Icotinib Combined With SBRT for Patients With Metastatic Non-squamous NSCLC With EGFR Mutation

This is an interventional treatment trial for Lung Cancer Stage IV focused on measuring EGFR mutation icotinib SBRT Read More

Inclusion Criteria:

• Histologic documentation of primary lung carcinoma, non-squamous histology with EGFR mutation.
• Stage disease according to the 7th Edition of the American Joint Committee on Cancer staging system
• Not received radiotherapy, chemotherapy or other biological treatment
• Measureable disease
• Life expectancy of>=12 months
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
• Absolute neutrophil count (ANC)>=2,500/mm^3
• Hemoglobin>=9.0 g/dL
• Total bilirubin<=1.5 x upper limit of normal(ULN)
• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate transaminase [AST]) and serum glutamic pyruvic transaminase (SGPT) (alanine transferase [ALT])<=2.5 x ULN in patients without liver or bone metastases; <5 x ULN in patients with liver or bone metastases
• Cockcroft-Gault calculated creatinine clearance of>=45 ml/min or creatinine<=1.5 x ULN
• Prothrombin time (PT)<=1.5 x ULN
• Partial thromboplastin time (PTT)<=ULN
• Negative pregnancy test done<=7 days prior to randomization, for women of childbearing potential only
• Provide informed written consent
• Willing to return to Sichuan cancer hospital for follow-up
• Willing to provide tissue and blood samples for correlative research purposes

Exclusion Criteria:

• Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
• Known allergic to EGFR TKI any ingredients
• Prior chemotherapy or treatment for metastatic non-small cell lung cancer
• Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive, per MD discretion
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
• Other active malignancy<=3 years prior to randomization;
• Ongoing or active infection, symptomatic congestive heart failure , cardiac arrhythmia, psychiatric illness/social situations, or any other medical condition that would limit compliance with study requirements
• History of bleeding diathesis or coagulopathy
• Inadequately controlled hypertension (systolic blood pressure of>150 mmHg or diastolic pressure>100 mmHg on anti-hypertensive medications)
• Serious non-healing wound, ulcer, bone fracture, or have undergone a major surgical procedure, open biopsy, or significant traumatic injury <=28 days or core biopsy <=7 days prior to randomization
• Pregnancy or breast-feeding women
• Other situation which researchers think that doesn't fit into the group