RT Journal Article
SR Electronic
T1 Equivalent efficacy study of QL1101 and bevacizumab on untreated advanced non-squamous non-small cell lung cancer patients: a phase 3 randomized, double-blind clinical trial
JF Cancer Biology and Medicine
JO Cancer Biol Med
FD China Anti-Cancer Association
SP 816
OP 824
DO 10.20892/j.issn.2095-3941.2020.0212
VO 18
IS 3
A1 Chu, Tianqing
A1 Lu, Jun
A1 Bi, Minghong
A1 Zhang, Helong
A1 Zhuang, Wu
A1 Yu, Yan
A1 Shi, Jianhua
A1 Chen, Zhendong
A1 Zhang, Xiaochun
A1 Guo, Qisen
A1 Liu, Quan
A1 Wu, Huijuan
A1 Fang, Jian
A1 Hu, Yi
A1 Wang, Xiuwen
A1 Han, Cuicui
A1 Li, Kai
A1 Han, Baohui
YR 2021
UL http://www.cancerbiomed.org/content/18/3/816.abstract
AB Objective: This phase 3 study aimed to test equivalence in efficacy and safety for QL1101, a bevacizumab analogue in Chinese patients with untreated locally advanced non-squamous non-small cell lung cancer (NSCLC).Methods: Eligible patients were randomly assigned 1:1 to receive carboplatin and paclitaxel in combination with either QL1101 or bevacizumab, 15 mg/kg every 3-week for 6 cycles. This was followed by maintenance treatment with single agent QL1101 every 3-week. The primary end-point was objective response rate (ORR), with secondary end-points being progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and adverse events (AEs).Results: Of 675 patients, 535 eligible patients were randomized to the QL1101 group (n = 269) and bevacizumab group (n = 266). ORRs were 52.8% and 56.8%, respectively, for the QL1101 and bevacizumab groups, with an ORR hazard ratio 0.93 (95% confidence interval: 0.8–0131.1). The PFS, OS, DCR, and AEs were comparable between the 2 groups, which remained the same after stratification according to epidermal growth factor receptor mutation or smoking history.Conclusions: QL1101 showed similar efficacy and safety profiles as compared to bevacizumab among Chinese patients with untreated locally advanced non-squamous NSCLC.