A Phase II Study of Erlotinib and Predictive Markers as First-Line Treatment of Advanced Non-Small Cell Lung Cancer for Patients Unfit for Chemotherapy
- Histological or cytological documented diagnosis of inoperable, locally advanced,
recurrent or metastatic (Stage IIIB or Stage IV) NSCLC.
- Chemo-naïve patients.
- Patients who are in the investigator's opinion not medically suitable for
- Measurable disease according to the RECIST criteria.
- ECOG performance status of 0 - 3.
- Life expectancy of at least 12 weeks.
- Patients must be able to take oral medication.
- Serum calcium within normal ranges
- ≥ 4 weeks since prior surgery or radiation therapy
- For all females of childbearing potential a negative pregnancy test must be obtained
within 48 hours before starting therapy and must use effective contraception
- 18 years of age or older
- Written (signed) Informed Consent to participate in the study
- Prior systemic antitumor therapy
- Any unstable systemic disease which according to the investigator contraindicates the
use of the study drug render the subject at high risk from treatment complications
(including active infection, unstable angina, myocardial infarction within the
previous month, inflammatory bowel disease, hepatic disease with serum bilirubin ≥ 2
upper limit of normal (ULN) or AST and/or ALT ≥ 2 x ULN (or ≥ 5 x ULN if clearly
attributable to liver metastasis), renal disease with acute renal failure or serum
creatinine ≥ 5 x ULN.
- Any other malignancies within 5 years (except for adequately treated carcinoma in
situ of the cervix or basal or squamous cell skin cancer).
- Nursing mothers or pregnant woman.
- Hypersensitivity to Tarceva or co-formulants.
- Patients with brain metastasis or spinal cord compression that has not yet been
definitively treated with surgery and/or radiation.
- Patients with brain metastasis or spinal cord compression that not are in a stable
condition despite treatment with steroids.