A Study Exploring Efficacy of SIBP04 in Subjects With Non-squamous Non-small Cell Lung Cancer

Summary

This trial is a randomized, double-blind, parallel-controlled, multicenter phase III clinical study. To evaluate the clinical efficacy of SIBP04 in patients with locally advanced, metastatic or recurrent non-squamous non-small cell lung cancer.

Timeline

Start

2020-04-17

Primary completion

2022-12-26

Completion

2023-01-12

Outcome

Met primary endpoint

paper 0.97 (90% CI, 0.8578-1.0900) in the PPS population, respectively, both within the prespecified equivalence margin of 0.75-1.33. PMID 40697509 ↗

Publications

• Shi Y, Bi M, Li Q, Wang G, Chen J, Li M, Shi J, Mei J, Ji Y, Xia Q, Feng Y, Xu S, Zhang T, Gao X, Tang S, Weng J, Cao Z, Wu H, Ren X, Xie H, Liu H, Liu Q, Yin X, Luo X, Chen J, Zhang H, Guo Z, Ding C, Jin X, Sun R, Yang S. Efficacy and safety of bevacizumab biosimilar SIBP04 compared with bevacizumab (Avastin(R)) as first-line treatment for locally advanced or metastatic non-squamous non-small-cell lung cancer: A randomized, double-blind, phase 3 trial. Cancer Pathog Ther. 2025 Jan 6;3(4):337-345. doi: 10.1016/j.cpt.2025.01.001. eCollection 2025 Jul.
• Qu A, Zhang S, Zou H, Li S, Chen D, Zhang Y, Li S, Zhang H, Yang J, Yang Y, Huang Y, Li X, Zhang Y. Outcome benefits of bevacizumab biosimilar (SIBP04) combined with carboplatin and paclitaxel in advanced non-squamous non-small-cell lung cancer patients with EGFR mutation: subgroup analysis of a prospective, randomized phase III clinical trial. J Cancer Res Clin Oncol. 2023 Nov;149(14):12713-12721. doi: 10.1007/s00432-023-05103-4. Epub 2023 Jul 15.

Drugs

Indications