Ignite Creation Date:
2025-12-25 @ 1:09 AM
Ignite Modification Date:
2026-01-04 @ 3:35 PM
Study NCT ID:
NCT03132493
Status:
COMPLETED
Last Update Posted:
2018-11-14
First Post:
2017-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nivolumab in the Real World: Analysis of the Expanded Use in Spanish Patient
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077594', 'term': 'Nivolumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 676}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-12', 'studyFirstSubmitDate': '2017-04-25', 'studyFirstSubmitQcDate': '2017-04-26', 'lastUpdatePostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free survival', 'timeFrame': 'At 12 months', 'description': 'time from inclusion to progression'}], 'secondaryOutcomes': [{'measure': 'Overall Response rate', 'timeFrame': 'At 12 months', 'description': 'Percentage of patient reaching a complete, partial or stable disease'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non Small Cell Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.gecp.org', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The investigators will be retrospectively review the case note of patients registered in the EAP of Nivolumab.\n\nA standard anonymous data collection form will be used to collect data and to analyze it.\n\nPatients with advanced Non-Small Cell Lung Cancer previously treated and included in the SPANISH expanded access programme of nivolumab.', 'detailedDescription': 'This study will help to understand the efficacy of Nivolumab in the real world setting within the SPANISH expanded access programme.\n\nThe main objective of this study is to evaluate nivolumab efficacy in terms of Overall Survival (OS), Progression Free Survival (PFS), Overall Response Rate (ORR) and safety in the clinical practice.\n\nThe efficacy variables will be assessed for patients (squamous vs non-squamous) who received second line therapies or third lines and subsequent lines and also, long responders will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients eligible for the trial are those treated in the EAP of nivolumab in Spain. The total number of patients to be included will be 1400 from 150 participating sites in Spain (anticipated data)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Squamous or Non-Squamous, non small cell lung cancer (NSCLC), Stage IIIb/IV (histologically or cytologically confirmed), relapsed after 1 prior platinum-based systemic treatment and who received treatment within the SPANISH expanded access programme of nivolumab (EAP)\n2. Alive patients must have signed and dated an IRB/IEC-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 do not receive treatment'}, 'identificationModule': {'nctId': 'NCT03132493', 'acronym': 'NIVEX', 'briefTitle': 'Nivolumab in the Real World: Analysis of the Expanded Use in Spanish Patient', 'organization': {'class': 'OTHER', 'fullName': 'Spanish Lung Cancer Group'}, 'officialTitle': 'A Retrospective, Multicenter and Observational Study of Nivolumab Monotherapy Treatment in Subjects With Advanced or Metastatic Squamous (Sq) or Non-Squamous (Non-Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimens for the Treatment of Stage IIIb/IV NSCLC Within the Expanded Access Program (EAP) in SPAIN', 'orgStudyIdInfo': {'id': 'GECP 16/05_NIVEX'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Nivolumab 10 MG/ML', 'type': 'DRUG', 'otherNames': ['Opdivo'], 'description': 'nivolumab 3 mg/kg as an intravenous infusion every 2 weeks until progression'}]}, 'contactsLocationsModule': {'locations': [{'zip': '03804', 'city': 'Alcoy', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Hospital Virgen de los Lirios', 'geoPoint': {'lat': 38.70545, 'lon': -0.47432}}, {'zip': '03202', 'city': 'Elche', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Hospital de Elche', 'geoPoint': {'lat': 38.26218, 'lon': -0.70107}}, {'zip': '03293', 'city': 'Elche', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Hospital Universitario de Vinalopó', 'geoPoint': {'lat': 38.26218, 'lon': -0.70107}}, {'zip': '03600', 'city': 'Elda', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Hospital General Universitario de Elda', 'geoPoint': {'lat': 38.47783, 'lon': -0.79157}}, {'zip': '08916', 'city': 'Badalona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'H. Germans Trias i Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '08304', 'city': 'Mataró', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de Mataró', 'geoPoint': {'lat': 41.54211, 'lon': 2.4445}}, {'zip': '08208', 'city': 'Sabadell', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Corporació Sanitaria Parc Taulí', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}, {'zip': '08220', 'city': 'Terrassa', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Consorci Sanitari de Terrassa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}, {'zip': '08221', 'city': 'Terrassa', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari Mútua de Terrassa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}, {'zip': '48960', 'city': 'Galdakao', 'state': 'Bizkaia', 'country': 'Spain', 'facility': 'Hospital de Galdakao', 'geoPoint': {'lat': 43.23073, 'lon': -2.8429}}, {'zip': '20014', 'city': 'Donostia / San Sebastian', 'state': 'Gipuzkoa', 'country': 'Spain', 'facility': 'Hospital Universitario de Donostia', 'geoPoint': {'lat': 43.31283, 'lon': -1.97499}}, {'zip': '15009', 'city': 'A Coruña', 'state': 'La Coruña', 'country': 'Spain', 'facility': 'Centro Oncológico de Galicia', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'city': 'Las Palmas de Gran Canaria', 'state': 'Las Palmas', 'country': 'Spain', 'facility': 'Hospital 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': '28942', 'city': 'Fuenlabrada', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario de Fuenlabrada', 'geoPoint': {'lat': 40.28419, 'lon': -3.79415}}, {'zip': '28911', 'city': 'Leganés', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Severo Ochoa', 'geoPoint': {'lat': 40.32718, 'lon': -3.7635}}, {'zip': '28935', 'city': 'Móstoles', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario de Móstoles', 'geoPoint': {'lat': 40.32234, 'lon': -3.86496}}, {'zip': '28981', 'city': 'Parla', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Infanta Cristina', 'geoPoint': {'lat': 40.23604, 'lon': -3.76752}}, {'zip': 'Madrid', 'city': 'Pozuelo de Alarcón', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Quirón Madrid', 'geoPoint': {'lat': 40.43293, 'lon': -3.81338}}, {'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'facility': 'Clínica Universitaria de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'facility': 'Complejo Hospitalario de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '43204', 'city': 'Reus', 'state': 'Tarragona', 'country': 'Spain', 'facility': 'Hospital Sant Joan de Reus', 'geoPoint': {'lat': 41.15612, 'lon': 1.10687}}, {'zip': '46800', 'city': 'Xàtiva', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Lluís Alcanyís', 'geoPoint': {'lat': 38.99042, 'lon': -0.51852}}, {'zip': '48903', 'city': 'Barakaldo', 'state': 'Vizcaya', 'country': 'Spain', 'facility': 'Hospital de Cruces', 'geoPoint': {'lat': 43.29639, 'lon': -2.98813}}, {'zip': '48013', 'city': 'Bilbao', 'state': 'Vizcaya', 'country': 'Spain', 'facility': 'Hospital de Basurto', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'zip': '15006', 'city': 'A Coruña', 'country': 'Spain', 'facility': 'Hospital Universitario a Coruña', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '08003', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Vall d' Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'H. Universitario Quirón Dexeus', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de Sant Pau Y de La Santa Creu', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08243', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'H. Althaia', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '16002', 'city': 'Cuenca', 'country': 'Spain', 'facility': 'Hospital Virgen de la Luz', 'geoPoint': {'lat': 40.06667, 'lon': -2.13333}}, {'zip': '17007', 'city': 'Girona', 'country': 'Spain', 'facility': 'Hospital Dr. Josep Trueta', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}, {'zip': '18012', 'city': 'Granada', 'country': 'Spain', 'facility': 'Hospital Clínico San Cecilio', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '19002', 'city': 'Guadalajara', 'country': 'Spain', 'facility': 'Hospital 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': '24071', 'city': 'León', 'country': 'Spain', 'facility': 'Complejo Asistencial Universitario de León', 'geoPoint': {'lat': 42.60003, 'lon': -5.57032}}, {'zip': '27003', 'city': 'Lugo', 'country': 'Spain', 'facility': 'Hospital Universitario Lucus Augusti', 'geoPoint': {'lat': 43.00992, 'lon': -7.55602}}, {'zip': '28007', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital General Universitario Gregorio Marañón', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28033', 'city': 'Madrid', 'country': 'Spain', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28035', 'city': 'Madrid', 'country': 'Spain', 'facility': 'H.U. Puerta de Hierro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Fundación Jimenez Diaz', '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': '28703', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Infanta Sofía', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'H. Carlos Haya', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen de la Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '30008', 'city': 'Murcia', 'country': 'Spain', 'facility': 'H. Morales Messeguer', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'zip': '30120', 'city': 'Murcia', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario Virgen de la Arrixaca', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'zip': '07010', 'city': 'Palma de Mallorca', 'country': 'Spain', 'facility': 'Hospital Son Espases', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '07198', 'city': 'Palma de Mallorca', 'country': 'Spain', 'facility': 'H. Son Llàtzer', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '37007', 'city': 'Salamanca', 'country': 'Spain', 'facility': 'Hospital Clinico de Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}, {'zip': '38010', 'city': 'Santa Cruz de Tenerife', 'country': 'Spain', 'facility': 'Hospital Nuestra Señora Candelaria', 'geoPoint': {'lat': 28.46824, 'lon': -16.25462}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Virgen del Rocío', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '46009', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Instituto Valenciano de Oncología', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46014', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital General de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46017', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Dr. Peset', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46500', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital de Sagunto', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital 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': 'H. Miguel Servet', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}, {'zip': '01009', 'city': 'Vitoria-Gasteiz', 'state': 'Áraba', 'country': 'Spain', 'facility': 'Hospital Universitario de Áraba', 'geoPoint': {'lat': 42.84998, 'lon': -2.67268}}], 'overallOfficials': [{'name': 'Delvys Rodríguez, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Insular de Gran Canaria'}, {'name': 'Margarita Majem, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spanish Lung Cancer Group', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}