A Single-arm Phase II Clinical Trial of Serplulimab Combined With Concurrent Chemoradiotherapy for Limited-stage Small Cell Lung Cancer(LS-SCLC).
Small cell lung cancer(SCLC) has a poor prognosis and a relatively short overall survival time, urgently requiring innovative treatment strategies to improve the prognosis of such patients. Immunotherapy has become an important component of first-line therapy for extensive-stage small cell lung cancer (ES-SCLC). Studies have found that, compared to chemotherapy alone, the combination of Surlidumab with carboplatin and etoposide can extend the median overall survival in ES-SCLC to over 15 months. However, to date, research on the use of immunotherapy in combination with concurrent chemoradiotherapy (CCRT) in limited-stage small cell lung cancer (LS-SCLC) remains limited. This study aims to explore the clinical benefits of Surlidumab in combination with concurrent chemoradiotherapy in LS-SCLC and evaluate the safety of immunotherapy in combination with CCRT as first-line treatment for LS-SCLC. At the same time, it seeks to identify tumor-related biomarkers that can effectively predict the efficacy of immunotherapy and prognosis.
• Aged 18 years or older
• Diagnosed with small cell lung cancer by histology or cytology, and staged as limited stage (stage II-III according to the 8th edition of AJCC Cancer Staging)
• Treatment-naïve population, not having received any prior targeted therapy, chemotherapy, radiation therapy, or immunotherapy for anti-tumor treatment
• Measurable lesions based on RECIST 1.1
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. ECOG assessment should be conducted within 7 days prior to the first dose of the study intervention
• Baseline hematologic, blood biochemistry, and urine biochemistry tests confirming sufficient bone marrow and organ function
• Life expectancy of at least 6 months
• Male participants: Male participants must agree to use effective contraception during the study treatment and for at least 180 days after the last dose, and must not donate sperm during this period
• Female participants must not be pregnant or lactating, and must meet at least one of the following conditions:
‣ Women who are not capable of reproduction or
⁃ Agree to use effective contraception during the treatment and for at least 180 days after the last dose
⁃ Women capable of reproduction must undergo a serum or urine pregnancy test within 72 hours before starting the medication, and the result must be negative (minimum sensitivity 25 IU/L or equivalent units of HCG)
∙ (11) Signed informed consent form