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
| Autor: | Quan Liu, M. Bi, Yi Hu, Yan Yu, Helong Zhang, Jianhua Shi, Zhendong Chen, Xiaochun Zhang, Jian Fang, Tianqing Chu, Baohui Han, Kai Li, Jun Lu, Cuicui Han, Wu Zhuang, Xiuwen Wang, Huijuan Wu, Qisen Guo |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Oncology
Cancer Research medicine.medical_specialty Bevacizumab equivalence Phases of clinical research bevacizumab non-squamous nsclc chemistry.chemical_compound clinical efficacy Internal medicine medicine Adverse effect Lung cancer RC254-282 business.industry Hazard ratio Neoplasms. Tumors. Oncology. Including cancer and carcinogens medicine.disease Carboplatin Clinical trial Paclitaxel chemistry Original Article biosimilar business medicine.drug |
| Zdroj: | Cancer Biology & Medicine, Vol 18, Iss 3, Pp 816-824 (2021) Cancer Biology & Medicine |
| ISSN: | 2095-3941 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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