A Phase II Clinical Trial to Evaluate the Efficacy and Safety of PM8002(Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With EGFR-mutant Advanced Non-squamous NSCLC Who Have Failed to EGFR-TKI Treatment
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 64
- 试验地点
- 1
- 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 is a phase II study to evaluate the efficacy and safety of PM8002 in combination with pemetrexed and carboplatin in patients with EGFR-mutant locally advanced or metastatic non-squamous NSCLC who have failed to EGFR-TKI treatment.
详细描述
This study is a phase II, single-arm study, 64 participants were enrolled as of 6 Feb 2024, and recruitment was completed.
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 male or female.
- •Have a histologically or cytologically confirmed stage IIIB/IIIC NSCLC that is unresectable and not fit for radical concurrent chemoradiotherapy, or metastatic non-squamous NSCLC (IV).
- •with EGFR mutation confirmed by tumor histology or cytology or hematology prior to EGFR-TKI treatment.
- •EGFR-TKI resistance, confirmed by RECIST v1.
- •have adequate organ function.
- •The investigator confirms at least one measurable lesion according to RECIST v1.
- •A measurable lesion located in the field of previous radiation therapy or after local treatment may be selected as a target lesion if progression is confirmed.
- •The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1.
排除标准
- •Squamous cell > 10%. If small cell types are present, the subject is not eligible for inclusion.
- •Have other driving gene mutations that can obtain effective treatment.
- •Have previously received systemic anti-tumor treatment other than EGFR-TKI for advanced non-squamous NSCLC.
- •Have received systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of study drugs.
- •Have received EGFR-TKI treatment, within 14 days prior to the first dose of study drugs
- •Anticoagulant or thrombolytic agent within 10 days prior to the first dose of study drugs.
- •Evidence and history of severe bleeding tendency or coagulation dysfunction.
- •The toxicity of previous anti-tumor therapy has not been alleviated.
- •Symptomatic central nervous system metastases (CNS) metastasis and/or cancerous meningitis.
- •Have suffered from the second primary active malignant tumor in the past 5 years.
研究组 & 干预措施
PM8002+Chemotherapy
Subjects will be administered with PM8002 plus pemetrexed and carboplatin via intravenously (IV) Q3W for 4 cycles, followed by PM8002 and pemetrexed until progression or for a maximum of 2 years.
干预措施: PM8002 (Drug)
PM8002+Chemotherapy
Subjects will be administered with PM8002 plus pemetrexed and carboplatin via intravenously (IV) Q3W for 4 cycles, followed by PM8002 and pemetrexed until progression or for a maximum of 2 years.
干预措施: Carboplatin (Drug)
PM8002+Chemotherapy
Subjects will be administered with PM8002 plus pemetrexed and carboplatin via intravenously (IV) Q3W for 4 cycles, followed by PM8002 and pemetrexed until progression or for a maximum of 2 years.
干预措施: Pemetrexed (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Up to approximately 2 years
Objective response rate is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.
次要结局
- Progression free survival (PFS)(Up to approximately 2 years)
- Overall survival (OS)(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)
- Correlation between PD-L1 expression and antitumor effect(Up to approximately 2 years)