Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2026-01-05 @ 2:09 AM
Study NCT ID:
NCT04068168
Status:
COMPLETED
Last Update Posted:
2025-11-17
First Post:
2019-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open Label, Multicenter, Real World Practice of Durvalumab (Imfinzi PMS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}], 'ancestors': [{'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'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 712}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2019-08-07', 'studyFirstSubmitQcDate': '2019-08-22', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety (AE, SAE, ADR, SADR, AESI, DAE, fatal AE)', 'timeFrame': 'for up to 1 year after the first dose of Imfinzi', 'description': 'safety outcome'}, {'measure': 'Dose interruptions', 'timeFrame': 'for up to 1 year after the first dose of Imfinzi', 'description': 'Safety outcome'}, {'measure': 'Duration of treatment', 'timeFrame': 'for up to 1 year after the first dose of Imfinzi', 'description': 'Safety outcome'}], 'secondaryOutcomes': [{'measure': 'Progression free survival (PFS)', 'timeFrame': 'for up to 1 year after the first dose of Imfinzi', 'description': 'efficacy outcome'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': 'for up to 1 year after the first dose of Imfinzi', 'description': 'efficacy outcome'}, {'measure': 'Duration of response (DoR)', 'timeFrame': 'for up to 1 year after the first dose of Imfinzi', 'description': 'efficacy outcome'}]}, 'conditionsModule': {'conditions': ['Lung Cancer, Biliary Tract Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D4194R00004&attachmentIdentifier=95177cc7-3dc5-4f80-83f5-a1141ed6686f&fileName=CSR_Synopsis_Redacted.pdf&versionIdentifier=', 'label': 'CSR Synopsis\\_Redacted'}]}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to assess safety and efficacy of Imfinzi (durvalumab) in a real world setting in patients treated with Imfinzi under the approved indication in Korea.', 'detailedDescription': 'Primary objective : To assess safety of Imfinzi for patients treated with Imfinzi under the approved indication in Korea\n\nOutcome Measure:\n\n* Safety (adverse event (AE), serious adverse events (SAE), adverse drug reaction (ADR), serious adverse drug reaction (SADR), adverse events of special interest (AESI), adverse events leading to discontinuation (DAE), and adverse events leading to deaths (fatal AE))\n* Dose interruptions\n* Duration of treatment\n* Reason for treatment discontinuation Secondary objective: To assess efficacy of Imfinzi for patients treated with Imfinzi under the approved indication in Korea\n\nOutcome Measure:\n\n* Progression free survival (PFS)\n* Objective response rate (ORR)\n* Duration of response (DoR)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Imfinzi treatment according to the approved label', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible for Imfinzi treatment according to the approved label\n* Provision of signed and dated written informed consent by the patient or legally acceptable representative\n\nExclusion Criteria:\n\n* Current participation in any interventional trial\n* Other off-label indications according to the approved label'}, 'identificationModule': {'nctId': 'NCT04068168', 'acronym': 'Imfinzi PMS', 'briefTitle': 'Open Label, Multicenter, Real World Practice of Durvalumab (Imfinzi PMS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Open Label, Multicenter, Real World Practice of Durvalumab (Imfinzi PMS)', 'orgStudyIdInfo': {'id': 'D4194R00004'}}, 'contactsLocationsModule': {'locations': [{'city': 'Anyang-si', 'state': 'South Korea', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.3925, 'lon': 126.92694}}, {'city': 'Bucheon-si', 'state': 'South Korea', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Busan', 'state': 'South Korea', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Changwon', 'state': 'South Korea', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 35.22806, 'lon': 128.68111}}, {'city': 'Changwon-si', 'state': 'South Korea', 'country': 'South Korea', 'facility': 'Research Site'}, {'city': 'Cheonan', 'state': 'South Korea', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 36.8065, 'lon': 127.1522}}, {'city': 'Chuncheon', 'state': 'South Korea', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}, {'city': 'Daegu', 'state': 'South Korea', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daejeon', 'state': 'South Korea', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Goyang-si', 'state': 'South Korea', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'city': 'Gwangju', 'state': 'South Korea', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Hwasun-gun', 'state': 'South Korea', 'country': 'South Korea', 'facility': 'Research Site'}, {'city': 'Iksan-si', 'state': 'South Korea', 'country': 'South Korea', 'facility': 'Research Site'}, {'city': 'Incheon', 'state': 'South Korea', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Jeju-do', 'state': 'South Korea', 'country': 'South Korea', 'facility': 'Research Site'}, {'city': 'Jeonju', 'state': 'South Korea', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'city': 'Pohang-si', 'state': 'South Korea', 'country': 'South Korea', 'facility': 'Research Site'}, {'city': 'Seongnam-si', 'state': 'South Korea', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'city': 'Seoul', 'state': 'South Korea', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Suwon', 'state': 'South Korea', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'city': 'Uijeongbu-si', 'state': 'South Korea', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.7415, 'lon': 127.0474}}, {'city': 'Wŏnju', 'state': 'South Korea', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}, {'city': 'Yangsan', 'state': 'South Korea', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}, {'city': 'Yongin-si', 'state': 'South Korea', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.29686, 'lon': 127.08042}}]}, 'ipdSharingStatementModule': {'url': 'https://astrazenecagroup-dt.pharmacm.com/DT/Home', 'timeFrame': 'AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.', 'ipdSharing': 'YES', 'description': 'Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.\n\nAll request will be evaluated as per the AZ disclosure commitment:\n\nhttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared', 'accessCriteria': 'When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}