Clinical Study of Anlotinib in Maintenance Treatment of Advanced NSCLC

Exclusion Criteria

• •Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors affecting drug use and absorption;
• •There is a third interstitial effusion (e.g. massive pleural and ascites) that cannot be controlled by drainage or other means;
• •Radiotherapy, surgical treatment, or other targeted therapy for non-small cell lung cancer was given within four weeks before the first study drug was administered;
• •Researchers judged that they had not recovered from previous adverse events before taking the drug for the first time (NCI-CTCAE Version 4.0 Grade \> Grade 1);
• •Patients with multiple or active (uncontrolled) brain metastases, cancerous meningitis, spinal cord compression, or with brain or pia mater diseases detected by CT or MRI at screening time (patients with single brain metastases whose symptoms were stable and had completed treatment within 28 days prior to the first use of the research drug) may be enrolled in the group, but only through craniocerebral MRI, CT or venography. Shadow evaluation confirmed no symptoms of cerebral hemorrhage;
• •Participated in other drug clinical trials within 4 weeks before taking the first research drug;
• •There was a history of bleeding. Within 4 weeks before screening, any bleeding events with a severe grade of 3 or more in CTCAE 4.0 occurred;
• •Having a history of thrombosis, or judging by researchers, abnormal coagulation function has clinical significance, tends to bleed, or is undergoing thrombolysis or anticoagulation therapy;
• •Hemoptysis was evident within 2 months before the first study drug was administered;
• •Patients with hypertension who could not be well controlled by a single antihypertensive drug (systolic pressure \> 140 mmHg, diastolic pressure \> 90 mmHg); patients with a history of unstable angina pectoris; newly diagnosed angina pectoris in the first three months of screening or myocardial infarction events in the first six months of screening; arrhythmia (including QTcF: males \> 450 ms, females) Long-term use of antiarrhythmic drugs and New York Heart Association Classification (\> Class II) cardiac insufficiency were required;
• •Urinary routine indicated that urinary protein (++) and confirmed 24-hour urinary protein quantification \> 1.0 G;
• •Long-term union of wounds or incomplete healing of fractures;
• •Other malignant tumors in the past five years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma;
• •Those with allergic constitution or known history of allergy to the drug components of this regimen;
• •Has a history of immunodeficiency, including HIV positive testing, or other acquired, congenital immunodeficiency disorders, or organ transplantation history;
• •The baseline pregnancy test was positive for pregnant, lactating or fertile women, and the patients of childbearing age who were unwilling to take effective contraceptive measures during the whole period of the test were unwilling to take effective contraceptive measures;
• •According to the judgement of researchers, there are concomitant diseases that seriously endanger patients'safety or affect patients' completion of research;
• •There was a clear history of neurological or psychiatric disorders, including epilepsy or dementia;
• •Researchers believe that patients are not suitable for any other situation in this study.