SAKK 16/18: Immune-modulatory radiotherapy to enhance the effects of neoadjuvant PD-L1 blockade after neoadjuvant chemotherapy in patients with resectable stage III (N2) non-small cell lung cancer (NSCLC)—A multicenter phase II trial.

作者：Laetitia Mauti, Tobias Finazzi, Lisa Holer, Adrienne Bettini, David König, Martin Früh, Simon Haefliger, Alfredo Addeo, Michael Mark, Martin Buess, Patrizia Froesch, Wolf Dieter Janthur, Christine Waibel, Christoph Ackermann, Patrick Dorn, Bernhard Scheibe, Miklos Pless, Matthias Gückenberger, Spasenija Savic Prince, Sacha I. Rothschild · 发表于：Journal of Clinical Oncology · 年份：2023 · DOI：10.1200/jco.2023.41.16_suppl.8547 · 被引用次数：12 · 研究领域：Lung Cancer Diagnosis and Treatment、Cancer Immunotherapy and Biomarkers、Esophageal Cancer Research and Treatment

8547 Background: Neoadjuvant chemo-immunotherapy has become a new standard of care in locally advanced, resectable NSCLC. The SAKK 16/14 trial demonstrated a major improvement in pathological response (pCR), major pathological remission (MPR) and event-free survival (EFS) with the addition of perioperative durvalumab after standard induction chemotherapy (ChT) with cisplatin and docetaxel. Based on data suggesting a potential enhancement of immunotherapy efficacy, the ongoing SAKK 16/18 trial investigates the addition of immune-modulatory radiotherapy (RT) given concurrently with neoadjuvant durvalumab. Methods: In this non-comparative randomized phase II trial patients (pts) with resectable stage IIIA-B(N2) (cT1-3 or T4 due to size N2 M0) NSCLC receive 3 cycles of cisplatin 100mg/m2 and docetaxel 85mg/m2 followed by durvalumab (1500mg) and one of three randomized RT regimens before tumor resection and adjuvant durvalumab for 1 year. RT is delivered to the primary tumor only, using either 20x2 Gy, 5x5 Gy, or 3x8 Gy (deliverd inhomogenously). RT planning is optimized for strict organ at risk and mediastinal lymph node sparing. The primary endpoint is 1-year EFS. We report a preplanned interim analysis of the secondary endpoints safety, surgical outcomes and pathological response after surgery in 25 pts. Results: At data cut-off on Oct 8, 2022, 25 pts had reached post-operative day 30 and a total of 31 pts were included in the safety analysis. Thirty pts (97%) had at least one ...