Phase II Trial to Modulate Intermediate Endpoint Biomarkers in Former Smokers

Inclusion Criteria:

- Male or female, 55 years of age or older who has a diagnosis of a Lung RADS 3

- History of cigarette smoking with ≥ 30 pack years

- Quit smoking ≥ 3 months (Negative cotinine by urine dipstick)

- Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to
1

- Able to swallow study pills

- Able to undergo Low Dose Computer Tomography (LDCT)

- Not allergic to components of study agents

- Willing to participate in smoking cessation maintenance program if relapse occurs

- Willing to discontinue current vitamin/mineral supplement use and substitute with a
standard multivitamin supplement provided for the study

- Willing to comply with proposed visit and treatment schedule

- Able to understand and willing to sign a written informed consent document

- Participants must have normal organ and marrow function

- Willing to use contraception during the intervention period of 6 months (males and
females)

- Not pregnant or lactating nor planning to become pregnant or lactate during the 6
month study intervention period..

Exclusion Criteria:

- Prior history of cancer (except non-melanoma of skin) or other co-existing cancers

- Significant co-morbid disease

- Hypoxemia with the required use of supplemental oxygen

- Use of inhaled steroids within 6 weeks of trial enrollment

- Presence of nodule meeting Lung-RADS 4 criteria

- Have taken doxycycline or tetracycline less than or equal to 2 weeks

- Females- pregnant or lactating (throughout the duration of intervention of 6 months)

- Unwilling to use effective form of birth control (Males and females) (throughout the
duration of intervention of 6 months).