Abstract 177TiP
Background
Numerous studies have demonstrated the efficacy and safety of combining immunotherapy and chemotherapy in the perioperative management of resectable non-small cell lung cancer (NSCLC), while the short-term efficacy and long-term survival benefits still remain confined, underscoring the urgency to explore novel immunotherapy regimens. Adebrelimab, an anti-PD-L1 monoclonal antibody, exerts the antitumor effects by blocking the PD-1/PD-L1 interaction. Recaticimab is humanized monoclonal antibody targeting PCSK-9, which enhances the expression of low-density lipoprotein receptor (LDLR) on hepatocyte surfaces. The association between PCSK-9 and tumor cells has been delineated that PCSK-9 promotes tumor cell proliferation, invasion, and metastasis while inhibiting apoptosis. This study aims to assess the efficacy and safety of the combination of adebrelimab, chemotherapy, and recaticimab in the perioperative treatment of resectable NSCLC.
Trial design
This single-center, prospective, single-arm, phase II clinical trial enrolled adult participants with histologically confirmed NSCLC. Eligible participants must have at least one measurable lesion (≥5 mm in diameter) and no prior systemic therapy for NSCLC. Approximately 35 patients will be administered 150 mg of recaticimab via subcutaneous injection and 1200 mg of adebrelimab via intravenous infusion both on Day 1 of each 21-day treatment cycle (3 cycles in total) as neoadjuvant therapy; afterwards, patients without disease progression will undergo surgery; adjuvant therapy involving 1200 mg of adebrelimab administered intravenously on Day 1 of each 21-day cycle will begin 4–8 weeks post-surgery and not exceed 1 year. The primary endpoint is Pathological Complete Response (pCR) Rate. Secondary endpoints include Major Pathological Response (MPR) Rate, Objective Response Rate (ORR), Overall Survival (OS), Event-Free Survival (EFS), Disease-Free Survival (DFS), and safety profile assessment. Ethical approval of the study was obtained in May 2024, and recruitment has since commenced. To date, 4 out of the planned 35 patients have been enrolled.
Clinical trial identification
ChiCTR2400086014.
Legal entity responsible for the study
Beijing chest Hospital, Capital Medical University.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.