Study protocol for JCOG1807C (DEEP OCEAN): a interventional prospective trial to evaluate the efficacy and safety of durvalumab before and after operation or durvalumab as maintenance therapy after chemoradiotherapy against superior sulcus non-small cell lung cancer

• Main Authors: Aokage, K. (Author), Fukuda, H. (Author), Fukutani, M. (Author), Horinouchi, H. (Author), Ishikura, S. (Author), Kanato, K. (Author), Kataoka, T. (Author), Koyama, S. (Author), Kumagai, S. (Author), Lung Cancer Surgical Study Group of the Japan Clinical Oncology Group (Author), Nakamura, N. (Author), Nishikawa, H. (Author), Ohe, Y. (Author), Tsuboi, M. (Author), Wakabayashi, M. (Author), Watanabe, S.-I (Author), Zenke, Y. (Author)
• Format: Article
• Language: English
• Published: NLM (Medline) 2022
• Subjects: Antibodies, Monoclonal; cancer staging; Carcinoma, Non-Small-Cell Lung; chemoradiotherapy; Chemoradiotherapy; durvalumab; human; Humans; immune-checkpoint inhibitor; Lung Neoplasms; lung tumor; monoclonal antibody; Multicenter Studies as Topic; multicenter study (topic); multidisciplinary; Neoplasm Staging; non small cell lung cancer; Pancoast; pathology; procedures; Prospective Studies; prospective study; superior sulcus tumour
• Online Access: View Fulltext in Publisher
• Physical Description: 5
• ISBN: 14653621 (ISSN)
• DOI: 10.1093/jjco/hyab208

BACKGROUND: Superior sulcus tumours (SSTs) are relatively uncommon and one of the most intractable lung cancers among non-small cell lung cancer (NSCLC). We planned a multicenter, single-arm confirmatory trial of new multidisciplinary treatment using immune-checkpoint inhibitor. The aim is to evaluate the safety and efficacy of new multidisciplinary treatment with perioperative durvalumab after chemoradiotherapy (CRT). METHODS: The primary endpoint is 3-year overall survival. Patients receive induction CRT with sequential two courses of durvalumab, followed by surgical resection for resectable SST. The regimen for CRT is two courses of cisplatin and S-1, and concurrent radiotherapy (66 Gy/33 Fr). After surgery, 22 courses of post-operative durvalumab therapy are administered. For unresectable SST, an additional 22 courses of durvalumab are administered after induction durvalumab. RESULTS: In two cases as a safety cohort, the safety of intervention treatment up to 30 days after surgery was examined, and there were no special safety signals. Patient enrollment has now resumed in the main cohort. CONCLUSIONS: The results of this study may contribute to the establishment of a new standard of care for SST, which is an intractable NSCLC. © The Author(s) 2022. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: [e-mail].