NCT05055167进行中（未招募）2 期
A Phase II Study of Envafolimab as First-line Treatment of Aged Patients With High PD-L1 Expression Stage in Advanced Non-small-cell Lung Cancer(NSCLC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
Explore the efficacy and safety of Envafolimab in first line treatment of elderly patients with locally advanced or metastatic non-small cell lung cancer with high PD-L1 expression, view to providing better treatment options for elderly patients with high PD-L1 expression and improving the survival and prognosis of patients .
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent.
- •Age strictly at least 70 years.
- •Cytologically or histologically proven NSCLC(adenocarcinoma, epidermoid carcinoma, large-cell carcinoma) of locally advanced (stage IIIb/IIIc), metastatic, or relapsing (stage IV) according to the American Joint Committee on Cancer Staging Handbook.
- •Presence of at least one measurable target lesion (RECIST rules) in a non irradiated region.
- •No previous systemic chemotherapy for lung cancer.
- •PD-L1≥50% in tissue samples detected by immunohistochemistry.
- •Life expectancy sup 12 weeks.
- •Normal hematologic function.
排除标准
- •EGFR-sensitive mutations or ALK rearrangements
- •Previous treatment with immune checkpoint inhibitors
- •Presence of symptomatic brain metastases；
- •Chinese patent medicine with anti-lung cancer indications or immunoregulatory drugs (including thymopeptide, interferon and interleukin, except for the local use of pleural effusion control) for systemic treatment；
- •Another previous or concomitant cancer, except for basocellular cancer of the skin or treated cervical cancer in situ；
- •Concurrent administration of one or several other antitumor therapies；
- •Concurrent participation in another clinical trial；
- •Active autoimmune disease requiring systemic treatment occurred within 2 years prior to initial；
- •Systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days prior to initial administration；
- •Contraindication to the study drugs；
- •Has not fully recovered from toxicity and/or complications caused by any intervention prior to the commencement of treatment (i.e., grade 1 or baseline, excluding fatigue or hair loss);
- •A history of human immunodeficiency virus (HIV) infection;
- •Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected greater than the upper limit of normal value in the laboratory of the research center);
- •Active HCV infected;
- •Recent vaccination within 30 days before the first administration (cycle 1, day 1);
- •Other severe concurrent disorders that occurred during the prior six months before enrollment (myocardial infection, severe or unstable angor, NYHA class 3 or 4 congestive heart failure, transient or constituted cerebral ischemic attack, psychiatric or neurological disorders preventing the patient from understanding the trial, uncontrolled infections).
研究组 & 干预措施
Envafolimab
Experimental
Elderly NSCLC Patients with high PD-L1 expression
干预措施: Envafolimab (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: 48 months
The proportion of subjects who achieve Complete Response (CR) and Partial Response (PR) by the best response from the first dose of Almonertinib to the end of study.
次要结局
未报告次要终点
研究者
研究点 (1)
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