Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-01-07 @ 1:12 PM
Study NCT ID:
NCT06154967
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-04
First Post:
2023-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Explore the Effect of Immune-induced Stereotactic Body Radiotherapy (SBRT) on Reversing Immunoresistance in Stage IIIc/IV Non-small Cell Lung Cancer (NSCLC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000707970', 'term': 'tislelizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-01', 'studyFirstSubmitDate': '2023-11-23', 'studyFirstSubmitQcDate': '2023-12-01', 'lastUpdatePostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Overall Response Rate out of the radiation field', 'timeFrame': 'Individual patients should be evaluated within 3 days after the patient follow-up examination', 'description': 'To evaluate the efficacy of this protocol，Measurements were based on recist1.1'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-Small Cell Lung Cancer Without Mutation in Epidermal Growth Factor Receptor (Disorder)']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn about in describe participant population. The main questions it aims to answer are:\n\nthe outcomes of the efficacy (ORR) and safety (adverse events, including irAEs, AE, SAEs, and laboratory indicators) of continued immunotherapy in patients with immune-resistant IIIc/IV metastatic NSCLC treated with immune-induced radiotherapy (SBRT).\n\nParticipants will be asked to accept the treatment of ICIs regimen and SBRT plan as follows:\n\nICIs regimen: tislelizumab 200mg every 3 weeks, the first dose was given 7 days after the last SBRT treatment, then the first day of each cycle, 21 days as a cycle until disease progression.\n\nSBRT plan: The radiation dose and fractionation of SBRT should be evaluated according to the size and location of the tumor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with IIIc/IV NSCLC confirmed by histology and imaging\n2. Previous treatment with anti-PD1 or anti-PDL1, and resistantance to ICIs\n3. Without standard treatment regimen\n4. At least one measurable target (primary tumour or metastasis) according to RECIST v1.1\n5. Age ≥ 18 and ≤ 75\n6. ECOG PS ≤ 2\n7. Life expectancy ≥ 3 months\n\nExclusion Criteria:\n\n1. Autoimmune disease that might be aggravated during treatment with an immuno-stimulating agent (patients with type I diabetes, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible)\n2. Immunosuppressive long-term treatment (patients necessitating a corticotherapy are eligible if they are administered in doses \\< or = to the equivalent of 10 mg of prednisone daily, administration of steroids by a route resulting in minimal systemic exposure (local, intra-anal, intraocular or inhalation) are eligible).\n3. Transplant patients (including stem cell transplants), HIV positive or other immune deficiency syndromes\n4. Active infection by HBV or HCV Known severe hypersensitivity to monoclonal antibodies or history of anaphylactic shock, or uncontrolled asthma\n5. Patient with interstitial pneumonitis or pulmonary fibrosis or any other known severe respiratory insufficiency\n6. Patient already included in another clinical trial during treatment with an experimental'}, 'identificationModule': {'nctId': 'NCT06154967', 'briefTitle': 'To Explore the Effect of Immune-induced Stereotactic Body Radiotherapy (SBRT) on Reversing Immunoresistance in Stage IIIc/IV Non-small Cell Lung Cancer (NSCLC)', 'organization': {'class': 'OTHER', 'fullName': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}, 'officialTitle': 'To Explore the Effect of Immune-induced Stereotactic Body Radiotherapy (SBRT) on Reversing Immunoresistance in Stage IIIc/IV Non-small Cell Lung Cancer (NSCLC)', 'orgStudyIdInfo': {'id': 'DPCC-20231122'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ICIs regimen: tislelizumab 200mg every 3 weeks, the first dose was given 7 days after the last SBRT', 'interventionNames': ['Radiation: tereotactic body radiotherapy']}], 'interventions': [{'name': 'tereotactic body radiotherapy', 'type': 'RADIATION', 'otherNames': ['tislelizumab'], 'description': 'In second-line and later treatment, the treatment regimen of SBRT combined with tislelizumab is used', 'armGroupLabels': ['ICIs regimen: tislelizumab 200mg every 3 weeks, the first dose was given 7 days after the last SBRT']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Medical Director, Oncology', 'investigatorFullName': 'Xiong Yanli, MD', 'investigatorAffiliation': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}}}}