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

Summary

This is a single arm, multi-center clinical trial. The goal of this clinical trial is to evaluate the efficacy, safety and biomarkers of Tafolecimab combined with Sintilimab and Chemotherapy as first-line treatment for patients with extensive-stage small cell lung cancer (ES-SCLC). Tafolecimab is a recombinant fully humanized monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK-9), which can reduce low-density lipoprotein-C levels and increase the expression level of major histocompatibility complex class I (MHC-I) on tumor cells. Sintilimab is a fully humanized IgG4 monoclonal antibody targeting programmed cell death protein 1 (PD-1).

Eligibility

Key Inclusion Criteria:

* 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).

Key Exclusion Criteria:

* Previously receiving systemic anti-tumor therapy for ES-SCLC;
* Combined SCLC (mixed SCLC and NSCLC histological types) or transformed SCLC confirmed by histological or cytological examination;
* 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;
* Active central nervous system (CNS) metastases (asymptomatic patients with stable lesions allowed);
* Severe cardiovascular disease;
* Severe chronic/active infections requiring systemic antibacterial, antifungal or antiviral treatment within 2 weeks before enrollment;
* 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;
* Pregnancy or lactation;
* Having a disease that requires systemic corticosteroids or other immunosuppressants to be treated within ≤14 days before enrollment;
* Requiring at least monthly or more frequent drainage of pleural and/or pericardial or peritoneal effusion;
* Using attenuated live vaccines, or planned to receive attenuated live vaccines within 28 days before enrollment;
* 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;
* Toxicity caused by previous anti-cancer treatment has not recovered to baseline or stable state at the time of enrollment;
* Creatinine clearance rate \< 60 mL/min (cisplatin) or \< 45 mL/min (carboplatin)
* Uncontrolled or symptomatic hypercalcemia.

Conditions6

Interventions4

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