Consolidation thoracic radiotherapy following quadruple induction with benmelstobart, anlotinib, and chemotherapy for extensive-stage small cell lung cancer: rationale and protocol of a phase II study

作者：Zhou Y, Zhu H, Yang S, Liu J, Yu M, Sun J, Yang C, Cui Y, Liu N · 发表于：Translational lung cancer research · 年份：2026 · DOI：10.21037/tlcr-2026-1-0114 · 被引用次数：47 · 研究领域：Extensive-stage small cell lung cancer (ES-SCLC)、anlotinib、benmelstobart、consolidative radiotherapy、phase II clinical trial

BACKGROUND: Extensive-stage small cell lung cancer (ES-SCLC) remains a highly aggressive malignancy with limited survival outcomes. While first-line immune checkpoint inhibitors combined with platinum-based chemotherapy have improved survival, the benefit is modest. Emerging evidence supports the integration of anti-angiogenic therapy and thoracic radiotherapy (TRT) to enhance systemic and local control. However, a comprehensive multimodal regimen combining chemotherapy, immunotherapy, anti-angiogenic therapy, and TRT has not been systematically evaluated. This study aims to assess the safety, feasibility, and preliminary efficacy of a multimodal treatment strategy involving induction with benmelstobart [an anti-programmed death-ligand 1 (PD-L1) antibody], platinum-etoposide chemotherapy, and anlotinib, followed by consolidation with benmelstobart, anlotinib, and sequential TRT in patients with untreated ES-SCLC. METHODS: This is a prospective, single-center, single-arm, phase II, open-label trial conducted at Tianjin Medical University Cancer Institute & Hospital. Twenty-five patients with histologically confirmed, treatment-naive ES-SCLC and measurable disease per Response Evaluation Criteria in Solid Tumors, version 1.1 will be enrolled. The regimen consists of-induction phase: 4 cycles of benmelstobart (1,200 mg IV q21d), carboplatin (area under the curve 5) or cisplatin (75-80 mg/m2) on day 1, etoposide (100 mg/m2 IV days 1-3), and oral anlotinib (12 mg once daily, 2 we...