过去十年非小细胞肺癌放疗联合免疫检查点抑制剂临床试验的特点与创新点

Characteristics and innovative points of clinical trials of radiotherapy combined with immune checkpoint inhibitors in NSCLC over the past decade.

作者信息

Li Mengting, Ding Peng

机构信息

Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.

Tongji Medical College, Institute of Radiation Oncology, Union Hospital, Huazhong University of Science and Technology, Wuhan, China.

出版信息

Front Med (Lausanne). 2025 Jul 22;12:1598505. doi: 10.3389/fmed.2025.1598505. eCollection 2025.

DOI:10.3389/fmed.2025.1598505

PMID:40766057

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12321536/

Abstract

BACKGROUND

This study aims to statistically and qualitatively evaluate the characteristics of immunoradiotherapy (iRT) clinical trials for non-small cell lung cancer (NSCLC) registered on the ClinicalTrials.gov website over the past decade, to help researchers grasp current research trends and design higher-quality iRT clinical trials in the future.

METHODS

We conducted a cross-sectional, descriptive study of interventional non-small cell lung cancer iRT clinical trials registered from 2014 to 2024. This study focuses on the combination of different radiotherapy methods with immune checkpoint inhibitors (ICIs), minimizing attention to new immunotherapeutic drugs. It emphasizes the exploration of radiotherapy and suitable patient populations. Therefore, the types of ICIs are limited to PD-1/PD-L1 and CTLA-4 inhibitors, and the main innovative points of the included clinical trials were categorized and statistically analyzed.

RESULTS

As of 24 June 2024, 196 clinical trials were available for analysis. Among these trials, more than 76% of clinical trials focused on patients with stage III and higher NSCLC. About 35.2% of the studies were still recruiting, only 14.8% were marked as completed, and 12.8% had failed, with slow enrollment, safety, and funding issues being the main reasons for failure. Phase 2 trials (56.1%) led significantly, with only 11.7% of trials reaching phase 3; hence, 55.6% had a sample size of fewer than 50 participants. Nearly half (45.4%) of the studies were multi-center trials, and 54.6% had data monitoring. Durvalumab was explicitly mentioned in 30.1% of the studies. Most clinical trials (64.3%) focused on innovating radiotherapy dose adjustments, with 104 studies adopting a hypofractionated radiotherapy-based protocol.

CONCLUSION

The number of iRT clinical trials in the NSCLC field is rapidly increasing. Most patients are in locally advanced stages or higher, with phase 2 trials predominating. Durvalumab is the representative drug, and researchers are particularly interested in optimizing radiotherapy doses, with a tendency to adopt hypofractionated radiotherapy.

摘要

背景

本研究旨在对过去十年在ClinicalTrials.gov网站上注册的非小细胞肺癌（NSCLC）免疫放射治疗（iRT）临床试验的特征进行统计和定性评估，以帮助研究人员把握当前研究趋势，并在未来设计出更高质量的iRT临床试验。

方法

我们对2014年至2024年注册的介入性非小细胞肺癌iRT临床试验进行了横断面描述性研究。本研究重点关注不同放疗方法与免疫检查点抑制剂（ICIs）的联合，尽量减少对新型免疫治疗药物的关注。它强调放疗和合适患者群体的探索。因此，ICIs的类型限于PD-1/PD-L1和CTLA-4抑制剂，并对纳入临床试验的主要创新点进行分类和统计分析。

结果

截至2024年6月24日，有196项临床试验可供分析。在这些试验中，超过76%的临床试验聚焦于III期及以上的NSCLC患者。约35.2%的研究仍在招募患者，只有14.8%被标记为已完成，12.8%已失败，入组缓慢、安全性和资金问题是失败的主要原因。2期试验（56.1%）占主导地位，只有11.7%的试验进入3期；因此，55.6%的试验样本量少于50名参与者。近一半（45.4%）的研究是多中心试验，54.6%有数据监测。30.1%的研究明确提到了度伐利尤单抗。大多数临床试验（64.3%）专注于创新放疗剂量调整，104项研究采用了基于大分割放疗的方案。