Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.
Department of Respiratory Medicine, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
Clin Lung Cancer. 2023 Jun;24(4):371-375. doi: 10.1016/j.cllc.2023.01.008. Epub 2023 Feb 1.
Platinum-based combination therapy plus a programmed cell death 1/programmed cell death ligand 1 (PD-1/PD-L1) inhibitor is a standard treatment for patients with stage IV non-small cell lung cancer. However, necitumumab is used with gemcitabine and cisplatin as a first-line treatment option for squamous cell lung cancer (SqCLC). Furthermore, the combination of necitumumab with immune checkpoint inhibitors has the potential to enhance tumor immunity and improve the therapeutic effect. Thus, we planned and initiated this phase I/II study to evaluate the safety and efficacy of necitumumab plus pembrolizumab, nanoparticle albumin-bound (nab)-paclitaxel), and carboplatin therapy for patients with previously untreated SqCLC.
In phase I, the primary endpoint is the tolerability and recommended dose of necitumumab combined with pembrolizumab plus nab-paclitaxel and carboplatin. In phase II, the primary endpoint is the overall response rate. Secondary endpoints are disease control rate, progression-free survival, overall survival, and safety. Forty-two patients will be enrolled in phase II.
This is the first study to investigate the efficacy and safety of necitumumab plus pembrolizumab combined with platinum-based chemotherapy in patients with previously untreated SqCLC.
铂类联合治疗加程序性细胞死亡 1/程序性细胞死亡配体 1（PD-1/PD-L1）抑制剂是晚期非小细胞肺癌患者的标准治疗方法。然而，尼妥珠单抗联合吉西他滨和顺铂用于治疗鳞状细胞肺癌（SqCLC）的一线治疗方案。此外，尼妥珠单抗与免疫检查点抑制剂联合使用有可能增强肿瘤免疫，提高治疗效果。因此，我们计划并启动了这项 I/II 期研究，以评估尼妥珠单抗联合帕博利珠单抗、白蛋白结合型紫杉醇（nab-紫杉醇）和卡铂治疗未经治疗的 SqCLC 患者的安全性和疗效。
在 I 期，主要终点是评估尼妥珠单抗联合帕博利珠单抗联合 nab-紫杉醇和卡铂的耐受性和推荐剂量。在 II 期，主要终点是总缓解率。次要终点是疾病控制率、无进展生存期、总生存期和安全性。将招募 42 名患者进入 II 期。
这是第一项研究，旨在评估尼妥珠单抗联合帕博利珠单抗联合铂类化疗治疗未经治疗的 SqCLC 患者的疗效和安全性。
