Sintilimab Combined With Tafolecimab and Chemotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer

Prior treatment

• Previously receiving systemic anti-tumor therapy for ES-SCLC;
• Receiving other investigational drugs or participated in other interventional clinical studies within 4 weeks before signing the informed consent form;
• Receiving systemic immunostimulant treatment within 4 weeks before enrollment;
• Severe chronic/active infections requiring systemic antibacterial, antifungal or antiviral treatment within 2 weeks before enrollment;
• Having a disease that requires systemic corticosteroids or other immunosuppressants to be treated within ≤14 days before enrollment;
• Using attenuated live vaccines, or planned to receive attenuated live vaccines within 28 days before enrollment;
• Toxicity caused by previous anti-cancer treatment has not recovered to baseline or stable state at the time of enrollment;

Other illness

• Severe cardiovascular disease;
• Active hepatitis B virus (HBV)/ hepatitis C virus (HCV)/ human immunodeficiency virus (HIV) infection;
• Active autoimmune diseases, a history of interstitial lung disease, or other uncontrolled systemic diseases;
• Known to be allergic to Sintilimab or Tafolecimab or its excipients, having a history of severe allergic reaction to any monoclonal antibody, or having a history of allergy to cisplatin, carboplatin or etoposide;

Lab values

• Creatinine clearance rate \< 60 mL/min (cisplatin) or \< 45 mL/min (carboplatin)

Other

• Combined SCLC (mixed SCLC and NSCLC histological types) or transformed SCLC confirmed by histological or cytological examination;
• Active central nervous system (CNS) metastases (asymptomatic patients with stable lesions allowed);
• Pregnancy or lactation;
• Requiring at least monthly or more frequent drainage of pleural and/or pericardial or peritoneal effusion;
• Uncontrolled or symptomatic hypercalcemia.

• Age ≥18 years, ECOG performance status 0-1;
• Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) according to Veterans Administration Lung Study Group criteria;
• Previously not receiving systemic treatment for ES-SCLC;
• Greater than or equal to 1 measurable lesion exists according to RECIST v1.1;
• Expected survival \>= 12 weeks;
• Adequate organ system functions (no blood transfusion or component blood use within 14 days before testing).