Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT06287320
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2024-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Predictive Biomarkers in Patients With Locally Advanced Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007167', 'term': 'Immunotherapy'}], 'ancestors': [{'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '10 ml whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-23', 'studyFirstSubmitDate': '2024-02-23', 'studyFirstSubmitQcDate': '2024-02-23', 'lastUpdatePostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Event', 'timeFrame': 'AEs and SAEs must be collected from the start of treatment to 28 days after discontinuation of study drug, up to 24 months.', 'description': 'The incidence of adverse events (AEs) and serious adverse events (SAEs) is evaluated by CTCAE 5.0. Appropriate description of AEs and laboratory data/vital signs will be produced. Number of patients who had at least one adverse event will be calculated.'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival (PFS)', 'timeFrame': 'From date of first treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.', 'description': 'Defined as the time from date of first treatment until the date of first documented progression or date of death from any cause, whichever came first.'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'From the date of first treatment to the date of any documented death due to any cause, assessed up to 24 months.', 'description': 'Defined as the time from the date of first treatment to the date of any documented death due to any cause.'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Tumor assessment using RECIST will be performed at baseline then every 3 months from the first treatment until objective progression or death from any cause, assessed up to 24 months.', 'description': 'The objective response rate (ORR) will be calculated as the number of patients with CR or PR per RECIST Criteria.\n\nComplete Response (CR): Disappearance of all target lesions; Partial Response (PR): \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'Tumour assessment using RECIST will be performed at baseline then every 3 months from first treatment until objective progression or death from any cause, assessed up to 24 months.', 'description': 'DCR will be calculated as the number of patients with CR, PR or sustained SD≥6 weeks per RECIST Criteria.\n\nComplete Response (CR): Disappearance of all target lesions; Partial Response (PR): \\>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peripheral blood lymphocyte subsets'], 'conditions': ['Locally Advanced Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This study is a prospective cohort study to evaluate the peripheral blood lymphocyte subsets as predicative biomarkers reflecting the efficacy and toxicity in patients with locally advanced non-small cell lung cancer (NSCLC) received chemoradiotherapy (CRT) with or without immune checkpoint inhibitors (ICIs).', 'detailedDescription': 'All patients had a pathologically confirmed locally advanced NSCLC according to the 8th AJCC staging system and received definitive radiotherapy, concurrently or sequentially combined with platinum-based doublet chemotherapy. The peripheral blood samples at various time points including before radiation, 4 weeks after beginning of radiation, the end of radiation, 1 month post radiation, and 1 month post consolidation immunotherapy were collected for lymphocyte subsets detection.\n\nThe subjects will be divided into two groups according to whether patients received ICIs, namely, NSCLC patients received CRT plus ICIs and NSCLC patients received CRT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive locally advanced NSCLC patients treated with definitive CRT with or without ICIs at hospital.', 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 18-75 years; ECOG score 0-2.\n2. Pathologically confirmed locally advanced NSCLC according to the 8th AJCC staging system.\n3. Received definitive radiotherapy, concurrently or sequentially combined with platinum-based doublet chemotherapy.\n4. No serious medical diseases and dysfunction of major organs, such as blood routine, liver, kidney, heart and lung function.\n\nExclusion Criteria:\n\n1. Pathologic type was adenocarcinoma with EGFR gene mutation or ALK gene rearrangement.\n2. Patients with other active malignancies within 5 years or at the same time.\n3. Active or previously documented autoimmune or inflammatory diseases (including inflammatory bowel disease, diverticulitis \\[except diverticular disease\\], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener' s syndrome).\n4. History of allogeneic organ transplantation.\n5. History of active primary immunodeficiency.\n6. Patients with uncontrolled concurrent diseases, including but not limited to persistent or active infection (including tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus, etc.), symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled arrhythmia, active interstitial lung disease, severe chronic gastrointestinal disease with diarrhea or mental illness.\n7. Women of child-bearing potential who are pregnant or breastfeeding.\n8. The investigator judged other situations not suitable for inclusion in this study."}, 'identificationModule': {'nctId': 'NCT06287320', 'briefTitle': 'The Predictive Biomarkers in Patients With Locally Advanced Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}, 'officialTitle': 'The Peripheral Blood Lymphocyte Subsets as Predicative Biomarkers Reflecting the Efficacy and Toxicity in Patients With Locally Advanced Non-small Cell Lung Cancer Received Chemoradiotherapy With or Without Immunotherapy', 'orgStudyIdInfo': {'id': 'Bioplc'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NSCLC patients received CRT plus ICIs', 'description': 'For it\'s an observational study, locally advanced NSCLC patients received CRT with induction immunotherapy or consolidation immunotherapy will be divided into the group "NSCLC patients received CRT plus ICIs".', 'interventionNames': ['Radiation: concurrent or sequential chemoradiotherapy', 'Drug: Immunotherapy']}, {'label': 'NSCLC patients received CRT', 'description': 'For it\'s an observational study, locally advanced NSCLC patients received CRT without immunotherapy will be divided into the group "NSCLC patients received CRT".', 'interventionNames': ['Radiation: concurrent or sequential chemoradiotherapy']}], 'interventions': [{'name': 'concurrent or sequential chemoradiotherapy', 'type': 'RADIATION', 'description': 'Thoracic radiation therapy(with the prescribed dose of 50-70 Gy), concurrently or sequentially combined with platinum-based doublet chemotherapy.', 'armGroupLabels': ['NSCLC patients received CRT', 'NSCLC patients received CRT plus ICIs']}, {'name': 'Immunotherapy', 'type': 'DRUG', 'description': 'anti-PD-1/anti-PD-L1 immune checkpoint inhibitors', 'armGroupLabels': ['NSCLC patients received CRT plus ICIs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Nan Bi, MD, PhD', 'role': 'CONTACT', 'email': 'binan_email@163.com'}], 'facility': 'Chinese Academy of Medical Science and Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Nan Bi, MD', 'role': 'CONTACT', 'email': 'binan_email@163.com', 'phone': '8601087788799'}], 'overallOfficials': [{'name': 'Nan Bi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese Academy of Medical Sciences and Peking Union Medical College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}