Department of Oncology, The Second Affiliated Hospital of Zunyi Medical University, Zunyi, Guizhou, China.
Department of Oncology, The First People's Hospital of Zunyi, Zunyi, Guizhou, China.
Technol Cancer Res Treat. 2024 Jan-Dec;23:15330338241249690. doi: 10.1177/15330338241249690.
Cadonilimab (AK104) is a bispecific IgG-single-chain Fv fragment (ScFv) antibody that binds to PD-1 and CTLA-4. Cadonilimab has shown encouraging anti-tumour activity and a favourable safety profile in several tumour types. In second-line treatment, there is no defined standard of care for patients with extensive-stage small-cell lung cancer (ES-SCLC). Cadonilimab is expected to show substantial clinical efficacy.
To assess the antitumor activity and safety of cadonilimab monotherapy or combination with conventional therapy in ES-SCLC patients who failed first-line treatment.
In this multicenter, open-label, phase II study, ES-SCLC patients who had failed first-line treatment, also aged 18 years to 70 years with histologically or cytologically confirmed ES-SCLC, and an Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0-2 were eligible. Patients will receive cadonilimab 10 mg/kg every three weeks (Q3 W) among 24 months until progressive disease (PD) or adverse events (AE) discovery. The primary endpoint is progression-free survival (PFS).
NCT05901584.
Cadonilimab（AK104）是一种双特异性 IgG-单链 Fv 片段（ScFv）抗体，可与 PD-1 和 CTLA-4 结合。Cadonilimab 在多种肿瘤类型中显示出令人鼓舞的抗肿瘤活性和良好的安全性。在二线治疗中，广泛期小细胞肺癌（ES-SCLC）患者没有明确的标准治疗方法。Cadonilimab 有望显示出显著的临床疗效。
评估 Cadonilimab 单药或联合常规治疗在一线治疗失败的 ES-SCLC 患者中的抗肿瘤活性和安全性。
在这项多中心、开放标签、II 期研究中，符合条件的 ES-SCLC 患者为一线治疗失败、年龄在 18 岁至 70 岁之间、组织学或细胞学确诊为 ES-SCLC、东部肿瘤协作组体能状态（ECOG-PS）为 0-2 的患者。患者将接受 Cadonilimab 10 mg/kg，每 3 周（Q3W）治疗 24 个月，直到疾病进展（PD）或出现不良反应（AE）。主要终点是无进展生存期（PFS）。
NCT05901584。
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