Adebrelimab combined with oral etoposide for older patients and patients with poor performance status In small cell lung cancer: A multicenter, open-label, phase II clinical study.

Abstract

TPS293 Background: Small cell lung cancer (SCLC) is a highly aggressive, high-grade neuroendocrine carcinoma characterized by rapid proliferation and early metastatic dissemination. Recent research has demonstrated that adebrelimab plus platinum-based chemotherapy have demonstrated promising anti-tumour activity in first-line treatment of SCLC in CAPSTONE-1 trial. However, a substantial proportion of patients—particularly older patients and those with poor performance status (ECOG PS ≥2) or significant comorbidities—cannot tolerate standard platinum-based regimens due to reduced tolerance to systemic therapy. In such cases, oral etoposide is an active single-agent option. Therefore, this study aims to evaluate the efficacy and safety of adebrelimab combined with oral etoposide as a first-line treatment for SCLC in older patients and those with poor performance status. Methods: In this multicenter, open-label, phase II trial, 47 patients with extensive-stage SCLC or limited-stage, diagnosed histologically or cytologically, and who are treatment-naive are anticipated to be enrolled. Key inclusion criteria are: age≥65 years, or an Eastern Cooperative Oncology Group performance status of 2 or 3, an expected life expectancy of at least 3 months, and adequate organ function, not indicated for curative surgery or chemoradiotherapy. Additionally, patients aged < 65 years with an ECOG PS of 0-1 may be considered if they have extensive comorbidities. Key exclusion criteria included risk of bleeding, uncontrolled hypertension, uncontrolled effusions, active serious infections, autoimmune disease, or uncontrolled symptomatic brain metastases. Patients will be dosed adebrelimab (1200 mg, iv, every 3 weeks) in combination with oral etoposide (75 mg, po, once daily). The primary endpoint is progression-free survival and the secondary endpoints are objective response rate, disease control rate, overall survival, safety and quality of life. The study is actively recruiting. Clinical trial information: NCT07398560 .