Atezo-Brain研究评估了阿特珠单抗联合化疗治疗复发难治性非小细胞肺癌（NSCLC）患者未治疗脑转移。这是一项单臂II期临床试验，纳入了未经治疗且没有神经症状或无症状但有药物治疗的晚期非鳞状细胞NSCLC患者。地塞米松每日最高可用4毫克一次。阿特珠单抗加卡铂和培美曲塞治疗4至6个周期，然后继续以阿特珠单抗加培美曲塞治疗直至疾病进展，最长治疗2年。主要终点包括在12周时确定无进展生存（PFS）率，以及前9周内Ⅲ级或Ⅳ级不良事件的发生率。根据神经肿瘤内科脑转移反应评估标准评估颅内结局。共纳入40例患者，其中22例（55%）在基线接受皮质类固醇治疗。总体12周PFS率为62.2%（95%可信区间[CrI]，47.1至76.2）。前9周内Ⅲ级或Ⅳ级不良事件发生率为27.5%。大多数神经事件为Ⅰ级和Ⅱ级，但5例患者（12.5%）出现Ⅲ级至Ⅳ级神经事件。随访中位数为31个月时，颅内中位PFS为6.9个月，应答率为42.7%（95% CrI，28.1至57.9）。全身中位PFS为8.9个月，应答率为45%（95% CrI，28.1至57.9）。中位总生存时间（OS）为11.8个月（95% CI，7.6至16.9），2年OS率为27.5%（95% CI，16.6至45.5）。阿特珠单抗加卡铂和培美曲塞在未经治疗的晚期非鳞状细胞NSCLC患者中显示出良好的活性和可接受的安全性。

The Atezo-Brain study evaluated atezolizumab combined with chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC) with untreated brain metastases, a population traditionally excluded from trials.This single-arm phase II clinical trial enrolled patients with advanced nonsquamous NSCLC with untreated brain metastases without neurologic symptoms or asymptomatic with medical treatment. Dexamethasone was allowed up to 4 mg once daily. Atezolizumab plus carboplatin and pemetrexed was given for four to six cycles followed by atezolizumab plus pemetrexed until progression for a maximum of 2 years. The primary end points were to determine the progression-free survival (PFS) rate at 12 weeks and the incidence of grade ≥3 adverse events during the first 9 weeks. Intracranial outcomes were assessed using response assessment in neuro-oncology brain metastases criteria.Forty patients were enrolled and 22 (55%) were receiving corticosteroids at baseline. The overall 12-week PFS rate was 62.2% (95% credibility interval [CrI], 47.1 to 76.2). The rate of grade 3/4 adverse events during the first 9 weeks was 27.5%. Most neurologic events were grade 1 and 2 but five patients (12.5%) experienced grade 3-4 neurologic events. With a median follow-up of 31 months, intracranial median PFS was 6.9 months and response rate was 42.7% (95% CrI, 28.1 to 57.9). Systemic median PFS was 8.9 months and response rate was 45% (95% CrI, 28.1 to 57.9). The median overall survival (OS) was 11.8 months (95% CI, 7.6 to 16.9) and the 2-year OS rate was 27.5% (95% CI, 16.6 to 45.5).Atezolizumab plus carboplatin and pemetrexed demonstrates activity in patients with advanced nonsquamous NSCLC with untreated brain metastases with an acceptable safety profile.