Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2026-03-09 @ 12:14 PM
Study NCT ID:
NCT04500535
Status:
COMPLETED
Last Update Posted:
2025-11-24
First Post:
2020-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Participants With Advanced Non-Small Cell Lung Cancer Treated With Nivolumab in France After at Least One Prior Chemotherapy-based Treatment by Lung Initiative on Sequence Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], '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': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 535}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2020-08-03', 'studyFirstSubmitQcDate': '2020-08-03', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to treatment failure (TTF)', 'timeFrame': 'Up to 3 years'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'Up to 3 years'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Up to 3 years'}, {'measure': 'Time to next therapy (TTNT)', 'timeFrame': 'Up to 3 years'}, {'measure': 'Best overall response rate (BORR)', 'timeFrame': 'Up to 3 years'}, {'measure': 'Distribution of participant demographics characteristics: Age', 'timeFrame': 'Index date (treatment initiation date for each individual patient'}, {'measure': 'Distribution of participant demographics characteristics: Sex', 'timeFrame': 'Index date (treatment initiation date for each individual patient)'}, {'measure': 'Distribution of clinical characteristics: Smoking status', 'timeFrame': 'Index date (treatment initiation date for each individual patient)'}, {'measure': 'Distribution of clinical characteristics: ECOG at initial diagnosis and at nivolumab initiation', 'timeFrame': 'Index date (treatment initiation date for each individual patient)'}, {'measure': 'Distribution of clinical characteristics: Histology', 'timeFrame': 'Index date (treatment initiation date for each individual patient)'}, {'measure': 'Distribution of clinical characteristics: TNM classification', 'timeFrame': 'Index date (treatment initiation date for each individual patient)', 'description': 'TNM=Tumor Nodes Metastases'}, {'measure': 'Distribution of clinical characteristics: Location of metastases', 'timeFrame': 'Index date (treatment initiation date for each individual patient)'}, {'measure': 'Distribution of clinical characteristics: EGFR mutation', 'timeFrame': 'Index date (treatment initiation date for each individual patient)', 'description': 'EGRF=Epidural Growth Factor Receptor'}, {'measure': 'Distribution of clinical characteristics: ALK translocation', 'timeFrame': 'Index date (treatment initiation date for each individual patient)', 'description': 'ALK= Anaplastic Lymphoma Kinase'}, {'measure': 'Distribution of clinical characteristics: HER2 mutation', 'timeFrame': 'Index date (treatment initiation date for each individual patient)', 'description': 'HER2=Human Epidermal Growth Factor Receptor 2'}, {'measure': 'Distribution of clinical characteristics: BRAF mutation', 'timeFrame': 'Index date (treatment initiation date for each individual patient)'}, {'measure': 'Distribution of clinical characteristics: KRAS mutation', 'timeFrame': 'Index date (treatment initiation date for each individual patient)'}, {'measure': 'Distribution of clinical characteristics: ROS1 mutation', 'timeFrame': 'Index date (treatment initiation date for each individual patient)'}, {'measure': 'Distribution of clinical characteristics: MET mutation', 'timeFrame': 'Index date (treatment initiation date for each individual patient)'}, {'measure': 'Distribution of clinical characteristics: PD-L1 expression', 'timeFrame': 'Index date (treatment initiation date for each individual patient)', 'description': 'PD-L1=Programmed Death Ligand 1'}, {'measure': 'Distribution of clinical characteristics: PD-L1 expression on tumor or stromal cells', 'timeFrame': 'Index date (treatment initiation date for each individual patient)', 'description': 'PD-L1=Programmed Death Ligand 1'}, {'measure': 'Incidence of Adverse Drug Reactions', 'timeFrame': '36 months after nivolumab treatment initiation'}, {'measure': 'Incidence of Seriousness criteria', 'timeFrame': '36 months after nivolumab treatment initiation'}, {'measure': 'Incidence of Intensity/ Grade', 'timeFrame': '36 months after nivolumab treatment initiation'}, {'measure': 'Incidence of AE duration', 'timeFrame': 'Follow-up period (Week 4 to Week 156)'}, {'measure': 'Incidence of Action taken regarding the BMS treatment', 'timeFrame': 'Follow-up period (Week 4 to Week 156)'}, {'measure': 'Incidence of Incidence rate', 'timeFrame': 'Follow-up period (Week 4 to Week 156)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non Small Cell Lung Cancer'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '40946253', 'type': 'DERIVED', 'citation': 'Godbert B, Gobbini E, Decroisette C, Lena H, Khalife Y, Brellier F, Fleuriet A, Zysman M, Egenod T, Moro Sibilot D, Girard N. Real-World Use and Immunotherapy Rechallenge Outcomes with Nivolumab in Advanced Non-small Cell Lung Cancer in France: Interim Results of the LIST Study. Oncol Ther. 2025 Dec;13(4):1071-1086. doi: 10.1007/s40487-025-00381-z. Epub 2025 Sep 14.'}], 'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to describe the following, for each cohort, in real world conditions in France:\n\n* The characteristics and treatment sequence of patients treated with nivolumab\n* The effectiveness of nivolumab treatment\n* The safety profile of nivolumab\n* Treatment patterns (e.g. duration of treatment, subsequent treatments) of nivolumab\n* The patient-reported outcomes (PRO) in patients treated with nivolumab, at baseline and during follow up using the EuroQoL-5D-3L'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The target population will be constituted using multistage sampling, in which physicians (pulmonologists and/or oncologists) from eligible hospitals are to identify and recruit the participants. Eligible hospitals will be selected among PMSI sites (national hospital discharge database) and only hospitals with a minimum of 40 patients treated for lung cancer and with chemotherapy in 2018 will be considered to ensure sufficient enrollment.', 'healthyVolunteers': True, 'eligibilityCriteria': 'For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* Pathologically confirmed diagnosis of advanced NSCLC\n* Whose physician has already decided to initiate a treatment with nivolumab for the treatment of advanced NSCLC according to the European label\n* Previously treated with at least one prior chemotherapy- containing regimen\n\nExclusion Criteria:\n\n* Participants taking part in an interventional study for lung cancer treatment for which nivolumab is one of the investigational drugs\n* Participants with a diagnosis of another primary cancer within the past five years\n* Participants receiving IO within 12 weeks prior to nivolumab first infusion in the context of the present study\n\nOther protocol-defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT04500535', 'acronym': 'LIST', 'briefTitle': 'A Study of Participants With Advanced Non-Small Cell Lung Cancer Treated With Nivolumab in France After at Least One Prior Chemotherapy-based Treatment by Lung Initiative on Sequence Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Multi-Center, Longitudinal, Prospective, Observational, Multi-Cohort Study of Patients With Advanced Non-Small Cell Lung Cancer Treated With Nivolumab in France After at Least One Prior Chemotherapy-based Treatment (LIST, Lung Initiative on Sequence Therapy)', 'orgStudyIdInfo': {'id': 'CA209-7HX'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Immuno-oncology (IO)-naïve patients'}, {'label': 'Cohort 2', 'description': 'IO-experienced patients for whom last IO discontinuation was not primarily related to IO-toxicity'}, {'label': 'Cohort 3', 'description': 'IO-experienced patients for whom last IO discontinuation was primarily due to IO-toxicity'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75248', 'city': 'Paris', 'country': 'France', 'facility': 'Local Institution - 0001', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}