A Phase Ⅱ Trial of Neoadjuvant Toripalimab Plus Platinum-doublet Chemotherapy in Locally Advanced NSCLC.

Summary

This is a Phase 2, prospective, single-arm, open-Label, single-center study that to find out (1)The effectiveness and safety of toripalimab combined with platinum-doublet chemotherapy as a preoperative neoadjuvant therapy for locally advanced (stage IIB, IIIA, and resectable stage IIIB) NSCLC, (2)The best treatment time for this combination of neoadjuvant therapy before surgery, (3)The effectiveness and safety of combination of neoadjuvant therapy as salvage neoadjuvant therapy after failure of neoadjuvant chemo-only for locally advanced non-small cell lung cancer.

Timeline

Start

2020-12-18

Primary completion

2023-05-21

Completion

2024-05-01

Publications

• Liu B, Tao Y, Zhuo M, Xu LD, Cheng X, Tao W, Xie Z, Lv C, Wang Y, Li S, Zhang S, Huang M, Wang Y, Li X, Zhu Y, Cui X, Zhou X, Han B, Zhang E, Huang YS, Chen W, Wang J, Yan S, Wu N. The role of dynamic monitoring of plasma cell-free DNA methylation in predicting pathological response in resectable stage IIB-IIIB non-small cell lung cancer: biomarker analyses from a prospective phase II trial. BMC Med. 2025 Nov 5;23(1):611. doi: 10.1186/s12916-025-04419-x.
• Tao Y, Li X, Liu B, Wang J, Lv C, Li S, Wang Y, Chen J, Yan S, Wu N. Association of early immune-related adverse events with treatment efficacy of neoadjuvant Toripalimab in resectable advanced non-small cell lung cancer. Front Oncol. 2023 May 15;13:1135140. doi: 10.3389/fonc.2023.1135140. eCollection 2023.

Drugs

Indications