Phase 3 study of benmelstobart in combination with chemotherapy followed by sequential combination with anlotinib for the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sq-NSCLC).

作者：Yuankai Shi, Longhua Sun, Runxiang Yang, Dingzhi Huang, Yongzhong Luo, Haichuan Su, Qiang Liu, Peng Zhang, XingYa Li, Xiangjiao Meng, Yu Yao, Lingfeng Min, Yan Wang, Lei Yang, Conghua Xie, Junquan Yang, Jianhua Shi, Zhi Xu, Hongbo Wu, Honghai Wang · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.16_suppl.8514 · 被引用次数：5 · 研究领域：Lung Cancer Research Studies、Lung Cancer Diagnosis and Treatment、Lung Cancer Treatments and Mutations

8514 Background: PD-1/ PD-L1 inhibitors plus platinum-based chemotherapy is the standard first-line therapy for locally advanced or metastatic sq-NSCLC. Improvements in clinical benefits of sq-NSCLC receiving antiangiogenic agents and immune-checkpoint inhibitors have remained elusive, highlighting an urgent need to develop new therapeutic strategies. TQB2450-III-12 is a multicenter, randomized, double-blind, parallel-controlled phase III study of benmelstobart (PD-L1 inhibitor) in combination with chemotherapy followed by sequential combination with anlotinib (multi-targeted angiogenesis inhibitor) versus tislelizumab plus chemotherapy as first-line therapy for locally advanced or metastatic sq-NSCLC. Methods: Patients with unresectable locally advanced or metastatic sq-NSCLC without prior systematic therapy were randomized 1:1 to receive benmelstobart (1200 mg, Q3W) plus chemotherapy for 4 cycles followed with benmelstobart plus anlotinib (10mg, P.O., D1-D14, Q3W) (group A) or tislelizumab (200mg, Q3W) plus chemotherapy for 4 cycles followed with tislelizumab (group B). Paclitaxel (175 mg/m 2 , day 1) and carboplatin (area under the concentration [AUC] of 5, day 1) were given every 3 weeks. The primary endpoint was PFS per RECIST 1.1 by independent review committee and the key secondary endpoint was OS. Here we present the primary interim analysis for PFS per prespecified analysis plan. Results: As of March 1, 2024, 565 patients were randomized 1:1 to group A and group B. B...