Key inclusion criteria | Key exclusion criteria |
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• Histological diagnosis of advanced non-small cell lung cancer (III/IV) with measurable lesions; • No other chemotherapy and radiation therapy to be planned recently. I • Aged 18 to 75 years, male or female; • Evidence of activating mutations of EGFR(exon 19 deletion or exon 21 Leu858Arg point mutation)and can be treated with gefitinib; • Patients must have a Karnofsky performance status greater than or equal to 80%; • There is no disease progression after being treated with gefitinib for 8 weeks; • Adequate bone marrow reserve and adequate live and renal functions: hemoglobin ≥9 g/dL, absolute neutrophil (segmented and bands) count (ANC) ≥ 1.5 × 109/L, lymphocytes count ≥ lower limit of normal reference value, platelet count ≥8 × l010/L, serum creatinine ≤1.5 × high limit of normal reference value, Serum bilirubin ≤2 × upper limit of normal reference value, both of AST/ALT ≤2 × upper limit of normal reference value; • Women of childbearing potential must have a negative pregnancy test (within 7 days) prior to receiving treatment of study agent; • Life expectancy greater than 12 months; • Patients have ability to understand and subscribe of informed consent. | • Organ dysfunction defined as follows: significant cardiovascular disease (i.e. New York Heart Association [NYHA] class 3 congestive heart failure, myocardial infarction within the past 6 months, unstable angina, coronary angioplasty within the past 6 months, uncontrolled atrial or ventricular cardiac arrhythmias); Liver function grading Child-Pugh C; renal function failure or uremia; respiratory failure; disturbance of consciousness; • Patients with genetic diseases; • Known central nervous system tumors including metastatic brain disease, unless treated and stable; • Suffering from lymphoma, leukemia and myelodysplastic syndrome (MDS); • Serious infections requiring antibiotics treatment, bleeding disorders; • History of bone marrow or stem cell transplantation, or allograft transplantation; • Patients with immunodeficiency disease or autoimmune disease, except vitiligo; • Patients with allergy history, especially allergy to heterologous proteins; • Uncontrolled infectious diseases and other serious diseases, such as patients with HIV positive, active HBV and HCV hepatitis; • Patients with chronic disease which is undergoing immune reagents or hormone therapy (Topical or inhalational corticosteroids are permitted); • Patients with concurrent chemotherapy or in five half-life periods of the used chemotherapy drugs; • Pregnant or breast-feeding women; • Mental impairment or addictive disorders that may interfere the ability to sign informed consent; • Lack of availability for immunological and clinical follow-up assessment. |