Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2026-01-04 @ 7:37 PM
Study NCT ID:
NCT04187768
Status:
COMPLETED
Last Update Posted:
2022-07-20
First Post:
2019-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunological Profile Changes In Patients With Advanced 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'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial 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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '10 mL of blood will be collected at each time point'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-19', 'studyFirstSubmitDate': '2019-12-03', 'studyFirstSubmitQcDate': '2019-12-03', 'lastUpdatePostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change in myeloid derived suppressive cells (MDSCs)', 'timeFrame': 'baseline and cycle 3', 'description': 'change in MDSCs before and after treatment'}, {'measure': 'Mean change in B regulatory cells (Bregs)', 'timeFrame': 'baseline and cycle 3', 'description': 'change in Bregs before and after treatment'}, {'measure': 'Mean change in T regulatory cells (Tregs) before and after treatment', 'timeFrame': 'baseline and cycle 3', 'description': 'change in Tregs before and after treatment'}], 'secondaryOutcomes': [{'measure': 'Describe the programmed death-ligand 1 (PD-L1) expression profile on peripheral blood MDSCs, Bregs, and Tregs', 'timeFrame': 'baseline, cycle 3'}, {'measure': 'Describe the programmed death-ligand 1 (PD1) expression profile on peripheral blood MDSCs, Bregs, and Tregs', 'timeFrame': 'baseline, cycle 3'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blood Donation', 'Lung Cancer', 'Non Small Cell Lung Cancer'], 'conditions': ['Non Small Cell Lung Cancer', 'Non Small Cell Lung Cancer Metastatic', 'Healthy']}, 'descriptionModule': {'briefSummary': 'This is a blood collection study being conducted to better understand and describe the immunological blood profile changes in patients with advanced non small cell lung cancer undergoing treatment with checkpoint inhibitor therapy. Blood will be collected from healthy volunteers and patients with non small cell lung cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with advanced NSCLC and healthy volunteers with no diagnosis of cancer, known immunodeficiency or other serious chronic illness', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ≥ 18 years old at the time of informed consent\n2. Written informed consent and HIPAA authorization for release of personal health information.\n3. Subjects with histologically and radiographically confirmed NSCLC.\n4. Subjects must have stage IV disease or recurrent disease.\n5. Subjects should be treatment naïve (systemic therapies) or have received prior chemotherapy in the first line setting. Prior radiation or surgery is permissible.\n6. Subjects who are eligible to receive single agent immunotherapy must have documentation of a PD-L1 Tumor Proportion Score (TPS) of at least 1%.\n7. Subjects with Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n\nExclusion Criteria:\n\n1. Subjects with curable or potentially curable NSCLC.\n2. Subjects should not have contraindications to treatment with immune checkpoint inhibitors per standard criteria.\n3. Patients with targetable mutations eligible for treatment with molecularly targeted small molecule inhibitor therapy.\n4. Subjects eligible for combination treatment with chemoimmunotherapy.'}, 'identificationModule': {'nctId': 'NCT04187768', 'briefTitle': 'Immunological Profile Changes In Patients With Advanced Non-Small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Immunological Profile Changes In Patients With Advanced Non-Small Cell Lung Cancer Undergoing Treatment With Checkpoint Inhibitor Monotherapy', 'orgStudyIdInfo': {'id': 'CTO-IUSCC-0701'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Group', 'description': 'Healthy volunteers will donate a sample of blood to be used as controls'}, {'label': 'NSCLC Group', 'description': 'Patients with advanced NSCLC will have blood collected prior to treatment and after completing 3 cycles of immune checkpoint therapy. . If a patient is noted to have progressive disease after 2 cycles of treatment, a sample will be collected after the 2nd cycle. If a patient is noted to have pseudoprogression (determined at the discretion of the treating physician), an additional sample may be collected after 3 cycles of therapy.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Melvin & Bren Simon Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Nasser Hanna, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana Unversity'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine, Tom and Julie Wood Family Foundation Professor of Lung Cancer Clinical Research', 'investigatorFullName': 'Nasser Hanna', 'investigatorAffiliation': 'Indiana University'}}}}