Budesonide in Treating Patients With Lung Nodules at High Risk of Developing Lung Cancer

Inclusion criteria

• ✓. Current smokers or former smokers that have stopped within the last 15 years
• ✓. Smoking history \> 20 pack/years
• ✓. Age \> 50 years
• ✓. Persistent lung nodules detected at Low dose computed tomography (LDCT) scan from previous year with 1 of the following:- longest diameter between 4\&5 mm. Nodules may be stable or grown from the previous year (\< 5 mm does not require additional diagnostic follow-up); longest diameter between 5.1 \& 8 mm. Nodules may be stable or grown from the previous year. If grown, doubling time should be \>1 year; longest diameter \> 8 mm with negative PET scan, negative CT enhancement. Nodule should have grown with a doubling time between 1\& 5 years; -longest diameter \>8mm, non solid or partially solid nodules, stable or grown with doubling time between 1\&5 years
• ✓. Eastern Cooperative Oncology Group (ECOG) performance status \< 1 (Karnofsky \>60%)
• ✓. Participants must have normal organ and marrow function as defined below: Leukocytes \>3,000/mL, absolute neutrophil count greater than 1,500/mL, platelets greater than 100,000/mL, total bilirubin lower than 1.5 \* upper normal institutional limits, aspartate aminotransferase (AST or SGOT)/alanine aminotransferase (ALT or SGPT) lower than 1.5 \* upper normal institutional limits, creatinine lower than 1.5 \* upper normal institutional limits
• ✓. Females must be postmenopausal (ie, at least 1 year passed after the last menstruation), surgically sterile, or using acceptable contraceptive measures as judged by the Investigator. (A fertile woman is defined as being of child-bearing potential, from first menstruation to 1 year after last menstruation.). Negative serum beta-HCG for women of childbearing potential will be required at baseline. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
• ✓. Ability to understand and the willingness to sign a written informed consent document.