Our previous basic research shows that radiotherapy combined with PARP inhibitors not only has direct antitumor effect in SCLC, but also can enhance antitumor immunity. At the same time, their combination can enhance the expression of PD-L1, which is considered to have a negative role in immune response. We found that triple therapy combined with PARP inhibitor and radiation plus anti-PD-1 can significantly enhance the antitumor effect and enhance the infiltration of cytotoxic T cells and memory T cells in SCLC model with immune function. More and more clinical evidence has confirmed the advantages of radiotherapy combined with immunity, especially in the treatment of inoperable locally advanced NSCLC. At present, some clinical studies have made breakthrough progress and successfully rewritten the guidelines.
This study adopts a single arm design. It is planned to include 53 patients with extensive stage small cell lung cancer who have previously received 1-2-line treatment (including one systematic platinum containing treatment) and received niraparib combined with treprizumab and radiotherapy (SBRT). The main purpose of this study was to explore the efficacy and safety of niraparib combined with treprizumab and radiotherapy in the treatment of extensive small cell lung cancer who had previously received 1-2 lines of therapy (including one systematic platinum-containing therapy). The patients entered the trial period immediately after signing the informed consent. The first cycle: first, they receive niraparib (200mg QD), selected non target lesions suitable for SBRT for radiotherapy (8Gy x 3f) on the fourth day, and added treprizumab immunotherapy 240mg intravenous drip q3w on the seventh day. Start of the second cycle: continue to receive the combined treatment of treprizumab (240mg D1 q3w) + niraparib (200mg QD), one cycle every 21 days until the disease progresses, and the maximum use time is 2 years. The previous radiotherapy site cannot be used as the radiotherapy focus again, and the imaging evaluation is carried out according to RECIST 1.1 standard.
Clinical trial identification
NCT05162196; Release date: March 2025.
Legal entity responsible for the study
Zailaboratory. Junshi Biosciences.
All authors have declared no conflicts of interest.