LIBELULE: A Randomized Phase III Study to Evaluate the Clinical Relevance of Early Liquid Biopsy in Patients With Suspicious Metastatic Lung Cancer.

Methods

The phase III LIquid Biopsy for the Early detection of LUng cancer Lesion trial (NCT03721120) included patients with radiological suspicion of advanced lung cancer.

第三阶段的LIquid Biopsy for the Early detection of LUng cancer Lesion试验（NCT03721120）包括了有晚期肺癌影像学怀疑的患者。

They were randomized (1:1), the control arm receiving diagnostic procedures according to each center's practice, and the liquid biopsy arm with additional testing performed at the first visit using the InVisionFirst-Lung assay.

患者被随机分为（1:1），对照组接受各中心实践的诊断程序，而液态活检组在首次就诊时使用InVisionFirst-Lung检测进行额外测试。

Treatment initiation and type were defined according to the European Society for Medical Oncology guidelines.

治疗的开始和类型是根据欧洲肿瘤内科学会的指南定义的。

Primary endpoint was the time from randomization to initiation of appropriate treatment on the basis of informative genomic and pathological results in the intention-to-treatpopulation.

主要终点是从随机分组到基于有信息的基因组和病理结果开始适当治疗的时间，在意向治疗人群中进行评估。

Results

A total of 319 patients were enrolled (liquid biopsy [LB]: 161; control: 158).

共有319名患者入组（液体活检[LB]：161；对照组：158）。

The median age was 68 years, 28.8% were non-smokers, 18.1% had a performance status of 2 or higher, and 56.7% had adenocarcinoma.

中位年龄为68岁，28.8%为非吸烟者，18.1%的患者表现状态为2或更高，56.7%患有腺癌。

In the LB arm, 81% of patients had circulating tumor DNA findings.

在LB组中，81%的患者有循环肿瘤DNA发现。

The mean TTI was not significantly reduced (LB: 29.0 d; control 34 d (p = 0.26)).

平均治疗时间间隔（TTI）没有显著减少（LB组：29.0天；对照组：34天（p = 0.26））。

Sensitivity analyses found a shorter TTI in patients from the LB arm who received systemic treatment (LB: 29.1 d; control: 38.9 d, p = 0.01), in patients with advanced non-squamous NSCLC (LB: 29.5 d; control: 40.3 d, p = 0.01), and in patients with first-line targetable alterations (LB: 21d; control 37.4 d) (p = 0.004).

敏感性分析发现，在接受系统治疗的LB组患者中（LB: 29.1天；对照组：38.9天，p = 0.01），在晚期非鳞状NSCLC患者中（LB: 29.5天；对照组：40.3天，p = 0.01），以及在一线可靶向改变的患者中（LB: 21天；对照组37.4天）（p = 0.004），TTI较短。

Time to contributory genomic results was significantly reduced (LB: 17.9 d; control: 25.6 d, p < 0.001).

具有临床意义的基因组结果时间显著缩短（实验组：17.9天；对照组：25.6天，p < 0.001）。

Conclusions

Early liquid biopsy testing did not significantly shorten the TTI in unselected patients referred for suspected advanced lung cancer.

早期液体活检检测在未筛选的疑似晚期肺癌患者中，并没有显著缩短TTI（治疗时间间隔）。

Nevertheless, it could reduce the TTI in patients eligible for systemic treatment, particularly for those with actionable alterations.

然而，它可以在适合全身治疗的患者中减少TTI，特别是对于那些具有可操作改变的患者。