[Translation] A randomized, double-blind, placebo-controlled phase 3 study of rovalpituzumab tesirine as maintenance therapy following first-line platinum-based chemotherapy in patients with extensive-stage small cell lung cancer (MERU)
主要:评价与安慰剂相比,Rovalpituzumab Tesirine 能否改善完成4个疗程一线含铂化疗(顺铂或卡铂联合伊立替康或依托泊苷)后具有持续临床获益(SD、PR 或CR)的广泛期SCLC受试者的无进展生存期和总生存期。 次要:通过确定客观缓解率(ORR)、临床获益率(CBR)和缓解持续时间(DOR),评价Rovalpituzumab Tesirine 的抗肿瘤活性,并使用EORTC QLQ-C30/LC-13问卷评估患者报告结局(PRO)的变化情况。
[Translation] Primary: To evaluate whether Rovalpituzumab Tesirine can improve progression-free survival and overall survival compared with placebo in subjects with extensive-stage SCLC who have completed 4 cycles of first-line platinum-containing chemotherapy (cisplatin or carboplatin combined with irinotecan or etoposide) and have sustained clinical benefit (SD, PR or CR). Secondary: To evaluate the anti-tumor activity of Rovalpituzumab Tesirine by determining the objective response rate (ORR), clinical benefit rate (CBR) and duration of response (DOR), and to assess changes in patient-reported outcomes (PROs) using the EORTC QLQ-C30/LC-13 questionnaire.