Status:
UNKNOWN
Adebrelimab Combined With Bevacizumab and Docetaxel for Advanced Non-Squamous Non-small Cell Lung Cancer After Progression on First-line Immunotherapy
Lead Sponsor:
The First Affiliated Hospital of Xinxiang Medical College
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 w...
Detailed Description
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 enrollm...
Eligibility Criteria
Inclusion
- voluntarily enrolled in this study and signed the Informed Consent Form (ICF).
- age ≥ 18 years and both sexes
- 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.
- objective imaging progression (RECIST v1.1 assessment) after subjects have received a first-line regimen containing immune checkpoint inhibitor therapy.
- the immune checkpoint inhibitor-containing therapy PFS of ≥ 6 months on first- line therapy.
- imaging evaluation (CT or MRI) with at least one measurable target lesion (according to RECIST v1.1) within 4 weeks prior to enrollment.
- an ECOG PS score of 0-1 within 4 weeks prior to enrollment.
- an expected survival of ≥ 12 weeks.
- Adequate function of vital organs
- 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.
Exclusion
- 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)
- patients with known EGFR-sensitive mutations (19Exon del/21Exon L858R), positive ALK/ROS1 fusion.
- 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)
- 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.
- 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)).
- 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
- 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.
- those with severe vascular lesions (including aneurysms or arterial thrombosis requiring surgical treatment) within 6 months prior to enrollment
- late first-line treatment with anti-angiogenic agents, including but not limited to bevacizumab, apatinib, anlotinib, ramucirumab, lenvatinib, etc.; treatment with docetaxel.
Key Trial Info
Start Date :
December 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06182800
Start Date
December 27 2023
End Date
December 30 2025
Last Update
December 27 2023
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