Once-daily savolitinib in Chinese patients with pulmonary sarcomatoid carcinomas and other non-small-cell lung cancers harbouring MET exon 14 skipping alterations: a multicentre, single-arm, open-label, phase 2 study.
Once-daily savolitinib in Chinese patients with pulmonary sarcomatoid carcinomas and other non-small-cell lung cancers harbouring MET exon 14 skipping alterations: a multicentre, single-arm, open-label, phase 2 study.
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DOI：
10.1016/s2213-2600(21)00084-9
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发表时间：
2021-10-01
期刊：
影响因子：
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通讯作者：
Su, Weiguo
中科院分区：
文献类型：
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作者：
Lu, Shun;Fang, Jian;Su, Weiguo
背景：Savolitinib是一种选择性MET酪氨酸激酶抑制剂。我们研究了savolitinib在肺肉瘤样癌和其他MET外显子14跳跃突变阳性（METex14阳性）的非小细胞肺癌（NSCLC）亚型患者中的活性和安全性。方法：我们在中国32家医院进行了一项多中心、单臂、开放标签、2期研究。符合条件的患者为18岁或18岁以上的局部晚期或转移性METex14阳性肺肉瘤样癌或其他NSCLC亚型患者，对一种或多种标准治疗表现出疾病进展或毒性不耐受，或被认为临床上不适合标准治疗，未接受过MET治疗，且有可测量的疾病。患者接受600 mg（体重≥50 kg）或400 mg（体重
BACKGROUND: Savolitinib is a selective MET tyrosine-kinase inhibitor. We investigated the activity and safety of savolitinib in patients with pulmonary sarcomatoid carcinoma and other non-small-cell lung cancer (NSCLC) subtypes positive for MET exon 14 skipping alterations (METex14-positive).METHODS: We did a multicentre, single-arm, open-label, phase 2 study across 32 hospitals in China. Eligible patients were 18 years or older with locally advanced or metastatic METex14-positive pulmonary sarcomatoid carcinoma or other NSCLC subtypes, had either presented with disease progression or toxicity intolerance towards one or more standard treatments or were deemed clinically unsuitable for standard treatment, were MET inhibitor-naive, and had measurable disease. Patients received either 600 mg (bodyweight ≥50 kg) or 400 mg (bodyweight