A Study of Famitinib Plus Docetaxel in Patients With Advanced Non-squamous and Non-Small Cell Lung Cancer (NSCLC)

Exclusion Criteria

• •1. More than one chemotherapy treatment regimen (except,either neoadjuvant or adjuvant or neoadjuvant plus adjuvant) for advanced and/or metastatic or recurrent NSCLC;
• •2. Previous therapy with other VEGFR inhibitors (including sunitinib,sorafenib,pazopanib,axitinib,other than bevacizumab) or docetaxel for treatment of NSCLC;
• •3. Radiographical evidence of cavitary or necrotic tumours;
• •4. Centrally located tumours with radiographical evidence (CT or MRI) of local invasion of major blood vessels;
• •5. Pre-existing ascites and/or clinically significant pleural effusion;
• •6. Pulmonary hemorrhage/ bleeding event ≥ CTCAE gr. 2 before initiating investigational drugs;
• •7. History of clinically significant haemoptysis within the past 3 months（24h \>half teaspoon）;
• •8. Current peripheral neuropathy greater than CTCAE grade 2;
• •9. Other malignancy within the past 3 years other than basal cell skin cancer, or carcinoma in situ of the cervix;
• •10. Active brain metastases (such as stable time ≤ 4 weeks,no radiotherapy treatment,any symptoms,or seizures treatment needing) or leptomeningeal disease.;
• •11. Treatment with other investigational drugs or other anti-cancer therapy, or treatment in another clinical trial within the past 4 weeks before start of therapy or concomitantly with this trial;
• •12. Persistence of clinically relevant therapy related toxicities from previous chemotherapy and/or radiotherapy;
• •13. Treatment with cytotoxic drugs, radiotherapy(except extremities and brain) , immunotherapy , monoclonal antibody, or TKI inhibitor therapy within the past 4 weeks, being previous anti-cancer treatment interval ≤ 4 weeks.;
• •14. Patients with hypertension using combination therapy (systolic blood pressure\>140 mmHg, diastolic blood pressure\>90 mmHg). Patients with unstable angina, myocardial ischemia or myocardial infarction in the past 6 months, congestive heart failure\>NYHA II,and arrhythmia (including QTcF interval ≥ 450ms for male and 470ms for female);
• •15. Urine protein ≥ + + and confirmed the 24-hour urinary protein\>1.0 g;
• •16. History of major thrombotic or clinically relevant major bleeding event in the past 6 months，and known inherited predisposition to bleeding or thrombosis;
• •17. PT or APTT bias from normal range≥50%;
• •18. Application of anticoagulants or vitamin K antagonists such as warfarin, heparin or its analogues;If the prothrombin time international normalized ratio (INR) ≤ 1.5, with the purpose of prevention, the use of small doses of warfarin (1mg orally, once daily) ， low-dose aspirin (less than 100mg daily) is allowed;
• •19. Preexisting thyroid dysfunction, even using medical therapy, thyroid function cannot maintain in the normal range;
• •20. Diabetes mellitus can not controlled with hypoglycemic agent;
• •21. Active or chronic hepatitis C and/or B infection with liver dysfunction;
• •22. History of immunodeficiency disease, concurrent acquired or congenital immunodeficiency,or history of organ transplantation;
• •23. Serious infections requiring systemic antibiotic therapy;
• •24. Variety of factors that affect the oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction);
• •25. Significant weight loss (\>10 %) within the past 6 months;
• •26. Pregnancy , breast feeding or child bearing potential, a positive urine or serum pregnancy test result 7 days before initiating famitinib;
• •27. Active alcohol or drug abuse;
• •28. Any contraindications for therapy with docetaxel；History of severe hypersensitivity reactions to docetaxel or other drugs formulated with polysorbate 80 (Tween 80)；Hypersensitivity to famitinib and/or the excipients of the trial drugs；Hypersensitivity to contrast media;
• •29. Psychological, familial, sociological, or geographical factors potentially hampering compliance with the study protocol and follow-up schedule;
• •30. Patients unable to comply with the protocol;
• •31. Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.