Non-Small Cell Lung Cancer
Conditions
Interventions
control group:Take Icotinib (125mg, tid, before meals) orally
experimental group:Take Apatinib (250mg qd, after meals) + Icotinib (125mg, tid, before meals) orally
Sponsors
The Affiliated Hospital Guangdong Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Histologicaly and cytologicaly diagnosed as non-squamous non-small cell lung cancer which is for the first-time treatment of locally advanced lung cancer(stage IIIb, unable for multiple disciplinary team), or metastatic lung cancer(stage IV) with EGFR mutation.The diagnosis of non-small cell lung cancer based on sputum cytology is not acceptable; If there are a variety of tumor components, the main cell types should be classified; 2.Fresh tissue or paraffin samples are positive for EGFR gene mutation by dna-sequencing or ARMS detection; 3.The lesions can be measured (at least one can be evaluated according to the standard of RECIST 1.1 standard, namely, the longest diameter is at least 10mm; if the CT scan layer's thickness is greater than 5mm, the lesion diameter is twice as thick as the thickness of the layer; If the lesion is the lymph node, measure the short diameter at least 15 mm; 4.aged from 18 to 75 years; 5.(ECOG PS) 0-1; 6.The expected survival time surpass 12 weeks; 7.Hematological function: ANC=1.5 x 10^9/L, and PLT=100 x 10^9/L, HGB=9 g/dL; 8. Liver function: TBIL <1.5 ULN, ASTALT <2.5ULN(for patients without liver metastasis)and ASTALT <5 ULN (for patients with liver metastasis); 9. Kidney function:ScR =1.5x ULNCcr=50mL/min (urine test paper showed that urinary protein <2 +). For patients with urinary protein=2+, the 24-hour urine protein content should be less than 1 g; 10. (one week before study) INR=1.5PTT or APTT= 1.5 x ULN; 11. Women of child-bearing age should be carried out in the group of 7 days before the pregnancy test (urine), and the results were negative, and willing to during the trial and 8 weeks after the last give the experimental drug USES appropriate methods of contraception. For men, it is necessary to agree to use appropriate methods of birth control or surgical sterilization within 8 weeks of the trial period and the end of the trial; 12.To be able to comply with the research and follow-up procedures; 13.The subject understands and voluntarily signs the written informed consent.
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.Undegone HER targeted therapy, such as erlotinib, gefitinib, cetuximab, trastuzumab, etc; 3.Previously treated with VEGFR inhibitors; 4.Undergone any systemic anti-NSCLC treatment, including cytotoxic drug therapy or radiotherapy, targeted therapy (e.g., monoclonal antibody), biologic therapy; Have participated in clinical trials of other drugs in the past 3 weeks; 5. Before studysubjects had active brain metastases (previously without appropriate radiotherapy,or symptom stabilization time less than 4 weeks, or with clinical symptoms,or need to receive symptomatic treatment, etc.); meningitis carcinomatosa, spinal compression, or positive for brain orleptomeningeal disease while screening CT or MRI (21 days before the completion of treatment and symptomatic patients with brain metastases can be enrolled if treated in 21 days before the completion, but nedd to undergo brain MRI, CT or venous angiography to confirm as no cerebral hemorrhage); 6. Imaging examinations(CT or MRI) show tumor lesions is less than 5mm distant from the large blood vessels , or central tumor invading localized large blood vessels; 7.Imaging examinations(CT or MRI) showe the significant pulmonary cavity or necrotic tumors; 8.Uncontrollable hypertension(SBP=140 mmHg or DBP= 90 mmHg, despite of best drug treatment); 9.Suffering from grade II myocardial ischemia or myocardial infarction, poor control of arrhythmia (including QTc intermittent= 450 ms for males or=470 ms for females); 10.According to NYHA standard, grade III-IV heart failure, or LVEF 1.5 or PT>ULN + 4 seconds or APTT> 1.5 ULN, with bleeding tendency or receiving thrombolytic or anticoagulant therapy; application of anticoagulant or vitamin K antagonists such as (INR) = 1.5, allowing the use of low-dose heparin for the purpose of prevention (adult daily dosage of 0.6 million to 1.2) in the case of prothrombin time international standard Million U or small doses of aspirin (daily dosage = 100 mg); 12.Suferring from arterial thrombosis or deep venous thrombosis within 6 months prior to enrollment, or patients with evidence of thrombosis or bleeding tendency within 2 months prior to enrollment, regardless of severity; hemoptysis within 2 weeks prior to enrollment For the blood was red or 1/2 teaspoon); 13.There were significant clinical signs of bleeding or a clear bleeding tendency in the first 3 months of randomization, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood occlusion ++ and above, or with vasculitis; 14.12 months prior to randomized thrombosis ,suferring from cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism occurred within 12 months before randomization; 15.Known as hereditary or acquired bleeding and thrombosis tendencies (such as hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc.); 16.Long-drawn-out wound or fracture; 17.Four weeks before random,surgery or severe traumatic injury, fractures or ulcers; 18. routine urine test shows urinary protein = + +, or 24-hours urine protein = 1.0g; 19.Clinical symptoms and be necessary for surgical treatment of serous effusion (including pleural effusion, ascites, pericardial ef
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Duration of Response;Disease Control Rate;Objective Response Rate;Quality of Life; | — |
Countries
China
Contacts
Public ContactZhixiong Yang
The Affiliated Hospital Guangdong Medical University
Outcome results
None listed