Nanoscale Artificial Nose in Monitoring Response and Detecting Recurrence After Surgery or Radiation Therapy in Patients With Stage I or Stage II Non-Small Cell Lung Cancer

PRIMARY OBJECTIVES:

I. Determine if a suitable fraction of patients become NA-NOSE negative within three years
post treatment. We will test the hypothesis that this fraction is at most 30% versus the
alternative that it is at least 50%.

SECONDARY OBJECTIVES:

I. Determine if patients who become NA-NOSE negative post treatment then become NA-NOSE
positive prior to clinical recurrence.

II. Estimate the time post treatment needed to become NA-NOSE negative. III. Estimate the
lead time gained between a negative to positive NA-NOSE transition and clinical recurrence.

OUTLINE:

Patients undergo breath sample collection for the NA-NOSE breath test at baseline (2
pre-treatment samples), and post treatment samples at regularly scheduled follow up visits,
for 2 years in the absence of disease progression.

Inclusion Criteria:

- Patients must either have histologic or pathologically confirmed non-small cell lung
cancer (NSCLC) or suspicious nodules/lesions which are going to be surgically resected
before they are pathologically confirmed

- Patients must have stage I or II disease based on the parameters for staging NSCLC
found in the American Joint Committee on Cancer (AJCC) cancer staging handbook seventh
edition

- Patients must be deemed to be eligible candidates for either surgery or stereotactic
radiation

- Stereotactic radiation treatment of stage I disease or adjuvant chemotherapy is
allowed at the discretion of treating physician for the participating subject

- Patients who will have surgical resections must consent to the use of post-surgery
tumor samples for correlative molecular studies

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

- Ability to travel to appointments and willingness to participate in this study

- Ability to understand and willingness to sign a consent and Health Insurance
Portability and Accountability Act (HIPAA) authorization form

Exclusion Criteria:

- Patients who have had a prior lung cancer within the last five years from the current
diagnosis

- Patients having a prior malignancy within the past 3 years other than resected of
basal or squamous cell carcinoma of the skin, any in situ malignancy, or low-risk
prostate cancer after curative therapy

- Patients with any prior systemic therapy for the current diagnosis of lung cancer

- Patients with a diagnosis of advanced stage disease (stage III or IV)

- Patients who are unable to comply with study and/or follow up procedures

- Patients who have uncontrolled intercurrent illness including, but not limited to
psychiatric illness/social situations that would limit compliance with study
requirements

- Patients who are pregnant or are breast feeding