drugset / Trial / NCT03629925
Sintilimab in Combination With Gemcitabine and Platinum-Based Chemotherapy as First-Line Therapy for Advanced or Metastatic Squamous NSCLC
RandomizedParallel-groupDouble-blindTreatment
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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |
| Background | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Background | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |