Abstract 105TiP
Background
Patients with non-small cell lung cancer (NSCLC) and brain metastases (BM) often face limited treatment options. NSCLC patients with PD-L1≥50% may benefit from anti-PD immunomonotherapy. Anti-angiogenic therapy can help reduce brain edema and modulate the local tumor microenvironment, while combined immunotherapy has a synergistic effect. Previous prospective randomized controlled studies included a small number of patients with BM and did not consider PD-L1 expression levels, all of which were classified as subgroup analyses, thus not providing a reliable basis for clinical treatment. Adebrelimab is an anti-PD-L1 monoclonal antibody that blocks the PD-1/PD-L1 pathway to play an anti-tumor role. Famitinib is a small molecule multi-target tyrosine kinase inhibitor that exerts antitumor effects by inhibiting angiogenesis. The study aims to evaluate the efficacy and safety of adebrelimab combined with famitinib in treating advanced NSCLC with BM and PD-L1≥50%.
Trial design
BRAIN-AF01 is a single-center, prospective, single-arm trial. Patients of advanced NSCLC, BM and PD-L1≥50% are eligible. At baseline, patients are required to have at least one measurable intracranial lesion, defined as≥5 mm, and should not have received prior systemic treatment for NSCLC. Approximately 32 patients will receive 20 mg of famitinib orally once daily, and 1200 mg of adebrelimab by intravenous infusion on Day 1 of each 21-day treatment cycle. Treatment continues until disease progression, withdrawal of consent, the development of unacceptable side effects, or the fulfillment of other discontinuation criteria. The primary endpoint is the objective response rate (ORR). Secondary endpoints include progression-free survival (PFS), disease control rate (DCR), intracranial ORR (iORR), intracranial PFS (iPFS), overall survival (OS), and safety. Exploratory endpoints will focus on drug concentration in peripheral blood compared with cerebrospinal fluid, metabolomic characteristics, dynamic ctDNA genomic characteristics, and multimodal 3T/7TMRI imaging characteristics. The corresponding author Li Xiaoyan designed this study.
Clinical trial identification
ChiCTR2300079126 Release date: 2023.12.26.
Legal entity responsible for the study
Beijing TianTan Hospital, Capital, Medical, University.
Funding
Beijing Natural Science Foundation (7242007).
Disclosure
All authors have declared no conflicts of interest.