A Randomized, Open-Label, Active-Controlled, Multi-Center Study to Compare Efficacy, Safety, and Tolerability of KN046 Combined With Lenvatinib Versus Docetaxel in Subjects With Non-Small Cell Lung Cancer After Failure of Anti-PD-(L)1 Agent
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- DLT
研究概览
简要总结
This is a phase 2/3, multicenter, randomized, open, positive-controlled study of patients with advanced non-small cell lung cancer whose disease has progressed after prior anti-PD-(L)1 therapy. Subjects should have documented progressive disease during prior treatment with first- or second-line PD-(L)1 and platinum-containing dual-agent chemotherapy.Subjects will be randomized to two treatment groups in a 1:1 ratio.
Treatment Group: KN046 5mg/kg Q3W + lenvatinib recommended for phase III dose (RP3D) every day.
Control group: Docetaxel 75mg/m2 Q3W .
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Untreated active central nervous system metastasis or leptomeningeal metastasis;
- •Is currently participating and receiving an investigational drug or has participated in a study of an investigational drug within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first dose of trial treatment;
- •Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the first administration of trial treatment and/or if the subject has not fully recovered from the surgery within 4 weeks of the first administration of trial treatment;
- •Curative radiation within 3 months of the first dose of trial treatment;
- •Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement doses, equivalent to < 10 mg prednisone daily, inhaled steroids and topical use of steroids);
- •Vaccination within 28 days of the first administration of trial treatment, except for administration of inactivated vaccines;
- •Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management;
- •History or current active autoimmune disease that might deteriorate when receiving an immunostimulatory agent;
- •Previous malignant disease;
- •History of uncontrolled intercurrent illness;
- •Prior therapy with any antibody/drug targeting T cell coregulatory proteins;
- •Has received treatment with lenvatinib or docetaxel or VEGFR-TKI;
- •Known severe hypersensitivity reactions to antibody drug;
- •Is pregnant or breastfeeding;
- •Other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance.
研究组 & 干预措施
Cohort 1: KN046 plus Lenvatinib RP3D.
Experimental arm: Cohort 1: KN046 5mg/kg every 3 weeks + lenvatinib RP3D every day until progressive disease or unacceptable toxicity.
干预措施: KN046 (Biological)
Cohort 1: KN046 plus Lenvatinib RP3D.
Experimental arm: Cohort 1: KN046 5mg/kg every 3 weeks + lenvatinib RP3D every day until progressive disease or unacceptable toxicity.
干预措施: Lenvatinib (Drug)
Docetaxel
Active Comparator: docetaxel 75 mg/m² every 3 weeks until progressive disease or unacceptable toxicity.
干预措施: Docetaxel (Drug)
结局指标
主要结局
DLT
时间窗: 28 days or 21 days
Dose limit toxicity (phase 2)
OS
时间窗: up to 2 years
Overall survival (OS) was defined as the time from randomization to death due to any cause (phase 3).
PFS
时间窗: up to 2 years
Progression-free survival (PFS) was defined as the time from randomization grouping to the first documented disease progression or death from any cause as evaluated by the investigator according to RECIST 1.1 criteria (phase 3).
次要结局
- ORR(up to 2 years)
- DCR(up to 2 years)
- DOR(up to 2 years)
- CBR(up to 2 years)
- TTR(up to 2 years)