Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-04 @ 9:26 PM
Study NCT ID:
NCT02777567
Status:
COMPLETED
Last Update Posted:
2020-09-10
First Post:
2016-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
KOREA Study (Korea Osimertinib Real World Evidence Study to Assess Safety and Efficacy)
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 315}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-08', 'studyFirstSubmitDate': '2016-05-13', 'studyFirstSubmitQcDate': '2016-05-17', 'lastUpdatePostDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion (%) of patients with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI)', 'timeFrame': 'up to one year', 'description': 'Proportion (%) of patients with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI)'}, {'measure': 'Severity of (S)AEs', 'timeFrame': 'up to one year', 'description': 'Severity of (S)AEs'}], 'secondaryOutcomes': [{'measure': 'ORR (Objective response rate), if available', 'timeFrame': 'up to one year', 'description': 'ORR (Objective response rate), if available'}, {'measure': 'PFS (Progression free survival), if available', 'timeFrame': 'up to one year', 'description': 'PFS (Progression free survival), if available'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Non-Small Cell Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5160R00009&attachmentIdentifier=92919e00-80b9-49a7-b77f-ff6dbe6d9738&fileName=D5160R00009_synopsis.pdf&versionIdentifier=', 'label': 'redacted synopsis'}]}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to assess the safety and efficacy of single agent Tagrisso (Osimertinib, hereinafter "the study drug") in a real world setting in adult patients with advanced or metastatic, epidermal growth factor receptor (EGFR) T790M mutation-positive Non-Small Cell Lung Cancer (NSCLC), Who Have Progressed on or after EGFR tyrosine kinase receptor (TKI) therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with locally advanced or metastatic, EGFR T790M mutation-positive NSCLC, who have progressed on or after EGFR tyrosine kinase receptor (TKI) therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Eligible for, or on active study drug treatment according to the approved label; patients with locally advanced or metastatic, EGFR T790M mutation-positive NSCLC, who have progressed on or after EGFR tyrosine kinase receptor (TKI) therapy\n* 2\\. Provision of signed and dated written informed consent by the patient or legally acceptable representative\n\nExclusion Criteria:\n\n* 1\\. History of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug\n* 2\\. Pregnancy and/or breast feeding\n* 3\\. Current participation in any interventional trial'}, 'identificationModule': {'nctId': 'NCT02777567', 'acronym': 'KOREA', 'briefTitle': 'KOREA Study (Korea Osimertinib Real World Evidence Study to Assess Safety and Efficacy)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Open Label, Multicenter, Real World Treatment Study of Single Agent Tagrisso for Patients With Advanced/Metastatic Epidermal Growth Factor Receptor (EGFR) T790M Mutation-Positive Non-Small Cell Lung Cancer (NSCLC), Who Have Progressed on or After EGFR Tyrosine Kinase Receptor (TKI) Therapy', 'orgStudyIdInfo': {'id': 'D5160R00009'}}, 'contactsLocationsModule': {'locations': [{'city': 'South Korea', 'state': 'South Korea', 'country': 'South Korea', 'facility': 'Research Site'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}