Department of Thoracic Oncology, Thoraxklinik at University Hospital of Heidelberg, Röntgenstraße 1, 69126, Heidelberg, Germany.
Translational Lung Research Center Heidelberg TLRCH, Member of the German Center for Lung Research DZL, Im Neuenheimer Feld 156, 69120, Heidelberg, Germany.
BMC Cancer. 2022 Sep 24;22(1):1011. doi: 10.1186/s12885-022-10074-9.
Recently, the combination of the programmed death-ligand 1 (PD-L1) inhibitor atezolizumab with first-line chemotherapy has demonstrated to improve outcome for patients with advanced small cell lung cancer (SCLC), leading to approval of this regimen. At the same time, accumulating (pre-)clinical data suggest synergisms of radiotherapy and immunotherapy via the radiation-mediated induction of anti-tumor immunogenicity. Combining the recent findings, the TREASURE trial aims at further enhancing response to upfront chemo-immunotherapy by the addition of thoracic radiotherapy (TRT).
METHODS/DESIGN: The TREASURE trial is a randomized, multicenter, phase II clinical trial ( ClinicalTrials.gov identifier, NCT04462276). One hundred four patients suffering from extensive disease (ED) SCLC, with any response to the standard of care induction chemo-immunotherapy will be randomized to receive atezolizumab maintenance therapy with or without TRT. The primary endpoint of this study is overall survival (OS). Secondary endpoints include further measures of efficacy, safety, and the collection of biomarker samples. A safety interim analysis will take place after n = 23 patients receiving TRT have been observed for three months after the end of TRT.
This trial will investigate whether treatment efficacy can be improved by adding TRT to atezolizumab maintenance therapy in ED SCLC patients with any response after chemo-immunotherapy. Safety and feasibility of such a regimen will be evaluated, and biomaterials for a translational research project will be collected. Together, the results of this trial will deepen our comprehension of how checkpoint inhibition and radiotherapy interact and contribute to the evolving landscape of SCLC therapy.
Clinicaltrials.gov identifier: NCT04462276 (Date of initial registration: 8th July 2020), https://clinicaltrials.gov/ct2/show/NCT04462276 Eudra-CT Number: 2019-003916-29 (Date of initial registration: 30th March 2020), https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-003916-29/DE.
最近，程序性死亡配体 1（PD-L1）抑制剂阿替利珠单抗联合一线化疗已被证明可改善晚期小细胞肺癌（SCLC）患者的预后，这导致了该方案的批准。与此同时，越来越多的（临床前）临床数据表明，放射治疗通过放射介导的抗肿瘤免疫原性诱导与免疫治疗具有协同作用。结合最近的发现，TREASURE 试验旨在通过添加胸部放射治疗（TRT）进一步提高一线化疗免疫治疗的反应。
方法/设计：TREASURE 试验是一项随机、多中心、II 期临床试验（ClinicalTrials.gov 标识符：NCT04462276）。104 例患有广泛期（ED）SCLC 的患者，对标准护理诱导化疗免疫治疗有任何反应，将被随机分配接受阿替利珠单抗维持治疗加或不加 TRT。本研究的主要终点是总生存期（OS）。次要终点包括进一步的疗效、安全性测量以及生物标志物样本的收集。在接受 TRT 的 n = 23 例患者在 TRT 结束后观察 3 个月后，将进行安全性中期分析。
该试验将研究在接受化疗免疫治疗后有任何反应的 ED SCLC 患者中，加用 TRT 能否提高阿替利珠单抗维持治疗的疗效。将评估这种治疗方案的安全性和可行性，并收集用于转化研究项目的生物材料。总的来说，该试验的结果将加深我们对检查点抑制和放射治疗如何相互作用并为 SCLC 治疗的不断发展做出贡献的理解。
Clinicaltrials.gov 标识符：NCT04462276（初始注册日期：2020 年 7 月 8 日），https://clinicaltrials.gov/ct2/show/NCT04462276 Eudra-CT 编号：2019-003916-29（初始注册日期：2020 年 3 月 30 日），https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-003916-29/DE。
