Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-03-08 @ 11:20 PM
Study NCT ID:
NCT03133234
Status:
COMPLETED
Last Update Posted:
2018-11-20
First Post:
2017-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Osimertinib in Ethnic Chinese With EGFR and T790M Mutated NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Macau']}, 'interventionBrowseModule': {'meshes': [{'id': 'C000596361', 'term': 'osimertinib'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-19', 'studyFirstSubmitDate': '2017-04-13', 'studyFirstSubmitQcDate': '2017-04-25', 'lastUpdatePostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ORR', 'timeFrame': 'Followed up with 6 months after last patient in', 'description': 'Overall response rate (ORR), defined as the proportion of patients with a best response of "responding" to treatment by investigator assessment'}], 'secondaryOutcomes': [{'measure': 'PFS', 'timeFrame': 'Followed up 10 months after last subject in', 'description': 'Progression free survival (PFS), defined as the time from the date of first dose of osimertinib to the date of investigator-assessed disease progression or death from any cause during study. Subjects who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment'}, {'measure': 'T790M mutation testing time', 'timeFrame': 'Within 14 days after enrollment date', 'description': 'Average turnaround time.'}, {'measure': 'Treatment patterns', 'timeFrame': 'Followed up 10 months after last patient in', 'description': 'To assess by number of previous adopted/current/future therapies as recorded on the case report form'}, {'measure': 'Adverse events', 'timeFrame': 'Follow up 10 months after last patient in.', 'description': 'To assess by number of adverse events as recorded on the case report form.'}, {'measure': 'Adverse event intensity', 'timeFrame': 'Follow up 10 months after last patient in.', 'description': 'To assess by intensity of adverse events as recorded on the case report form, which will be measured by CTCAE grade system'}, {'measure': 'T790M mutation testing sample', 'timeFrame': 'Within 14 days after enrollment date', 'description': 'To assess by proportion of testing samples types as recorded on the case report form.'}, {'measure': 'T790M mutation testing platform', 'timeFrame': 'Within 14 days after enrollment date', 'description': 'To assess by proportion of each testing platform as recorded on the case report form.'}, {'measure': 'EGFR testing mutation subtype', 'timeFrame': 'Within 14 days after enrollment date', 'description': 'To assess by proportion of EGFR mutation subtype as recorded on the case report form'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['T790M Positive NSCLC Patients']}, 'referencesModule': {'references': [{'pmid': '31442277', 'type': 'DERIVED', 'citation': 'Cao Y, Qiu X, Xiao G, Hu H, Lin T. Effectiveness and safety of osimertinib in patients with metastatic EGFR T790M-positive NSCLC: An observational real-world study. PLoS One. 2019 Aug 23;14(8):e0221575. doi: 10.1371/journal.pone.0221575. eCollection 2019.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=14680&filename=Study%20report%20%20of%20osimertinib%20retrospective%20RWE%20study%20in%20Macau.pdf', 'label': 'CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'To assess the effectiveness and safety of osimertinib treatment in a real world setting.', 'detailedDescription': 'The current study will not only assess the effectiveness of osimertinib treatment in a real world setting, but will also help us to understand the real-world testing patterns among T790M mutation positive locally advanced or metastatic NSCLC patients who have progressed after EGFR TKI treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Locally advanced or metastatic T790M mutation-positive NSCLC patients progressed after EGFR TKI treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Above 18 years of age;\n* Locally advanced (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy\n* Confirmed T790M mutation\n* Progressed on previous EGFR TKI treatment. Patients may have also received additional lines of treatment\n* Received osimertinib treatment in the participating site between May 1st and Oct 31st 2016\n\nExclusion Criteria:\n\n• Enrolment in studies that prohibit any participation in this observational study'}, 'identificationModule': {'nctId': 'NCT03133234', 'briefTitle': 'Effect of Osimertinib in Ethnic Chinese With EGFR and T790M Mutated NSCLC', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'An Observational, Retrospective, Real World Study of Osimertinib in Ethnic Chinese Patients With Locally Advanced/Metastatic T790M Mutation-Positive Non-small-cell Lung Cancer (NSCLC )Progressed on Previous Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI).', 'orgStudyIdInfo': {'id': 'D5160R00016'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'EGFR T790M Patients', 'description': 'Patients with locally advanced/metastatic EGFR T790M positive NSCLC progressed on previous EGFR TKI', 'interventionNames': ['Drug: osimertinib']}], 'interventions': [{'name': 'osimertinib', 'type': 'DRUG', 'description': 'Oral dose of 80mg once daily', 'armGroupLabels': ['EGFR T790M Patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Macau', 'country': 'China', 'facility': 'Kiang Wu Hospital'}], 'overallOfficials': [{'name': 'Yabing Cao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kiang Wu Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}