Phase I/II Study of Polyphenon E in Addition to Erlotinib in Advanced Non Small Cell Lung Cancer

Inclusion Criteria:

1. Biopsy proven NSCLC

2. Stage IIIB or IV measurable disease burden after routine staging work up.

3. Documented disease progression after first or second line chemotherapy. This will be
assessed using the Response Evaluation Criteria in Solid Tumors (RECIST)

4. Ability to give informed consent and willingness to adhere to study protocol

5. Ability to take oral medication

6. Age ≥ 18 years.

7. Eastern Cooperative Oncology Group (ECOG) Performance Status between 0-2

8. Adequate hematological, hepatic and renal function defined as below:

granulocyte count > 1500/mm3, platelet count > 100.000/mm3, serum creatinine < 1.5;
bilirubin, AST, ALT and ALP at or below IULN All lab values should be obtained within
14 days of registration.

9. Patients have to have recovered from any toxic effects of prior chemotherapy or
radiation therapy to a Grade 1 or less (except from alopecia). Enrollment should
occur no less than 28 days after completion of prior therapy.

10. Ability to comply with the use of contraceptive measures starting 1 week before and
ending 2 weeks after the last dose of study drug.

Exclusion Criteria:

1. Liver or kidney problems that would interfere with metabolism of study drug. This
includes any preexisting elevation of AST, ALT, ALP or bilirubin.

2. Any condition that would hamper informed consent or ability to comply with the study
protocol

3. Participation in another research study in the last three months

4. Known malignancy at any site other than NSCLC

5. Recent consumption of green tea (5 or more cups per day within one week of study
enrollment)

6. Significant history of cardiac disease, e.g. uncontrolled hypertension, unstable
angina, congestive-heart failure, myocardial infarction within the last six months or
ventricular arrhythmias requiring medication.

7. Presence of metastatic brain lesions

8. Documented history of bleeding diathesis

9. Need to be on therapeutic anticoagulation

10. Pregnant and lactating women

11. Patients with a known seizure disorder who are taking Phenytoin, Carbamazepine or
Phenobarbital

12. Patients taking medications known to interfere with erlotinib metabolism as listed
below.

- Atazanavir

- Clarithromycin

- Indinavir

- Itraconazole

- Ketoconazole

- Nefazodone

- Nelfinavir

- Ritonavir

- Saquinavir

- Telithromycin

- Troleandomycin

- Voriconazole

- Rifampicin

- Rifabutin

- Rifapentine

- Phenytoin

- Carbamazepine

- Phenobarbital

- St John's Wort.