A Multi-center, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of Serplulimab Plus Bevacizumab and Chemotherapy for EGFRm+ Locally Advanced or Metastasis Non-Squamous NSCLC Patients After EGFR-TKI Treatment Failure
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- ORR(Overall Response Rate)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Serplulimab Plus Bevacizumab and chemotherapy in TKI-resistant EGFR-mutated non-squamous NSCLC Chinese patients.
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
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
- •Signed written informed consent before any trial-related processes;
- •Age ≥ 18 years and ≤70 years male or females;
- •Has a histologically or cytologically confirmed stage IIIB/IIIC (American Joint Committee on Cancer [AJCC] 8th edition) NSCLC that is unresectable and not fit for radical concurrent chemoradiotherapy, or metastatic / recurrent non-squamous NSCLC;
- •Patients with EGFR mutation confirmed by tumor histology or cytology or hematology prior to EGFR-TKI treatment
- •EGFR-TKI resistance, confirmed by RECIST 1.1
- •The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
排除标准
- •History of severe allergies to any study drug
- •Has previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or any other stimulatory or inhibitory agents of T cell receptors
- •Previous exposure to VEGF inhibitor for anti-cancer treatment
- •Patients with untreated symptomatic brain metastases. Patients with treated brain metastases will be allowed if brain imaging obtained greater than 4 weeks from trial enrollment reveals stable disease.
- •Has received a live-virus vaccination within 28 days of planned treatment start
- •Interstitial lung disease or pneumonitis requiring oral or IV glucocorticoids Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study
研究组 & 干预措施
Serplulimab+Bevacizumab+Pemetrexed+Carboplatin
Using Serplulimab in combination with bevacizumab, carboplatin and pemetrexed to treat patients with EGFR mutated, advanced non-small cell lung cancer (NSCLC) after failure of EGFR tyrosine kinase inhibitors.
干预措施: Serplulimab (Drug)
Serplulimab+Bevacizumab+Pemetrexed+Carboplatin
Using Serplulimab in combination with bevacizumab, carboplatin and pemetrexed to treat patients with EGFR mutated, advanced non-small cell lung cancer (NSCLC) after failure of EGFR tyrosine kinase inhibitors.
干预措施: Bevacizumab Biosimilar HLX04 (Drug)
Serplulimab+Bevacizumab+Pemetrexed+Carboplatin
Using Serplulimab in combination with bevacizumab, carboplatin and pemetrexed to treat patients with EGFR mutated, advanced non-small cell lung cancer (NSCLC) after failure of EGFR tyrosine kinase inhibitors.
干预措施: Pemetrexed (Drug)
Serplulimab+Bevacizumab+Pemetrexed+Carboplatin
Using Serplulimab in combination with bevacizumab, carboplatin and pemetrexed to treat patients with EGFR mutated, advanced non-small cell lung cancer (NSCLC) after failure of EGFR tyrosine kinase inhibitors.
干预措施: Carboplatin (Drug)
结局指标
主要结局
ORR(Overall Response Rate)
时间窗: From start of treatment to 12 months
The proportion of subjects who have a complete response (CR) or a partial response (PR)
次要结局
- PFS(Progression Free Survival)(From start of treatment to 24 months)
- AE(Adverse Event)(From start of treatment to 24 months)
- OS(Overall Survival)(From start of treatment to 24 months)