Sintilimab in Combination With Gemcitabine and Platinum-Based Chemotherapy as First-Line Therapy for Advanced or Metastatic Squamous NSCLC

Summary

Efficacy and Safety Evaluation of IBI308 in Patients with Advanced or Recurrent Squamous NSCLC

Timeline

Start

2018-09-28

Primary completion

2020-03-25

Completion

2021-09-30

Outcome

Met primary endpoint

paper sintilimab-GP continued to reveal a meaningful improvement in PFS than placebo-GP (hazard ratio = 0.536 [95% confidence interval: 0.422-0.681], p < 0.00001). PMID 34048947 ↗

Publications

• Jiang M, Sun J, Hu C, Wu L, Fan Y, Wang Z, Liu L, Wu C, Wu F, Gao G, Li F, Wang L, Li X, Cheng L, Peng B, Zhou H, Zhou C. A tumor cornification and immune-infiltration-based scheme for anti-PD-1 plus chemotherapy response in advanced squamous cell lung carcinoma. Med. 2025 Feb 14;6(2):100516. doi: 10.1016/j.medj.2024.09.005. Epub 2024 Oct 11.
• Zhou C, Wu L, Fan Y, Wang Z, Liu L, Chen G, Zhang L, Huang D, Cang S, Yang Z, Zhou J, Zhou C, Li B, Li J, Fan M, Cui J, Li Y, Zhao H, Fang J, Xue J, Hu C, Sun P, Du Y, Zhou H, Wang S, Zhang W. Sintilimab Plus Platinum and Gemcitabine as First-Line Treatment for Advanced or Metastatic Squamous NSCLC: Results From a Randomized, Double-Blind, Phase 3 Trial (ORIENT-12). J Thorac Oncol. 2021 Sep;16(9):1501-1511. doi: 10.1016/j.jtho.2021.04.011. Epub 2021 May 25.

Drugs

Indications