lung cancer
Conditions
Interventions
Sponsors
National Cancer Center/Cancer Hospital & Shenzhen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed diagnosis of locally advanced or metastatic NSCLC with positive EGFR sensitive mutations; 2. the complete early non-small cell lung cancer after radical treatment received adjuvant therapy, and disease relapse, participants need to ensure that adjuvant therapy over time from this study first dosing interval more than 6 months, and auxiliary treatment led to a variety of toxic effects have been restored (according to the CTCAE v4.03 standard judgment level 1 or less, except for hair loss); 3. male or female aged 18 to 75 years, and sign the informed consent; 4. with an ECOG score of 0 or 1, expect to survive for more than 6 months; 5. Agree to provide previously stored tumor tissue samples or to perform biopsy to collect tumor lesion tissue for biomarker analysis; 6. good organ function: laboratory tests meet the following requirements: absolute value of neutrophils (ANC) >=1.5x10^9/L, platelet count >=100x10^9/L, hemoglobin >=90 g/L, WBC >=3.0x10^9/L; Liver function: total bilirubin =2(+) at baseline, 24-hour urine protein quantification must be =50%; 8. able to communicate well with investigators and follow study guidelines for visits, treatment, laboratory tests and other related procedures.
Exclusion criteria
Exclusion criteria: 1. patients who have previously received systemic therapy (previous adjuvant or neoadjuvant therapy is allowed); 2. patients with symptomatic brain metastases at the beginning of treatment (patients with brain metastases who have received previous treatment are eligible for inclusion if asymptomatic brain metastases persist for at least 4 weeks while receiving a stable dose of medication); 3. Patients who participate in clinical trials for interventional tumors during or within the last 30 days prior to first-line treatment.Patients who participate in other intervention studies during second-line treatment or above should not be excluded from this study; 4. patients with a history of tracheal - esophageal fistula, gastrointestinal perforation or gastrointestinal fistula, and intra-abdominal abscess within 6 months prior to the start of treatment; 5. severe cardiovascular and cerebrovascular disease, including cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction and significant vascular disease (including but not limited to aortic aneurysm requiring surgical repair or recent arterial thrombosis) within the first 6 months;Patients with unstable angina, New York heart association (NYHA) classification (appendix 4) or greater magnitude II heart failure and arrhythmia drugs can't control; 6. subjects who were randomized to receive bronchothorax radiation within the first 4 weeks or who had not recovered from radiation-related toxicity. For all other anatomical sites, subjects who received radiotherapy within the first 2 weeks of randomization or who did not recover from radiosurgery related toxicity; 7. major surgical intervention was planned within the first 4 weeks of the randomized trial or during the trial period (investigators determined that there was a risk of bleeding or wound-healing complications); 8. have bleeding tendency, high bleeding risk or coagulation dysfunction, including thrombotic disease in the first 6 months and/or a history of hemoptysis in the first 3 months (single hemoptysis volume >=2.5ml); Full dose oral or parenteral anticoagulants or thrombolytic agents or aspirin (>325 mg/ d) or other non-steroidal anti-inflammatory drugs that inhibit platelet function in the near future (less than 10 days after receiving the first study drug treatment);Or prior to surgery, the researchers determined a bleeding tendency; 9. subjects whose chest CT scan during the screening period was highly suspicious of idiopathic pulmonary fibrosis, organized pneumonia, drug-related pneumonia, idiopathic pneumonia, or active pneumonia; 10. imaging studies show signs of invasion of the great vessels by a tumor that has completely approached, surrounded, or invaded the internal lumen of the great vessels (e.g., pulmonary artery or superior vena cava); 11. presence of poorly controlled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg) after combination of two or more antihypertensive drugs during the screening period, and prior history of hypertensive crisis or hypertensive encephalopathy; 12. unhealed wounds, active gastrointestinal ulcers, and fractures (excluding healed old fractures); People who are known to be allergic to anvitin; 13. pregnant or nursing women; 14. women of child-bearing age or male subjects who do not wish to use effective contraception during the study period or within 6 months after the last dose of the study drug; 15. subjects who have
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR; | — |
Countries
China
Contacts
Public ContactZhe Wang
National Cancer Center/Cancer Hospital & Shenzhen Hospital
Outcome results
None listed