NCT04740021Unknown2 期
A Single-arm, Open-lable, Multicenter, Phase II Clinical Study of LP002 in Combination With Chemotherapy for Patients With Extensive Stage Small Cell Lung Cancer
Taizhou HoudeAoke Biomedical Co., Ltd.8 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2020年12月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 46
- 试验地点
- 8
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
LP002 is a highly selected recombinant humanized anti-PD-L1 monoclonal antibody. This is a single-arm, multicenter study to evaluate the efficacy and safety of LP002 in combination with chemotherapy in patients with extensive stage samll cell lung cancer.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be willing and able to provide written informed consent for the trial;
- •Age ≥ 18 and ≤ 79 years old, male or female;
- •Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system).
- •No prior systemic therapy 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.
- •Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •Has a life expectancy of ≥3 months.
- •Has at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.
- •Has adequate organ function.
- •Female participants of childbearing potential should have a negative pregnancy within 72 hours before the first dose of trial treatment. Male and female participants should agree to use an adequate method of contraception during the experiment and 24 weeks after the last administration of the test drugs.
排除标准
- •Histologically or cytologically confirmed mixed SCLC.
- •Suffered from other malignant tumors in the past 5 years (except skin basal cell carcinoma, squamous cell carcinoma, and cervical carcinoma in situ that have been effectively controlled).
- •Prior to the first administration of the study drug, there was a grade > 1 toxicity (excluding hair loss) caused by previous anti-tumor treatments.
- •Has received prior therapy with an anti-PD-1, or anti-PD-L1, or anti-CTLA-4 agents.
- •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •Has uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- •Uncontrolled or symptomatic hypercalcemia.
- •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 the first dose of trial treatment.
- •Has active autoimmune disease that has required systemic treatment in past 2 years.
- •Has received a major surgery within 4 weeks prior to the first dose of trial treatment.
- •Has received system treatment with corticosteroids (dose >10mg/day prednison or other therapeutic hormones) within 2 weeks prior to the first dose of trial treatment.
- •Previous or present interstitial lung disease or non-communicable pneumonia, except for radiation pneumonia.
- •Has uncontrolled systemic disease, such as diabetes or hypertension.
- •Has a history of testing positive for human immunodeficiency virus (HIV), or known acquired immunodeficiency syndrome (AIDS), or stem cell transplantation or organ transplantation.
- •Has untreated chronic hepatitis B or chronic hepatitis B virus (HBV) DNA exceeding 500 IU/ mL or active hepatitis C virus (HCV). Subjects with non-active HBsAg carriers, treated and stable hepatitis B (HBV DNA < 10^3 copies/ml or <500 IU/ mL) , and cured hepatitis C can be enrolled. Subjects with positive HCV antibodies are eligible only if the HCV RNA test results are negative.
- •Has serious infections within 4 weeks or active infections requiring systemic treatment within 2 weeks prior to the first dose of trial treatment.
- •Has a history of severe allergic reaction to any other monoclonal antibodies.
- •Has participated in other anticancer drug clinical trials within 4 weeks.
- •Is pregnant or breastfeeding.
- •Has received a live vaccine within 30 days prior to the first dose of trial treatment.
- •According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
研究组 & 干预措施
Experimental: LP002+EP
Experimental
Participants recieve LP002 10 mg/kg intravenous (IV) on day 1 PLUS carboplatin titrated to an area under the plasma drug concentration-time curve [AUC] 5 IV on day 1 PLUS etoposide 100 mg/m^2 IV on days 1, 2 and 3 of each 21-day cycle
干预措施: LP002 (Drug)
Experimental: LP002+EP
Experimental
Participants recieve LP002 10 mg/kg intravenous (IV) on day 1 PLUS carboplatin titrated to an area under the plasma drug concentration-time curve [AUC] 5 IV on day 1 PLUS etoposide 100 mg/m^2 IV on days 1, 2 and 3 of each 21-day cycle
干预措施: Carboplatin (Drug)
Experimental: LP002+EP
Experimental
Participants recieve LP002 10 mg/kg intravenous (IV) on day 1 PLUS carboplatin titrated to an area under the plasma drug concentration-time curve [AUC] 5 IV on day 1 PLUS etoposide 100 mg/m^2 IV on days 1, 2 and 3 of each 21-day cycle
干预措施: Etoposide (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: Up to approximately 15 months
PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 assessed by investigators or death due to any cause, whichever occurs first.
次要结局
- Objective Response Rate (ORR)(up to approximately 15 months)
- Disease Control Rate (DCR)(up to approximately 15 months)
- Duration of Response (DOR)(up to approximately 15 months)
- Number of Participants Who Experienced an Adverse Event (AE)(up to approximately 15 months)
研究者
研究点 (8)
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