Combination of Erlotinib and Bevacizumab as Second-line Treatment in Patients With Non-small Cell Lung Cancer

Inclusion Criteria:

• Histologically or cytologically confirmed, unresectable locally advanced (stage IIIB with pleural effusion) and/or metastatic (stage IV) NSCLC
• Progression to first-line therapy for advanced/metastatic NSCLC
• Bi-dimensionally measurable disease (not included in radiation field)
• ECOG performance status of 0-2
• Life expectancy of more than 6 months
• Adequate liver (serum bilirubin <1.5 times the upper normal limit, AST and ALT <2.5 times the upper normal limit in the absence of demonstrable liver metastases, or <5 times the upper normal limit in the presence of liver metastases,adequate renal function (serum creatinine <1.5 times the upper normal limit),and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function
• Signed informed consent

Exclusion Criteria:

• Central nervous system involvement (unless if the patient has being previously irradiated and is clinically stable)
• Presence of a centrally located mass or a tumor mass in close relation to large vessels or a mass with cavitation.
• Surgery or radiation therapy within the last 14 days from study entry
• Active infection
• History of life-threatening hemoptysis / hematemesis, history of thrombosis or use of anti-coagulation therapy
• History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction, ventricular arrhythmias) or stroke within the previous 6 months or uncontrolled hypertension
• Patients on other experimental treatment protocols
• History of a second primary malignancy (other than basal-cell skin carcinoma or in situ carcinoma of the cervix)
• Psychiatric illness or social situation that would preclude study compliance
• Pregnant or lactating women