[Translation] A multicenter, randomized, open-label, two-arm, phase II study to evaluate the efficacy of encorafenib plus cetuximab versus irinotecan/cetuximab or infusional 5-fluorouracil (5-FU)/leucovorin (FA)/irinotecan (FOLFIRI)/cetuximab in Chinese patients with metastatic colorectal cancer and BRAF V600E mutation (including a safety run-in phase)
为了证明与ARRAY 818-302研究相同剂量的联用疗法(encorafenib和cetuximab)在转移后经过一到两种先前疗法后疾病发生进展的BRAF V600E突变mCRC中国本土受试者中的治疗效果是一致的,以提供桥接数据。
[Translation] To demonstrate that the combination therapy (encorafenib and cetuximab) at the same dose as in the ARRAY 818-302 study is consistent with treatment efficacy in Chinese subjects with BRAF V600E-mutant mCRC who have progressed after one to two prior therapies in metastatic settings and to provide bridging data.