A Randomized Controlled Trial of Systemic and Topical Treatments for Rash Secondary to Erlotinib in Advanced Stage IIIB or IV Non-Small Cell Lung Cancer

Inclusion Criteria:

1. Histologically or cytological documented diagnosis of inoperable, locally advanced,
recurrent or metastatic (stage IIIB or stage IV) non-small cell lung cancer.

2. Evidence of disease (measurable disease is not mandatory).

3. 18 years of age or older.

4. ECOG performance status of 0 - 3.

5. Written informed consent prior to study-specific screening procedures, with the
understanding that the patient has the right to withdraw from the study at any time,
without prejudice.

Exclusion Criteria:

1. A history of another cancer other than basal cell carcinoma or cervical cancer in
situ within the past 3 years

2. Prior therapy with any type of cancer growth factor inhibitor (EGFR inhibitor or
agent targeting this family of growth factor receptors)

3. Life expectancy of less than 12 weeks.

4. Ongoing toxic effects from prior chemotherapy.

5. Pregnant or lactating women.

6. Females of childbearing potential who have a positive or no pregnancy test (pregnancy
tests must be obtained within 72 hours before starting therapy). (Postmenopausal
women must have been amenorrheic for at least 12 months to be considered of
non-childbearing potential).

7. Male or female patients with reproductive potential who are unwilling to use
effective and reliable contraceptive methods throughout the course of the study and
for 90 days after the last dose of study medication.

8. Ongoing treatment with any inhibitors or inducers of CYP3A4 activity

9. Any unstable systemic disease (including active infection, grade 4 hypertension,
unstable angina, congestive heart failure, hepatic, renal or metabolic disease).

10. Any significant ophthalmologic abnormality, especially severe dry eye syndrome,
keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other
disorder likely to increase the risk of corneal epithelial lesions.

11. Unwilling or unable to comply with the protocol for the duration of the study.

12. Patients who have experienced prior hypersensitivity reaction to active ingredients
or excipients of the following compounds: erlotinib, minocycline, tetracycline,
doxycycline or clindamycin.