2024-517200-10-00招募中2 期
FoRT 05- BEAT Phase II randomized trial comparing atezolizumab versus atezolizumab plus bevacizumab as first-line treatment in PD-L1 high advanced non-small-cell lung cancer patients
Fondazione Ricerca Traslazionale32 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2024年11月26日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 32
- 主要终点
- Overall Survival (OS) in patients treated with atezolizumab alone versus atezolizumab-bevacizumab combination
研究概览
简要总结
To assess whether the combination of atezolizumab and bevacizumab improves overall survival (OS) over atezolizumab as single agent in untreated PD-L1 high metastatic NSCLC.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of stage IV non-squamous NSCLC with no evidence of EGFR sensitizing mutations or ALK or ROS1 rearrangements. 2) Availability of tumor tissue. 3) 3) Evidence of high levels of PD-L1 expression evaluated with immunohistochemistry (=50% by 22C3 or SP263 or TC/IC 3 scoring by SP 142) . 4) No previous chemotherapy. Patients who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 6 months from randomization since the last dose of chemotherapy and/or radiotherapy. 5) ECOG performance status 0-
- •Life expectancy > 3 months 7) Age =18 years. 8) Measurable disease, as defined by RECIST v1.
- •Adequate hematologic and organ function, defined by the following laboratory results obtained within 28 days prior to randomization: o ANC = 1500 cells/µL without granulocyte colony-stimulating factor support o Platelet count = 100,000/µL without transfusion o Hemoglobin = 9.0 g/dL Patients may be transfused to meet this criterion o AST, ALT, and alkaline phosphatase = 2.5 × ULN, with the following exceptions: ¿ Patients with documented liver metastases: AST and/or ALT = 5 × ULN ¿ Patients with documented liver or bone metastases: alkaline phosphatase = 5 × ULN. o Serum bilirubin = 1.25 × ULN o Patients with known Gilbert disease who have serum bilirubin level = 3 mg/dL may be enrolled o Calculated creatinine clearance (CRCL) = 45 mL/min or calculated CRCL must be = 60 mL/min 10) Patient compliance to trial procedures. 11) Written informed consent.
排除标准
- •No tumor tissue available.
- •PD-L1 expression < 50 % or PD-L1 expression unknown or not assessable
- •Patient positive for EGFR mutations or ALK or ROS1 rearrangements.
- •Patients with squamous histology or with specific contraindication to bevacizumab therapy.
- •Previously treated with chemotherapy
- •Concomitant radiotherapy or chemotherapy.
- •Previous therapy with any checkpoint inhibitor.
- •Pregnancy or lactating women who are pregnant, lactating, or intending to become pregnant during the study.
- •Symptomatic brain metastases
- •Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression
- •Leptomeningeal disease.
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- •Uncontrolled or symptomatic hypercalcemia
- •Malignancies other than NSCLC within 5 years prior to randomization
- •History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- •Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells
- •History of autoimmune disease
- •History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
- •Positive test for HIV
- •Patients with active hepatitis B or hepatitis C.
- •Active tuberculosis
- •Severe infections within 4 weeks prior to randomization
- •Significant cardiovascular disease
- •Major surgical procedure other than for diagnosis within 28 days prior to randomization
- •Prior allogeneic bone marrow transplantation or solid organ transplant
- •Administration of a live, attenuated vaccine within 4 weeks before randomization
- •metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease
- •Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment
- •Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to randomization
- •Prior treatment with CD137 agonists or immune checkpoint blockade therapies, antiPD-1, and anti-PD-L1 therapeutic antibodies
- •Treatment with systemic immunostimulatory agents
- •Treatment with systemic immunosuppressive medications
- •Patients who have received acute, low-dose, systemic immunosuppressant medications
- •The use of steroids are permitted only as inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension, low-dose supplemental corticosteroids for adrenocortical insufficiencyand corticosteroids for CT pre treatment.
- •Inadequately controlled hypertension
- •Prior history of hypertensive crisis or hypertensive encephalopathy
- •Significant vascular disease
- •History of hemoptysis (= one-half teaspoon of bright red blood per episode) within 1 month prior to randomization;
- •Current or recent use of aspirin or treatment with dipyramidole, ticlopidine, clopidogrel, and clostazol
- •Current use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes that has not been stable for > 2 weeks prior to randomization
- •Prophylactic anticoagulation for the patency of venous access devices is allowed
- •Prophylactic use of low-molecular-weight heparin
- •Core biopsy or other minor surgical procedure, excluding placement of a vascular access device,
- •History of abdominal or tracheosphageal fistula or gastrointestinal perforation
- •Serious, non-healing wound, active ulcer, or untreated bone fracture
- •Proteinuria
- •Known sensitivity to any component of bevacizumab E.5 - End Points
结局指标
主要结局
Overall Survival (OS) in patients treated with atezolizumab alone versus atezolizumab-bevacizumab combination
Overall Survival (OS) in patients treated with atezolizumab alone versus atezolizumab-bevacizumab combination
次要结局
未报告次要终点
研究者
Federico Cappuzzo
Scientific
Fondazione Ricerca Traslazionale
研究点 (32)
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