The preliminary results of a randomized phase II trial evaluating induction toripalimab plus chemotherapy followed by concurrent chemoradiotherapy and consolidation toripalimab in bulky unresectable stage III non-small-cell lung cancer (InTRist).

作者：Yu Wang, Jianyang Wang, Lei Deng, Tao Zhang, Wenyang Liu, Yuqi Wu, Yongbo Xiang, Zhijie Wang, Nan Bi · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.16_suppl.8012 · 被引用次数：11 · 研究领域：Lung Cancer Treatments and Mutations、Lung Cancer Diagnosis and Treatment、Lung Cancer Research Studies

8012 Background: Unresectable stage III NSCLC patients with large tumor volumes remain challenging. Our previous retrospective study has showed promising results of induction chemoimmunotherapy before definitive chemoradiotherapy (CRT) for these patients. Here we report preliminary results of the randomized phase II study on this regimen. Methods: This InTRist study is a randomized, single-center, phase 2 trial, enrolling patients with unresectable stage III NSCLC with bulky diseases, and without EGFR/ALK alterations. Bulky diseases were defined as primary tumor ≥5 cm in greatest dimension or metastatic lymph nodes ≥2 cm in shortest diameter. Eligible patients were 1:1 randomly assigned to receive induction toripalimab (240 mg every 3 weeks) plus platinum-based doublet chemotherapy for 2 cycles (toripalimab group) versus induction chemotherapy alone for 2 cycles (chemo group) followed by concurrent CRT (60 Gy radiotherapy plus concurrent platinum-based chemotherapy). All patients without disease progression or grade ≥2 pneumonitis after CRT received consolidation toripalimab (240 mg every 3 weeks) for up to 12 months. Randomization was stratified according to histologic type. The primary endpoint was progression-free survival (PFS) from randomization. This trial is registered with ClinicalTrials.gov, NCT05888402. Results: BetweenJanuary 20th, 2023 and October 8th, 2024, 52 patients were randomized to induction toripalimab (n = 27) or chemo (n = 25) groups. By the data cutoff ...