Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-03-02 @ 4:04 PM
Study NCT ID:
NCT03457220
Status:
COMPLETED
Last Update Posted:
2020-12-21
First Post:
2018-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study to Evaluate AZD9291 Treatment in Patients With T790M Positive 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 423}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-17', 'studyFirstSubmitDate': '2018-03-01', 'studyFirstSubmitQcDate': '2018-03-01', 'lastUpdatePostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Response Rate (RR)', 'timeFrame': 'Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 12 months', 'description': "RR is defined as the percentage of subjects with the best overall response of 'responding', which is defined as complete response (CR) or partial response (PR), by investigator's assessment"}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 12 months', 'description': "DCR is defined as the percentages of subjects who have the best overall response of CR, PR, or SD, which is determined by investigator's assessment."}, {'measure': 'Time to treatment discontinuation (TTD)', 'timeFrame': 'Time from patient first dose to data cut off (up to 32 months)', 'description': 'TTD is defined as the time interval (in months) from the date of the first dose of AZD9291 in the EAP until the date of the single use of AZD9291 discontinuation for any reason'}], 'primaryOutcomes': [{'measure': 'Progression free survival (PFS)', 'timeFrame': 'Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 12 months', 'description': 'PFS is defined as the time interval (in months) from the first dose of AZD9291 in the EAP to the date of disease progression'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 24 months', 'description': 'OS is defined as the time interval (in months) from the date of the first dose of AZD9291 in the EAP until the date of death due to any cause'}]}, 'conditionsModule': {'conditions': ['Non Small Cell Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5160R00021&attachmentIdentifier=d9ab5d4f-73bd-434e-9cb4-4205c318fd9e&fileName=D5160R00021_redacted_csr_synopsis.pdf&versionIdentifier=', 'label': 'CSR\\_Synopsis'}]}, 'descriptionModule': {'briefSummary': 'AZD9291 Early Access Program (EAP) was available in Taiwan during October 2015 to September 2016, a time period before the approval of AZD9291, to supply the unlicensed AZD9291 for the NSCLC patients who received at least one prior EGFR TKI therapy. At the end of September 2016, more than 450 patients have been under AZD9291 treatment through the EAP. This observational study aims to evaluate the clinical benefit of AZD9291 treatment for these patients who were in the EAP', 'detailedDescription': 'AZD9291 Early Access Program (EAP) was available in Taiwan during October 2015 to September 2016, a time period before the approval of AZD9291, to supply the unlicensed AZD9291 for the NSCLC patients who received at least one prior EGFR TKI therapy. At the end of September 2016, more than 450 patients have been under AZD9291 treatment through the EAP. This observational study aims to evaluate the clinical benefit of AZD9291 treatment for these patients who were in the EAP'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All the available patients who have participated in the AZD9291 EAP will be screened for the eligible criteria for data collection in this observational study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 20 years of age\n* Patients who were in the AZD9291 Early Access Program\n* Received at least one dose of AZD9291 treatment as mono-therapy, supported by available source documents\n* Patient who discontinued the single use of AZD9291, had disease progression, or died under AZD9291 treatment, whichever comes last, during the period from October 01, 2015 to December 31, 2018\n* Patients agree to provide the written informed consent or the informed consent is waived by IRB.\n\nExclusion Criteria:\n\n• Patients who did not receive at least one dose of EGFR TKI for the treatment of EGFR mutation (+) NSCLC'}, 'identificationModule': {'nctId': 'NCT03457220', 'briefTitle': 'An Observational Study to Evaluate AZD9291 Treatment in Patients With T790M Positive Non-small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'An Observational Study to Evaluate AZD9291 Treatment in Patients With EGFR T790M Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer Following Progression on at Least One Prior EGFR TKI Treatment', 'orgStudyIdInfo': {'id': 'D5160R00021'}}, 'contactsLocationsModule': {'locations': [{'zip': '807', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Research Site', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '83301', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Research Site', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '40705', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Research Site', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '70403', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'Research Site', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'zip': '73657', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'Research Site', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'zip': '10002', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Research Site', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '112', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Research Site', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}