advanced NSCLC with EGFR mutation
Conditions
Interventions
experimental group:third generation EGFR - TKI+navelbine
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Informed consent has been signed. 2. At least 18 years of age. 3. According to the judgment of the investigator, the patient can comply with the study protocol. 4. Locally inoperable advanced NSCLC (stage ? B and unwilling to receive comprehensive treatment), metastatic NSCLC (stage ?) or recurrent non-squamous NSCLC confirmed by histopathology or cytology. A diagnosis of non-squamous NSCLC based on sputum cytology alone will not be accepted. 5. Deletion mutation of exon 19 or L858R mutation of exon 21 was found in highly sensitive EGFR mutation test. 6. The physical status score of the Eastern Oncology Collaboration group (ECOG) ranged from 0 to 1. 7. Life expectancy =12 weeks. 8. No prior systemic cytotoxic chemotherapy for locally advanced, metastatic, or relapsing disease. For patients undergoing adjuvant chemotherapy before or after surgery, at least 6 months should have elapsed since the last dosing date. 9. Patients who have received radiotherapy may only be enrolled if they meet the following conditions: A) The patient had no history of radiotherapy for lung regional lesions within the first 28 days of randomization. B) For radiotherapy outside the chest area, there must be a minimum interval of 28 days from the last irradiation date at random. (If salvage radiotherapy to alleviate bone metastasis is received within 2 weeks, the patient must recover from all toxic effects). 10. Measurable lesions at baseline. The presence of at least one measurable lesion according to RECIST version 1.1. However, the site of radiotherapy should not be considered as a measurable lesion. 11. Hematological functions should meet the following requirements: A) Neutrophil absolute count (ANC) =1.5×10^9/L, and B) Platelet count =100×10^9/L, and C) Hemoglobin =9 g/dL (which can be maintained or exceeded by transfusion). 12. Liver function meets: A) Total bilirubin <1.5× normal upper limit (ULN), and B) In patients without liver metastasis, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were <2.5×ULN; In patients with liver metastasis, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were <5×ULN 13. Renal function is satisfied: A) Serum creatinine =1.5×ULN or creatinine clearance =45 mL/min, and B) Proteinuria <2+ was detected by urine dipstick. For baseline urine dipstick test results Patients with proteinuria =2+ should undergo a 24-hour urine collection and should be required Confirm urinary protein =1 g within 24 hours. 14. International standardized ratio (INR) =1.5 and partial prothrombin time (PTT or aPTT) =1.5 ×ULN during the first 7 days of randomization.
Exclusion criteria
Exclusion criteria: 1. Mixed adenosquamous carcinoma with squamous components. 2. Patients with evidence of central nervous system (CNS) metastasis, except those without any symptoms or those with symptoms but stable for at least 28 days after treatment with CNS metastasis. 3. A history of hemoptysis (defined as blood loss in a single event > 2.5ml within 3 months prior to randomization). 4. Imaging examination found evidence of tumor invasion of major blood vessels. The investigator or local radiologist must exclude evidence that the tumor is completely adjacent to, surrounding, or extending into the lumen of major blood vessels, such as the pulmonary artery or superior vena cava. 5. Had major surgery (including open biopsy) or severe trauma within the previous 28 days, or expected major surgery during the study period. 6. Tissue chip biopsy or other minor surgery shall not be accepted within 7 days prior to the start of the study, except for vascular access device placement. However, vascular access devices should be placed 2 days or more before the study begins. 7. History or evidence of hereditary hemorrhagic constitution or coagulation disorder that increases the risk of bleeding. 8. Uncontrolled hypertension (blood pressure: systolic >150 mmHg and/or diastolic >100mmHg). 9. Previous history of hypertensive crisis or hypertensive encephalopathy. Significantly (active) 10. Clinical cardioascular disease, including but not limited to cerebrovascular accident (CVA) or transient ischemic attack (TIA) (random before 6 months or less), myocardial infarction (random before 6 months or less), unstable angina and congestive heart failure (New York heart association class ? degrees or higher) or during the study period need medication, And severe arrhythmias that may interfere with research to treat regular or uncontrolled arrhythmias. 11. Severe vascular disease (including but not limited to aortic aneurysms requiring surgical repair or recent arterial thrombosis) within 6 months prior to randomization. 12. Presence of unhealed wounds, active peptic ulcers, or fractures. 13. A history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the first 6 months of randomization. 14. Are pregnant or breast-feeding, or plan to become pregnant during the study period. 15. Received any other investigational drug or participated in another clinical trial within the 28 days prior to randomization. 16. Known allergy to vinorelbine or oxitinib or amitinib or accumitinib or any of its excipients, as well as other chemotherapy drugs. 17. There is evidence of persistent or active infections requiring intravenous antibiotic administration; Any other disease, neurological or metabolic disorder; Medical examination or laboratory findings reasonably suspect the presence of a disease or condition that contraindicates the use of the investigational drug or places the patient at a higher risk of treatment-related complications. 18. Patients diagnosed with tracheoesophageal fistula. 19. Prior chemotherapy or use of other systemic anticancer agents (e.g., monoclonal antibodies, tyrosine kinase inhibitors, EGFR inhibitors, and VEGF receptor inhibitors) for current stage disease (stage ? B disease not suitable for combination therapy and stage iv or postoperative recurrent disease). Note: Prior adjuvant or neoadjuvant therapy for nonmetastatic disease completed =6 months prior to randomization may be permitted. 20. Incomplete upper dig
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival ;disease control rate;duration of remission;overall survival;time to treatment failure; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety;objective remission rate; | — |
Countries
China
Contacts
Public ContactWei Li
The First Affiliated Hospital of Soochow University
Outcome results
None listed