death or cancer progression or treatment discontinuation, whichever occurs first.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Other: No InterventionParticipants with advanced or metastatic ALK positive NSCLC who have been prescribed with brigatinib in real-world will be observed both prospectively and/or retrospectively at the local clinical practice setting and data will be taken from medical records of the routine visit after every 12 weeks from the start of treatment up to 24 weeks of follow up or death or cancer progression or treatment discontinuation, whichever occurs first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with a diagnosis of ALK positive metastatic NSCLC that are treated with brigatinib.
Key inclusion criteria (1 listed)
- 1. With either a diagnosis of ALK positive metastatic NSCLC previously treated with crizotinib OR a diagnosis of ALK positive metastatic NSCLC previously not treated with an ALK inhibitor. Have received at least one dose of brigatinib according to approved indications.
Key exclusion criteria (1 listed)
- Note: There are no specific exclusion criteria.
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 |
|---|---|---|
| No InterventionThis is a non-interventional study. | Other | All Participants |
Primary outcome
Number of Participants Reporting One or More Adverse Events (AEs) of Special Interest
Time frame: Up to 24 week
AEs of special interest includes Pneumonitis, interstitial lung disease, including early onset pulmonary events or symptoms; Hypertension; Bradycardia; Drug interactions with strong or moderate CYP3A inhibitors and inducers; hepatic toxicity; Myopathy, including elevation of creatine phosphokinase rhabdomyolysis and cardiomyopathy; Pancreatitis including elevation of lipase and amylase; Macular degeneration, retinopathy and visual disturbances and Embryo-fetal toxicity.
Number of Participants Reporting One or More AEs
Time frame: Up to 24 week
Number of Participants Reporting One or More Serious Adverse Events (SAEs)
Time frame: Up to 24 week
Number of Participants Reporting One or More Non-serious Adverse Events (Non-SAEs)
Time frame: Up to 24 week
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 24 week
Central Nervous System Objective Response Rate (CNS-ORR)
Time frame: Up to 24 week
Progression-Free Survival (PFS)
Time frame: From first administration of study drug to the date of disease progression or death due to any cause (up to 24 week)
Overall Survival (OS)
Time frame: From first administration of study drug to death (up to 24 week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Derived from this study: PubMed 40011377Martin C, Malcervelli GI, Martinengo GL, Levit P, Servienti P, Malaver E, Brion L, Patronella V, Zumarraga A, Zarba J. Safety and Effectiveness of Brigatinib in Anaplastic Lymphoma Kinase (ALK) Positive Metastatic Non-Small Cell Lung Cancer (NSCLC) in Argentina: A Post-Marketing Surveillance Study. Drugs Real World Outcomes. 2025 Jun;12(2):227-235. doi: 10.1007/s40801-025-00484-z. Epub 2025 Feb 26.
- Related InfoLink 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.
Related trials for Carcinoma, Non-Small-Cell Lung
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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 Carcinoma, Non-Small-Cell Lung and Anaplastic Lymphoma Kinase, run by Takeda at 1 site in Argentina.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 18 Apr 2023. 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 Argentina. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants Reporting One or More Adverse Events (AEs) of Special Interest (time frame: Up to 24 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04887519, which also lists 1 linked publication.
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 Apr 2023.