Abstract 343TiP
Background
Although PD-L1 immune checkpoint inhibitor (ICI) shows promising efficacy in the treatment of extensive-stage small cell lung cancer (ES-SCLC), the prognosis and therapeutic options for ES-SCLC patients (pts) remain a major concern. In the CAPSTONE-1 study, the median overall survival (OS) of patients was significantly prolonged with adebrelimab plus chemotherapy. Previous clinical data has indicated a synergistic effect between PARP inhibitors and ICIs, with pathological findings revealing higher PARP1 expression levels in SCLC tissue. Based on above evidence, this study aims to evaluate the efficacy and safety of PARP inhibitor combined with ICI in the treatment of ES-SCLC.
Trial design
In this prospective, single-arm phase II clinical study, 35 eligible participants aged 18–75 years with histological or pathological diagnosis of ES-SCLC, Eastern Cooperative Oncology Group (ECOG) performance status of 0–1, measurable disease by RECIST version 1.1, and no prior treatment will be recruited. Eligible pts will intravenously receive four 21-day cycles of adebrelimab (1200 mg, day 1) and fuzuloparib (100 mg, twice a day) with carboplatin (area under the curve of 5 mg/ml per min, day 1) and etoposide (100 mg/m2 bodysurface area, days 1–3) in induction phase; pts with disease control will receive maintenance treatment with adebrelimab and fuzuloparib until disease progression or no clinical benefit. The primary endpoint is progression-free survival rate at 6 months. The secondary endpoints include OS, objective response rate (ORR), duration of response (DoR) and safety. Enrolment of participants is ongoing.
Clinical trial identification
ChiCTR2400083241.
Legal entity responsible for the study
The authors.
Funding
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.