Induction Therapy With Chemoimmunotherapy Followed by Surgery for Unresectable Stage III Non-small Cell Lung Cancer: a Single-center, Single-arm, Prospective Clinical Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Major pathological response (MPR) rate
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Camrelizumab in combination with platinum doublet neoadjuvant chemotherapy before surgery [neoadjuvant phase], followed by Camrelizumab alone after surgery [adjuvant phase] in participants with unresectable stage III non-small cell lung cancer.
详细描述
Concurrent chemoradiotherapy is the recommended therapeutic approach for patients with unresectable stage III non-small cell lung cancer(NSCLC), although surgery offers the chance of cure. With combined radiation and chemotherapy, the prognosis of unresectable stage III NSCLC remains poor. Immunotherapy combined with chemotherapy has been shown to be efficacious as treatment for advanced non-squamous non-small-cell lung cancer (NSCLC) without targetable genetic aberrations. Camrelizumab, a humanised monoclonal antibody against PD-1, has shown its efficacy in the treatment of advanced NSCLC. This study is to studying neoadjuvant camrelizumab plus double platinum based chemotherapy followed by surgery to see how well it works in treating patients with unresectable stage III NSCLC.
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
- •Written informed consent provided.
- •Age 18-70 when signing the consent form, both male and female;
- •The ECOG score is 0 or 1;
- •Unresectable stage III non-small cell lung cancer confirmed by histopathology or cytology（III A-bulky N2, III B，IIIC）;
- •Adequate hematological function, liver function and renal function;
- •Female participants should not be pregnant or breast-feeding.
排除标准
- •EGFR mutation or ALK mutation was positive;
- •Previously received systemic anti-tumor therapy for non-small cell lung cancer;
- •Subjects who have received chest radiotherapy in the past;
- •Known human immunodeficiency virus (HIV) infection;
- •Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease);
- •Pregnancy or breast-feeding women;
- •Ingredients mixed with small cell lung cancer patients.
研究组 & 干预措施
PD-1+Chemo+surgery+PD-1
Participants will receive neoadjuvant Carrelizumab plus double platinum based chemotherapy for 3 cycles, followed by surgical resection and adjuvant Carrelizumab for 16 cycles.
干预措施: Carrelizumab (Drug)
PD-1+Chemo+surgery+PD-1
Participants will receive neoadjuvant Carrelizumab plus double platinum based chemotherapy for 3 cycles, followed by surgical resection and adjuvant Carrelizumab for 16 cycles.
干预措施: Pemetrexed (Nonsquamous NSCLC) or Nab-paclitaxel(Squamous NSCLC) (Drug)
PD-1+Chemo+surgery+PD-1
Participants will receive neoadjuvant Carrelizumab plus double platinum based chemotherapy for 3 cycles, followed by surgical resection and adjuvant Carrelizumab for 16 cycles.
干预措施: Carboplatin (Drug)
PD-1+Chemo+surgery+PD-1
Participants will receive neoadjuvant Carrelizumab plus double platinum based chemotherapy for 3 cycles, followed by surgical resection and adjuvant Carrelizumab for 16 cycles.
干预措施: Surgery (Procedure)
结局指标
主要结局
Major pathological response (MPR) rate
时间窗: 1 year
MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy.
次要结局
- Resectability rate(1 year)
- Percentage of incidence of adverse Events(approximately 16.5 months overall)
- PFS(2 year)
- OS(2 year)