Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned coprimary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.

In a randomized, open-label, phase III NEJ009 study, gefitinib plus chemotherapy significantly improved progression-free survival (PFS) and overall survival (OS) compared with gefitinib-alone in patients with untreated non–small-cell lung cancer harboring mutations in epidermal growth factor receptor. Herein, we report the updated survival outcome and long-term tolerability. Patients were randomly assigned to gefitinib (gefitinib 250 mg orally, once daily) and gefitinib combined with carboplatin plus pemetrexed (GCP in a 3-week cycle for six cycles followed by concurrent gefitinib and pemetrexed maintenance) groups. At the data cutoff (May 22, 2020), GCP demonstrated significantly better PFS2 (hazard ratio, 0.77; 95% CI, 0.62 to 0.97; P = .027) than gefitinib. However, the updated median OS was 38.5 months (95% CI, 31.1 to 47.1) and 49.0 months (95% CI, 41.8 to 56.7) in the gefitinib and GCP groups, respectively (hazard ratio, 0.82; 95% CI, 0.64 to 1.06; P = .127). The OS in both groups was similar for the overall patient population. No severe adverse events occurred since the first report. This updated analysis revealed that the GCP regimen improved PFS and PFS2 with an acceptable safety profile compared with gefitinib-alone. GCP is more efficient than gefitinib monotherapy as a first-line treatment for non–small-cell lung cancer with epidermal growth factor receptor mutations.

临床试验通常包括在不同时间成熟的多个终点。初始报告通常基于主要终点，可能会在关键计划的联合主要或次要分析尚不可用时发布。临床试验更新提供了传播研究的更多结果的机会，这些研究发表在JCO或其他地方，主要终点已经报告。

在一项随机、开放标签的 III 期 NEJ009 研究中，与单独使用吉非替尼相比，吉非替尼加化疗显着改善了未经治疗的携带突变的非小细胞肺癌患者的无进展生存期 (PFS) 和总生存期 (OS)表皮生长因子受体。在此，我们报告更新的生存结果和长期耐受性。患者被随机分配到吉非替尼（吉非替尼 250 mg 口服，每日一次）和吉非替尼联合卡铂加培美曲塞（GCP 以 3 周为一个周期进行六个周期，然后吉非替尼和培美曲塞同时维持）组。在数据截止时（2020 年 5 月 22 日），GCP 显示出明显更好的 PFS2（风险比，0.77；95% CI，0.62 至 0.97；P= .027) 比吉非替尼。然而，吉非替尼组和 GCP 组更新后的中位 OS 分别为 38.5 个月（95% CI，31.1 至 47.1）和 49.0 个月（95% CI，41.8 至 56.7）（风险比，0.82；95% CI，0.64 至1.06；P = .127）。两组患者的总生存期相似。自第一次报告以来没有发生严重的不良事件。这一更新的分析显示，与单独使用吉非替尼相比，GCP 方案改善了 PFS 和 PFS2，且安全性可接受。作为表皮生长因子受体突变的非小细胞肺癌的一线治疗，GCP 比吉非替尼单一疗法更有效。