A Biomarker-Integrated Study in Chemorefractory Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
This study is the "umbrella" or screening study in a group of 5 studies known as the BATTLE
(Biomarker-integrated Approaches of Targeted Therapy of Lung Cancer Elimination) program.
In order to participate in one of the research studies, you must first agree to take part in
this screening study, which will be used to determine if you are eligible. After
participating in this study, you may be assigned to a study that is using an investigational
drug. The investigational drug(s) to be used in each of the 4 studies are not approved by
the Food and Drug Administration (FDA) for commercial use in this setting; however, the FDA
has permitted its use in these research studies.
If you agree to participate in this screening study, your complete medical history
(including smoking history) will be recorded and you will have a physical exam, including
measurement of vital signs (blood pressure, pulse, temperature, and breathing rate), height,
and weight. You will have blood (about 2 teaspoons) drawn for routine tests. You will also
have blood (about 1-2 tablespoons) drawn to check your blood clotting function, thyroid
function, and lipid (fat) levels. You will have a urine test, a performance status
evaluation (questions about your ability to perform everyday activities), and an
electrocardiogram (ECG -- a test that measures the electrical activity of the heart).
Your tumor will be evaluated by chest x-ray and computed tomography (CT) or magnetic
resonance imaging (MRI) scans to evaluate the status of the disease. You will have a brain
MRI. Women who are able to have children must have a negative blood (about 1 teaspoon)
pregnancy test before receiving the study drug.
A sample of your tumor tissue will be collected for biomarker analysis. If your tumor
tissue cannot be reached, you will not be able to participate in this research study. To
collect a tumor biopsy, you will have either a CT-guided core biopsy, bronchoscopy, or other
type of biopsy (such as subcutaneous, cutaneous, or lymph node). You will be asked to stop
taking any medication that affects blood-clotting (such as aspirin or coumadin) before the
For the cutaneous (skin) biopsy, you will be given a local anesthetic by either a spray or
shot to numb your skin. A small cut will be made to remove all or a piece of the affected
For the CT-guided core biopsy of the lung, subcutaneous, and/or lymph node biopsy, a tissue
sample is withdrawn from an organ or suspected tumor mass using a very thin needle and a
syringe. The needle is guided while being viewed by the physician on a CT scan. Any site
that can be safely biopsied will be considered for the collection of tissue. Sites not
commonly biopsied include kidneys, adrenal glands, and brain.
For the bronchoscopy, you will be given drugs to relax, and then a local anesthetic will be
sprayed into your nose and throat to numb those areas. A slim, flexible tube with a light
will be placed through your nose or mouth and into your lungs. A small brush will be fed
through the tube and into your lungs. The brush will gently scrape off a sample of lung
tissue. Tweezers will then be fed through the tube to collect the tissue samples (biopsy).
A small amount of water will be sprayed into your lungs and then suctioned out through the
tube to collect tissue samples and mucous samples.
For the CT-guided core biopsy or bronchoscopy, you should not take any medications by mouth
or have any solid food for at least 6 hours before the procedure. You also should not have
any liquids 2 hours before the procedure.
If you are eligible to take part in this study, you will be assigned to 1 of the 4 research
studies based on the results of your tumor analysis. You will be asked to read and sign a
separate informed consent to take part in one of the research studies.
You have the right to leave the study at any time. If you choose to stop participating in
this study, you should contact the study chair and/or research nurse. Your doctor may
decide to take you off this study if your medical condition gets worse and/or you are unable
to comply with study requirements.
This is an investigational study. Up to 250 patients will take part in this study. All
will be enrolled at M. D. Anderson.
Observational Model: Case-Only, Time Perspective: Prospective
Biomarker Profile Assessment (before randomized allocation to research study)
William N. William Jr., MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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