| Title: |
Anti-PD1 based precision induction therapy in unresectable stage III non-small cell lung cancer: a phase II umbrella clinical trial. |
| Authors: |
Yi, Chengxiang, Bian, Dongliang, Wang, Jue, Hu, Shiqi, Sun, Liangdong, Yan, Yilv, Wang, Suyu, Shen, Ziyun, Yu, Huansha, Yang, Yong, Zhou, Yirui, Liu, Xiaogang, Song, Nan, Zhu, Yuming, Zhao, Deping, Jiang, Gening, Duan, Liang, He, Wenxin, Xie, Dong, Dai, Jie |
| Source: |
Nature Communications; 2/27/2025, Vol. 16 Issue 1, p1-17, 17p |
| Abstract: |
The efficacy and safety of induction-immunotherapy followed by surgery for unresectable Stage III non-small cell lung cancer (NSCLC) remain challenging. In this open-label, single-center, phase II clinical umbrella trial (ChiCTR2000035367), 100 unresectable Stage III NSCLC patients are enrolled. Patients with PD-L1 expression ≥ 50% but contraindications to anti-angiogenic therapy receive immuno-monotherapy. Patients with PD-L1 expression ≥ 1% and no contraindications to anti-angiogenic therapy receive immunotherapy plus anti-angiogenesis therapy. Patients with PD-L1 expression between 1% and 49%, contraindications to anti-angiogenic therapy, or negative/unknown PD-L1 expression receive chemoimmunotherapy. The primary endpoint is the major pathological response (MPR) rate. Among 47 surgically-treated patients, the MPR rate is 61.7% (95% confidence interval [CI]: 46.4%-75.5%), achieving the prespecified endpoint. For secondary endpoints, the objective response rate for all patients is 54.0% (95% CI: 43.7-64.0). The median event-free survival is 29.9 months (95% CI: 17.0-42.7). Most common adverse event is anemia (49.0%). Exploratory transcriptomic analyses reveal Bone Marrow Stromal Cell Antigen 1 (BST1) as a promising biomarker for response to chemoimmunotherapy. Generally, for unresectable stage III NSCLC patients, anti-PD1 based induction-therapy according to PD-L1 expression and contraindication to antiangiogenic therapy followed by surgery is a feasible option.Induction-immunotherapy before surgery has been suggested for patients with unresectable stage III non-small cell lung cancer (NSCLC). Here, the authors report a phase 2 umbrella clinical trial where patients with unresectable stage III NSCLC receive anti-PD1-based induction-therapy based on PD-L1 expression and contraindications to antiangiogenic therapy. [ABSTRACT FROM AUTHOR] |
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| Database: |
Complementary Index |
