Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT05129202
Status:
COMPLETED
Last Update Posted:
2023-04-10
First Post:
2021-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outcomes With Immune Checkpoint Inhibitor for Patients With Non-Small-Cell Lung Cancer and Stable Brain Metastases
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': 'D016233', 'term': 'Immunotherapy, Active'}], 'ancestors': [{'id': 'D007114', 'term': 'Immunization'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-07', 'studyFirstSubmitDate': '2021-11-10', 'studyFirstSubmitQcDate': '2021-11-10', 'lastUpdatePostDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ORR', 'timeFrame': 'November 2017- October 2021', 'description': 'disease remission rate'}, {'measure': 'PFS', 'timeFrame': 'November 2017- October 2021', 'description': 'progression free survival'}], 'secondaryOutcomes': [{'measure': 'OS', 'timeFrame': 'November 2017- October 2021', 'description': 'Overall survival'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '37195128', 'type': 'DERIVED', 'citation': 'Huang Z, Wu F, Xu Q, Song L, Zhang X, Wang Z, Deng L, Zhang Y, Zeng L, Yang N. Intracranial activity of first-line immune checkpoint inhibitors combined with chemotherapy in advanced non-small cell lung cancer. Chin Med J (Engl). 2023 Jun 20;136(12):1422-1429. doi: 10.1097/CM9.0000000000002720. Epub 2023 May 17.'}]}, 'descriptionModule': {'briefSummary': 'Non-small cell lung cancer patients may have brain metastases at diagnosis. Patients with brain metastasis may contribute as poor prognosis factors. This trial aims to explore the efficacy and the safety of immune checkpoint inhibitors in non small cell lung cancer patients with initial brain metastasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with brain metastasis received immunotherapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1.Diagnosed with advanced non-small cell lung cancer 2.Patients with brain metastasis 3. Treated with ICIs\n\nExclusion Criteria:\n\n* 1.Patients with a clear driver mutation that can be targeted for first-line treatment'}, 'identificationModule': {'nctId': 'NCT05129202', 'acronym': 'OMESIA', 'briefTitle': 'Outcomes With Immune Checkpoint Inhibitor for Patients With Non-Small-Cell Lung Cancer and Stable Brain Metastases', 'organization': {'class': 'OTHER', 'fullName': 'Hunan Province Tumor Hospital'}, 'officialTitle': 'Outcomes With Immune Checkpoint Inhibitor for Patients With Non-Small-Cell Lung Cancer and Stable Brain Metastases：A Retrospective Study', 'orgStudyIdInfo': {'id': 'OMESIA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chemotherapy alone or chemotherapy combined with anti-angiogenesis', 'description': 'patients with Chemotherapy'}, {'label': 'immuntherapy', 'description': 'patients treated with immune checkpoint inhibitor monotherapy or combination therapy.', 'interventionNames': ['Drug: immune therapy']}], 'interventions': [{'name': 'immune therapy', 'type': 'DRUG', 'description': 'The patient receives immunotherapy', 'armGroupLabels': ['immuntherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410013', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Hunan Cancer Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'overallOfficials': [{'name': 'Yongchang C Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hunan Cancer Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hunan Province Tumor Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Head of Medical Oncology, Principal Investigator, Clinical Professor', 'investigatorFullName': 'Yongchang Zhang', 'investigatorAffiliation': 'Hunan Province Tumor Hospital'}}}}