Non-small cell lung cancer
Conditions
Interventions
gefitinib/NKT:NKT cells +gefitinib
Sponsors
Affiliated hospital of Jiangsu University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histological diagnosis of advanced non-small cell lung cancer (III/IV) with measurable lesions; 2. No other chemotherapy and radiation therapy to be planned recently. If other chemotherapies had to be used, five half-life periods of the used drugs would be waited before starting this study; 3. Aged 18 to 75 years, male or female; 4. Evidence of activating mutations of EGFR and can be treated with gefitinib; 5. Patients must have a Karnofsky performance status greater than or equal to 80%; 6. There is no disease progression after being treated with gefitinib for 8 weeks; 7. Adequate bone marrow reserve and adequate live and renal functions: hemoglobin =9 g/dL, absolute neutrophil (segmented and bands) count (ANC) =1.5 × 10^9/L, lymphocytes count?lower limit of normal reference value, platelet count?8×l0^10/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; 8. Women of child bearing potential (1849 years of age ) must have a negative pregnancy test prior to receiving treatment of study agent within 7 days; 9. Life expectancy greater than 12 months; 10. Have ability to understand and subscribe of informed consent.
Exclusion criteria
Exclusion criteria: 1. 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 six months, unstable angina, coronary angioplasty within the past six months, uncontrolled atrial or ventricular cardiac arrhythmias; Child-Pugh C; renal function failure or uremia; respiratory failure; disturbance of consciousness; 2. Patients with genetic diseases; 3. Known central nervous system tumors including metastatic brain disease, unless treated and stable; 4. Suffering from lymphoma, leukemia and myelodysplastic syndrome (MDS); 5. Serious infections requiring antibiotics treatment, bleeding disorders; 6. History of bone marrow or stem cell transplantation, or allograft transplantation; 7. Patients with immunodeficiency disease or autoimmune disease, except vitiligo; 8. Patients with allergy history, especially allergy to heterologous proteins; 9. Uncontrolled infectious diseases and other serious diseases, such as patients with HIV positive, active HBV and HCV hepatitis; 10. Patients with chronic disease which is undergoing immune reagents or hormone therapy (Topical or inhalational corticosteroids are permitted); 11. Patients with concurrent chemotherapy or in five half-life periods of the used chemotherapy drugs; 12. Pregnant or breast-feeding women; 13. Mental impairment or addictive disorders that may interference the ability to sign informed consent; 14. Lack of availability for immunological and clinical follow-up assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Progression;Objective Response Rate;Disease control rate;Overall survival;Serum tumor markers; | — |
Countries
China
Contacts
Public ContactDeyu Chen
Jiangsu University
Outcome results
None listed