Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT06849518
Status:
RECRUITING
Last Update Posted:
2025-02-28
First Post:
2025-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Longitudinal Plasma PD-L1 Testing With Immunotherapy in Lung Cancer
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A Circulogene liquid biopsy testing for plasma NGS ctDNA and plasma cfRNA PD-L1 expression will be drawn (i) pre-treatment, (ii) at cycle 2 treatment, (iii) every other cycle while on combined doublet chemotherapy-immune treatment, (iv) at 3 months post-starting treatment, (v) at 6 months post-starting treatment, and (vi) upon discontinuation of ICI treatment due to planned completed duration of ICI treatment or upon progressing disease. ICI treatment and radiographic evaluations will be standard of care as determined by the treating oncologist.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-26', 'studyFirstSubmitDate': '2025-02-24', 'studyFirstSubmitQcDate': '2025-02-24', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of plasma cfRNA PD-L1 by qPCR expression* with ICI treatment and response.', 'timeFrame': 'up to 24 months', 'description': 'Circulogene ImmunoClear Assay'}], 'secondaryOutcomes': [{'measure': 'Correlation of plasma cfRNA PD-L1 expression* results with any available tissue PD-L1 protein expression.', 'timeFrame': 'up to 24 months', 'description': 'Circulogene ImmunoClear Assay'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer (NSCLC)']}, 'descriptionModule': {'briefSummary': 'This is a prospective pilot study to assess dynamic changes of plasma cell-free RNA (cfRNA) PD-L1 expression in patients with lung cancer undergoing immune checkpoint inhibitor (ICI) based therapy. Results will be correlated with radiographic assessment of immunotherapy treatment response and plasma NGS ctDNA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All patients with a diagnosis of stage IV or inoperable stage IIIB NSCLC without planned primary radiation therapy undergoing anti-PD-1/L1 based ICI treatment.\n2. Chemo-immune or dual anti-PD-1/L1 with anti-CTLA-4 based regimens are eligible as long as receiving an anti-PD-1/L1 monoclonal antibody.\n3. A documented informed consent will be obtained prior to inclusion in the study. All discussions with patients will be held in strictest confidence and out of earshot of the general public. Patients will be fully informed that their participation in the study is voluntary. Patients may decline to be part of the study. Their decision to participate in the study will not affect the care they receive.\n\nExclusion Criteria:\n\n1. No anti-PD-1/L1 monoclonal antibody treatment.\n2. Planned primary radiation therapy.\n3. Small-cell lung cancer histology.'}, 'identificationModule': {'nctId': 'NCT06849518', 'briefTitle': 'Study of Longitudinal Plasma PD-L1 Testing With Immunotherapy in Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Ballad Health'}, 'officialTitle': 'Study of Longitudinal Plasma PD-L1 Testing With Immunotherapy in Lung Cancer', 'orgStudyIdInfo': {'id': '2276376'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'plasma NGS ctDNA and plasma cfRNA PD-L1 expression', 'interventionNames': ['Diagnostic Test: Circulogene liquid biopsy testing']}], 'interventions': [{'name': 'Circulogene liquid biopsy testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'A Circulogene liquid biopsy testing for plasma NGS ctDNA and plasma cfRNA PD-L1 expression.', 'armGroupLabels': ['plasma NGS ctDNA and plasma cfRNA PD-L1 expression']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37660', 'city': 'Kingsport', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Charles Mays, PhD, CCRP, CCRC', 'role': 'CONTACT', 'email': 'Charles.Mays@balladhealth.org', 'phone': '423-431-5654'}], 'facility': 'Ballad Health Cancer Care', 'geoPoint': {'lat': 36.54843, 'lon': -82.56182}}], 'centralContacts': [{'name': 'Charles Mays, PhD, CCRP, CCRC', 'role': 'CONTACT', 'email': 'Charles.Mays@balladhealth.org', 'phone': '423-431-5654'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ballad Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}