Durvalumab after radiotherapy in patients with unresectable stage III non-small-cell lung cancer ineligible for chemotherapy: the DUART phase II nonrandomized controlled study

作者：Andrea Riccardo Filippi, M.R. García Campelo, Jean-Baptiste Paoli, Diane Kowalski, Chiara Bennati, Paolo Borghetti, D. Cortinovis, Angelo Delmonte, Carlo Genova, Sylvie Van Hulst, Robert Mróz, Sergiusz Nawrocki, I. Toledano, Giuseppe Tonini, Francesco Agustoni, G. Wetherill, Zhen Zhu, I. Diaz Perez, K. Foroutanpour, Nefeli Georgoulia, Rafał Dziadziuszko · 发表于：ESMO Open · 年份：2025 · DOI：10.1016/j.esmoop.2025.105560 · 被引用次数：7 · 研究领域：Lung Cancer Diagnosis and Treatment、Lung Cancer Research Studies、Cancer Immunotherapy and Biomarkers

BACKGROUND: Currently, patients with unresectable stage III non-small-cell lung cancer (NSCLC) ineligible for chemotherapy receive radiotherapy alone, with unsatisfactory results. DUART was a phase II single-arm trial of durvalumab in patients without progression after radiotherapy for unresectable stage III NSCLC. PATIENTS AND METHODS: Patients were enrolled into parallel cohorts per radiotherapy dose (A: definitive; B: palliative) and received durvalumab (1500 mg every 4 weeks for up to 12 months). The primary endpoint was incidence of grade 3/4 possibly related adverse events (PRAEs) within 6 months of durvalumab initiation. Secondary endpoints included objective response rate, progression-free survival (PFS), and overall survival (OS). Exploratory circulating tumor (ctDNA) analyses utilized a targeted methylation assay (GRAIL, Inc.). RESULTS: As of 06 December 2023, 102 patients received durvalumab (cohort A: 53; cohort B: 49); 18.8%/73.3%/7.9% had Eastern Cooperative Oncology Group performance status 0/1/2 and median age was 79.0 years. Overall, 9.8% [95% confidence interval (CI) 4.8% to 17.3%] had grade 3/4 PRAEs within 6 months of durvalumab initiation. Median PFS (investigator assessed) was 9.2 months, with a 12-month landmark rate of 39.6%. Median OS was 21.1 months and the 12-month landmark rate was 64.7%. Patients who were ctDNA positive at cycle 1 or 7 had shorter PFS versus patients who were ctDNA negative at the same time point. CONCLUSIONS: The safety profile o...