A Clinical Trial of Fruquintinib in Patients With Advanced Non-small Cell Lung Cancer

Inclusion Criteria: 1. Fully understand the study and sign the informed consent form voluntarily; 2. Histologically and/or cytologically diagnosed with local advanced and/or metastatic stage IIIB/IV non-squamous NSCLC; 3. Previously failed to two chemotherapy regimens(treatment failure is defined as disease progression or intolerable toxicity), patients with positive EGFR mutation permitted to treated by EGFR-TKI previously; patients with EGFR wild type or unknown whether or not treated by EGFR-TKI previously; 4. Aged 18-75 years (inclusive); 5. Body weight ≥40 kg; 6. Evident measurable lesion(s) (according to RECIST1.1); 7. ECOG Performance Status 0-1; 8. Expected survival \>12 weeks Exclusion Criteria: 1. Treatment in another clinical trials in the past 3 weeks; or treatment with systemic anti-tumor chemotherapy, radiotherapy or biotherapy within 3 weeks prior to administration of the study drug; 2. Previous therapy with VEGF/VEGFR inhibitors; 3. Unrecovered from toxicity caused by previous anti-cancer treatment (CTCAE \>grade 1), or not completely recovered from previous surgery; 4. Previous active brain metastasis (without radiotherapy previously, or symptoms stable \< 4 weeks, or with clinical symptoms, or with medication to control symptoms); 5. Other malignancies except basal cell carcinoma or cervical carcinoma in situ in the past 5 years; 6. Uncontrolled clinical active infection, e.g. acute pneumonia and active hepatitis B; 7. Dysphagia or known drug malabsorption; 8. Present active duodenal ulcer, ulcerative colitis, intestinal obstruction and other gastrointestinal diseases or other conditions that may lead to gastrointestinal bleeding or perforation according to the investigators' judgment; or with a history of intestinal perforation or intestinal fistula; 9. Have evidence or a history of thrombosis or bleeding tendency, regardless of seriousness; 10. Stroke and/or transient ischemic attack within 12 months prior to enrollment; 11. Appropriate organ function. Patients with any of the following conditions will be excluded: * Absolute neutrophil count (ANC) \<1.5×109/L, platelet \<100×109/L or hemoglobin \<9 g/dL within 1 week prior to enrollment; * Serum total bilirubin \>1.5 upper limit of normal (ULN), alanine transaminase and aspartate transferase \>1.5×ULN; ALT and AST \> 3×ULN in patients with liver metastasis; * Electrolyte abnormality of clinical significance; * Blood creatinine \>ULN and creatinine clearance \<60 ml/min; * Urine protein 2+ or above, or 24 h urine protein quantification ≥1.0 g/24 h; * Activated partial thromboplastin time (APTT) or/and INR and prothrombin time (PT) \>1.5×ULN (according to reference range in each clinical study center); 12. Uncontrolled hypertension, systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg with medication; or heart failure NYHA classification ≥ grade 2; 13. Heart function evaluation: left ventricular ejection fraction \<50% (echocardiography); 14. Acute myocardial infarction, severe/unstable angina or coronary bypass surgery within 6 months prior to enrollment; history of arterial thrombosis or deep venous thrombosis; 15. Skin wound, surgical site, wound site, severe mucosal ulcer or fracture without complete healing; 16. Female subjects who are pregnant or lactating or of child bearing potential with positive pregnancy test result before the first dose; 17. Patients with child bearing potential who or whose sexual partners are not willing to take contraceptive measures; 18. Any clinical or laboratory abnormalities unfit to participate in this clinical trial according to the investigator's judgment; 19. Serious psychological or psychiatric disorders which may affect subject compliance in this clinical study; 20. Allergy to Fruquintinib and/or excipient contained in trial drugs.