Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-31 @ 4:11 AM
Study NCT ID:
NCT04647357
Status:
UNKNOWN
Last Update Posted:
2020-11-30
First Post:
2020-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of SHR-1316 Maintenance Therapy for Limited Stage Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-11-27', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2023-12-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-27', 'studyFirstSubmitDate': '2020-11-27', 'studyFirstSubmitQcDate': '2020-11-27', 'lastUpdatePostDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS', 'timeFrame': 'Up to approximately 24 months', 'description': 'progression-free survival'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Limited-stage Small Cell Lung Cancer, LS-SCLC']}, 'descriptionModule': {'briefSummary': 'SHR-1316 as Maintenance therapy for limited stage small cell lung cancer without progression after first line platinum based concurrent chemoradiotherapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The age is 18-75 years old (including both ends), regardless of gender;\n2. Histologically confirmed limited stage small cell lung cancer ;\n3. ECOG PS 0 \\~ 1;\n4. Patients received at least 2 cycles of platinum based chemotherapy and radiotherapy, and completed within 1 to 42 days before the first medication.\n5. The last chemotherapy must be finished before or at the same time of radiotherapy.\n6. The disease did not progress after concurrent chemoradiotherapy;\n7. The expected survival time was more than 3 months;\n8. Pulmonary function: FEV1 \\> 70%;\n\nExclusion Criteria:\n\n1. The subjects volunteered to participate in the study, signed the informed consent form, had good compliance and cooperated with the follow-up.\n2. Mixed SCLC or NSCLC confirmed by histology;\n3. Locally advanced small cell lung cancer receiving sequential chemoradiotherapy;\n4. Have received anti-tumor therapy of systemic immune checkpoint inhibitors for SCLC;\n5. Extensive SCLC;\n6. Operable SCLC (clinical stage T1-2N0, except for those who are contraindicated or refuse surgery);\n7. Interstitial pneumonia\n8. History of active, known or suspected autoimmune diseases and autoimmune diseases, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc.\n9. HIV, active Hepatitis B or Hepatitis C infection'}, 'identificationModule': {'nctId': 'NCT04647357', 'briefTitle': 'A Trial of SHR-1316 Maintenance Therapy for Limited Stage Small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}, 'officialTitle': 'A Trial of SHR-1316 Maintenance Therapy for Limited Stage Small Cell Lung Cancer Without Progression After First Line Concurrent Chemoradiotherapy Treatment', 'orgStudyIdInfo': {'id': 'LS-SCLC-MT-IIT-SHR1316'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR-1316', 'interventionNames': ['Drug: SHR-1316']}], 'interventions': [{'name': 'SHR-1316', 'type': 'DRUG', 'description': 'Anti-PD-L1 antibody，Maintenance therapy, The drug was administered every three weeks', 'armGroupLabels': ['SHR-1316']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Xiaorong Dong, PhD', 'role': 'CONTACT', 'email': 'xiaorongdong@hust.edu.cn', 'phone': '027-85872859'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Xiaorong Dong', 'investigatorAffiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}}}}