A Single-center, Prospective, Single-arm Phase Ⅱ Trial of Neoadjuvant Toripalimab Plus Platinum-doublet Chemotherapy in Locally Advanced NSCLC.
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Major pathological response (MPR) rate
研究概览
简要总结
This is a Phase 2, prospective, single-arm, open-Label, single-center study that to find out (1)The effectiveness and safety of toripalimab combined with platinum-doublet chemotherapy as a preoperative neoadjuvant therapy for locally advanced (stage IIB, IIIA, and resectable stage IIIB) NSCLC, (2)The best treatment time for this combination of neoadjuvant therapy before surgery, (3)The effectiveness and safety of combination of neoadjuvant therapy as salvage neoadjuvant therapy after failure of neoadjuvant chemo-only for locally advanced non-small cell lung cancer.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign the informed consent form before starting any trial related procedure.
- •18-80 years old, male or female.
- •Non-small cell lung cancer confirmed by cytology or histology. Evaluation by the researchers to confirm resectable stage IIB, IIIA or resectable stage IIIB (CT3-4N2M0) NSCLC patients without any treatment before.
- •If the pathological type is adenocarcinoma, genetic testing is required.
- •Newly treated patients or patients with failure of traditional preoperative neoadjuvant chemotherapy can be enrolled;
- •ECOG PS 0-
- •Good cardiac function, left ventricular ejection fraction >50%;
- •Good respiratory function, able to tolerate radical resection of lung cancer;
- •Bone marrow hematopoietic function is good, leukocyte> 4×10^9/l; Hemoglobin> 10g/dl; Platelet > 100×10^9/l;
- •Good renal function, glomerular filtration rate>60 ml/min.
- •Good liver function, Total bilirubin(TBIL)<1.5ULN, AST<2.5 ULN, ALT<3ULN;
- •There must be at least one evaluable focus judged according to recist1.1 standard.
排除标准
- •small cell lung cancer confirmed by cytology or histology. Pathologic type was adenocarcinoma with EGFR gene mutation or ALK gene rearrangement.
- •Advanced lung cancer, or unresectable lung cancer A patient who had received preoperative neoadjuvant radiotherapy for NSCLC. Patients who have a history of active autoimmune disease or potentially recurrent autoimmune disease.
- •Patients with active hepatitis Allergic to study drug (Toripalimab ,cisplatin, carboplatin, paclitaxel, gemcitabine and pemetrexed) components excipients.
- •Patients were given antibiotics within 2 weeks. The investigator considered that the subject's comordities or other conditions may affect the compliance with the protocol or are not suitable for participating in this study
研究组 & 干预措施
Toripalimab Combined With Platinum-containing Dual-agent.
Toripalimab combined with platinum-containing dual-agent as a neoadjuvant Therapy for Non-small Cell Lung Cancer.
干预措施: Toripalimab combination with platinum-containing dual-drug chemotherapy. (Drug)
结局指标
主要结局
Major pathological response (MPR) rate
时间窗: At time of surgery
MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the pathological examination of resected specimens.
次要结局
- R0 surgical resection rate(At time of surgery)
- Objective response rate (ORR)(Baseline (Prior to surgery))
- Adverse Events (AEs)(Approximately 2 years after the last patient registered.)
- Complete pathological response (pCR) rate(At time of surgery)
- Event-free survival(EFS)(Approximately 2 years after the last patient registered.)
研究者
Wu Nan
Head of Department
Peking University Cancer Hospital & Institute