study of anlotinib as the maintenance therapy for extensive-stage small cell lung cancer

Conditions: Extensive-stage Small Cell Lung Cancer

Summary: 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.


Eligibility criteria:
inclusion criteria: * 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. exclusion criteria: * 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.

Keywords: small cell lung cancer; anlotinib; maintenance therapy