NCT05047250进行中（未招募）3 期
A Phase III, Single-Arm Multicenter Study of Atezolizumab (Anti-PD-L1 Antibody) in High PD-L1 Expression, Chemotherapy-Naïve Patients With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 28
- 主要终点
- Overall survival (OS)
研究概览
简要总结
This is a Phase III, single arm, multicenter study designed to evaluate the efficacy and safety of atezolizumab in high PD-L1 expression, chemotherapy-naïve, without a sensitizing EGFR mutation or ALK translocation patients with stage IV non-squamous or squamous NSCLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECOG performance status of 0 or
- •Histologically or cytologically confirmed, Stage IV non-squamous or squamous NSCLC.
- •No prior treatment for Stage IV non-squamous or squamous NSCLC.
- •Patients who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy, or chemo-radiotherapy with curative intent for non-metastatic disease must have experienced a treatment free interval of at least 6 months from enrollment since the last chemotherapy, radiotherapy, or chemo-radiotherapy cycle.
- •Tumor TC3 or IC3, as determined by SP142 performed by a central laboratory on previously obtained archival tumor tissue or tissue obtained from a biopsy at screening.
- •Measurable disease, as defined by RECIST v1.
- •Adequate hematologic and end-organ function.
- •Life expectancy ≥3 months.
- •For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating.
排除标准
- •Known sensitizing mutation in the EGFR gene or ALK fusion oncogene.
- •Symptomatic, untreated, or actively progressing CNS metastases.
- •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 ≥2 weeks prior to enrollment.
- •Current leptomeningeal disease.
- •Uncontrolled tumor-related pain.
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
- •Uncontrolled or symptomatic hypercalcemia.
- •Malignancies other than NSCLC within 5 years prior to enrollment, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome.
- •Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within at least 5 months after the last dose of atezolizumab.
- •History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
- •Known allergy or hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation.
- •Active or history of autoimmune disease or immune deficiency.
- •History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
- •Positive human immunodeficiency virus (HIV) test result at screening.
- •Patients with active hepatitis B or active hepatitis C at screening.
- •Active tuberculosis.
- •Severe infections within 4 weeks prior to randomization, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.
- •Significant cardiovascular disease.
研究组 & 干预措施
Atezolizumab
Experimental
Participants will receive IV infusion of atezolizumab on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by investigators.
干预措施: Atezolizumab (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: Atezolizumab initiation to death from any cause (up to approximately 28 months)
Overall survival (OS) is defined as the time from atezolizumab initiation to death from any cause.
次要结局
- Progression-free survival (PFS)(Atezolizumab initiation to the first occurrence of disease progression or death from any cause (whichever occurs first), (up to approximately 28 months))
- OS Rate at 1-Year(Atezolizumab initiation to 1-year)
- OS Rate at 2-Year(Atezolizumab initiation to 2-year)
- Objective Response Rate (ORR)(Randomization up to approximately 34 months)
- Duration of Response (DOR)(Randomization up to approximately 34 months)
- Percentage of Participants With Adverse Events(Randomization up to approximately 34 months)
研究者
研究点 (28)
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