A Multicenter, Open-lable, Randomized Phase III Study of PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 404
- 试验地点
- 47
- 主要终点
- Overall survival (OS)
研究概览
简要总结
PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study will evaluate the efficacy and safety of PM8002 in combination with Paclitaxel as second-line treatment for SCLC
详细描述
This multicenter, randomized, open-label phase III study will evaluate the efficacy and safety of PM8002 in combination with Paclitaxel versus Investigator's Choice (Topotecan or Paclitaxel) as second-line treatment for subjects with SCLC.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary participation in this clinical study; full understanding of the study and voluntary signing the informed consent form; willing to follow and abling to complete all trial procedures;
- •Age ≥18 years but ≤75 years;
- •Histologically or cytologically confirmed SCLC;
- •Advanced SCLC that has progressed or replased after first-line platinum-containing chemotherapy (extensive-stage patients must have received immune checkpoint inhibitors);
- •Having adequate organ functions;
- •The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
- •Life expectancy of 12 weeks or more;
- •Having at least one measurable tumor lesion according to RECIST v1.1;
排除标准
- •History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs;
- •Previous treatment with Paclitaxel or Topotecan or anti-vascular endothelial growth factor (VEGF) target drugs;
- •Current presence of severe superior vena cava syndrome and spinal cord compression;
- •Adverse events resulting from prior anti-tumor therapies should be assessed and graded according to the CTCAE 5.0 criteria, subjects whose AEs have not returned to Grade 1 or below;
- •Evidence of significant clotting disorder or other significant bleeding risk;
- •History of severe, uncontrollable, or active cardiovascular diseases within 6 months;
- •Current presence of uncontrollable pleural, pericardial, and peritoneal effusions;
- •Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
- •History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
- •History of alcohol abuse, psychotropic substance abuse or drug abuse;
- •Pregnant or lactating women;
- •Other conditions considered unsuitable for this study by the investigator.
研究组 & 干预措施
PM8002+Paclitaxel
Subjects will be administered with PM8002 in combination with Paclitaxel via intravenously (IV) infusion.
干预措施: PM8002 (Drug)
PM8002+Paclitaxel
Subjects will be administered with PM8002 in combination with Paclitaxel via intravenously (IV) infusion.
干预措施: Paclitaxel (Drug)
Chemotherapy
Subjects will be administered with Investigator's Choice(Topotecan or Paclitaxel) via intravenously (IV) infusion Q3W.
干预措施: Paclitaxel (Drug)
Chemotherapy
Subjects will be administered with Investigator's Choice(Topotecan or Paclitaxel) via intravenously (IV) infusion Q3W.
干预措施: Topotecan (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: Up to approximately 32 months from first patient in
Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis are censored at the date of the last follow-up.
次要结局
- Progression-Free Survival (PFS) assessed by evaluated by investigator(Up to approximately 32 months from first patient in)
- Objective response rate (ORR) evaluated by investigator(Up to approximately 32 months from first patient in)
- Disease control rate (DCR)(Up to approximately 32 months from first patient in)
- Time to response (TTR)(Up to approximately 32 months from first patient in)
- Duration of response (DOR)(Up to approximately 32 months from first patient in)
- 6 month PFS rate(Up to approximately 32 months from first patient in)
- 12 month PFS rate(Up to approximately 32 months from first patient in)
- 12 month OS rate(Up to approximately 32 months from first patient in)
- Incidence and severity of Adverse Event (AE) according to CTCAE 5.0(Up to 30 days after last treatment)
- Anti-drug antibody (ADA)(Up to 30 days after last treatment)
- Health related quality of life (HRQoL)(Up to 30 days after last treatment)