Kyushu University Hospital, Department of Respiratory Medicine, Fukuoka, 812-8582, Japan.
Iwakuni Clinical Center, Department of Respiratory Medicine, Yamaguchi, 740-8510, Japan.
Future Oncol. 2024;20(37):2927-2936. doi: 10.1080/14796694.2024.2409621. Epub 2024 Oct 29.
For patients with advanced/metastatic non-small-cell lung cancer (NSCLC) without actionable genomic alterations and low (<50%) PD-L1 expression, pembrolizumab plus pemetrexed and platinum chemotherapy is a preferred first-line treatment. These patients have comparatively worse outcomes than those with higher PD-L1 expression, underscoring the need for new combination strategies. Datopotamab deruxtecan (Dato-DXd), a TROP2-directed antibody-drug conjugate, has demonstrated encouraging antitumor activity and safety in this patient population. We describe the rationale and design of TROPION-Lung07, a randomized, open-label Phase III study assessing Dato-DXd in combination with pembrolizumab with/without platinum-based chemotherapy versus pembrolizumab plus pemetrexed and platinum-based chemotherapy in patients with advanced/metastatic non-squamous NSCLC without actionable genomic alterations and <50% PD-L1 expression. Primary study objectives are progression-free survival and overall survival. NCT05555732 (ClinicalTrials.gov).
对于无驱动基因改变且 PD-L1 表达低（<50%）的晚期/转移性非小细胞肺癌（NSCLC）患者，帕博利珠单抗联合培美曲塞和铂类化疗是首选的一线治疗方案。这些患者的预后较 PD-L1 高表达患者差，这强调了需要新的联合治疗策略。靶向 Trop-2 的抗体偶联药物（ADC）德曲妥珠单抗（Dato-DXd）在这一患者人群中显示出令人鼓舞的抗肿瘤活性和安全性。我们描述了 TROPION-Lung07 的基本原理和设计，这是一项随机、开放标签的 III 期研究，评估了 Dato-DXd 联合或不联合铂类化疗与帕博利珠单抗联合培美曲塞和铂类化疗治疗无驱动基因改变且 PD-L1 表达<50%的晚期/转移性非鳞状 NSCLC 患者的疗效。主要研究目标是无进展生存期和总生存期。NCT05555732（ClinicalTrials.gov）。
