International Multi-center Open-label Randomized Clinical Trial of Efficacy, Safety and Pharmacokinetics of BCD-100 (JSC "BIOCAD", Russia) Monotherapy Compared to Docetaxel as Second-line Therapy of Patients With Advanced Inoperable or Metastatic Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 发起方
- Biocad
- 入组人数
- 218
- 试验地点
- 8
- 主要终点
- Overall survival
研究概览
简要总结
International multi-center open-label randomized clinical trial of efficacy, safety and pharmacokinetics of BCD-100 (JSC BIOCAD, Russia) monotherapy compared to docetaxel as second-line therapy of patients with advanced inoperable or metastatic non-small cell lung cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Verified diagnosis of non-small cell lung cancer
- •Verified progression of the disease after or during first-line chemotherapy based on platinum drugs
- •Absence of mutation of EGFR and ALK genes
- •ECOG score 0-1
- •At least one lesion, that is measurable according to RECIST 1.1 criteria
- •Absence of severe organ pathology
- •Anticipated live duration more that 12 weeks after screening
- •Brain metastases with clinical symptoms requiring glucocorticoids and/or anticonvulsant drugs
排除标准
- •EGFR and/or ALK mutations
- •Patients with severe of live-threatening acute complications of the disease
- •Intersticial lung diseases or pneumonitis
- •Concomitant diseases that affect safety evaluation
- •Autoimmune diseases
- •Endocrine diseases that could not be compensated by hormonal therapy
- •Patient needs glucocorticoids
- •Significant liver or renal diseases
- •Lactate dehydrogenase exceeds upper limit of normal more that 2-fold
- •More that 1 chemotherapy lines for advanced/metastatic non-small cell lung cancer treatment
- •Anti-tumor treatment ending less then 28 days before screening
- •Prior therapy with anti-CTLA4 and/or anti-PD-1/PD-L1/PD-L2 drugs
- •Prior therapy with docetaxel
- •Concomitant oncological diseases except treated cervical carcinoma in situ or radically resected squamous-cell carcinoma
- •Allergy to drugs based on monoclonal antibodies or docetaxel or polysorbate 80, severe reactions to paclitaxel
- •Pregnancy and lactation
研究组 & 干预措施
BCD-100 monotherapy
Patients will receive solution of BCD-100 in a dose 3 mg/kg every 3 weeks as intravenous infusion until progression of the disease or signs of intolerable toxicity
干预措施: BCD-100 (Drug)
Docetaxel monotherapy
Patients will receive solution of docetaxel in a dose 75 mg per square meter every 3 weeks as intravenous infusion until progression of the disease or signs of intolerable toxicity, maximum 6 cycles
干预措施: Docetaxel (Drug)
结局指标
主要结局
Overall survival
时间窗: 1 year
Percent of patients who are alive after 1 year of therapy
次要结局
- Overall response rate(1 year)
- Progression-free survival(1 year)