Abstract 216TiP
Background
Small cell lung cancer (SCLC) is a highly aggressive subtype of lung cancer. Despite initial responses, the majority of patients with limited-stage SCLC experience relapse, and long-term survival remains unsatisfactory. Novel treatment strategies are in need to enhance therapeutic outcomes. With the inspiring results of PACIFIC trial in non-small cell lung cancer (NSCLC), and CAPIAN and IMpower133 trial in extensive-stage SCLC, immunotherapy has increasingly gained attention. Serplulimab, a PD-1 inhibitor, showed great antitumor activity in ASTRUM-005 trial and has been recommended as first-line therapy in extensive-stage SCLC. Hypofractionation radiotherapy has emerged as a promising approach in the management of limited-stage SCLC, offering the advantage of shorter treatment duration and potential benefits combining with subsequent immunotherapy. This clinical trial aims to address whether serplulimab following hypofractionation radiotherapy and chemotherapy could bring better outcomes in limited-stage SCLC.
Trial design
This single-arm, phase II trial will enroll fifty-five eligible patients diagnosed with limited-stage SCLC. All patients will receive four cycles chemotherapy. Recommended regimens are etoposide in combination with cisplatin or carboplatin. Thoracic radiation should initiate no later than the third cycle of chemotherapy. It is planned to target the primary tumor and involved mediastinal lymph node regions. For simulation, 4D-CT simulation positioning and enhanced CT positioning image scanning should be performed as far as possible. A total of 45Gy in 15 fractions over 3 weeks will be delivered. Prophylactic cranial irradiation(PCI) is routinely scheduled for patients without progression after chemoradiotherapy, and hippocampal avoidance is highly recommended. 25Gy in 10 fractions over 2 weeks to the brain will be prescribed. Patients without disease progression will receive intravenous infusion of serplulimab 300mg every 3 weeks for up to one year. Regular follow-up assessments will be conducted to monitor treatment responses, survival outcomes, and potential adverse events.
Clinical trial identification
NCT05443646.
Legal entity responsible for the study
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College.
Funding
Shanghai Henlius Biotech, Inc.
Disclosure
All authors have declared no conflicts of interest.