Ignite Creation Date:
2025-12-24 @ 4:17 PM
Ignite Modification Date:
2026-02-21 @ 9:03 AM
Study NCT ID:
NCT04285866
Status:
COMPLETED
Last Update Posted:
2022-06-07
First Post:
2020-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spanish Real World Data on Patients Treated With Durvalumab After Chemoradiotherapy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000613593', 'term': 'durvalumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 245}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-02', 'studyFirstSubmitDate': '2020-02-24', 'studyFirstSubmitQcDate': '2020-02-24', 'lastUpdatePostDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'From date of the first dose of durvalumab received (within the EAP) to the date of disease progression, death, or the end of follow-up, assessed up to 60 months', 'description': 'To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating PFS'}], 'secondaryOutcomes': [{'measure': '1-year survival rate', 'timeFrame': '1 year', 'description': 'To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating 1-year survival rate.'}, {'measure': 'To describe adverse events of special interest (AESIs)', 'timeFrame': 'From date of the first dose of durvalumab received (within the EAP) to the date of disease progression, death, or the end of follow-up, assessed up to 60 months', 'description': 'To describe AESIs leading to treatment temporary interruption or permanent discontinuation of durvalumab, or which require interventions of concomitant use of corticosteroids, immunosupressants and/or endocrine therapies.'}, {'measure': 'Time and site of disease progression or relapse', 'timeFrame': 'From date of the first dose of durvalumab received to the date of disease progression, assessed up to 60 months', 'description': 'To estimate time and sites of disease progression or relapse in metastatic setting.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Locally advanced small cell lung cancer', 'SCLC', 'lung cancer', 'durvalumab after chemotherapy', 'real world data'], 'conditions': ['Small Cell Lung Cancer (SCLC)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.gecp.org', 'label': 'Web page of the sponsor where users can find more information about Fundación GECP studies'}]}, 'descriptionModule': {'briefSummary': 'This is a non-interventional, observational, multicentre, one-arm, non-comparative, and retrospective study.\n\nThe study is based on the collection of data about the patients treated with Durvalumab after chemoraditherapy in the real world. The patients participating in this non-interventional study will not receive treatment in relation to the study. The primary objective is to assess affectiveness of durvalumab in patients treated in real-life settings by evaluating Progression Free Survival.', 'detailedDescription': 'Lung Cancer represent approximately 13% of total cancer diagnoses worldwide and continues to be the leading cause of cancer-related mortality. Stage III represents between 25-30% of NSCLC and the majority of them are unresectable. The standard treatment in unresectable patients was chemoradiotherapy consurrently if possible.\n\nThe PACIFIC study is a phase III study to evaluate the efficacy and safety of durvalumab as a sequential therapy concurrent platinum-based chemotherapy and thoracic RT. The study was positive for both primary endpoints progression-free survival and overall survival. After that, it was decided to open an early acces programme ti provide acces to durvalumab for patients with locally advanced, unresectable NSCLC (stage III) tho have not progressed following chemoradiation.\n\nThis observational study is based on the collection of data about the patients treated with Durvalumab after chemoraditherapy in the real world.\n\nThe study will include all patients who have participated in the EAP between 1 September 2017 up to 21 December 2018 and have received at least 1 dose of durvalumab.\n\nThe primary objective is to assess affectiveness of durvalumab in patients treated in real-life settings by evaluating Progression Free Survival. Other secondary objectives are:\n\nTo assess effectiveness of durvalumab in patients treated in real-life settings by evaluating 1-year survival rate, to describe adverse events of special interests, to stimate time and sites of disease progression or relapse in metastatic setting, to describe details on durvalumab treatment, to describe demographic and clinical characteristics of stage III unresectable NSCLC patients treated with Durvalumab, to describe previous chemoradiotherapy strategy, to describe the baseline staging status, to further assess subsequent treatments pattern at the time of disease progression including duration of therapy and type of therapy, and to explore healthcare resource utilization while on durvalumab treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who have parcipated in the EAP between 1 September 2017 up to 21 December 2018 and have received at least 1 dose of durvalumab.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients must have histologically or cytologically documented diagnosis of NSCLC with a locally advanced, or locally recurrent, unresectable (stage III) disease (according to American Joint Committee on Cancer \\[AJCC\\] lung cancer edition 7 or 8).\n2. Age ≥ 18 years at time of study Entry\n3. Patients must have been treated with chemotherapy and radiotherapy concurrently or sequentially and shown no progressive disease following chemoradiation\n4. Patients must have been enrolled in durvalumab EAPs between 1 September 2017 and 21 December 2018.\n5. Patients must have been treated with at least one dose of durvalumab within the EAP\n6. Alive patients must have signed, dated and IRB/EC-approved written informed consent\\* form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.\n\nExclusion Criteria:\n\n1. Alive patients who do not want to sign and date an IRB/IEC-approved written informed consent form.\n2. Patients who were accepted in the EAP, but did not receive treatment.\n3. Patients treated with durvalumab in clinical studies prior to the index date (first dose of durvalumab received within the EAP'}, 'identificationModule': {'nctId': 'NCT04285866', 'acronym': 'S-REAL', 'briefTitle': 'Spanish Real World Data on Patients Treated With Durvalumab After Chemoradiotherapy.', 'organization': {'class': 'OTHER', 'fullName': 'Fundación GECP'}, 'officialTitle': 'Spanish Real World Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy.', 'orgStudyIdInfo': {'id': 'GECP 19/02_S-REAL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Durvalumab Group', 'description': 'Patients who have participated in the EAP between 1 September 2017 up to 21 December 2018 and have received at least 1 dose of durvalumab.', 'interventionNames': ['Drug: Durvalumab']}], 'interventions': [{'name': 'Durvalumab', 'type': 'DRUG', 'otherNames': ['MEDI4736'], 'description': 'Durvalumab after chemoradiotherapy', 'armGroupLabels': ['Durvalumab Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15706', 'city': 'Santiago de Compostela', 'state': 'A Coruña', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Santiago', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': '07198', 'city': 'Palma de Mallorca', 'state': 'Balearic Islands', 'country': 'Spain', 'facility': 'Hospital Universitario Son Llàtzer', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '08916', 'city': 'Badalona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari Germans Trias i Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '08402', 'city': 'Granollers', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital General de Granollers', 'geoPoint': {'lat': 41.60797, 'lon': 2.28773}}, {'zip': '08208', 'city': 'Sabadell', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Corporació Sanitaria Parc Taulí', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}, {'zip': '20014', 'city': 'Donostia / San Sebastian', 'state': 'Basque Country', 'country': 'Spain', 'facility': 'Hospital Universitario de Donostia', 'geoPoint': {'lat': 43.31283, 'lon': -1.97499}}, {'zip': '39008', 'city': 'Santander', 'state': 'Cantabria', 'country': 'Spain', 'facility': 'Hospital Marqués de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '08041', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '35016', 'city': 'Las Palmas de Gran Canaria', 'state': 'Gran Canaria', 'country': 'Spain', 'facility': 'Hospital Universitario Insular de Gran canaria', 'geoPoint': {'lat': 28.10178, 'lon': -15.41573}}, {'zip': '28922', 'city': 'Alcorcón', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Fundación Alcorcón', 'geoPoint': {'lat': 40.34582, 'lon': -3.82487}}, {'zip': '29603', 'city': 'Marbella', 'state': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Costa del Sol', 'geoPoint': {'lat': 36.51543, 'lon': -4.88583}}, {'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'facility': 'Clínica Universidad de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '33011', 'city': 'Oviedo', 'state': 'Principality of Asturias', 'country': 'Spain', 'facility': 'Hospital Universitario Central de Asturias', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'zip': '38010', 'city': 'Santa Cruz de Tenerife', 'state': 'Tenerife', 'country': 'Spain', 'facility': 'Hospital Nuestra Señora de Candelaria', 'geoPoint': {'lat': 28.46824, 'lon': -16.25462}}, {'zip': '46600', 'city': 'Alzira', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitario De La Ribera', 'geoPoint': {'lat': 39.15, 'lon': -0.43333}}, {'zip': '48013', 'city': 'Bilbao', 'state': 'Vizcaya', 'country': 'Spain', 'facility': 'Hospital Universitario de Basurto', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'zip': '15006', 'city': 'A Coruña', 'country': 'Spain', 'facility': 'Hospital de A Coruña', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '03010', 'city': 'Alicante', 'country': 'Spain', 'facility': 'Hospital General de Alicante', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '08003', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Consorci Mar Parc de Salut de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '14004', 'city': 'Córdoba', 'country': 'Spain', 'facility': 'Hospital Universitario Reina Sofía', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '18016', 'city': 'Granada', 'country': 'Spain', 'facility': 'Hospital Universitario Clínico San Cecilio', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '19002', 'city': 'Guadalajara', 'country': 'Spain', 'facility': 'Hospital Universitario de Guadalajara', 'geoPoint': {'lat': 40.62862, 'lon': -3.16185}}, {'zip': '23007', 'city': 'Jaén', 'country': 'Spain', 'facility': 'Complejo Hospitalario de Jaén', 'geoPoint': {'lat': 37.76922, 'lon': -3.79028}}, {'zip': '28006', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital La Princesa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28007', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital General Universitario Gregorio Marañón', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clínico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Fundación Jiménez Díaz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28050', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital de Sanchinarro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28702', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Infanta Sofía', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '32005', 'city': 'Ourense', 'country': 'Spain', 'facility': 'Complexo Hospitalario de Ourense', 'geoPoint': {'lat': 42.33669, 'lon': -7.86407}}, {'zip': '37007', 'city': 'Salamanca', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}, {'zip': '40002', 'city': 'Segovia', 'country': 'Spain', 'facility': 'Hospital General de Segovia', 'geoPoint': {'lat': 40.94808, 'lon': -4.11839}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Virgen del Rocío', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '45071', 'city': 'Toledo', 'country': 'Spain', 'facility': 'Hospital Virgen de la Salud', 'geoPoint': {'lat': 39.8581, 'lon': -4.02263}}, {'zip': '46009', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitari i Politécnic La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '47003', 'city': 'Valladolid', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Valladolid', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}, {'zip': '50009', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Hospital Clínico Lozano Blesa', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}, {'zip': '50009', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Hospital Universitario Miguel Servet', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'overallOfficials': [{'name': 'Pilar Garrido, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fundación GECP Investigator'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación GECP', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}