Ensartinib in Resected ALK-Positive Non-Small-Cell Lung Cancer.

Whether ensartinib, a second-generation ALK inhibitor, is safe and effective in such patients is unknown.

第二代ALK抑制剂恩沙替尼在这些患者中是否安全有效尚不清楚。

Methods

In this phase 3, double-blind, randomized trial involving patients with completely resected, ALK-positive stage IB to IIIB NSCLC after adjuvant chemotherapy, we randomly assigned patients in a 1:1 ratio to receive ensartinib at a dose of 225 mg once daily or placebo for 24 months.

在这项涉及完全切除的ALK阳性I B至IIIB期非小细胞肺癌（NSCLC）患者、接受辅助化疗后的III期、双盲、随机试验中，我们以1:1的比例随机分配患者，接受每日一次225毫克的ensartinib或安慰剂治疗，为期24个月。

The primary end point was disease-free survival in patients with stage II to IIIB NSCLC.

主要终点是II期至IIIB期非小细胞肺癌（NSCLC）患者的无病生存期。

The key secondary end point was disease-free survival in the overall patient population.

主要次要终点是在整个患者群体中的无病生存期。

Results

A total of 274 patients were randomly assigned to receive ensartinib or placebo (137 patients in each group).

共有274名患者被随机分配接受恩沙替尼或安慰剂治疗（每组137名患者）。

At 24 months, the percentage of patients with stage II to IIIB disease who were alive and disease-free was 86.4% in the ensartinib group and 53.5% in the placebo group (hazard ratiofor disease recurrence or death, 0.20; 95% confidence interval[CI], 0.11 to 0.38; P<0.001).

在24个月时，II期至IIIB期患者在ensartinib组中无病生存的比例为86.4%，而在安慰剂组中为53.5%（疾病复发或死亡的风险比为0.20；95%置信区间[CI]，0.11至0.38；P<0.001）。

In the overall patient population, the percentage of patients who were alive and disease-free was 87.3% in the ensartinib group and 57.2% in the placebo group (hazard ratio, 0.20; 95% CI, 0.10 to 0.37; P<0.001).

在所有患者中，ensartinib组无病生存的患者比例为87.3%，而安慰剂组为57.2%（风险比为0.20；95%置信区间[CI]，0.10至0.37；P<0.001）。

Overall survivaldata were immature.

总生存数据尚不成熟。

Adverse events of grade 3 or higher occurred in 35.8% of the patients who received ensartinib (most commonly rash) and in 18.2% of those who received placebo.

35.8%的接受ensartinib治疗的患者（最常见的是皮疹）和18.2%的接受安慰剂治疗的患者出现了3级或更高级别的不良事件。

Conclusions

Among patients with completely resected stage IB to IIIB ALK-positive NSCLC, the percentage of patients who were alive and disease-free at 24 months was significantly higher with ensartinib than with placebo.

在完全切除的IB至IIIB期ALK阳性非小细胞肺癌患者中，24个月时仍存活且无病的患者比例，使用恩沙替尼治疗的显著高于使用安慰剂的。

(Funded by Betta Pharmaceuticals; ELEVATE ClinicalTrials.gov number, NCT05341583.).

(该研究由Betta Pharmaceuticals公司资助；ELEVATE临床试验的ClinicalTrials.gov编号为NCT05341583。)