Efficacy and Safety of Sintilimab Combined With Tafolecimab and Chemotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer (STAR-SCLC)：A Prospective, Single Arm Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- Progression-free Survival as Assessed by RECIST v1.1
研究概览
简要总结
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).
详细描述
Eligible patients will receive 4 cycles of Tafolecimab (300mg, sc, d1, Q3W) in combination with Sintilimab (200mg, iv, d1, Q3W), along with etoposide and either carboplatin (AUC 5 mg/mL/min) or cisplatin (75 mg/m2) administered intravenously on days 1, 2, and 3 of each 3-week cycle for up to 4 to 6 cycles. Subsequently, patients will receive maintenance therapy with Sintilimab and Tafolecimab until disease progression, the occurrence of intolerable toxicities, or the treatment duration reaches 2 years. If the investigator assesses potential evidence of clinical benefit, continuing treatment after disease progression is permitted.
PRIMARY OBJECTIVES:
I. To evaluate the progression-free survival (PFS) of Tafolecimab combined with Sintilimab and chemotherapy as first-line treatment regimens for patients with extensive-stage small cell lung cancer (ES-SCLC).
SECONDARY OBJECTIVES:
I. To evaluate the safety of of Tafolecimab combined with Sintilimab and chemotherapy as first-line treatment regimens for patients with ES-SCLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Tafolecimab + Sintilimab + Chemotherapy
Eligible patients will receive 4 cycles of Tafolecimab (300 mg, sc, d1, Q3W) in combination with Sintilimab (200 mg, iv, d1, Q3W), along with etoposide and either carboplatin (AUC 5 mg/mL/min) or cisplatin (75 mg/m2) for up to 4 to 6 cycles. Subsequently, they will receive maintenance therapy with Sintilimab and Tafolecimab until disease progression, the occurrence of intolerable toxicities, or the completion of 2 years of treatment. Etoposide (100 mg/m2) will be administered intravenously on days 1, 2, and 3 of each 3-week cycle, while carboplatin or cisplatin will be given intravenously on day 1 of each 3-week cycle.
干预措施: Tafolecimab (Drug)
Tafolecimab + Sintilimab + Chemotherapy
Eligible patients will receive 4 cycles of Tafolecimab (300 mg, sc, d1, Q3W) in combination with Sintilimab (200 mg, iv, d1, Q3W), along with etoposide and either carboplatin (AUC 5 mg/mL/min) or cisplatin (75 mg/m2) for up to 4 to 6 cycles. Subsequently, they will receive maintenance therapy with Sintilimab and Tafolecimab until disease progression, the occurrence of intolerable toxicities, or the completion of 2 years of treatment. Etoposide (100 mg/m2) will be administered intravenously on days 1, 2, and 3 of each 3-week cycle, while carboplatin or cisplatin will be given intravenously on day 1 of each 3-week cycle.
干预措施: Sintilimab (approved) (Drug)
Tafolecimab + Sintilimab + Chemotherapy
Eligible patients will receive 4 cycles of Tafolecimab (300 mg, sc, d1, Q3W) in combination with Sintilimab (200 mg, iv, d1, Q3W), along with etoposide and either carboplatin (AUC 5 mg/mL/min) or cisplatin (75 mg/m2) for up to 4 to 6 cycles. Subsequently, they will receive maintenance therapy with Sintilimab and Tafolecimab until disease progression, the occurrence of intolerable toxicities, or the completion of 2 years of treatment. Etoposide (100 mg/m2) will be administered intravenously on days 1, 2, and 3 of each 3-week cycle, while carboplatin or cisplatin will be given intravenously on day 1 of each 3-week cycle.
干预措施: Etoposide (Drug)
Tafolecimab + Sintilimab + Chemotherapy
Eligible patients will receive 4 cycles of Tafolecimab (300 mg, sc, d1, Q3W) in combination with Sintilimab (200 mg, iv, d1, Q3W), along with etoposide and either carboplatin (AUC 5 mg/mL/min) or cisplatin (75 mg/m2) for up to 4 to 6 cycles. Subsequently, they will receive maintenance therapy with Sintilimab and Tafolecimab until disease progression, the occurrence of intolerable toxicities, or the completion of 2 years of treatment. Etoposide (100 mg/m2) will be administered intravenously on days 1, 2, and 3 of each 3-week cycle, while carboplatin or cisplatin will be given intravenously on day 1 of each 3-week cycle.
干预措施: Carboplatin / Cisplatin (Drug)
结局指标
主要结局
Progression-free Survival as Assessed by RECIST v1.1
时间窗: From enrollment to the end of treatment at 12 months
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.
次要结局
- Objective Response Rate as Assessed by RECIST v1.1(From enrollment to the end of treatment at 12 months)
- Progression-free Survival Rate as Assessed by RECISIT v1.1(From enrollment to the end of treatment at 6 months and 12 months)
- Overall Survival Rate as Assessed by RECISIT v1.1(From enrollment to the end of treatment at 12 months and 24 months)
- Disease Control Rate as Assessed by RECISIT v1.1(From enrollment to the end of treatment at 12 months)
- Duration of Response as Assessed by RECISIT v1.1(From enrollment to the end of treatment at 12 months)
- Percentage of Participants with Treatment-Related Adverse Events as Assessed by NCI-CTCAE v5.0(From enrollment to the end of treatment at 12 months)
- Overall survival as Assessed by RECISIT v1.1(From enrollment to the end of treatment at 24 months)