A Phase II Trial of Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pathologic complete response rate
研究概览
简要总结
This study aims to evaluate the efficacy and safety of neoadjuvant camrelizumab combined with chemotherapy in resectable stage IIIA and IIIB (T3-4N2) non-small cell lung cancer (NSCLC) patients. Inclusion criteria are: age 18-75, pathologically confirmed resectable stage IIIA-IIIB (T3-4N2) NSCLC, absence of EGFR, ALK, and ROS1 gene mutations, and Eastern Cooperative Oncology Group (ECOG) status 0-1. All patients receive three cycles of camrelizumab combined with platinum-based doublet chemotherapy, followed by curative surgery within 4-6 weeks after completion of chemotherapy. Patients undergo 18F-fluorodeoxyglucose (FDG) PET/CT scans in 1 week before treatment and 1 week before surgery, and peripheral blood samples are collected for biomarker analysis. The primary endpoints for follow-up are pathologic complete response (pCR) rate and major pathological response (MPR) rate, while secondary endpoints include safety and progression-free survival. Exploratory endpoints include molecular imaging research and biomarker analysis.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75
- •Pathologically confirmed resectable stage IIIA-IIIB (T3-4N2) NSCLC
- •Absence of EGFR, ALK, and ROS1 gene mutations
- •Eastern Cooperative Oncology Group (ECOG) status 0-1
- •Signed written informed consent prior to the implementation of any trial-related rocedures
- •Adequate organ function, evidenced by laboratory results with no contraindications to chemotherapy: Absolute neutrophil count ≥ 1,500 х109/L, Thrombocytes ≥ 100 х 109/L, Hemoglobin ≥ 90 mg/L, Creatinine ≤ 1.5 x ULN or creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 40 mL/min, Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5 x upper limit of normal (ULN), Alkaline phosphatase (ALP) > 5 x ULN, Bilirubin > 1.5 х ULN
排除标准
- •Patients diagnosed with any other malignant tumor
- •Have received prior therapy with chemotherapy or immune checkpoint inhibitor
- •Insufficient caloric and/or fluid intake despite consultation with a dietitian and/or tube feeding
- •Have an active infection requiring systemic therapy that has not resolved 3 days (simple infection, such as cystitis) to 7 days (severe infection, such as pyelonephritis) before the first dose of trial treatment
- •Patients who cannot tolerate chemoradiotherapy or surgery due to severe cardiac, lung dysfunction
- •A history of interstitial lung disease or non-infectious pneumonia
- •Active autoimmune disease with systemic therapy (ie, use of disease modifiers, corticosteroids, or immunosuppressive drugs) in the past 2 years
- •Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibody) and various viral hepatitis infections
- •Patients who have received allogeneic stem cell or solid organ transplantation
- •Women during pregnancy or lactation
研究组 & 干预措施
Camrelizumab Plus Chemotherapy Arm
Patients were assigned to receive 3 cycles of camrelizumab (200 mg) plus chemotherapy (nab-paclitaxel, 130 mg/m2 or pemetrexed (for adenocarcinoma), 500mg/m2 plus platinum [cisplatin, 75 mg/m2; carboplatin, area under the curve, 5])
干预措施: Camrelizumab Plus Chemotherapy (Drug)
结局指标
主要结局
Pathologic complete response rate
时间窗: From date of surgery to 14 days later
No histological evidence of malignancy was found in the primary tumor and metastatic lymph nodes
Major Pathological Response Rate
时间窗: From date of surgery to 14 days later
No more than 10% of tumor cells were found in neoadjuvant surgical specimens
次要结局
- Adverse events(24 weeks)
- Disease-free survival(24 months)
研究者
Xue Meng
MD, PhD
Shandong Cancer Hospital and Institute