Neoadjuvant Camrelizumab, Nab-paclitaxel and Carboplatin in Patients With Stage IB-IIIA Non-small Cell Lung Cancer (NANE-LC): A Prospective, Single-arm, Multicenter, Phase II Study
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Major pathologic response (MPR) Rate
研究概览
简要总结
This prospective, single-arm, multicenter, phase II trial enrolled 40 patients who underwent surgery after three cycles of neoadjuvant therapy with camrelizumab, nab-paclitaxel, and carboplatin. The MPR is the primary endpoint, and the pCR, the complete resection rate, the objective response rate, the disease-free survival, adverse events, and quality of life are the secondary endpoints. The exploratory endpoints will be used to establish a multiomics artificial intelligence system for neoadjuvant therapy effect prediction and decision-making assistance based on radiomics, metabolism, genetic, and clinic-pathological characteristics and to explore drug resistance mechanisms.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Camrelizumab + Nab-paclitaxel + Carboplatin
干预措施: Camrelizumab + Nab-paclitaxel + Carboplatin (Drug)
结局指标
主要结局
Major pathologic response (MPR) Rate
时间窗: After surgery (approximately 10 weeks)
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
- Objective response rate(ORR)(approximately 9 weeks)
- Evaluation of the pathological complete response (pCR)(After surgery (approximately 10 weeks))
- Evaluation of complete resection (R0) rate(After surgery (approximately 10 weeks))
- Serious adverse events (SAEs)(approximately 9 weeks)
- Disease free survival (DFS)(36 months)
- Adverse events (AEs)(approximately 9 weeks)
- Overall survival (OS)(36 months)
- Qol Quality of Life(36 months)
研究者
Herui Yao
Principal Investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University