Ignite Creation Date:
2025-12-24 @ 1:56 PM
Ignite Modification Date:
2026-02-02 @ 1:25 AM
Study NCT ID:
NCT04994795
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-21
First Post:
2021-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Multimodal Signatures Associated With Response to Treatment and Prognosis of Patients With Stage IV Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-20', 'studyFirstSubmitDate': '2021-07-15', 'studyFirstSubmitQcDate': '2021-08-05', 'lastUpdatePostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment response at first evaluation', 'timeFrame': '6-12 weeks after treatment start', 'description': 'Predict treatment response at first evaluation using baseline data'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival', 'timeFrame': 'Through study completion, expected 6-14 months contingent on cohort', 'description': 'Predict Progression-Free Survival (PFS) using data at baseline and first evaluation'}, {'measure': 'Overall Survival', 'timeFrame': 'Through study completion, expected 8-20 months contingent on cohort', 'description': 'Predict Overall Survival (OS) using data at baseline and first evaluation'}, {'measure': 'Duration of Response', 'timeFrame': 'Through study completion, expected 6-14 months contingent on cohort', 'description': 'Predict Duration of Response (DoR) using data at baseline and first evaluation'}, {'measure': 'Time-To-Progression', 'timeFrame': 'Through study completion, expected 6-14 months contingent on cohort', 'description': 'Predict Time-To-Progression (TTP) using data at baseline and first evaluation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NSCLC', 'Immunotherapy', 'Chemotherapy', 'Predictive models', 'Radiomics', 'Multimodal', 'Genomics', 'Machine learning'], 'conditions': ['Non-small Cell Lung Cancer Metastatic']}, 'descriptionModule': {'briefSummary': 'Predicting response to therapy and disease progression in stage IV NSCLC patients treated with pembrolizumab monotherapy, chemotherapy-pembrolizumab combination therapy or chemotherapy alone in the first-line setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients diagnosed with stage IV NSCLC (de novo or earlier stage progression to stage IV), without oncogene-activating mutations eligible for targeted therapy, that are treated in the first-line setting with either pembrolizumab monotherapy, chemotherapy and pembrolizumab combination therapy, or chemotherapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult ≥18 years old\n* Patient diagnosed with Stage IV NSCLC (de novo or earlier stage progression to stage IV)\n* Absence of oncogene activating mutations eligible patients to targeted therapy (EGFR, ALK)\n* Cohort A: Received first line treatment with pembrolizumab monotherapy\n* Cohort B: Received first line treatment with chemotherapy and pembrolizumab combination therapy\n* Cohort C: Received first line treatment with chemotherapy doublet\n\nExclusion Criteria:\n\n* Prior anti-cancer therapy for actual stage IV NSCLC\n* Critical data missing (e.g., PD-L1 status, baseline millimetric imaging, first evaluation millimetric imaging)\n* Patients participating in other clinical trials that modify the standard of care'}, 'identificationModule': {'nctId': 'NCT04994795', 'acronym': 'DEEP-Lung-IV', 'briefTitle': 'Predictive Multimodal Signatures Associated With Response to Treatment and Prognosis of Patients With Stage IV Non-small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sophia Genetics SAS'}, 'officialTitle': 'Deep Learning-Enabled Exploration of Predictive Signatures in a Multicenter Retrospective and Prospective Observational Study Allowing the Analysis of the Aggregation of Multimodal Clinical, Biological, Genomic and Radiomics Data Associated With the Response to Treatment and Prognosis of Patients With Stage IV Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'SGDLIV'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pembrolizumab monotherapy', 'interventionNames': ['Other: Predictive models (data collection)']}, {'label': 'Chemotherapy and pembrolizumab combination therapy', 'interventionNames': ['Other: Predictive models (data collection)']}, {'label': 'Chemotherapy doublet', 'interventionNames': ['Other: Predictive models (data collection)']}], 'interventions': [{'name': 'Predictive models (data collection)', 'type': 'OTHER', 'description': 'Machine learning predictive models', 'armGroupLabels': ['Chemotherapy and pembrolizumab combination therapy', 'Chemotherapy doublet', 'Pembrolizumab monotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Holden Comprehensive Cancer Center at University of Iowa Health Care', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'UMASS Memorial Health', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Comprehensive Cancer Center', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Huntsman Cancer Institute', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Carbone Comprehensive Cancer Center at University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '71681-603', 'city': 'Brasília', 'country': 'Brazil', 'facility': 'DASA - Hospital Brasilia', 'geoPoint': {'lat': -15.77972, 'lon': -47.92972}}, {'zip': '24020-096', 'city': 'Niterói', 'country': 'Brazil', 'facility': 'DASA - Hospital de Niteroi', 'geoPoint': {'lat': -22.88333, 'lon': -43.10361}}, {'zip': '22061-080', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'DASA - Hospital São Lucas', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '01409-902', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'DASA - Hospital Nove De Julho', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'AC Camargo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Toronto', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '93000', 'city': 'Bobigny', 'country': 'France', 'facility': 'Avicenne Hospital', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '92100', 'city': 'Boulogne-Billancourt', 'country': 'France', 'facility': 'Ambroise Paré Hospital', 'geoPoint': {'lat': 48.83545, 'lon': 2.24128}}, {'zip': '69002', 'city': 'Lyon', 'country': 'France', 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'La Pitié Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75020', 'city': 'Paris', 'country': 'France', 'facility': 'Tenon Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '92150', 'city': 'Suresnes', 'country': 'France', 'facility': 'Foch Hospital', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}, {'zip': '83100', 'city': 'Toulon', 'country': 'France', 'facility': 'Centre Hospitalier de Toulon', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}, {'zip': '04103', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'University Hospital Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Shaare Zadek Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '43100', 'city': 'Parma', 'country': 'Italy', 'facility': 'University Hospital Of Parma', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Policlinico Gemelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '33100', 'city': 'Udine', 'country': 'Italy', 'facility': 'Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Fundacion jimenez diaz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28222', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Puerta De Hierro Hospital', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '46009', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Instituto Valenciano De Oncologia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Philippe Menu, MD-PhD, MBA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'SOPHiA GENETICS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sophia Genetics SAS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}