Numerous clinical trials investigating neoadjuvant immune checkpoint inhibitors (ICI) have been performed over the last 5 years. As the number of neoadjuvant trials increases, attention must be paid to identifying informative trial endpoints. Complete pathologic response has been shown to be an appropriate surrogate endpoint for clinical outcomes, such as event-free survival or overall survival, in breast cancer and bladder cancer, but it is less established for non-small-cell lung cancer (NSCLC). The simultaneous advances reported with adjuvant ICI make the optimal strategy for early-stage disease debatable. Considering the long time required to conduct trials, it is important to identify optimal endpoints and discover surrogate endpoints for survival that can help guide ongoing clinical research. Endpoints can be grouped into two categories: medical and surgical. Medical endpoints are measures of survival and drug activity; surgical endpoints describe the feasibility of neoadjuvant approaches at a surgical level as well as perioperative attrition and complications. There are also several exploratory endpoints, including circulating tumor DNA clearance and radiomics. In this review, we outline the advantages and disadvantages of commonly reported endpoints for clinical trials of neoadjuvant regimens in NSCLC.

中文翻译：

---

肺癌早期免疫治疗新辅助试验的理想终点是什么？

过去 5 年进行了大量研究新辅助免疫检查点抑制剂 (ICI) 的临床试验。随着新辅助试验数量的增加，必须注意确定信息丰富的试验终点。完全病理缓解已被证明是乳腺癌和膀胱癌临床结果（例如无事件生存期或总生存期）的适当替代终点，但对于非小细胞肺癌 (NSCLC) 来说，这一点尚未确定。辅助 ICI 的同时报道的进展使得早期疾病的最佳策略存在争议。考虑到进行试验所需的时间很长，确定最佳终点并发现可以帮助指导正在进行的临床研究的生存替代终点非常重要。终点可以分为两类：内科终点和外科终点。医学终点是生存和药物活性的衡量标准；手术终点描述了手术层面新辅助方法的可行性以及围手术期损耗和并发症。还有几个探索性终点，包括循环肿瘤 DNA 清除和放射组学。在这篇综述中，我们概述了非小细胞肺癌新辅助方案临床试验中常见报告终点的优点和缺点。