neoadjuvant_thymic Epithelial Tumor

Summary

This is a Phase II single center, open-label, single arm study in patients with unresectable thymic epithelial tumors (Masaoka stage III, IVA). Patients will be treated with Pembrolizumab 200 mg, Docetaxel 75mg/m2, Cisplatin 75mg/m2 every 3 weeks for 3 cycles and will be evaluated for the operability. Patients with R0 resection will receive pembrolizumab 200mg for 32 cycles. Patient who had R1 resection will receive radiation 52.8Gy/24Fx with pembrolizumab 200mg for 32 cycles. Patients who had R2 resection will receive radiation 59.4Gy/27Fx with pembrolizumab 200mg for 32 cycles. Patients who showed non-progressive disease (PD) to initial neoadjuvant therapy but remained unresectable will receive radiation 59.4Gy/27Fx with 200mg for 32 cycles. Otherwise patients are off the study.

Timeline

Start

2019-04-29

Primary completion

2022-04-01

Completion

2023-04-01

Publications

• Bang YH, Noh JM, Lee B, Choi YL, Yang K, Pyo H, Kim H, Kim J, Jung HA, Sun JM, Lee SH, Ahn JS, Ahn MJ, Jeon YJ, Lee J, Cho JH, Kim HK, Choi YS, Park SY, Park S. Perioperative Pembrolizumab for Locally Advanced Thymic Epithelial Tumors: A Single-Arm, Phase 2 Trial. J Thorac Oncol. 2025 Dec;20(12):1829-1842. doi: 10.1016/j.jtho.2025.08.011. Epub 2025 Oct 19.

Drugs

Indications