Ignite Creation Date:
2025-12-26 @ 11:11 PM
Ignite Modification Date:
2025-12-26 @ 11:11 PM
Study NCT ID:
NCT04667312
Status:
COMPLETED
Last Update Posted:
2023-10-02
First Post:
2020-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observational Study of Durvalumab in Patients With Non-small-cell Lung Cancer in the United Kingdom
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000613593', 'term': 'durvalumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-29', 'studyFirstSubmitDate': '2020-11-27', 'studyFirstSubmitQcDate': '2020-12-11', 'lastUpdatePostDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '12 months', 'description': 'This study will estimate the proportion of patients known to be alive at 12 months post-index event'}, {'measure': 'Overall Survival', 'timeFrame': '24 months', 'description': 'This study will estimate the proportion of patients known to be alive at 24 months post-index event'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': '12 months', 'description': 'In this study, rwPFS will describe the proportion of patients known to be alive and free from disease progression at 12 months post-index event,'}, {'measure': 'Progression Free Survival', 'timeFrame': '24 months', 'description': 'In this study, rwPFS will describe the proportion of patients known to be alive and free from disease progression at 24 months post-index event,'}, {'measure': 'Second Progression Free Survival', 'timeFrame': '12 months', 'description': 'In this analysis, rwPFS2 describes the proportion of patients who progressed on durvalumab and who were known to be alive and had not progressed (including metastatic disease) on subsequent treatment at 12 months post-durvalumab initiation.'}, {'measure': 'Second Progression Free Survival', 'timeFrame': '24 months', 'description': 'In this analysis, rwPFS2 describes the proportion of patients who progressed on durvalumab and who were known to be alive and had not progressed (including metastatic disease) on subsequent treatment at 24 months post-durvalumab initiation.'}, {'measure': 'Best Overall Response', 'timeFrame': 'Up to 24 months', 'description': 'Best overall response, as recorded in medical records, will be described as complete response \\[CR\\], partial response \\[PR\\], stable disease \\[STD\\], absence of progression, progressive disease \\[PD\\], death, not recorded \\[NR\\]).'}, {'measure': 'Time to Treatment Discontinuation', 'timeFrame': 'Up to 24 months', 'description': 'Time from date of durvalumab initiation to date of discontinuation will be summarized using the Kaplan-Meier method, including the presentation of Kaplan-Meier plots.'}, {'measure': 'Time to first subsequent therapy', 'timeFrame': 'Up to 24 months', 'description': 'Time to initiation of first subsequent therapy will be summarized using the Kaplan-Meier method, including the presentation of Kaplan-Meier plots.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NSCLC unresectable stage III'], 'conditions': ['Non-Small Cell Lung Cancer NSCLC']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D4191R00038&attachmentIdentifier=8667ed8a-a98b-45a2-864c-577d46155d72&fileName=D4191R00038_CODAK_Study_Synopsis_Trial.Gov_20Sep23_.pdf&versionIdentifier=', 'label': 'CSR Synopsis 20Sep2023'}]}, 'descriptionModule': {'briefSummary': 'This is a retrospective observational research study to describe the characteristics and real-world clinical outcomes of patients with locally advanced, unresectable Stage III non-small cell lung cancer receiving durvalumab in the United Kingdom (the CODAK study). Physicians who have treated patients who have locally advanced, unresectable Stage III NSCLC with durvalumab will be requested to recruit patients to have their clinical data abstracted from their clinical records in line with local laws. Data from this study will provide UK-specific real-world data on patients receiving durvalumab through the Early Access Programme (EAP) or post-reimbursement.', 'detailedDescription': 'Primary Objectives\n\nThe primary study objectives, in patients with locally advanced, unresectable Stage III NSCLC treated with durvalumab as part of the UK EAP or non-EAP, are:\n\n1. To describe clinical outcomes\n2. To describe the patient demographic and clinical characteristics Secondary Objective\n\n1\\. To describe treatment patterns of durvalumab'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is adult patients with locally advanced, unresectable Stage III NSCLC treated with durvalumab following platinum based chemoradiotherapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has documented diagnosis of locally advanced, unresectable Stage III NSCLC\n* Patient has received platinum-based CRT and received ≥1 dose of durvalumab\n* Patient was initiated on durvalumab (index event) between 1st September 2017 and 31st December 2019 via the EAP or non-EAP\n* Patient was aged ≥18 years at durvalumab initiation\n\nExclusion Criteria:\n\n* Patients who participated in the PACIFIC-R study\n* Participation in any clinical study with an investigational product at the time of durvalumab initiation or during the observational period'}, 'identificationModule': {'nctId': 'NCT04667312', 'acronym': 'CODAK', 'briefTitle': 'Observational Study of Durvalumab in Patients With Non-small-cell Lung Cancer in the United Kingdom', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'CODAK: A Retrospective Observational Research Study to Describe the Characteristics and Real-world Clinical Outcomes of Patients With Locally Advanced, Unresectable Stage III Non-small Cell Lung Cancer Receiving Durvalumab in the UK.', 'orgStudyIdInfo': {'id': 'D4191R00038'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Durvalumab', 'type': 'DRUG', 'otherNames': ['Imfinzi'], 'description': 'Durvalumab'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CT1 3NG', 'city': 'Canterbury', 'country': 'United Kingdom', 'facility': 'East Kent Hospital', 'geoPoint': {'lat': 51.27904, 'lon': 1.07992}}, {'zip': 'CF14 2TL', 'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'Velindre Hospital', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'HG2 7SX', 'city': 'Harrogate', 'country': 'United Kingdom', 'facility': 'Harrogate and district NHS foundation Trust', 'geoPoint': {'lat': 53.99078, 'lon': -1.5373}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Leeds Teaching Hospitals NHS Trust', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'SE1 9RT', 'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW3 6JJ', 'city': 'London', 'country': 'United Kingdom', 'facility': 'The Royal Marsden NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'The Christie NHS Foundation', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'PO6 3LY', 'city': 'Portsmouth', 'country': 'United Kingdom', 'facility': 'Queen Alexandra Hospital', 'geoPoint': {'lat': 50.79899, 'lon': -1.09125}}, {'zip': 'TA1 5DA', 'city': 'Taunton', 'country': 'United Kingdom', 'facility': 'Musgrove Park Hospital', 'geoPoint': {'lat': 51.01494, 'lon': -3.10293}}, {'zip': 'TR1 3LJ', 'city': 'Truro', 'country': 'United Kingdom', 'facility': 'Royal Cornwall Hospitals NHS Trust', 'geoPoint': {'lat': 50.26526, 'lon': -5.05436}}], 'overallOfficials': [{'name': 'Kevin Franks', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Leeds Teaching Hospitals NHS Trust'}]}, '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. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.', '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'}}}}