Liu Xiaoli, Yin Xiaoyan, Zhuang Lulu, Wen Junxu, Wei Zhonghui, Cui Wenxing, Yu Minghao, Zhao Kaikai, Liu Lanping, Kong Lingling, Jiang Liyang, Jing Xuquan, Zhu Hui, Wang Xunqiang, Dong Xinjun, Yu Jinming, Meng Xiangjiao
Cheeloo College of Medicine, Shandong University, Jinan, Shandong, 250012, China.
Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical Sciences, Jiyan Road 440, Jinan, Shandong, 250117, China.
BMC Cancer. 2025 Mar 20;25(1):509. doi: 10.1186/s12885-025-13885-8.
There is a significant unmet need in treating patients with limited-stage small-cell lung cancer (LS-SCLC). The ETER701 study showed that Benmelstobart (TQB2450, an anti-PD-L1 antibody) combined with Anlotinib and chemotherapy achieved the longest progression-free survival (PFS) and overall survival (OS) as a first-line therapy in patients with extensive-stage small cell lung cancer (ES-SCLC). This suggests that TQB2450 and Anlotinib represent a promising treatment combination for LS-SCLC. This prospective study aimed to evaluate the efficacy and safety of TQB2450 combined with Anlotinib as maintenance therapy for LS-SCLC following concurrent or sequential chemoradiotherapy (CCRT or SCRT).
Patients who did not show disease progression after chemoradiotherapy were enrolled. They received TQB2450 and Anlotinib every 3 weeks for up to 24 months. TQB2450 was intravenously administered at a dose of 1200 mg every 3 weeks. Anlotinib was initiated at a dose of 8 mg daily for days 1-14; if well tolerated, the dose was increased to 10 mg. Adverse events (AEs) were recorded using electronic data capture system. The trial was registered at the ClinicalTrials.gov (NCT05942508, 06/07/2023).
Fifteen patients were enrolled in the study between May 31, 2023 and October 13, 2023. As of October 31, 2024, the median follow-up time was 15.13 months. The 12-month PFS rate was 86.7% (95% CI, 71.1-100.0), and the OS rate at 12 months was 100%. The disease control rate was 100%. AEs were reported in 13 patients (86.67%), with fatigue being the most common treatment related AE (40.00%). And two SAEs were observed (elevation in cardiac troponin T and cerebral infarction), which were determined to be unlikely unrelated to the trial drugs. Radiation pneumonitis (RP) occurred in three patients, all classified as grade 2, and one patient developed grade 1 immune-related pneumonitis. No grade 5 AEs occurred, and no patients withdrew from the study due to AEs.
TQB2450 combined with Anlotinib showed promising efficacy and well tolerance in patients with LS-SCLC following first-line treatment. A randomized, double-blind, placebo-controlled Phase III clinical study (ClinicalTrials.gov Identifier: NCT06469879) is being conducted to further explore the efficacy and safety of TQB2450 combined with Anlotinib as maintenance therapy after definitive CCRT or SCRT for LS-SCLC.
ClinicalTrials.gov Identifier: NCT05942508. Date of registration: 7 June 2023.
在治疗局限期小细胞肺癌（LS-SCLC）患者方面，存在重大未满足需求。ETER701研究表明，苯美司托巴特（TQB2450，一种抗PD-L1抗体）联合安罗替尼及化疗作为广泛期小细胞肺癌（ES-SCLC）患者的一线治疗，实现了最长的无进展生存期（PFS）和总生存期（OS）。这表明TQB2450和安罗替尼是LS-SCLC有前景的治疗组合。这项前瞻性研究旨在评估TQB2450联合安罗替尼作为同步或序贯放化疗（CCRT或SCRT）后LS-SCLC维持治疗的疗效和安全性。
纳入放化疗后未出现疾病进展的患者。他们每3周接受一次TQB2450和安罗替尼治疗，最长持续24个月。TQB2450每3周静脉注射一次，剂量为1200 mg。安罗替尼第1 - 14天每日起始剂量为8 mg；若耐受性良好，剂量增至10 mg。使用电子数据采集系统记录不良事件（AE）。该试验已在ClinicalTrials.gov注册（NCT05942508，2023年7月6日）。
2023年5月31日至2023年10月13日期间，15例患者入组本研究。截至2024年10月31日，中位随访时间为15.13个月。12个月PFS率为86.7%（95%CI，71.1 - 100.0），12个月OS率为100%。疾病控制率为100%。13例患者（86.67%）报告了AE，疲劳是最常见的与治疗相关的AE（40.00%）。观察到2例严重不良事件（心肌肌钙蛋白T升高和脑梗死），判定与试验药物不太可能无关。3例患者发生放射性肺炎（RP），均为2级，1例患者发生1级免疫相关性肺炎。未发生5级AE，也没有患者因AE退出研究。
TQB2450联合安罗替尼在一线治疗后的LS-SCLC患者中显示出有前景的疗效和良好耐受性。正在进行一项随机、双盲、安慰剂对照的III期临床研究（ClinicalTrials.gov标识符：NCT06469879），以进一步探索TQB2450联合安罗替尼作为LS-SCLC确定性CCRT或SCRT后维持治疗的疗效和安全性。
ClinicalTrials.gov标识符：NCT05942508。注册日期：2023年6月7日。
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