Drug-drug Interaction Study of Gefitinb on Apatinib in NSCLC Patients

Inclusion Criteria:

1. 18-75 years of age.
2. ECOG performance status: level 0\~1;
3. Anticipated life expectancy ≥ 12 weeks;
4. Lung cancer patients;
5. Major organs in good function;
6. Agree to take approved method of contraception during the clinical trail and 8 weeks after the last dose of apatinib. Female subject should be negative in the pregnancy test;
7. Able to comprehend and willing to sign an informed consent form (ICF)

Exclusion Criteria:

1. History of drug allergy, or allergic to apatinib or gefitinib or ingredients;
2. Squamous cancer, small-cell lung cancer;
3. Symptomatic central nervous system (CNS) metastases
4. Hypertension and couldn't be controlled with medicine;
5. Coagulation disorders;
6. Clinical significant bleeding in 3 months prior dosing;
7. Had surgery in four weeks prior dosing;
8. Disease that affect drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction;
9. Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess in 6 months prior dosing;
10. Urine protein ≥++, and urine protein ≥1.0g in 24 hours;
11. Active infection and need antimicrobial treatments;
12. History of psychiatric substance abuse;
13. Take any clinical trial drugs within four weeks prior dosing;
14. Take any drugs that have effect on gastric acid and metabolic enzyme CYP 3A and CYP2D6;
15. Combined with other viral infections (anti-HCV, anti-HIV positive, HBsAg positive) or combined with syphilis infection;
16. Addicted to alcohol and tobacco;
17. Take grapefruit or grapefruit product, drinks containing caffeine, xanthine and alcohol in 48 hours prior dosing;
18. The investigator believes that the subjects are not eligible to participate in this trial.