Utility of Endobronchial Ultrasound Guided Needle Biopsy in Early Stage Non- Small Cell Lung Cancer (NSCLC)

Study Procedures:

A procedure called EBUS-TBNA has been developed that might allow doctors to get samples of
lymph glands without performing an operation. The standard practice is a surgical operation
called a mediastinoscopy. If researchers find out that EBUS-TBNA is as accurate as
mediastinoscopy, it may mean that patients with lung cancer can avoid having surgery or will
be able to get treatment before surgery.

EBUS-TBNA:

If you agree to take part in this study, you will first have an EBUS-TBNA. This will be
performed on an out-patient basis under general anesthetic. The doctor will examine your
lungs for suspicious lymph glands with an ultrasound, and then will take a sample of tissue
from the lymph gland. This will be done using a flexible scope called a bronchoscope that
can be passed into the windpipe. The lymph glands around the wind pipe can be seen and then
removed with a small needle. The procedure should take about 1 hour.

Researchers will then analyze the lymph glands that were removed. Depending on whether or
not the lymph glands have cancer in them, your doctor will then recommend the most
appropriate therapy for you. This may include mediastinoscopy or some other appropriate
therapy.

All the data for the study will be stored with a password protected system.

Length of Study:

Your participation in this study will be over after you have completed EBUS-TBNA.

This is an investigational study. EBUS-TBNA is FDA approved for this procedure.

Up to 120 patients will take part in this study. All will be enrolled at MD Anderson.

Inclusion Criteria:

1. Patient must be >/= 18 years old.

2. Patient must have ECOG/Zubrod status 0-2.

3. Patient must have proven or suspected NSCLC (squamous cell, adenocarcinoma, or large
cell) and be clinical Stage I or II, according to the 1998 staging system of the
American Joint Commission on Cancer for lung cancer (T1-3 N0, T1-2 N1).

4. Patient must be eligible for definitive surgical therapy for primary NSCLC.

5. Patient or the patient's legally acceptable representative must provide written
informed consent prior to registration and any study-related procedures.

6. If the patient is a survivor of a prior invasive cancer, all of the following
criteria must apply: a. Patient has undergone potentially curative therapy for all
prior malignancies. b. No evidence of active / recurrent disease.

7. All females of childbearing age must have a negative pregnancy test before beginning
the study.

Exclusion Criteria:

1. Patient has received prior chemotherapy or radiotherapy for this cancer.

2. Patient is considered a poor risk for surgery due to non-malignant systemic disease
(cardiovascular, renal, etc.) that would preclude the treatment options.

3. Patient has contraindication to either endobronchial ultrasound or mediastinoscopy
such as: history of bleeding diathesis, latex allergy, mediastinoscopy, mediastinal
nodal resection, tracheostomy.

4. Patients malignancy consistent with well differentiated (carcinoid) neuroendocrine
histology.

5. Patient has two separate same histology lung tumors (where the question of two
separate primaries or metastatic disease makes definitive clinical staging
inaccurate).

6. Females who are pregnant and/or lactating.