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).
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;
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;
Single group
Tafolecimab
DrugPatients will receive Tafolecimab 300 mg every 3 weeks.
Sintilimab (approved)
DrugPatients will receive Sintilimab 200 mg every 3 weeks.
Etoposide
DrugPatients will recieve Etoposide (100 mg/m2) intravenously on days 1, 2, and 3 of each 3-week cycle.
Carboplatin / Cisplatin
DrugPatients will receive carboplatin (AUC 5 mg/mL/min) or cisplatin (75 mg/m2) intravenously on day 1 of each 3-week cycle for up to 4 to 6 cycles.
Progression-free Survival as Assessed by RECIST v1.1
Progression-free survival (PFS) refers to the period from the start of combined treatment until any objectively recorded tumor progression occurs or until the patient's death (for patients lost to follow-up, it is the last follow-up time; for patients still alive at the end of the study, it is the date of the follow-up termination) as assessed by RECIST v1.1.
Objective Response Rate as Assessed by RECIST v1.1
Objective response rate (ORR) refers to the proportion of patients whose tumors have shrunk to a certain extent and maintained that state for a certain period of time, including cases of complete response (CR) and partial response (PR) as assessed by RECIST v1.1.
Progression-free Survival Rate as Assessed by RECISIT v1.1
6-month and 12-month progression-free survival rate refers to the proportion of patients whose time from the start of treatment to any objectively recorded tumor progression or patient death is equal to or greater than 6 months and 12 months.
Overall Survival Rate as Assessed by RECISIT v1.1
12-month and 24-month overall survival rate refers to the proportion of patients whose time from the first administration of the drug to any cause of death was greater than or equal to 12 months and 24 months.
Disease Control Rate as Assessed by RECISIT v1.1
Disease control rate refers to the proportion of patients whose tumors have shrunk to a certain extent and maintained that state for a certain period of time. It includes cases of complete response (CR), partial response (PR), and stable disease (SD).
Click on the lead sponsor to view all of their trials.
Second Affiliated Hospital, Zhejiang University, School of Medicine
Lead sponsor
Innovent Biologics, Inc.
Collaborator
