Cisplatin and Gemcitabine With or Without Bevacizumab in EGFR Wild-type Non-Small Cell Lung Cancer

This is an interventional treatment trial for Lung Cancer focused on measuring Bevacizumab, gemcitabine, cisplatin, EGFR wild-type Read More

Inclusion Criteria:

• Histologic documentation of primary lung carcinoma, non-squamous histology with EGFR mutation Negative.
• Stage IIIB/IV 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
• Platelet count >= 100,000/mm^3
• Hemoglobin >= 9.0 g/dL
• Total bilirubin =< 1.5 x upper limit of normal (ULN)
• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [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
• Urine dipstick proteinuria < 2+ * Note: Patients discovered to have >= 2 + proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate < 1 g of protein in 24 hours
• 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
• 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; EXCEPTIONS: Non melanotic skin cancer or carcinoma-in-situ of the cervix
• History of myocardial infarction or other evidence of arterial thrombotic disease (angina)
• History of cerebral vascular accident (CVA) or transient ischemic attack (TIA) =< 6 months 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
• History of abdominal fistula, gastrointestinal perforation, or intrabdominal abscess =< 6 months prior to randomization
• History of hemoptysis >= grade 2 (defined as bright red blood of at least 2.5 mL) =< 3 months prior to randomization
• Pregnancy