Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-25 @ 2:00 PM
Study NCT ID:
NCT04291092
Status:
UNKNOWN
Last Update Posted:
2021-09-10
First Post:
2020-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Camrelizumab Combined With Local Treatment in NSCLC Patients With BM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial 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'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'C000631724', 'term': 'camrelizumab'}, {'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 63}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-03', 'studyFirstSubmitDate': '2020-01-08', 'studyFirstSubmitQcDate': '2020-02-27', 'lastUpdatePostDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6 month progression-free survival rate', 'timeFrame': '6 month', 'description': '6 month progression-free survival rate'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lung cancer', 'Brain Metastases', 'Camrelizumab', 'WBRT', 'SRS'], 'conditions': ['NSCLC Stage IV', 'Brain Metastases', 'Immunotherapy']}, 'referencesModule': {'references': [{'pmid': '39756446', 'type': 'DERIVED', 'citation': 'Xu Y, Chen K, Xu Y, Li H, Huang Z, Lu H, Huang D, Yu S, Han N, Gong L, Qin J, Chen J, Xie F, Hong W, Lin X, Cheng F, Luo X, Fan Y. Brain radiotherapy combined with camrelizumab and platinum-doublet chemotherapy for previously untreated advanced non-small-cell lung cancer with brain metastases (C-Brain): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2025 Jan;26(1):74-84. doi: 10.1016/S1470-2045(24)00643-0.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of Camrelizumab Combined with Chemotherapy and Local Treatment in non-small cell lung cancer with brain metastases.', 'detailedDescription': 'To evaluate the efficacy and safety of Camrelizumab Combined with Chemotherapy and Local Treatment of brain metastases (WBRT, r-knife, SRS, etc.) in non-small cell lung cancer patients with brain metastases .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18;\n2. ECOG is 0-1;\n3. Non-small cell lung cancer confirmed by histology; EGFR、ALK and ROS1 negative;\n4. The presence of brain metastases as determined by imaging, with unlimited numbers, the intracranial lesions had a maximum diameter of ≥ 0.5cm，allowing the presence of clinical symptoms of brain metastases;\n5. According to RECIST 1.1, there is at least one measurable extracranial and intracranial target lesion each;\n6. Sign informed consent and agree to collect the clinical efficacy and information of the patient.\n\nExclusion Criteria:\n\n1. Immunotherapeutic contraindications (including long-term use of hormones, history of radiation pneumonia, etc.)\n2. Active autoimmune diseases (e.g. vitiligo, psoriasis, hypothyroidism requiring hormone replacement therapy, etc.)\n3. Patients with active hepatitis B or C, HIV, active tuberculosis, etc.;\n4. Active infections requiring antimicrobial therapy (e.g. antimicrobial, antiviral, antifungal);\n5. History of known allogeneic organ transplantation and history of in vivo hematopoietic stem cell transplantation;\n6. Patients with interstitial lung disease or previous history of interstitial pneumonia;\n7. Having a history of substance abuse and unable to abstain from it or having mental disorders;\n8. who have participated in other clinical trials of antitumor drugs within 4 weeks before entering the group;\n9. Having used PD-1/PD-L1 and other immunotherapy drugs before entering the group;\n10. previous or concurrent with other untreated malignancies, except for cured basal cell carcinoma of the skin, carcinoma of the cervix in situ and superficial bladder cancer;\n11. (a) Pregnant or lactating women; those with fertility who are unwilling or unable to take effective contraception;\n12. The researchers judged other situations that might affect the conduct of clinical studies and the determination of their findings.'}, 'identificationModule': {'nctId': 'NCT04291092', 'briefTitle': 'Camrelizumab Combined With Local Treatment in NSCLC Patients With BM', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang Cancer Hospital'}, 'officialTitle': 'Camrelizumab Combined With Chemotherapy and Local Treatment in Non-small Cell Lung Cancer Patients With Brain Metastasis, a Single-arm, Multi-center, Open-labeled Phase II Clinical Trial', 'orgStudyIdInfo': {'id': 'XYJ20200101-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'single-arm', 'description': 'single-arm', 'interventionNames': ['Drug: Immunotherapy', 'Radiation: WBRT', 'Drug: Chemotherapy']}], 'interventions': [{'name': 'Immunotherapy', 'type': 'DRUG', 'otherNames': ['Camrelizumab'], 'description': 'Immunotherapy for brain metastasis', 'armGroupLabels': ['single-arm']}, {'name': 'WBRT', 'type': 'RADIATION', 'otherNames': ['SRS'], 'description': 'local therapy for brain metastasis', 'armGroupLabels': ['single-arm']}, {'name': 'Chemotherapy', 'type': 'DRUG', 'description': 'Chemotherapy for brain metastasis', 'armGroupLabels': ['single-arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yun Fan, Dr', 'role': 'CONTACT', 'email': 'fanyun@zjcc.org.cn', 'phone': '+86 057188122092'}], 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang Cancer Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'GongLei', 'investigatorAffiliation': 'Zhejiang Cancer Hospital'}}}}