EUCTR2020-000100-11-PT进行中（未招募）1 期
A PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABEL, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF TEZOLIZUMAB GIVEN IN COMBINATION WITH CABOZANTINIB VERSUS DOCETAXEL MONOTHERAPY IN PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER PREVIOUSLY TREATED WITH AN ANTI-PD-L1/PD-1 ANTIBODY AND PLATINUM-CONTAINING CHEMOTHERAPY
F. Hoffman-La Roche Ltd.0 个研究点目标入组 366 人开始时间: 2020年7月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 366
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age >= 18 years
- •- Histologically or cytologically confirmed metastatic NSCLC
- •- Documented radiographic disease progression during or following treatment with platinum-containing doublet chemotherapy and anti-PD-L1/PD-1 antibody, administered concurrently or sequentially for metastatic NSCLC
- •- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 outside the central nervous system (CNS) as assessed by investigator
- •- Known PD-L1 status or availability of tumor tissue for central PD-L1 testing
- •- Eastern Cooperative Oncology Group performance status score of 0 or 1
- •- Recovery to baseline or Grade <= 1 National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 from toxicities related to any prior treatments, unless adverse events are clinically nonsignificant and/or stable on supportive therapy in the opinion of the investigator
- •- Adequate hematologic and end-organ function
- •- For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs, for 5 months after the final dose of atezo and/or 4 months after the final dose of cabo
- •- For men: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating sperm for 4 months after the final dose of cabo, or for 6 months after the final dose of docetaxel
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 175
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 175
排除标准
- •- Prior therapy with the following agents for NSCLC: Cabo, Docetaxel, Combination of an anti-PD-L1/PD-1 antibody concurrently with a vascular endothelial growth factor -targeting tyrosine kinase inhibitor
- •- Treatment with investigational therapy within 28 days prior to initiation of study treatment
- •- Documentation of known sensitizing mutation in the epidermal growth factor receptor (EGFR) gene or anaplastic lymphoma kinase (ALK) fusion oncogene
- •- Patients with known ROS-1 rearrangements, BRAF V600E mutations, or other actionable oncogenes with approved therapies if available
- •- Symptomatic, untreated, or actively progressing CNS metastases
- •- History of leptomeningeal disease
- •- Uncontrolled tumor-related pain, pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures, uncontrolled or symptomatic hypercalcemia
- •- Any other active malignancy at the time of initiation of study treatment or diagnosis of another malignancy within 3 years prior to initiation of study treatment that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, incidental prostate cancer, or carcinoma in situ of the prostate, cervix, or breast
- •- Significant vascular disease (e.g., aortic aneurysm or arterial dissection requiring surgical repair or recent peripheral arterial thrombosis) within 6 months of initiation of study treatment
- •- Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
- •- Stroke, transient ischemic attack, myocardial infarction or other symptomatic ischemic events within 6 months of initiation of study treatment
- •- Active tuberculosis
- •- Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety
- •- Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
- •- Current treatment with anti-viral therapy for HBV
- •- Ongoing Grade = 2 sensory or motor neuropathy
- •- Active or history of autoimmune disease or immune deficiency
- •- Pharmacologically uncompensated, symptomatic hypothyroidism
- •- Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study
- •treatment or anticipation of need for such a vaccine during atezolizumab treatment
- •or within 5 months after the final dose of atezolizumab
- •- Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives prior to initiation of study treatment
- •- Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment
- •- Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation
- •- History of severe hypersensitivity to docetaxel or to other drugs formulated with polysorbate 80
- •- Concomitant anticoagulation with coumarin agents (e.g. warfarin), direct thrombin inhibitor dabigatran, direct factor Xa inhibitor betrixaban or platelet inhibitors (e.g. clopidogrel)
- •- Thromboembolic event within 6 months before initiation of study treatment
- •- History of risk factors for torsades de pointes
- •- Corrected QT interval corrected through use of Fridericia's formula > 480 ms per ECG within 14 days before initiation of study treatment
研究者
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