A Randomized, Open-label Study of Lobaplatin/Etoposide as First Line Therapy With or Without Anlotinib Maintenance Therapy in Patients With Extensive-stage Small-cell Lung Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Progression Free Survival Time
研究概览
简要总结
This is a prospective, randomized, open-label and active controlled phase II study. It plans to enroll 60 subjects with extensive stage small cell lung cancer (ES-SCLC). All subjects will be assigned randomly to the experimental arm or control arm. The primary endpoints would be overall survival and progression-free survival.
详细描述
Small cell lung cancer (SCLC) accounts for about 20% of lung cancer, has a high degree of malignancy, short doubling time, early and widespread metastasis, is sensitive to chemotherapy and radiotherapy, and has a high initial response rate, but is prone to secondary drug resistance and relapse. The treatment is mainly based on systemic chemotherapy.
SCLC has a more abundant vascular network than NSCLC. Anti-tumor vascular therapy combined with chemotherapy is considered the most promising SCLC first-line anti-tumor strategy. Anlotinib Hydrochloride has an anti-angiogenic effect and inhibits tumor's growth. It has been reported that Anlotinib has the dual benefits of both overall survival and progression-free survival in the treatment of multiple tumors, and has initially demonstrated its safety and efficacy. The ALTER 0303 study results showed that Anlotinib benefited both the overall and progression-free survival of NSCLC patients. However, there is no clinical study to probe its relevance to small cell lung cancer, and few studies have examined the status of Anlotinib in first-line treatment.
This randomized, open-label, controlled study is to evaluate the efficacy and safety of sequential EL regimen with Anlotinib hydrochloride as first-line treatment for extensive-stage SCLC. The study plan to enroll 60 ES-SCLC subjects and will provide evidence for the use of Anlotinib for SCLC first-line treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathologically confirmed patients with extensive small cell lung cancer;
- •Karnofsky performance status ≥70;
- •At least one lesion that can measured by CT;
- •Expected to survive for at least 3 months;
- •Peripheral blood and liver and kidney function within the following allowable range (tested within 7 days before treatment);
- •White blood cell (WBC) ≥3.0×109/L or Neutrophils (ANC) ≥1.5×109/L;
- •Hemoglobin (HGB) ≥80 g/L；
- •Platelet (PLT) ≥100×109/L;
- •Liver transaminases（AST/ALT）<3.0 times the normal range limit;
- •Total bilirubin（TBIL）<1.5 times the normal range limit;
- •Creatinine（CREAT）<1.5 times the normal range limit;
- •Patients of childbearing age (including female and male patients' partner) must take effective contraception methods;
- •Signed informed consent;
- •Known history of liver disease: Hepatitis B Virus (HBV) infection and Hepatitis B Virus DNA (HBV DNA ≥500 copies or ≥100 IU/ml); or Hepatitis C Virus (HCV) infection; or liver cirrhosis, etc.
- •Human immunodeficiency virus (HIV);
- •Subjects with difficulties in swallowing or known drug malabsorption; Those who meet each of the above criteria are included in the study.
排除标准
- •Other pathological types of tumor except for small cell lung cancer;
- •Patients with a history of severe allergies or allergies;
- •Pregnancy or breastfeeding women;
- •Patients who have previously participated in other clinical trials and have not yet terminated the trial;
- •Combined with other tumors at the time of initial diagnosis;
- •Patients who have previously participated in other clinical trials and have not yet terminated the trial;
- •Patients who have acute infection that difficult to control;
- •Drug abuse, substance abuse, chronic alcohol abuse, and AIDS patients. Those who meet any of the above criteria are not included in the study.
研究组 & 干预措施
Anlotinib/Lobaplatin/Etoposide
EL regimen for 4 cycles followed by Anlotinib Hydrochloride maintenance therapy
干预措施: Anlotinib Hydrochloride (Drug)
Anlotinib/Lobaplatin/Etoposide
EL regimen for 4 cycles followed by Anlotinib Hydrochloride maintenance therapy
干预措施: Lobaplatin (Drug)
Anlotinib/Lobaplatin/Etoposide
EL regimen for 4 cycles followed by Anlotinib Hydrochloride maintenance therapy
干预措施: Etoposide (Drug)
Lobaplatin/Etoposide
EL regimen for 4 cycles
干预措施: Lobaplatin (Drug)
Lobaplatin/Etoposide
EL regimen for 4 cycles
干预措施: Etoposide (Drug)
结局指标
主要结局
Progression Free Survival Time
时间窗: Time from randomization to first documented progression, assessed for up to 2 years
Progression free survival (PFS) is defined as the time from date of randomization to the date of objective disease progression or death due to any cause. Participants were censored at date of last PFS assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy, whichever was earlier.
次要结局
- Percentage of Participants With a Complete Response (CR) and Partial Response (PR) (Overall Response Rate)(Up to 2 years)
- Overall Survival(Time from randomization to death by any cause, assessed for up to 3 years)
研究者
Jiexia Zhang
Deputy Director
The First Affiliated Hospital of Guangzhou Medical University