A Phase II, Open-Label, Single-Arm, Prospective Clinical Study to Investigate the Efficacy and Safety of Tislelizumab Combined With Anlotinib as Maintenance Therapy Following Tislelizumab and Chemotherapy for Treatment Naïve Extensive Stage Small Cell Lung Cancer
This is an open-label, single-arm, prospective phase 2 study, evaluating the efficacy and safety of tislelizumab combined with Anlotinib as maintenance therapy following tislelizumab and chemotherapy for treatment naïve extensive stage small cell lung cancer.
• Histologically or cytologically confirmed ES-SCLC, defined by the American Joint Committee on Cancer (AJCC) 8th edition or the Veterans Administration Lung Study Group (VALG) staging system.
• No prior treatment for ES-SCLC. (Patients who have received prior chemoradiotherapy for limited-stage SCLC must have been treated with curative intent and experienced a treatment-free interval of ≥ 6 months between the completion of chemotherapy, radiotherapy, or chemoradiotherapy and diagnosis of ES-SCLC).
• ECOG performance status ≤ 1.
• Life expectancy ≥ 3 months.
• Adequate organ function as indicated by the following laboratory values (obtained ≤ 7 days before first dose):
• Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L,hemoglobin ≥ 90 g/L.
• International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x upper limit of normal (ULN).
• Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN.
• Serum total bilirubin ≤ 1.5 x ULN.
• Aspartate and alanine aminotransferase (AST and ALT) ≤ 2.5 x ULN, or AST and ALT ≤ 5 x ULN for patients with liver metastases.
⁃ Serum albumin (ALB) ≥ 25g/L.
⁃ Serum creatinine ≤ 1.5 x ULN or estimated glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
⁃ Able to provide written informed consent by the patient or by the patient's legally acceptable representative and can understand and agree to comply with the requirements of the study.
⁃ 18 to 75 years old on the day of signing the informed consent form (ICF).
⁃ Fertile patients must be willing to use highly effective contraception during the study period and for 120 days after the last dose of tislelizumab.