CAMPASS: Benmelstobart in combination with anlotinib vs pembrolizumab in the first-line treatment of advanced non-small cell lung cancer (aNSCLC)—A randomized, single-blind, multicenter phase 3 study.

作者：Baohui Han, Kai Li, Runxiang Yang, Yongzhong Luo, Wei Zuo, Chao Xie, Qingshan Li, Xingxiang Xu, Qiang Liu, Yan Yu, Qiming Wang, Tienan Yi, Yongxing Chen, Hongmei Sun, Xuhong Min, Huaqiu Shi, Hualin Chen, Jianhua Shi, Jinsheng Shi, Junzhen Gao · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.17_suppl.lba8502 · 被引用次数：8 · 研究领域：Lung Cancer Research Studies、Lung Cancer Treatments and Mutations、Lung Cancer Diagnosis and Treatment

LBA8502 Background: Anti-PD-(L) 1 monotherapy has been the standard first-line treatment for PD-L1 positive NSCLC, but its clinical benefit remains unsatisfactory. Benmelstobart (TQB2450) is a humanized monoclonal antibody against PD-L1 and anlotinib is a multikinase inhibitor that has been approved as the standard of care in the third-line treatment of NSCLC in China. This phase 3 study aimed to compare the efficacy of benmelstobart in combination with anlotinib and pembrolizumab as first-line treatment of PD-L1 positive aNSCLC. Methods: This is a randomized, single-blind, multicenter phase Ⅲ study (NCT04964479). Eligible patients (pts) were previous systemic treatment naïve, diagnosed with locally advanced or recurrent/metastatic NSCLC and had PD-L1 positive expression (defined as TPS ≥1%). Pts were randomized in a 2:1 ratio to receive either benmelstobart plus anlotinib (benmel+ anlo) or pembrolizumab plus placebo (pem+placebo). Anlotinib or placebo was administered orally at a dose of 12/0mg QD on days 1-14 of a 21-day cycle, while benmelstobart or pembrolizumab was given intravenously at a dose of 1200mg or 200mg on the first day of each cycle. The primary endpoint was progression-free survival (PFS) assessed by independent review committee (IRC). Results: Between August 2021 and December 2022, 531 pts were randomized (528 treated). At the data cutoff date of 20 May 2023, the median follow-up for PFS was 11.4 months for the benmel+anlo arm and 10.6 months for the pem+pla...