NSCLC
Conditions
Interventions
Experimental Group:Osimertinib:80mg po qd,continuous taken
Apatinib:500mg Po qd,continuous taken
Sponsors
Fourth Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years (man or female); 2. Pathologically diagnosed with NSCLC; 3. Imageology diagnosed with metastatic NSCLC (stage IV); 4. Patients with EGFR-TKI resistance (Gefitinib/Erlotinib/Icotinib) 5. Confirmation of T790M+ mutation status; 6. At least one measurable lesion(the long diameter of tumor lesions was=10mm on CT scan, and the short diameter of lymph node lesions was=15mm on CT scan, satisfying the criteria in RECIST1.1) 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 8. Major organ function has to meet the following certeria: a) HB=90 g/L b) ANC=1.5×10^9/L c) PLT=80×10^9/L d) ALT and AST=2.5?ULN, but=5?ULN if the transferanse elevation is due to liver metastases; e) TBIL=1.5?ULN, Serum creatinine=1.25?ULN; Endogenous creatinine clearance rate ?45 ml/min; 9. Life expectancy greater than or equal to 3 months; 10. Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 7 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. Men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks; 11. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Have received osimertinib (AZD9291) or the third-generation EGFR-TKI; 2. Slit lamp examination confirmed abnormal; 3. Imageology diagnosed with macrovascular invasion or encasement by cancer; 4. Have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 5. Patients who suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male = 450ms, female = 470ms). Grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF) 1.5 ULN, APTT > 1.5 ULN), with bleeding tendency; 9. Patients with pregnant or planning a pregnancy; 10. Patients with other malignant tumors within 5 years (except for the treated skin basal cell carcinoma and cervical carcinoma in situ); 11. History of psychiatric drugs abuse and can't quit or patients with mental disorders; 12. Less than 4 weeks from the last clinical trial; 13. The researchers think inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DOR;DCR;OS;safety; | — |
Countries
China
Contacts
Public ContactLei Wang
Fourth Hospital of Hebei Medical University
Outcome results
None listed