Changes in Circulating Tumor-Specific DNA in Patients With Non-Metastatic Non-Small Cell Lung Cancer

The purpose of this research study is to evaluate a blood test to measure circulating tumor
DNA (ctDNA). It is hypothesized that ctDNA may identify patients who can be considered for
additional therapy. 40 People with non-metastatic non-small cell lung cancer will be asked to
take part in this study. Participants will have approximately 3 teaspoons of blood withdrawn
from a vein at three different times. These times will be before primary treatment (either
surgery or radiation therapy), 1 month after primary treatment, and 4 months after primary
treatment. The total amount of blood withdrawn during the study will be approximately 9
teaspoons. Participants will be followed every 3 months for 12 months to determine if a
confirmed recurrence or progression has occurred. Participants will also be asked to complete
questionnaires on their quality of life and their smoking behaviors. As part of this study, a
blood sample will be obtained and DNA from participants blood sample will be purified. DNA,
or deoxyribonucleic acid, stores and transmits inherited traits, such as eye color or blood
type. As part of this research project, participant's DNA will be studied in an effort to
find out if there are genes that contribute to medical conditions like their cancer that are
part of the study. If participants have surgery to have tumor removed or if participants have
a biopsy of their tumor, the study would like to take some of the leftover tissue to purify
and study the DNA from the tissue sample.

Inclusion Criteria:

- Patients with histologically confirmed or clinically suspected stage I, II or III
NSCLC, provided such patients will be scheduled for a procedure that will provide
histologic confirmation of the diagnosis (if the procedure does not provide histologic
confirmation of the diagnosis of NSCLC the particular patient will be removed from the
study and replaced).

- Scheduled for treatment with surgery or radiotherapy (Stage I), surgery and
chemotherapy (Stage II), or chemoradiotherapy (Stage III). For stage I receiving
radiotherapy, treatment must be stereotactic body radiation therapy (SBRT) consisting
of 3-5 fractions.

- Ability to provide blood sample at the following time points: pre-treatment, 1 month
post definitive treatment, and 4 post definitive treatment.

- Ability to understand and the willingness to sign an IRB-approved informed consent
document.

- Staging studies including PET-CT for all patients prior to the initiation of primary
treatment, as a pretreatment requirement. For patients with Stage II and III, MRI or
CT of the brain is needed prior to the initiation of primary treatment. Patients,
however, may be registered and have the pretreatment blood sample collected, provided
that the staging studies are being scheduled. Registered patients who are found, after
screening tests, to have Stage IV disease will be removed from the study and replaced.

Exclusion Criteria:

- Females who are pregnant

- History of organ transplant.

- For stage II and III patients, must be able to receive chemotherapy.

- Active cardiovascular issues in the past 6 months.