Department of Respiratory Medicine, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
Department of Research and Development of Next Generation Medicine, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
BMC Cancer. 2022 Sep 8;22(1):964. doi: 10.1186/s12885-022-10056-x.
First-line treatment of nonsquamous non-small cell lung cancer (NSCLC) has undergone a paradigm shift to platinum combination therapy together with immune checkpoint inhibitors (ICIs). However, phase III studies of combinations of cytotoxic chemotherapy and ICIs have included only patients with maintained organ function, not those with renal impairment.
Cytotoxic chemotherapy-naïve advanced nonsquamous NSCLC patients aged 20 years or older with impaired renal function (creatinine clearance of 15 to 45 mL/min) are prospectively registered in this single-arm phase II study and receive combination therapy with carboplatin, nanoparticle albumin-bound (nab-) paclitaxel, and atezolizumab. Individuals with known genetic driver alterations including those affecting EGFR, ALK, ROS1, BRAF, MET, RET, and NTRK are excluded. We plan to enroll 40 patients over 2 years at 32 oncology facilities in Japan. The primary end point is confirmed objective response rate.
If the study demonstrates efficacy and safety of carboplatin/nab-paclitaxel/atezolizumab, then this combination regimen may become a treatment option even for nonsquamous NSCLC patients with impaired renal function.
Registered with Japan Registry for Clinical Trials on 25 February 2021 (jRCTs071200102).
一线治疗非鳞状非小细胞肺癌（NSCLC）已发生范式转变，采用铂类联合治疗和免疫检查点抑制剂（ICI）。然而，细胞毒性化疗联合 ICI 的 III 期研究仅包括器官功能保持的患者，而不包括肾功能损害的患者。
这项单臂 II 期研究前瞻性招募了 20 岁或以上肾功能受损（肌酐清除率 15 至 45mL/min）的初治晚期非鳞状 NSCLC 患者，并接受卡铂、白蛋白结合型紫杉醇（nab-紫杉醇）和阿替利珠单抗联合治疗。已知存在基因驱动改变的患者（包括影响 EGFR、ALK、ROS1、BRAF、MET、RET 和 NTRK 的改变）被排除在外。我们计划在日本的 32 个肿瘤学机构中，在 2 年内招募 40 名患者。主要终点是确认的客观缓解率。
如果该研究显示卡铂/nab-紫杉醇/阿替利珠单抗联合治疗的疗效和安全性，那么即使对于肾功能受损的非鳞状 NSCLC 患者，该联合方案也可能成为一种治疗选择。
2021 年 2 月 25 日在日本临床试验注册中心（jRCTs071200102）注册。
