EUCTR2015-004861-97-GB进行中（未招募）1 期
A PHASE I/III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF CARBOPLATIN PLUS ETOPOSIDE WITH OR WITHOUT ATEZOLIZUMAB (ANTIPD-L1 ANTIBODY) IN PATIENTS WITH UNTREATED EXTENSIVE-STAGE SMALL CELL LUNG CANCER
F. Hoffman-La Roche Ltd.0 个研究点目标入组 400 人开始时间: 2016年7月1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
- 400
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
- •- Male or female, 18 years of age or older
- •- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •- Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group (VALG) staging system
- •- No prior systemic treatment for ES-SCLC
- •- Patients who have received prior chemoradiotherapy for limited-stage SCLC must have been treated with curative intent and experienced a treatment-free interval of at least 6 months since last chemotherapy, radiotherapy, or chemoradiotherapy cycle from diagnosis of extensive-stage SCLC
- •- Patients with treated asymptomatic CNS metastases are eligible (only supratentorial and cerebral metastases allowed)
- •- Measurable disease, as defined by RECIST v1.1
- •- Adequate haematologic and end organ function
- •- Patients must submit a pre-treatment tumour tissue sample during the study. Any available tumour tissue sample can be submitted. The tissue sample should be submitted before or within 4 weeks after randomization; however, patients may be enrolled into the study before the pre-treatment tumor tissue sample is submitted
- •- For women of childbearing potential: agreement to remain abstinent or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of study treatment
- •- Men with female partners of childbearing potential or pregnant female partners must remain abstinent or use a condom during treatment with chemotherapy (i.e., carboplatin and etoposide) and for at least 6 months after the last dose of chemotherapy to avoid exposing the embryo
- •- For patients enrolled in the extended China enrollment phase: current resident of mainland China, Hong Kong or Taiwan and of Chinese ancestry
- •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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 280
排除标准
- •- Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
- •- Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >=1 week prior to randomization
- •- Leptomeningeal disease
- •- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
- •- Uncontrolled or symptomatic hypercalcaemia
- •- Malignancies other than SCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS > 90%) treated with expected curative outcome
- •- Women who are pregnant, lactating, or intending to become pregnant during the study
- •- History of autoimmune disease
- •- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
- •- Positive test for HIV
- •- Active hepatitis B or hepatitis C
- •- Active tuberculosis
- •- Severe infections at the time of randomization, including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia
- •- Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction or cerebrovascular accident within 3 months prior to randomization, unstable arrhythmias, or unstable angina
- •- Major surgical procedure other than for diagnosis within 28 days prior to randomization or anticipation of need for a major surgical procedure during the course of the study
- •- Prior allogeneic bone marrow transplantation or solid organ transplant
- •- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk for treatment complications
- •- Patients with illnesses or conditions that interfere with the capacity to understand, follow, and / or comply with study procedures
- •- Treatment with any other investigational agent with therapeutic intent within 28 days prior to randomization
- •- Administration of a live, attenuated vaccine within 4 weeks before randomization or anticipation that such a live attenuated vaccine will be required during the study.
- •- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- •- Treatment with systemic immunosuppressive medications within 1 weeks 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 or any component of the atezolizumab formulation
- •- History of allergic reactions to carboplatin or etoposide
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