First-line envafolimab plus recombinant human-endostatin in advanced non-small cell lung cancer with PD-L1 tumor proportion score ≥1% (Endouble): A multicenter, prospective, single-arm, phase 2 trial.

2026-05-29
Cancer 132(11)
- Changhong Dong
- Liang Liu
- Yun Qiao
- Mei Wang
- Daan Song
- Lihua Zhou
- Yajun Ji
- Yan Li
- Fendou Ding
- Hao Wang
- Min Zhuang
- Lei Wang
- Zhenghong Liu
- Haitao Fei
- Xiangjun Guo
- Baoxiang Bian
- Chunluan Yuan
- Guanghui Xu
- Lijian Fang
- Yan Li
- Ziyan Song
- Kaiyuan Hui
- Xiaodong Jiang

PubMed: 42216493
DOI: 10.1002/cncr.70479

Study Design

Type: Clinical Trial
Sample size: n = 33
Population: treatment-naive advanced patients with NSCLC with programmed death-ligand 1 (PD-L1)-positive and no driver gene mutations
Methods: All patients received treatment with envafolimab and Rh-endostatin every 21 days until disease progression or intolerable toxicity
Blinding: Open-label
Funding: Unclear

Background

This trial evaluates the efficacy and safety of combining envafolimab and recombinant human endostatin (Rh-endostatin) in advanced non-small cell lung cancer (NSCLC).

Methods

This trial included treatment-naive advanced patients with NSCLC with programmed death-ligand 1 (PD-L1)-positive and no driver gene mutations. All patients received treatment with envafolimab and Rh-endostatin every 21 days until disease progression or intolerable toxicity. The primary end points were objective response rate (ORR) and safety. Secondary end points included progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and duration of response (DOR). An exploratory analysis was conducted to identify biomarkers associated with treatment efficacy.

Results

A total of 33 patients were included for efficacy and safety analysis. The ORR was 48.5% (95% CI, 30.8%-66.5%), and the DCR was 81.8% (95% CI, 64.5%-93.0%). The median PFS was 12.3 months (95% CI, 3.1 months-21.5 months). With a median follow-up of 13.9 months, the median OS was not reached, and the 1-year OS rate was 73.9%. Treatment-related adverse events (TRAEs) were observed in 25 (75.8%) patients. Grade ≥3 TRAEs were observed in six patients, and there were no grade 4 or 5 AEs. Based on plasma proteomic analysis, receiver operator characteristic analysis yielded area under the curve (AUC) values of 0.77 (95% CI, 0.61-0.93) for MMP1 and 0.68 (95% CI, 0.49-0.87) for TNFRSF6B. The combined model demonstrated an AUC of 0.81 (95% CI, 0.66-0.96).

Conclusions

Envafolimab combined with Rh-endostatin demonstrated favorable efficacy and tolerable toxicity in patients with PD-L1-positive, advanced driver-gene negative NSCLC.