Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-29 @ 3:35 AM
Study NCT ID:
NCT05584267
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2022-10-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Treatment of Brain Metastasis of Lung Cancer Combined With Large-segmentation Precision Radiotherapy
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': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D007167', 'term': 'Immunotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-28', 'studyFirstSubmitDate': '2022-10-14', 'studyFirstSubmitQcDate': '2022-10-17', 'lastUpdatePostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intracranial progression-free survival', 'timeFrame': 'up to 2 years from enrollment', 'description': 'assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI'}, {'measure': 'sPFS', 'timeFrame': 'up to 2 years from enrollment', 'description': 'assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI'}], 'secondaryOutcomes': [{'measure': 'Objective Response rate', 'timeFrame': 'up to 2 years from enrollment', 'description': 'assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI'}, {'measure': 'overall survival', 'timeFrame': 'up to 2 years from enrollment', 'description': 'the time from enrollment until death or the last follow-up'}, {'measure': 'number of participants with treatment-related adverse events', 'timeFrame': 'up to 2 years from enrollment', 'description': 'number of participants with treatment-related adverse events as assessed by CTCAE v4.0'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This is a prospective multicenter clinical study. This study aims to construct an auxiliary decision-making system for lung cancer immunotherapy combined with radiotherapy by fusing three modes of imagomics, clinicopathological features, and molecular pathological features.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years of age on day of signing informed consent\n* Histopathology confirmed non-small cell lung cancer\n* Asymptomatic brain metastases\n* EGFR/ALK ROS1 driver gene mutation negative\n* RECIST 1.1 based available assessment of lesions\n* ECOG 0-1\n* Brain metastases 1-4\n* Single lesion ≤4cm\n\nExclusion Criteria:\n\n* Patients with contraindication of chemotherapy Pregnant or breast feeding women'}, 'identificationModule': {'nctId': 'NCT05584267', 'briefTitle': 'Immune Treatment of Brain Metastasis of Lung Cancer Combined With Large-segmentation Precision Radiotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Hunan Province Tumor Hospital'}, 'officialTitle': 'Multi-omics Evaluation System and Preferred Mode of Immune Treatment of Brain Metastasis of Lung Cancer Combined With Large-segmentation Precision Radiotherapy', 'orgStudyIdInfo': {'id': 'RENO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'cohort A', 'description': 'Chemotherapy + immunotherapy; Every three weeks, up to four cycles of chemotherapy', 'interventionNames': ['Drug: Chemotherapy + immunotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'cohort B', 'description': 'Chemotherapy + immunotherapy; Once every three weeks, up to 4 cycles of chemotherapy; WBRT, 3 Gy/ time, 10 times in total', 'interventionNames': ['Radiation: radiotherapy', 'Drug: Chemotherapy + immunotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'cohort C', 'description': 'Chemotherapy + immunotherapy; Once every three weeks, up to 4 cycles of chemotherapy; HFRT, 10 Gy/ time, 3 times in total', 'interventionNames': ['Radiation: radiotherapy', 'Drug: Chemotherapy + immunotherapy']}], 'interventions': [{'name': 'radiotherapy', 'type': 'RADIATION', 'description': 'Different cohorts received different doses of radiotherapy', 'armGroupLabels': ['cohort B', 'cohort C']}, {'name': 'Chemotherapy + immunotherapy', 'type': 'DRUG', 'description': 'Chemotherapy + immunotherapy', 'armGroupLabels': ['cohort A', 'cohort B', 'cohort C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410013', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yongchang Zhang, MD', 'role': 'CONTACT', 'email': 'zhangyongchang@csu.edu.cn', 'phone': '+86 731 89762323'}, {'name': 'Nong Yang, MD', 'role': 'CONTACT', 'email': 'yangnong0217@163.com', 'phone': '+86 731 89762321'}], 'facility': 'Hunan Cancer Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Yongchang C Zhang, MD', 'role': 'CONTACT', 'email': 'zhangyongchang@csu.edu.cn', 'phone': '+8613873123436', 'phoneExt': '7+861383123436'}, {'name': 'Nong C Yang, MD', 'role': 'CONTACT', 'email': 'yangnong0217@163.com', 'phone': '+8613873123436', 'phoneExt': '+8613873123436'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hunan Province Tumor Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yongchang Zhang', 'investigatorAffiliation': 'Hunan Province Tumor Hospital'}}}}