Lung cancer
Conditions
Interventions
experimental group:Apatinib combined with Docetaxel or pemetrexed
Control group: Docetaxel or pemetrexed
Sponsors
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. aged 18-75 years male and female; 2. ECOG 0-2; 3. Estimated survival time=12 weeks; 4. Histologicaly and cytologicaly diagnosed as non-squamous non-small cell lung cancer (stage IIIb, unable for multiple disciplinary team), or metastatic lung cancer(stage IV) with At least one imaging examination of measurable lesions (RECIST), CT or MR scan Long diameter of tumor = 10 mm; 5. without EGFR mutation; 6. First line treatment failure; 7. Subjects received treatment caused other damage has been restored, which accepts nitroso or mitomycin interval >=6 weeks; acceptance of other cytotoxic drugs, Avastin, radiation or surgery >=4 weeks, EGFR-TKI >=2 weeks; 8. The main organ function is normal, and meet the following standards:(1)The standard of blood routine examination should be consistent: HB=90 g/L, ANC=1.5×10^9/L, PLT=80×10^9/L; (2)Biochemical tests should meet the following criteria: TBIL<1.5'ULN, ALT and AST<2.5'ULN, and < 5'ULN for liver metastasis patients; 9. Fertile woman must perform a pregnancy test (serum or urine) 7 days before screened, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib. For man, surgical sterilization should be performed, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib; 10. Patients voluntarily entered the study and signed informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1. Pathologically diagnosed as squamous cell carcinoma, mixed non-small cell and small cell carcinoma, or squamous cell as the main component of mixed gonadal squamous cell carcinoma; 2. The activity of brain metastasis; 3. High blood pressure and failure to be reduced to normal range by antihypertensive drugs(Systolic pressure > 140 mmHg; 4. Suffering from coronary heart disease, arrhythmia or grade II (including QTc prolongation > 450 ms male, female, 470 MS) and Cardiac insufficiency; According to NYHA standard, III ~ IV cardiac insufficiency, or heart colour to exceed revealed left ventricular ejection fraction (LVEF) 1.5 or PT>ULN+4, or APTT>1.5 ULN), bleeding tendency or receiving coagulation therapy 7. Before randomization within 3 months had significant bleeding clinical significance or definite bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, baseline fecal occult blood and above, or suffering from vasculitis; 8. Before randomization within 2 months of active bleeding associated with hemoptysis (blood), or their daily hemoptysis amounted to half a teaspoon (2.5ml) or above; 9. Arterial / venous thrombosis occurred within the first 12 months before randomization, such as cerebral vascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism; 10. Patients with bleeding tendency, inherited or acquired bleeding tendency and thrombus tendency known to be present (Such as hemophilia, coagulopathy, thrombocytopenia, hypersplenism etc.); 11. Unhealed bone fracture or wound for long time; 12. There are several factors that affect oral medicine,such as unable to swallow, chronic diarrhea and intestinal obstruction; 13. Urine protein=++, or urine protein in 24 hours=1.0g; 14. Patients with a history of psychiatric drug abuse and can not be prevented or have mental disorders; 15. Participated in other cancer drug clinical trials within four weeks before randomization; 16. Before or at the same time with other untreated malignant tumor, basal cell carcinoma has been cured, except for cervical carcinoma in situ and superficial bladder cancer; 17. pregnant or lactating women;Patients are reluctant or unable to take effective contraceptive measures; 18. Active infections require antimicrobial treatment (for example, antimicrobial agents, antiviral agents, and antifungal agents); 19. Conditions determined by investigators to possibly affect the clinical study or determination of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DCR;QoL;the drug safety; | — |
Countries
China
Contacts
Public ContactGao Beili
Outcome results
None listed