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

作者：Dong C, Liu L, Qiao Y, Wang M, Song D, Zhou L, Ji Y, Li Y, Ding F, Wang H, Zhuang M, Wang L, Liu Z, Fei H, Guo X, Bian B, Yuan C, Xu G, Fang L, Li Y, Song Z, Hui K, Jiang X · 发表于：Cancer · 年份：2026 · DOI：10.1002/cncr.70479 · 研究领域：Carcinoma, Non-Small-Cell Lung、Lung Neoplasms、Endostatins、B7-H1 Antigen、Antineoplastic Combined Chemotherapy Protocols、Humans、Female、Male、Middle Aged、Aged、Prospective Studies、Recombinant Proteins

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 demons...