Phase II Study of SHR-1210(Anti-PD-1 Antibody) Combination With Apatinib Versus Pemetrexed and Carboplatin in Subjects With KRAS Mutant Stage IV Non-squamous Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Duration of Progression-Free Survival (PFS) as Assessed by the Independent Review Committee Using RECIST v1.1
研究概览
简要总结
This is a randomized, open-label, multi-center, phase II trial to evaluate the efficacy and safety of SHR-1210 plus apatinib mesylate versus Pemetrexed and Carboplatin in Subjects with KRAS mutant stage IV non-squamous 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with histopathological diagnosis of adenocarcinoma non-small cell lung cancer (NSCLC) and clinical stage IV
- •has not received prior systemic treatment for metastatic NSCLC.
- •Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status
- •confirmes by the central laboratory as KRAS gene mutation
- •Has archived Tumor tissue samples
- •Subject must have a measurable target lesion based on RECIST v1.1 .
- •Women of childbearing age must undergo a serological pregnancy test within 3 days before the first dose with negative results. Female subjects of reproductive age and male subjects whose spouse is a woman of reproductive age must agree to effective contraception within 180 days after the study period and the last dose of the study drug.
- •Subjects should be voluntarily participate in clinical studies and informed consent should be signed.
排除标准
- •active brain metastases and meningeal metastasis
- •uncontrollable tumor-related pain
- •massive pleural effusion, peritoneal effusion or pericardial effusion which cannot be controlled by repeated drainage;
- •radiotherapy to lung that is >30 Gy within 24 weeks before the first dose,
- •imaging (CT or MRI) showed that the tumor invading the large vessels
- •Known EGFR/ALK mutation.
- •subjects with any known or suspected autoimmune diseases
- •subjects with known or suspected interstitial pneumonia;
- •Subjects with severe cardiovascular and cerebrovascular diseases
- •arteriovenous thrombosis events, such as deep vein thrombosis and pulmonary embolism, occurred within 3 months;
- •female subjects who are pregnant or lactation or who plan to be pregnant during the study period;
- •positive HIV test;
- •active hepatitis B
- •evidence of active TB infection within 1 year before first dose;
- •severe infection occurred within 4 weeks before the first dose
- •patients with clinically significant bleeding symptoms or with obvious bleeding tendency in the first month
- •subjects who is on systemic immunogenic agents;
- •a history of severe allergic reactions to other monoclonal antibodies/fusion proteins;
- •History of severe allergic reactions to carboplatin or pemetrexed or their preventive drugs;
研究组 & 干预措施
SHR-1210 +apatinib
subject will receive SHR-1210 200mg every 2 weeks, apatinib 250mg every day
干预措施: SHR-1210 (Drug)
SHR-1210 +apatinib
subject will receive SHR-1210 200mg every 2 weeks, apatinib 250mg every day
干预措施: Apatinib (Drug)
chemotherapy
Pemetrexed 500mg/m2, Day 1 of each 21 day, 4 cycles carboplatin AUC 5 on Day 1 of each 21 day, 4 cycles followed by pemetrexed 500mg/m2 until progression Q3W
干预措施: Pemetrexed (Drug)
chemotherapy
Pemetrexed 500mg/m2, Day 1 of each 21 day, 4 cycles carboplatin AUC 5 on Day 1 of each 21 day, 4 cycles followed by pemetrexed 500mg/m2 until progression Q3W
干预措施: Carboplatin (Drug)
结局指标
主要结局
Duration of Progression-Free Survival (PFS) as Assessed by the Independent Review Committee Using RECIST v1.1
时间窗: up to approximately 40 months
PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the Independent Review Committee Using RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment.
次要结局
- Objective Response Rate (ORR)(up to approximately 40 months)
- Duration of Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1(up to approximately 40 months)
- Duration of Overall Survival (OS)(up to approximately 40 months)
- disease control rate (DCR)(up to approximately 40 months)
- Duration of response （DoR）(up to approximately 40 months)
- Adverse events (AEs)(up to approximately 40 months)