Study of 18F-Fluoro-PEG6-IPQA

18F-PEG6-IPQA is a solution that is designed to be attracted to tumor cells. The imaging
solution has a small dose of radiation added to it, which may help doctors see the cancer
cells better during imaging scans. This is the first study using 18F-PEG6-IPQA in humans.

Study Imaging:

If you are found to be eligible to take part in this study, you will visit the clinic on Day
1 for the injection of the study solution and PET scans. This imaging study will be
performed at FDA-cleared PET-CT scanners at MD Anderson sites, including at the Center for
Advanced Biomedical Imaging (CABI).

For up to 6 hours before the PET scans and computed tomography (CT) scans, you must not eat
or drink anything except water. This is called fasting.

A small tube will be placed in your arm and you will receive an injection of 18F-PEG6-IPQA.

After the injection, scanning will begin immediately. You will have 3 PET scanning sessions
with a PET/CT scanner. Before each PET scan, you will have a CT scan to make sure you are in
the right position for the PET scans. Each PET scan may last up to 1 hour. Each positioning
CT scan should take about 5 minutes. You will have a 10 minute "rest period" between each
PET scan.

Study Visits:

On Day 1:

- Before the imaging solution is injected, your vital signs and an ECG rhythm strip will
be collected. The study staff will insert an intravenous (IV) needle and line into each
of your arms.

- Right after the injection of the study drug, blood (about 2 tablespoons total) will be
drawn for pharmacokinetic (PK) testing from one of the existing IV lines. PK testing
measures the amount of study solution in the body at different time points. Blood will
be drawn at 1, 3, 8, 16, 30, 45, 60, 90, and 150 minutes after the injection of
18F-PEG6-IPQA for a total of 9 draws.

- About 30 minutes after the injection, your vital signs will be measured and the
injection site will be checked.

- Urine will be collected during the 10 minute rest periods in between scans or at the
completion of the 3-hour scanning period.

- After the scans are completed (about 3 hours after the injection) your vital signs and
injections site will be checked again, and you will have an ECG rhythm strip taken.
Blood (about 2 tablespoons) and urine will also be collected for routine tests.

On Days 2 and 7:

- Blood (about 2-3 tablespoons) will be drawn for routine tests.

- Your vital signs and the injection site will be checked

- You will be asked about any side effects you may be having since the injection.

End-of-Study Visit:

The end-of-study visit will be about 14 days after the injection of 18F-PEG6-IPQA and
imaging scans. The following tests and procedures will be performed:

- Blood (about 2-3 tablespoons) will be drawn for routine tests.

- You will have a physical exam, including measurement of your vital signs.

- The injection site will be checked.

- You will have an ECG.

Length of Study:

You will be in this study for about 14 days. You will be taken off study early if
intolerable side effects occur.

This is an investigational study. 18F-PEG6-IPQA is not FDA-approved or commercially
available for use in imaging scans. Its use in this study is investigational.

The scans performed with 18F-PEG6-IPQA are also considered investigational and will not be
used for planning any of your future cancer treatment.

Up to 15 patients will take part in this study. All participants will be enrolled at MD
Anderson.

Inclusion Criteria:

1. All patients must give written informed consent

2. Patients should have pathologically or cytologically confirmed Stage IV non-small
cell lung cancer with clinical or radiological evidence that it is not amenable to
therapy with curative intent. Prior EGFR tyrosine kinase inhibition (TKI) therapy is
permitted but not required.

3. Patients should be potential candidates for therapy with an EGFR tyrosine kinase
inhibitor or with an anti-EGFR monoclonal antibody by clinical criteria.

4. Patients should have clinical characteristics that would suggest an increased
probability of benefit from an EGFR inhibitor. Specifically, they should have known
EGFR mutations or high gene copy number.

5. Patients should have at least one tumor deposit that is > 1.0 cm in diameter, and
that is amenable to imaging

6. Patients should be Eastern Cooperative Oncology Group (ECOG) performance status 0-2

7. Patients with brain metastases are eligible provided they meet all other eligibility
criteria and do not require corticosteroids or enzyme-inducing anticonvulsants and
provided it is felt clinically that they will not require radiotherapy in the three
(3) weeks subsequent to their participation in the study

8. Women of childbearing potential must agree to use adequate contraception (hormonal or
barrier method of birth control; abstinence) prior to study entry and for the
duration of study participation. Childbearing potential will be defined as women who
have had menses within the past 12 months, who have not had tubal ligation or
bilateral oophorectomy. Should a woman become pregnant or suspect that she is
pregnant while participating in this study, she should inform her treating physician
immediately. The patient, if a man, agrees to use effective contraception or
abstinence

9. The patient must be considered legally capable of providing his or her own consent
for participation in this study

10. Subjects must be at least 18 years of age

Exclusion Criteria:

1. Radiotherapy, chemotherapy or any investigational agent within the previous 2 weeks
of administrating 18F-PEG6-IPQA for PET/CT imaging.

2. A non-investigational targeted agent within the previous 2 weeks of 18F-PEG6-IPQA for
PET/CT imaging.

3. Thoracic or abdominal surgery within the previous 2 weeks of 18F-PEG6-IPQA for PET/CT
imaging.

4. A tumor that is known to have a K-ras mutation

5. Squamous cell, large cell undifferentiated, neuroendocrine or small cell
undifferentiated carcinoma of the lung

6. A known other currently active malignancy. (Benign tumors and benign polyps, basal
cell carcinomas of skin, superficial papillary bladder tumors, and pre-invasive
carcinoma of the cervix are permitted)

7. Physical inability to undergo a scanning procedure (e.g., inability to lie flat for
the required period of time - three sessions of roughly an hour each with ten
minutes' rest in between)

8. Serum creatinine >1.5 x upper limit of normal (ULN), bilirubin >1.5 x ULN, AST > 3 x
ULN

9. 10. Hemoglobin < 8 g/dL, absolute neutrophil count < 1,500/mm3, platelet count
<100,000/mm3

10. Potentially life-threatening arrhythmia; myocardial infarct within the previous 3
months; unstable angina, or angina at rest; congestive heart failure (New York Heart
Association Functional Classification class II or worse), uncontrolled hypertension
(systolic BP > 160 or diastolic BP >100).

11. Active acute infection (i.e. currently treated with antibiotics). Patients with
chronic infections such as hepatitis B or C, mycobacterium avium or similar
infections will be eligible provided they meet all other eligibility criteria.

12. Oxygen saturation <90% on room air

13. Clinical requirement for systemic corticosteroids for control of cerebral edema or
for enzyme-inducing anticonvulsants. (Inhaled steroids and systemic steroids for
chronic obstructive pulmonary disease (COPD) are permitted).

14. Pregnant or nursing

15. Any condition that is unstable or could jeopardize the safety of the patient and his
or her compliance in the study, in the investigator's judgment