Abstract 1320TiP
Background
SBRT is an effective and noninvasive treatment, which achieves superior local control and survival. Combined with immune checkpoint inhibitors (ICIs), SBRT may not only amplify the in situ vaccination effect but also reprogram tumor microenvironment and improve systemic response to immunotherapy by abscopal effect. Meanwhile, bevacizumab can relieve immune suppression by activating dendritic cells (DCs) and inhibiting the activity of myeloid-derived suppressor cells (MDSCs) and regulatory T cells (Tregs). Therefore, SBRT combined with toripalimab (an anti-PD-1 antibody) and bevacizumab may have a synergistic effect and improve the efficacy.
Trial design
This is a prospective, multicenter, open-label, phase II study to evaluate the efficacy and safety of SBRT and toripalimab with/without bevacizumab in stage IV non-squamous NSCLC. Eligible patients (age 18-70 years) have received first-line platinum-based chemotherapy or ICIs (except toripalimab) previously with confirmed disease progression. Each patient has at least 3 measurable lesions evaluated by RECIST v1.1 and at least 2 lesions can be treated by SBRT. 60 patients will be enrolled and divided into 2 groups (30 patients in each group): SBRT (30-50Gy/5F for 2-4 lesions) plus toripalimab (240mg, Q3W) with or without bevacizumab (7.5 mg/kg, Q3W) until disease progression or intolerable toxicity. The primary endpoints are objective response rate (ORR) and ORR outside the radiation field (oORR). Secondary endpoints include progression-free survival (PFS), duration of response (DoR), overall survival (OS), the incidence of treatment-related adverse events (TRAEs) and the quality of life (QoL).
Clinical trial identification
NCT04238169.
Editorial acknowledgement
Legal entity responsible for the study
Second Affiliated Hospital of Army Military Medical University, Chongqing, China.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.