Lung Nodules Clinical Trials

• Participants must be current or former tobacco smokers (\>20 pack years)

• Participants must have multi-focal part-solid nodules (\>2 lesions, at least one with solid component \<9mm) with evidence of progression on at least one annual follow-up CT scan.

• Participants must not meet criteria for surgical intervention at the time of enrollment.

• Patient must be willing and able to provide blood samples (12 green-top tubes, roughly 100mL) at the five time points indicated in the Study Calendar.

• Age ≥ 18 years.

• ECOG 0-1. The exception will be Participants carrying long term disability (such as cerebral palsy) where the disability is not acute nor progressive, and unlikely to significantly affect their response to therapy. This must be documented in screening clinic visit note by investigator.

• Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 1 month and 6 months following completion of therapy, for woman and men, respectively. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

‣ Has not undergone a hysterectomy or bilateral oophorectomy; or

⁃ Has not been naturally postmenopausal for at least 24 consecutive months

• Ability to understand and the willingness to sign a written informed consent.

• Adequate organ and marrow function as defined below:

‣ Hematologic

⁃ \- Absolute neutrophil count (ANC) ≥1,500 /mcL

⁃ \- Platelets ≥100,000 /mcL

⁃ \- Hemoglobin ≥9 g/dL

⁃ Renal\*

⁃ \- Serum creatinine ≤1.5 X upper limit of normal (ULN) OR Measured or calculated (calculated per institutional standard) creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥60 mL/min GFR for patient with creatinine levels \> 1.5 X institutional ULN

⁃ Hepatic\*

⁃ \- Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for

⁃ \- Participants with total bilirubin levels \> 1.5 ULN

⁃ \- AST or ALT ≤ 2.5 X ULN

⁃ \- Albumin \>2.5 mg/dL

∙ If laboratory criteria are not met due to what the investigator determines to be a biologic cause (e.g. Gilbert's syndrome causing elevated bilirubin or excessive muscle mass affecting creatinine) or drug-related cause (e.g. elevating in transaminases due to HAART therapy, elevated INR due to anticoagulation) then the specific lab values will not be used to exclude patient from this trial. This determination will be made by PI.