Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-05 @ 5:23 PM
Study NCT ID:
NCT06487156
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate First-line Ipilimumab + Nivolumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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'}, {'id': 'D000074324', 'term': 'Ipilimumab'}], '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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2030-10-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-02', 'studyFirstSubmitDate': '2024-06-06', 'studyFirstSubmitQcDate': '2024-07-02', 'lastUpdatePostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-10-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'Up to 5 years'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Up to 5 years'}, {'measure': 'Overall response rate (ORR)', 'timeFrame': 'Up to 5 years'}, {'measure': 'Best overall response (BOR)', 'timeFrame': 'Up to 5 years'}, {'measure': 'Best overall response rate (BORR)', 'timeFrame': 'Up to 5 years'}, {'measure': 'Tumor response to treatment as classified by the treating physician and Response Evaluation Criteria in Solid Tumors (RECIST) criteria', 'timeFrame': 'Up to 5 years'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'Up to 5 years'}, {'measure': 'Time to response (TTR)', 'timeFrame': 'Up to 5 years'}, {'measure': 'European Quality of Life-5 Dimensions (EQ-5D) Score', 'timeFrame': 'Baseline and up to 5 years'}, {'measure': 'Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) results', 'timeFrame': 'Baseline and up to 5 years'}, {'measure': 'Treatment regimen', 'timeFrame': 'Up to 5 years'}, {'measure': 'Stage IV or recurrent, not previously treated, squamous and non-squamous NSCLC as confirmed by histology and/or cytology test results', 'timeFrame': 'Baseline'}, {'measure': 'Number of participants discontinuing treatment', 'timeFrame': 'Up to 5 years'}, {'measure': 'Management of Adverse Events (AEs)', 'timeFrame': 'Up to 5 years'}, {'measure': 'Participant socio-demographic characteristics', 'timeFrame': 'Baseline and up to 5 years'}, {'measure': 'Participant clinical characteristics', 'timeFrame': 'Baseline and up to 5 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-small cell lung cancer (NSCLC)'], 'conditions': ['Non-small Cell Lung Cancer (NSCLC)']}, 'referencesModule': {'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/recalls-market-withdrawals-safety-alerts', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to collect and evaluate real-world data to describe the outcomes, patient characteristics, safety profile and treatment patterns of first-line nivolumab plus ipilimumab treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) in Italy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients diagnosed with locally advanced or metastatic non-small cell lung cancer treated with nivolumab plus ipilimumab as first-line treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of stage IV or recurrent NSCLC (histologically or cytologically confirmed stage), without known EGFR- or ALK-alterations\n* Decision to initiate a first-line treatment with nivolumab plus ipilimumab for the treatment of NSCLC according to the Italy label has been made independently of the study\n* Patient is at least 18 years of age at time of treatment decision\n* Patient provided written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Current primary diagnosis of a cancer other than NSCLC that requires systemic or other treatment\n* Patients with known EGFR- or ALK-alterations\n* Previous treatment with nivolumab and/or ipilimumab\n* Patient already included in an interventional clinical trial for their advanced or recurrent NSCLC (but: Patients who have completed their participation in an interventional trial, who are not receiving study drug any more, and who are only followed-up for OS, can be enrolled)'}, 'identificationModule': {'nctId': 'NCT06487156', 'acronym': 'FINN', 'briefTitle': 'A Study to Evaluate First-line Ipilimumab + Nivolumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'FINN (First-line Ipilimumab + Nivolumab in NSCLC): An Italy, Nationwide, Prospective, Observational, Multicenter Study in Patients With First-line Nivolumab Plus Ipilimumab Therapy for Locally Advanced or Metastatic Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'CA209-1409'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants receiving first-line nivolumab plus ipilimumab', 'interventionNames': ['Drug: Nivolumab + ipilimumab']}], 'interventions': [{'name': 'Nivolumab + ipilimumab', 'type': 'DRUG', 'description': 'As per product label', 'armGroupLabels': ['Participants receiving first-line nivolumab plus ipilimumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandro Morabito, Site 0001', 'role': 'CONTACT', 'email': 'alessandromorabito1@virgilio.it', 'phone': '390817770291'}], 'facility': 'Istituto Nazionale Tumori - IRCCS Fondazione G.Pascale', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}], 'centralContacts': [{'name': 'BMS Study Connect Contact Center www.BMSStudyConnect.com', 'role': 'CONTACT', 'email': 'Clinical.Trials@bms.com', 'phone': '+1 855-907-3286'}, {'name': 'First line of the email MUST contain NCT # and Site #.', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}