Pilot Study of Preoperative Tarceva (Erlotinib) for Stages I/II Non-Small Cell Lung Cancer

Tarceva® (erlotinib) is a drug that blocks a receptor called the Epidermal Growth Factor
Receptor (EGFR) on certain cells including tumor cells. Blocking this receptor has been shown
to shrink tumors in some patients. Tarceva®(erlotinib) is approved for commercial use by the
U.S. Food and Drug Administration for treatment of Non-Small Cell Lung Cancer (NSCLC) after
failure of at least one chemotherapy treatment. However, it is not approved for the first
treatment of Non-Small Cell Lung Cancer (NSCLC), which is the treatment used in this study.

Patients with early stage non-small cell lung cancer will receive daily Tarceva® (erlotinib)
at 150 mg/day for 3 weeks followed by surgical resection at week 4. High resolution CT scans
for tumor response assessment will be obtained at baseline and after 3 weeks of treatment
with Tarceva® (erlotinib). Post-operative 2-year treatment with Tarceva® (erlotinib) will be
offered to patients who had at least a 50% (half) decrease in size of their tumor after
treatment with Tarceva® (erlotinib)and/or patients with tumors that were found to have the
receptor, Epidermal Growth Factor Receptor (EGFR), on their tumor cells at the time of their
surgery.

Post-operative chemotherapy will be administered at the discretion of the treating physician
to patients with stages IB and II. Patients who receive post-operative chemotherapy will
begin Tarceva (erlotinib)no sooner than 3 weeks from Day 1 of the last chemotherapy cycle and
no longer than 6 months after surgery. Follow-up for recurrence and survival will continue
for 2 years.

Inclusion Criteria:

- Biopsy proven stage I/II non-small cell lung cancer who are candidates for surgical
resection

- Ambulatory and capable of all self-care but may be unable to carry out any work
activities.

- Preoperative and postoperative high resolution CT scans done at NYPH-Weill Cornell
medical center for purposes of volumetric measurements.

- Acceptable cardiac, breathing, kidney, liver, and bone marrow functions.

- 18 years and older.

- Women of child-bearing potential must be taking adequate contraceptive precautions
prior to study entry and for the duration of study participation. A negative serum or
urine pregnancy test is required within 7-10 days of Tarceva® administration. Men and
premenopausal women of child bearing potential will follow an approved, medically
accepted birth control regimen or agree to abstain from heterosexual intercourse while
taking study drug and for 30 days following the last dose of study drug.

Exclusion Criteria:

- Cannot be on any other anti-cancer treatment during this study.

- Prior treatment with any EGFR inhibitor.

- Patients who had prior treatment with chemotherapy or radiation for this disease.

- Other active cancers.

- Tumors with a mixed histology of small cell and non-small cell carcinoma as well as
patients with pulmonary carcinoid tumors.

- Gastro-intestinal abnormalities, including active peptic ulcer or inflammatory bowel
disease.

- Hypersensitivity to compounds similar in chemical composition to Tarceva®.

- Active infection or serious underlying medical conditions which would impair protocol
treatment.