Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-25 @ 8:43 PM
Study NCT ID:
NCT05100069
Status:
RECRUITING
Last Update Posted:
2025-10-03
First Post:
2021-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Survey of Brigatinib Used To Treat People With Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000598580', 'term': 'brigatinib'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-02', 'studyFirstSubmitDate': '2021-10-28', 'studyFirstSubmitQcDate': '2021-10-28', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Adverse Events Related to Interstitial Lung Disease', 'timeFrame': 'Up to 1 year', 'description': 'An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-small Cell Lung Cancer (NSCLC)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.takeda.com/study-detail/6182c950eb0e19002afd69fa', 'label': 'To obtain more information on the study, click here/on this link.'}]}, 'descriptionModule': {'briefSummary': "This study is a survey in Japan of Brigatinib tablets used to treat Japanese people with non-small cell lung cancer. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.\n\nThe main aim of the study is to check for side effects related to lung disease from Brigatinib. During the study, participants with non-small cell lung cancer will take Brigatinib tablets according to their clinic's standard practice. The study doctors will check for side effects from Brigatinib for 1 year."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with unresectable advanced/recurrent ALK fusion gene-positive non-small cell lung cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria Participants with unresectable advanced/recurrent ALK fusion gene-positive non-small cell lung cancer.\n\nExclusion criteria Participants who has a history of hypersensitivity to any component of birigatinib.'}, 'identificationModule': {'nctId': 'NCT05100069', 'briefTitle': 'Survey of Brigatinib Used To Treat People With Non-Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'General Use-results Survey of Alunbrig Tablets "Non-small Cell Lung Cancer"', 'orgStudyIdInfo': {'id': 'C25026'}, 'secondaryIdInfos': [{'id': 'jRCT2031210404', 'type': 'REGISTRY', 'domain': 'jRCT'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Brigatinib Tablets', 'description': 'Brigatinib 90 milligrams (mg), tablet, orally, once daily for up to 7 days, followed by 180 mg, tablets, once daily for 51 weeks. Participants received interventions as part of routine medical care.', 'interventionNames': ['Drug: Brigatinib']}], 'interventions': [{'name': 'Brigatinib', 'type': 'DRUG', 'otherNames': ['Alunbrig Tablets'], 'description': 'Brigatinib Tablets', 'armGroupLabels': ['Brigatinib Tablets']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Takeda Selected Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'centralContacts': [{'name': 'Takeda Contact', 'role': 'CONTACT', 'email': 'medinfoUS@takeda.com', 'phone': '+1-877-825-3327'}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/takeda/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': "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.", 'accessCriteria': 'IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}