Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT04858204
Status:
COMPLETED
Last Update Posted:
2021-04-26
First Post:
2018-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Real Life Second-Line Nivolumab in Advanced Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 259}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-22', 'studyFirstSubmitDate': '2018-09-13', 'studyFirstSubmitQcDate': '2021-04-22', 'lastUpdatePostDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nivolumab Objective response rate', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Objective response rate evaluated by RECIST 1.1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Real-life', 'nivolumab'], 'conditions': ['NSCLC']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': '1. Malhotra J, Jabbour SK, Aisner J. Current state of immunotherapy for non-small cell lung cancer. Transl Lung Cancer Res. 2017 Apr;6(2):196-211. 2. Kazandjian D, Suzman DL, Blumenthal G, Mushti S, He K, Libeg M et al. FDA Approval Summary: Nivolumab for the Treatment of Metastatic Non-Small Cell Lung Cancer With Progression On or After Platinum-Based Chemotherapy. The Oncologist. 2016 May;21(5):634-42. 3. Brahmer J, Reckamp KL, Baas P, Crinò L, Eberhardt WE, Poddubskaya E et al. Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Jul 9;373(2):123-35. 4. Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE et al. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Oct 22;373(17):1627-39. 5. Herbst RS, Baas P, Kim D-W, Felip E, Pérez-Gracia JL, Han JY et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. The Lancet. 2016 Apr;387(10027):1540-50. 6. Rittmeyer A, Barlesi F, Waterkamp D, Park K, Ciardiello F, von Pawel J et al. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet Lond Engl. 2017 21;389(10066):255-65. 7. Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer Oxf Engl 1990. 2009 Jan;45(2):228-47. 8. Common Terminology Criteria for Adverse Events (CTCAE) - CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf'}]}, 'descriptionModule': {'briefSummary': 'Data regarding nivolumab as second line treatment in advanced non-small cell lung cancer (NSCLC) are based on selected populations and might not reflect daily practice. Investigators aimed at assessing efficacy and safety of nivolumab in a real-life setting and determining a subtype of NSCLC patients that are more likely to benefit from immunotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Advanced stage non-small cell lung cancer patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* advanced NSCLC (stage IIIB-IV)\n* failure of at least one line of chemotherapy.\n* age ≥18 years,\n* initiation of nivolumab between 01/09/2015 and 30/09/2016.\n\nExclusion Criteria:\n\n* nivolumab initiation after October 2016\n* prior involvement in an immunotherapy trial\n* refusal to participate.'}, 'identificationModule': {'nctId': 'NCT04858204', 'acronym': 'IMMUNOBZH', 'briefTitle': 'Real Life Second-Line Nivolumab in Advanced Non-Small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Real Life Second-Line Nivolumab in Advanced Non-Small Cell Lung Cancer: a French Observational Multicenter Study of 259 Patients (ABCT-IMMUNOBZH)', 'orgStudyIdInfo': {'id': 'IMMUNOBZH (29BRC17.0032)'}}, 'contactsLocationsModule': {'locations': [{'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'CHRU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '22101', 'city': 'Dinan', 'country': 'France', 'facility': 'CH DINAN', 'geoPoint': {'lat': 48.45553, 'lon': -2.05049}}, {'zip': '56100', 'city': 'Lorient', 'country': 'France', 'facility': 'Centre Hospitalier de Bretagne Sud', 'geoPoint': {'lat': 47.74817, 'lon': -3.37177}}, {'zip': '35000', 'city': 'Rennes', 'country': 'France', 'facility': 'CHU de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '22000', 'city': 'Saint-Brieuc', 'country': 'France', 'facility': 'Centre Hospitalier Yves Le Foll', 'geoPoint': {'lat': 48.51513, 'lon': -2.76838}}, {'city': 'St-Malo', 'country': 'France', 'facility': 'Centre hospitalier de Saint Malo', 'geoPoint': {'lat': 48.64738, 'lon': -2.00877}}, {'zip': '56017', 'city': 'Vannes', 'country': 'France', 'facility': 'CH de VANNES', 'geoPoint': {'lat': 47.65688, 'lon': -2.76205}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}