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Table 2 Eligibility criteria

From: A phase I/II clinical trial on the efficacy and safety of NKT cells combined with gefitinib for advanced EGFR-mutated non-small-cell lung cancer

Key inclusion criteria Key exclusion criteria
• 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.