INST 0601C: A Randomized Phase II Protocol of Erlotinib Versus Standard Platinum-Based Chemotherapy in Patients With Newly Diagnosed, Advanced Non-Small Cell Carcinoma of the Lung

Inclusion Criteria:

- Prior chemotherapy will be allowed for other invasive malignancies, provided at least
five years has elapsed since the completion of therapy and enrollment on this
protocol. No prior chemotherapy for metastatic NSCLC will be allowed. Prior adjuvant
or neoadjuvant chemotherapy for NSCLC will be allowed, provided at least six months
have elapsed from the last dose of chemotherapy to the documentation of relapsed
disease.

Baseline laboratory values (bone marrow, renal, hepatic):

- Adequate bone marrow function:

- Absolute neutrophil count >1000/µL

- Platelet count >100'000/µL

- Renal function:

- Serum creatinine < 2.0 mg %

- Hepatic function:

- Bilirubin <1.5x normal

- Serum calcium < 12 mg/dl

Other Eligibility Criteria:

- Signed Informed Consent

- ECOG/Zubrod/SWOG Performance Status <2 (Karnofsky Performance Status > 70%)

- Life expectancy > 8 weeks

- Male or female' age >18 years

- Patients of childbearing potential must be using an effective means of contraception.

- Histologic diagnosis of NSCLC that is advanced and cannot be treated adequately by
radiotherapy or surgery; or metastatic disease

Exclusion Criteria:

- Prior therapy with an epidermal growth factor receptor inhibitor, including
erlotinib, gefitinib, and cetuximab, as well as any investigational HER-1 inhibiting
agent

- Pregnant or lactating females

- Myocardial infarction or ischemia within the 6 months before Cycle 0' Day 0

- Uncontrolled' clinically significant dysrhythmia

- History of prior malignancy within the prior five years, with the exception of
non-melanoma carcinomas of the skin, and carcinoma in situ of the cervix

- Prior radiotherapy to an indicator lesion unless there is objective evidence of tumor
growth in that lesion

- Uncontrolled metastatic disease of the central nervous system (previously treated,
stable disease is allowable on this protocol)

- Radiotherapy within the 2 weeks before Cycle 1' Day 1

- Surgery within the 2 weeks before Cycle 1' Day 1

- Any co morbid condition that' in the view of the attending physician' renders the
patient at high risk from treatment complications