INTRODUCTION Consolidation durvalumab after chemoradiation (CRT) is the current standard of care in locally advanced non-small cell lung cancer. We hypothesized that adding immunotherapy concurrently with CRT (cCRT) increased efficacy without significant additive toxicity. METHODS This phase II study was conducted in two parts. Part 1 (N=10) administered conventionally fractionated CRT followed by consolidation chemotherapy-atezolizumab x 2 cycles and maintenance atezolizumab up to 1 year. Part 2 (N=30) administered cCRT with atezolizumab followed by the same consolidation and maintenance therapy as in Part 1. PD-L1 staining cutoffs (1% or 50%) using Dako 22c3 immunohistochemistry were correlated to clinical outcomes. RESULTS The overall toxicities for Parts 1/2 are: overall AE grade ≥ 3: 80%/80%; immune-related AEs ≥ grade 3: 30%/20%; pneumonitis ≥ grade 2: 10%/16%. For preliminary efficacy results, in Part 1, with a median follow up of 22.5 months (mos) the median PFS is 18.6 mos and OS is 22.8 mos . In Part 2, with a median follow up time of 15.1 mos, the median PFS is 13.2 mos and OS is not reached. There was no significant difference in cancer recurrence regardless of PD-L1 status. CONCLUSION Atezolizumab with cCRT is safe and feasible and has no added toxicities over historical rates.

中文翻译：

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阿特珠单抗联合放化疗治疗不可切除非小细胞肺癌的 II 期试验

引言 放化疗后巩固性 durvalumab (CRT) 是目前局部晚期非小细胞肺癌的护理标准。我们假设在 CRT (cCRT) 的同时添加免疫疗法可提高疗效，而不会产生显着的附加毒性。方法 该 II 期研究分两部分进行。第 1 部分 (N=10) 给予常规分次 CRT，然后是巩固化疗-atezolizumab x 2 个周期和维持 atezolizumab 长达 1 年。第 2 部分 (N=30) 使用 cCRT 和 atezolizumab，然后进行与第 1 部分相同的巩固和维持治疗。使用 Dako 22c3 免疫组织化学的 PD-L1 染色截止值（1% 或 50%）与临床结果相关。结果部分1/2的总体毒性为：总体AE等级≥3：80%/80%；免疫相关 AE ≥ 3 级：30%/20%；肺炎 ≥ 2 级：10%/16%。对于初步疗效结果，在第 1 部分中，中位随访时间为 22.5 个月 (mos)，中位 PFS 为 18.6 mos，OS 为 22.8 mos。在第 2 部分中，中位随访时间为 15.1 mos，中位 PFS 为 13.2 mos，未达到 OS。无论 PD-L1 状态如何，癌症复发都没有显着差异。结论 使用 cCRT 的 Atezolizumab 是安全可行的，并且没有比历史速率增加的毒性。