NSCLC
Conditions
Interventions
Trial group:GB222 combined chemotherapy
Control group:Bevacizumab combined chemotherapy
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years male and female; 2. Understand trial procedure and content and sign informed consent voluntarily; 3. Patients of advanced (phase IIIb, multidisciplinary treatment is not appropriate), metastatic (phase IV) or recurrent non-squamous and non-small cell lung cancer conformed by histology or cytology and cannot be cured by surgery. In case of several tumors, main cell components shall be classified; 4. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1; 5. Expected life = 6 months; 6. With at least one measurable and evaluable tumor (RECIST1.1 criteria); 7. Without severe hematological diseases, hemoglobin=90g/L, neutrophile granulocyte=1.5×10^9/L, blood platelet=100×10^9/L; 8. Total bilirubin=1.5xupper limit of normal (ULN) and for patients without liver metastasis, aspartate transaminase (AST) and alanine aminotransferase (ALT) <2.5xULN; for patients with liver metastasis, both of them <5xULN; 9. Serum creatinine=1.5xULN or creatinine clearance rate=50mL/min urine protein<2+ in routine urine test. For patients with urine protein =2+ in routine urine test, urine shall be collected in 24 hours and urine protein must<1.0g; 10. International normalized ratio (INR)=1.5, and partial thromboplastin time (PTT or aPTT) =1.5xULN; 11. Left ventricular ejection fraction (LVEF) =50%; 12. Pregnancy tests of women patients of childbearing age are negative. Men or women of childbearing age all agree to adopt effective contraception measures medically during the trial and within 6 months after the trial; 13. Patients may be visited on time and can execute good communication with researchers. Besides, they can complete the research according to regulations of the research.
Exclusion criteria
Exclusion criteria: 1. Central type squamous-cell carcinoma, mixed non-small cell and small cell cancer, or mixed adeno-squamous carcinoma with squamous cells as main component; 2. EGFR sensitive mutation (loss of exon 19, L858R mutation of exon 21) confirmed by tumor histology or cytology and (or) patients with ALK gene fusion/rearrangement (if EGFR or ALK status cannot be confirmed due to various reasons, they may be included); 3. With thrombotic diseases 6 months before screening shown in medical history or examination results; 4. With the sign of tumor invading great vessels shown in the images; researchers or radiologists must exclude patients with tumors fully approaching, surrounding or invading lumen of great vessels (eg. pulmonary artery or precava); 5. Central nervous system metastasis, patients with previous treatment or not cannot be included, including symptomatic brain metastases, meningeal metastases or spinal compression history. Brain metastases is confirmed by CT or MRI in screening; 6. Patients with chest radical radiotherapy within 30 days before screening, with palliative radiotherapy for bone diseases except chest within 2 weeks before treatment of the first dosing of research drug; 7. Patients with major surgical operation (including thoracotomy biopsy), major trauma, needing major surgery during treatment of the research 4 weeks before screening; 8. With minor surgical operation (including catheterization) within 48 hours before treatment of monoclonal antibody, bleeding tendency shall be judged by the researchers; 9. With the usage of aspirin (>325mg/day) or other known nonsteroidal anti-inflammatory drugs restraining function of blood platelet at present or recently (within 10 days before the first dosing of monoclonal antibody); 10. With the usage of full oral dose, anticoagulant outside intestines and stomach or thrombolytic agent for treatment at present or recently (within 10 days before the first dosing of monoclonal antibody), anticoagulant is allowed for preventive use; 11. Patients with hereditary bleeding tendency or blood coagulation disorders increasing bleeding risks or with thrombus shown in medical history or examination results; 12. Uncontrolled high blood pressure (systolic pressure>140mmHg and (or) diastolic pressure >90mmHg); 13. Patients with hypertensive crisis or hypertensive encephalopathy in the past; 14. Cardiovascular and cerebrovascular diseases with clinical significance (eg. activity), including but not limited to cerebral vascular accident (CAV) or transient ischemic attack (TIA) (=6 months before screening), myocardial infarction (=6 months before screening), unstable angina pectoris, congestive heart failure =II of New York Heart Association, severe arrhythmia needing drug therapy during the research or cannot controlled by drugs; 15. Prominent vascular diseases (including but not limited to aortic aneurysm needing surgery or recent artery thrombosis) within 6 random months; 16. Severe green wound, peptic ulcer or fracture in active phase; 17. With corrosive esophagitis or gastritis, inflammatory bowel disease or diverticulitis, abdominal fistula, gastrointestinal perforation or intraperitoneal abscesses within 6 months before screening; 18. Pregnant woman and breast feeding women; 19. With other treatment of trial drug or participation in other clinical trial within 30 days before screening; 20. Allergic to Bevacizumab or other ingredients and chemotherapeutics component, with all
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Countries
China
Contacts
Public ContactYuankai Shi
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed