EpicentRx, Inc, La Jolla, CA 92037, USA.
Clinical Trials Innovations, Mountain View, CA 94043, USA.
Future Oncol. 2019 Oct;15(30):3427-3433. doi: 10.2217/fon-2019-0317. Epub 2019 Sep 11.
RRx-001 is a cysteine-directed anticancer alkylating agent with activity in a Phase II study in platinum refractory small cell lung cancer. Here, we describe the design of REPLATINUM, an open-label, Phase III trial. 120 patients with previously platinum-treated small cell lung cancer in third line will be randomized 1:1 to receive RRx-001 followed by four cycles of a platinum doublet, and then alternating cycles of RRx-001 and single agent platinum until progression versus four cycles of a platinum doublet. At radiologic progression on the platinum doublet, patients may cross over to the RRx-001 arm. Primary objective: to demonstrate superior progression-free survival in the RRx-001 population. Secondary objectives: to demonstrate superiority for overall survival and objective response rate. Clinical Trial registration: NCT03699956.
RRx-001 是一种半胱氨酸定向的抗癌烷化剂，在铂类难治性小细胞肺癌的 II 期研究中具有活性。在这里，我们描述了 REPLATINUM 的设计，这是一项开放标签的 III 期试验。120 名先前接受过三线铂类治疗的小细胞肺癌患者将按照 1:1 的比例随机分配，接受 RRx-001 治疗，随后接受四个周期的铂类双联治疗，然后交替接受 RRx-001 和单药铂类治疗，直至进展，然后再接受四个周期的铂类双联治疗。在铂类双联治疗出现影像学进展时，患者可以交叉到 RRx-001 组。主要目标：证明 RRx-001 组的无进展生存期更优。次要目标：证明总生存期和客观缓解率的优越性。临床试验注册：NCT03699956。
