Single-arm phase II study of consolidation serplulimab following hypofractionated radiotherapy with concurrent chemotherapy for patients with limited stage small-cell lung cancer: ASTRUM-LC01 study protocol
Introduction With the inspiring results of the PACIFIC trial in non-small-cell lung cancer (NSCLC), and the CAPIAN and IMpower133 trials in extensive-stage small-cell lung cancer (SCLC), immunotherapy has increasingly gained attention. Serplulimab, a PD-1 inhibitor, showed great antitumour activity...
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BMJ Publishing Group
2025-05-01
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| Serier: | BMJ Open |
| Online adgang: | https://bmjopen.bmj.com/content/15/5/e085552.full |
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| author | Tao Zhang Jianchun Duan Xiaohong Zhou Jianzhong Cao Yuqi Wu Jianyang Wang Nan Bi Lei Deng |
| author_facet | Tao Zhang Jianchun Duan Xiaohong Zhou Jianzhong Cao Yuqi Wu Jianyang Wang Nan Bi Lei Deng |
| author_sort | Tao Zhang |
| collection | DOAJ |
| description | Introduction With the inspiring results of the PACIFIC trial in non-small-cell lung cancer (NSCLC), and the CAPIAN and IMpower133 trials in extensive-stage small-cell lung cancer (SCLC), immunotherapy has increasingly gained attention. Serplulimab, a PD-1 inhibitor, showed great antitumour activity in the ASTRUM-005 trial and has been recommended as first-line therapy in extensive-stage SCLC. Whether serplulimab following hypofractionation radiotherapy and chemotherapy could bring better outcomes in limited-stage SCLC remains to be answered.Methods and analysis We designed a prospective multicentre single-arm phase II clinical trial to evaluate both the efficacy and safety of chemoradiotherapy and consolidation by serplulimab in limited-stage SCLC. Eligible patients will receive standard chemotherapy for four cycles and concurrent thoracic radiotherapy with a total dose of 45 Gy in 3 weeks and a 3 Gy dose per fraction. Prophylactic cranial irradiation is recommended for responding patients. Serplulimab will be delivered afterwards every 3 weeks for up to 1 year. Based on sample size estimation, 55 patients will be enrolled in total.Ethics and dissemination Ethics approval was obtained from the Independent Ethics Committee of National Cancer Centre/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (22/236-3438).Trial registration number NCT05443646. |
| format | Article |
| id | doaj-art-8f097b336bb44d48a94de142033996bf |
| institution | Matheson Library |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-8f097b336bb44d48a94de142033996bf2025-07-11T09:55:09ZengBMJ Publishing GroupBMJ Open2044-60552025-05-0115510.1136/bmjopen-2024-085552Single-arm phase II study of consolidation serplulimab following hypofractionated radiotherapy with concurrent chemotherapy for patients with limited stage small-cell lung cancer: ASTRUM-LC01 study protocolTao Zhang0Jianchun Duan1Xiaohong Zhou2Jianzhong Cao3Yuqi Wu4Jianyang Wang5Nan Bi6Lei Deng7Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong, Hong KongDepartment of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaDepartment of Radiation Oncology, Jiamusi Medical College, Jiamusi, Heilongjiang, ChinaDepartment of Radiation Oncology, Shanxi Province Cancer Hospital/Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences, Taiyuan, People`s Republic of ChinaDepartment of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaDepartment of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaDepartment of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaDepartment of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaIntroduction With the inspiring results of the PACIFIC trial in non-small-cell lung cancer (NSCLC), and the CAPIAN and IMpower133 trials in extensive-stage small-cell lung cancer (SCLC), immunotherapy has increasingly gained attention. Serplulimab, a PD-1 inhibitor, showed great antitumour activity in the ASTRUM-005 trial and has been recommended as first-line therapy in extensive-stage SCLC. Whether serplulimab following hypofractionation radiotherapy and chemotherapy could bring better outcomes in limited-stage SCLC remains to be answered.Methods and analysis We designed a prospective multicentre single-arm phase II clinical trial to evaluate both the efficacy and safety of chemoradiotherapy and consolidation by serplulimab in limited-stage SCLC. Eligible patients will receive standard chemotherapy for four cycles and concurrent thoracic radiotherapy with a total dose of 45 Gy in 3 weeks and a 3 Gy dose per fraction. Prophylactic cranial irradiation is recommended for responding patients. Serplulimab will be delivered afterwards every 3 weeks for up to 1 year. Based on sample size estimation, 55 patients will be enrolled in total.Ethics and dissemination Ethics approval was obtained from the Independent Ethics Committee of National Cancer Centre/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (22/236-3438).Trial registration number NCT05443646.https://bmjopen.bmj.com/content/15/5/e085552.full |
| spellingShingle | Tao Zhang Jianchun Duan Xiaohong Zhou Jianzhong Cao Yuqi Wu Jianyang Wang Nan Bi Lei Deng Single-arm phase II study of consolidation serplulimab following hypofractionated radiotherapy with concurrent chemotherapy for patients with limited stage small-cell lung cancer: ASTRUM-LC01 study protocol BMJ Open |
| title | Single-arm phase II study of consolidation serplulimab following hypofractionated radiotherapy with concurrent chemotherapy for patients with limited stage small-cell lung cancer: ASTRUM-LC01 study protocol |
| title_full | Single-arm phase II study of consolidation serplulimab following hypofractionated radiotherapy with concurrent chemotherapy for patients with limited stage small-cell lung cancer: ASTRUM-LC01 study protocol |
| title_fullStr | Single-arm phase II study of consolidation serplulimab following hypofractionated radiotherapy with concurrent chemotherapy for patients with limited stage small-cell lung cancer: ASTRUM-LC01 study protocol |
| title_full_unstemmed | Single-arm phase II study of consolidation serplulimab following hypofractionated radiotherapy with concurrent chemotherapy for patients with limited stage small-cell lung cancer: ASTRUM-LC01 study protocol |
| title_short | Single-arm phase II study of consolidation serplulimab following hypofractionated radiotherapy with concurrent chemotherapy for patients with limited stage small-cell lung cancer: ASTRUM-LC01 study protocol |
| title_sort | single arm phase ii study of consolidation serplulimab following hypofractionated radiotherapy with concurrent chemotherapy for patients with limited stage small cell lung cancer astrum lc01 study protocol |
| url | https://bmjopen.bmj.com/content/15/5/e085552.full |
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