Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 4:21 PM
Study NCT ID:
NCT05675033
Status:
UNKNOWN
Last Update Posted:
2023-01-09
First Post:
2022-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serplulimab Combined With Anti-VEGF Antibody in Advanced Lung Adenocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077192', 'term': 'Adenocarcinoma of Lung'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D017671', 'term': 'Platinum Compounds'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-01-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2024-01-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-21', 'studyFirstSubmitDate': '2022-12-06', 'studyFirstSubmitQcDate': '2022-12-21', 'lastUpdatePostDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months', 'description': 'progression-free survival'}], 'secondaryOutcomes': [{'measure': 'ORR', 'timeFrame': 'up to 12 months', 'description': 'overall response rate'}, {'measure': 'DCR', 'timeFrame': 'up to 12 months', 'description': 'disease control rate'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]', 'timeFrame': 'up to 24 months', 'description': 'Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Adenocarcinoma', 'Stage IV Non-small Cell Lung Cancer', 'PD-1 Inhibitor', 'VEGF']}, 'descriptionModule': {'briefSummary': 'In order to further evaluate the efficacy of immunotherapy combined with antivascular therapy in the real world, we used Serpluimab combined with Bevacizumab and platinum-based chemotherapy in previously untreated EGFR/ALK-negative advanced non-squamous NSCLC patients, to evaluate the efficacy and safety of this regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fully understood this study and voluntarily signed the informed consent form (ICF);\n\n -≥ 18 years and ≤ 75 years old;\n* ECOG score 0-1;\n* Non-squamous NSCLC;\n* stage IV;\n* EGFR and ALK negative;\n* Treatment-naive;\n* According to RECIST1.1 criteria, there are measurable or evaluable lesions.\n\nExclusion Criteria:\n\n* Tumor histology or cytology confirmed that it was associated with squamous cell carcinoma or small cell lung cancer;\n* Patients with severe organ dysfunction were indicated by examination, Exclude subjects with any active, known or suspected autoimmune diseases;\n* The estimated survival time is less than 3 months.'}, 'identificationModule': {'nctId': 'NCT05675033', 'briefTitle': 'Serplulimab Combined With Anti-VEGF Antibody in Advanced Lung Adenocarcinoma', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Fujian Cancer Hospital'}, 'officialTitle': 'Serplulimab Combined With Anti-VEGF Antibody and Platinum-based Chemotherapy in Treat-naive EGFR/ALK-negative Advanced Lung Adenocarcinoma, a Single Arm Clinical Trail', 'orgStudyIdInfo': {'id': 'SCOG004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'study arm', 'description': 'This is a single arm study.', 'interventionNames': ['Drug: Serplulimab and Bevacizumab injection']}], 'interventions': [{'name': 'Serplulimab and Bevacizumab injection', 'type': 'DRUG', 'otherNames': ['platinum-based chemotherapy'], 'description': 'Serplulimab, 4.5mg/kg, intravenous injection, D1,Q21, until the disease progressed or showed intolerable side effects.\n\nBevacizumab injection, 7.5mg/kg, intravenous injection, D1, Q21, until the disease progressed or showed intolerable side effects.\n\nPlatinum-based chemotherapy: pemetrexed combined with carboplatin, D1-2, Q21, a total of 4 cycles.', 'armGroupLabels': ['study arm']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mei Fang Li, MD', 'role': 'CONTACT', 'email': '362952772@qq.com', 'phone': '+8615985795022'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Cancer Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}