Study of Use of CTC in NSCLC

Lung cancer remains the most common cause of cancer mortality in the world for both men and
women. More than half of patients diagnosed will die within the first year. Given these
concerning facts, we are in need of novel methodologies to diagnose patients at earlier
stages of the disease, more accurately predict treatment response / failure and predict
overall survival.

The use of CTC has been investigated and shown to predict progression free survival and
overall survival in metastatic breast cancer, and recommended as a breast cancer tumor
marker by the American Society of Clinical Oncology. There have also been relationships
between CTC's and survival, shown in metastatic colorectal and prostate cancer. However,
CTC's have not been thoroughly investigated in non-small cell lung cancer. This trial will
assess if the detection of circulating tumor cells could be used as a tool to help further
advance treatment for NSCLC patients.

Inclusion Criteria:

For subjects with lung malignancies:

- 18 years of age and older

- Diagnosis of new or recurrent non-small cell lung cancer

- Awaiting treatment and follow up

- Have radiographic measurable metastatic disease that can be followed

- Be able to sign an IRB approved informed consent form

- Life expectancy greater than 12 weeks

For subjects with COPD and without lung malignancies:

- 18 years of age and older

- Diagnosis of COPD

- No current or prior malignancies (except squamous or basal cell carcinoma of the
skin)

- Be able to sign an IRB approved informed consent form

For Healthy Control Subjects (Dry Runs):

- 18 years of age and older

- Has no current or prior malignancies (except squamous or basal cell carcinoma of the
skin)

- Patients must sign an IRB approved informed consent form

Exclusion Criteria:

For subjects with lung malignancies:

- Have other concurrent lung cancer malignancies, or any other form of malignancy
(except squamous or basal cell carcinoma of the skin)

- ECOG performance status of 4

- Pregnant female (self-reporting)

- Cognitively Impaired

- Prisoner

For subjects with COPD and without lung malignancies and Healthy Controls:

- Any other form of malignancy (except squamous or basal cell carcinoma of the skin)

- Pregnant female (self reporting)

- Cognitively impaired

- Prisoner