Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-26 @ 12:18 PM
Study NCT ID:
NCT06182800
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-27
First Post:
2023-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adebrelimab Combined With Bevacizumab and Docetaxel for Advanced Non-Squamous Non-small Cell Lung Cancer After Progression on First-line Immunotherapy
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': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000077143', 'term': 'Docetaxel'}], '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': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12-27', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-13', 'studyFirstSubmitDate': '2023-12-13', 'studyFirstSubmitQcDate': '2023-12-13', 'lastUpdatePostDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6-month PFS rate', 'timeFrame': '6 months', 'description': '6-Month PFS Rates for Adebrelimab Combined with Bevacizumab and Docetaxel in Patients with Advanced Non-Squamous NSCLC Progressed by First-Line Immunotherapy Evaluated by Investigators'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival (PFS)', 'timeFrame': 'up to 12 months', 'description': 'PFS is defined as the time elapsed between the start of treatment and the first sign of disease progression or death from any cause.'}, {'measure': 'Over survival (OS)', 'timeFrame': 'up to 18 months', 'description': 'OS is defined as the time elapsed between the initiation of treatment and mortality from any cause.'}, {'measure': 'objective response rate (ORR)', 'timeFrame': 'up to 12 months', 'description': 'Number of cases with completed/partial response after treatment as a percentage of evaluable cases.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This study is a prospective, single-arm, multicenter, phase II clinical study to observe and evaluate the efficacy and safety of adebrelimab in combination with bevacizumab and docetaxel in patients with advanced non-squamous NSCLC after progression on first-line immunotherapy.', 'detailedDescription': 'The study consisted of a screening period (no more than 4 weeks after patients signed informed consent until enrollment, with imaging assessments allowed to be archived within 4 weeks prior to enrollment), a treatment period (treatment termination defined as discontinuation of treatment for any reason, or withdrawal from the study for any reason), a safety follow-up period, and a survival follow-up period.\n\nScreening period:\n\nPatients were required to undergo a screening evaluation to determine their eligibility for the study within 4 weeks prior to enrollment.\n\nPatients eligible for the study receive adebrelimab, 1200 mg, Intravenous infusion, every 3 weeks (Q3W) + bevacizumab, 7.5 mg/kg, Intravenous infusion, Q3W +docetaxel 60-75 mg/m2, D1, Intravenous infusion, Q3W. docetaxel for 4 cycles, adebrelimab, bevacizumab use to progressive disease (PD), intolerable toxicity, patient withdrawal of informed consent, investigator decision to discontinue study treatment.\n\nTreatment period:\n\nPatients eligible for study enrollment were given medication sequentially on day 1 of each cycle, with a dosing window of ±5 days, and patients were required to complete various examinations including vital signs, height and weight, physical examination, laboratory tests, and physical status scores to assess tolerance for continued treatment. The specific examinations and requirements for each visit are shown in the study flow chart.\n\nEnd of treatment:\n\nEnd of treatment is defined as confirmation of disease progression or withdrawal from the study and requires an end-of-treatment visit ±5 days from the time of the decision to discontinue treatment and/or withdraw from the study.\n\nSafety follow-up. Safety follow-up visits will be conducted within 30±7, 60±7 days, and 90±7 days after the last dose.\n\nSurvival follow-up. Survival follow-up will be conducted every 3 months after safety follow-up and telephone follow-up is acceptable.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. voluntarily enrolled in this study and signed the Informed Consent Form (ICF).\n2. age ≥ 18 years and both sexes\n3. patients with metastatic or recurrent stage IV non-squamous NSCLC (AJCC 8th edition Tumor Node Metastasis (TNM) stage) proven by histopathological or cytopathological diagnosis, mainly including adenocarcinoma, large cell lung cancer, adenocarcinoma with squamous differentiation or adenosquamous carcinoma with predominantly adenocarcinoma component may also be enrolled if eligible by study assessment.\n4. objective imaging progression (RECIST v1.1 assessment) after subjects have received a first-line regimen containing immune checkpoint inhibitor therapy.\n5. the immune checkpoint inhibitor-containing therapy PFS of ≥ 6 months on first- line therapy.\n6. imaging evaluation (CT or MRI) with at least one measurable target lesion (according to RECIST v1.1) within 4 weeks prior to enrollment.\n7. an ECOG PS score of 0-1 within 4 weeks prior to enrollment.\n8. an expected survival of ≥ 12 weeks.\n9. Adequate function of vital organs\n10. Non-surgical sterilization or female patients of childbearing age must have a negative serum pregnancy test within 7 days prior to the first dose and must be non-lactating. Female patients of childbearing age or male patients whose partners are women of childbearing age must agree to use highly effective methods of contraception during the study period and for 6 months after the last administration of the study drug.\n\nExclusion Criteria:\n\n1. patients with other pathological tissue types of non-small cell lung cancer (including squamous cell carcinoma, mixed non-small cell and small cell lung cancer, and predominantly squamous adenosquamous carcinoma of the lung)\n2. patients with known EGFR-sensitive mutations (19Exon del/21Exon L858R), positive ALK/ROS1 fusion.\n3. patients with imaging showing signs of tumor invasion into the great vessels, where the tumor has completely approached, encircled, or invaded the lumen of a great vessel (e.g., pulmonary artery or superior vena cava)\n4. patients with hypertension whose blood pressure is not satisfactorily controlled by antihypertensive medication (sitting systolic blood pressure \\> 150 mmHg, or diastolic blood pressure \\> 100 mmHg), previous hypertensive crisis or hypertensive encephalopathy.\n5. those with a known hereditary bleeding tendency or coagulation disorders; those who have received full-dose anticoagulant or thrombolytic therapy within 10 days prior to enrollment, or those who have taken non-steroidal anti-inflammatory drugs with platelet inhibitory effects within 10 days prior to enrollment (except for prophylactic use of low-dose aspirin (≤325 mg/day)).\n6. had a hemoptysis of 2nd degree or greater with a single hemoptysis of ≥1/2 teaspoon (2.5 ml) within 3 months prior to enrollment thrombosis in the 6 months\n7. prior to enrollment and an arterial/venous thrombotic event within 1 year prior to screening, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, and pulmonary embolism.\n8. those with severe vascular lesions (including aneurysms or arterial thrombosis requiring surgical treatment) within 6 months prior to enrollment\n9. late first-line treatment with anti-angiogenic agents, including but not limited to bevacizumab, apatinib, anlotinib, ramucirumab, lenvatinib, etc.; treatment with docetaxel.'}, 'identificationModule': {'nctId': 'NCT06182800', 'briefTitle': 'Adebrelimab Combined With Bevacizumab and Docetaxel for Advanced Non-Squamous Non-small Cell Lung Cancer After Progression on First-line Immunotherapy', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Xinxiang Medical College'}, 'officialTitle': 'A Prospective Study of Adebrelimab Combined With Bevacizumab and Docetaxel in the Treatment of Advanced Non-Squamous Non-small Cell Lung Cancer After Progression on First-line Immunotherapy', 'orgStudyIdInfo': {'id': 'KY202319'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adebrelimab Combined with Bevacizumab and Docetaxel', 'description': 'Adebrelimab: 1200 mg Adebrelimab is given on day 1 of each cycle, with 1 dosing cycle every 3 weeks. The dosing time window may be ±5 days, but within 72 hours before each dose, subjects must complete an examination including all clinically necessary tests to assess tolerability of continued dosing, in addition to imaging. Subjects are also advised to remain in the hospital for observation 72 hours after the first dose.\n\nBevacizumab: 7.5 mg/kg Bevacizumab administered intravenously on day 1 of each cycle, with 1 dosing cycle every 3 weeks.\n\nDocetaxel: 60-75 mg/m2 Docetaxel is given on days 1 of each cycle by intravenous infusion for 1 dosing cycle every 3 weeks.', 'interventionNames': ['Drug: Adebrelimab Combined with Bevacizumab and Docetaxel']}], 'interventions': [{'name': 'Adebrelimab Combined with Bevacizumab and Docetaxel', 'type': 'DRUG', 'description': 'Adebrelimab: 1200 mg Adebrelimab is given on day 1 of each cycle, with 1 dosing cycle every 3 weeks. The dosing time window may be ±5 days, but within 72 hours before each dose, subjects must complete an examination including all clinically necessary tests to assess tolerability of continued dosing, in addition to imaging. Subjects are also advised to remain in the hospital for observation 72 hours after the first dose.\n\nBevacizumab: 7.5 mg/kg Bevacizumab administered intravenously on day 1 of each cycle, with 1 dosing cycle every 3 weeks.\n\nDocetaxel: 60-75 mg/m2 Docetaxel is given on days 1 of each cycle by intravenous infusion for 1 dosing cycle every 3 weeks.', 'armGroupLabels': ['Adebrelimab Combined with Bevacizumab and Docetaxel']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ying hua Ji', 'role': 'CONTACT', 'email': '54234317@qq.com', 'phone': '13663030446'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Xinxiang Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief of oncology', 'investigatorFullName': 'Yinghua Ji', 'investigatorAffiliation': 'The First Affiliated Hospital of Xinxiang Medical College'}}}}