A Randomized Controlled Multicenter Clinical Trial to Compare the Efficacy and Safety of Anlotinib as the Maintenance Therapy for Extensive-stage Small Cell Lung Cancer After Combined With Etoposide and Cisplatin Chemotherapy
试验速览
- 阶段
- 2 期
- 入组人数
- 116
- 主要终点
- Progression-free survival
研究概览
简要总结
Anlotinib has been approved as a third-line treatment for advanced non-small-cell lung cancer. A phase II clinical studies of small cell lung cancer (ALTER-1210) also showed that, compared with placebo, Anlotinib could improve the patients survival and had less toxic side effects after 2-3 line therapy. The purpose of this multicenter, randomized, prospective study is to investigate the efficacy and safety of Anlotinib as the maintenance therapy for Extensive-stage small cell lung cancer after combined with etoposide and cisplatin chemotherapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Histologic or cytologic diagnosis of small cell lung caner
- •Advanced small cell lung cancer who had no prior cisplatin-based chemotherapy or radiotherapy,at least one measurable lesion (by RECIST1.1)
- •Males or females between 18 Years to 75 Years.
- •Performance status of 0～2 on the ECOG criteria.
- •Main organs function is normal
- •Expected survival is above three months.
- •with asymptomatic brain metastases.
- •At least one measurable lung tumor lesion (according to RECIST criteria, the application of conventional technology, diameter length of the lesion >= 20mm or spiral CT >=10mm).
- •Adequate hematologic (Leukocyte count >= 4.0×109/L, neutrophil count>=2.0×109/L, hemoglobin>=95g/L, platelets>=100×109/L), hepatic function (aspartate transaminase (AST) & alanine transaminase(ALT)
- •=<upper normal limit(UNL) x1.5, bilirubin level =< UNL x 1.5).
- •Patient can take oral medicine.
- •Patients have the ability to understand and voluntarily sign the informed consent, and allow adequate follow-up.
排除标准
- •History of cardiovascular disease: congestive heart failure (CHF) > New York Heart Association (NYHA) II, active coronary artery disease(patients with myocardial infarction six months ago can be recruited), arrhythmias need to be treated (allow taking beta blockers or digoxin).
- •Serious clinical infection (> NCI-CTCAE version 4.0 ,infection standard II).
- •Patients with epilepsy who need to take medicine (such as steroids or anti epilepsy agents).
- •The patients had accepted allogeneic organ transplantation.
- •Bleeding tendency or coagulation disorders.
- •patients who need renal dialysis.
- •suffered from other tumor within 5 years( Except: cervical carcinoma in situ, cured basal cell carcinoma, cured bladder epithelial tumor).
- •uncontrolled hypertension (systolic pressure>150 mmHg , or diastolic pressure> 90 mmHg).
- •thrombosis or embolism(cerebrovascular accidents including transient ischemic attack within the last 6 months).
- •pulmonary hemorrhage >CTCAE grade 2 within 4 weeks before first use of drugs.
- •Other organ hemorrhage >CTCAE grade 3 within 4 weeks before first use of drugs.
- •severe uncured wounds, ulcers or fracture.
- •uncured dehydration.
- •Drugs abuse and medical, psychological or social conditions may interfere with the patient's participation in research or the results of the evaluation effect.
- •Patients are allergic to drugs used in research.
- •Factors influencing the safety and compliance of patients.
- •Inability to comply with protocol or study procedures.
- •Pregnant or breast-feeding.
- •The researcher believe that the Patient is not suitable to participate in the study.
研究组 & 干预措施
Anlotinib + Chemotherapy
Patients receive etoposide 100mg/m2 from day 1 to day 3, cisplatin 75mg/m2 on day 1, and Anlotinib 12mg/d on day 1 to day 14 , repeated every 21 days, a total of 4-6 cycles, and then continue to take Anlotinib 12mg/d on day 1 to day 14, repeated every 21 days until progressive Disease(PD).
干预措施: Anlotinib Hydrochloride; etoposide and cisplatin (Drug)
Chemotherapy
Patients receive etoposide 100mg/m2 from day 1 to day 3, cisplatin 75mg/m2 on day 1, repeated every 21 days, a total of 4-6 cycles, and then follow up observation until PD.
干预措施: etoposide and cisplatin (Drug)
结局指标
主要结局
Progression-free survival
时间窗: From randomization，each 42 days up to PD or death(up to 24 months
The first day of treatment to the date that disease progression is reported
次要结局
- Disease Control Rate(each 42 days up to intolerance the toxicity or PD (up to 24 months))
- Overall survival(From randomization until death (up to 5 years))
- Performance Status(the first date of treatment to 30 days after the last dose of study drug, assessed up to 24 months)
- Objective Response Rate(each 42 days up to intolerance the toxicity or PD (up to 24 months))
- Treatment-related adverse events(the first date of treatment to 30 days after the last dose of study drug,assessed up to 24 months)
研究者
Dong Wang
chief physician
Third Military Medical University