A Phase II Clinical Trial to Evaluate the Efficacy and Safety of PM8002 in Combination With Etoposide and Platinum in First-line Treatment of Extensive-Stage Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 17
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study to evaluate the efficacy and safety of PM8002 in combination with etoposide and platinum in first-line treatment of extensive-stage small cell lung cancer
详细描述
The study is divided into two parts.
The first part is single-arm study, 50 participants were enrolled as of 21 Nov 2023，and recruitment was completed.
The second part is randomized, double-blind study, active controlled design , which will be integrated to another global III study （NCT06712355）.
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 (Participant, Investigator)
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
- •Signed informed consent form before any trial-related processes;
- •Age ≥18 years;
- •Histologically or cytologically confirmed ES-SCLC;
- •No prior systemic therapy for ES-SCLC;
- •Have adequate organ function;
- •The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
- •Life expectancy of ≥12 weeks;
- •Had at least one measurable tumor lesion according to RECIST v1.1.
排除标准
- •Histologically or cytologically confirmed mixed SCLC;
- •History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs;
- •The toxicity of previous anti-tumor therapy has not been alleviated；
- •Have received anti-platelet therapy within 10 days prior to the first dose of the study drugs;
- •Evidence and history of severe bleeding tendency;
- •History of severe cardiovascular diseases within 6 months;
- •Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
- •History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
- •History of alcohol abuse, psychotropic substance abuse or drug abuse;
- •Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
- •Pregnant or lactating women;
- •Other conditions considered unsuitable for this study by the investigator.
研究组 & 干预措施
PM8002+Etoposide＋platinum
Subjects will be administered with PM8002 plus Etoposide and platinum via intravenously (IV) Q3W for 4 cycles, followed by PM8002 until progression or for a maximum of 2 years.
干预措施: PM8002 (Drug)
PM8002+Etoposide＋platinum
Subjects will be administered with PM8002 plus Etoposide and platinum via intravenously (IV) Q3W for 4 cycles, followed by PM8002 until progression or for a maximum of 2 years.
干预措施: Platinum (Drug)
PM8002+Etoposide＋platinum
Subjects will be administered with PM8002 plus Etoposide and platinum via intravenously (IV) Q3W for 4 cycles, followed by PM8002 until progression or for a maximum of 2 years.
干预措施: Etoposide (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Up to approximately 2 years
ORR is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.
次要结局
- Overall survival (OS)(Up to approximately 2 years)
- Progression free survival (PFS)(Up to approximately 2 years)
- Disease control rate (DCR)(Up to approximately 2 years)
- Duration of response (DOR)(Up to approximately 2 years)
- Time to response (TTR)(Up to approximately 2 years)
- Pharmacokinetic (PK) parameters(Up to 30 days after last treatment)
- Anti-drug antibody (ADA)(Up to 30 days after last treatment)
- Treatment related adverse events (TRAEs)(Up to 30 days after last treatment)