CALC-1 (Cetuximab in Advanced Lung Cancer): Study of 2 Methods of Combining Cetuximab and Gemcitabine in Patients With Advanced Non Small-cell Lung Cancer (CALC-1)

Inclusion Criteria: Signed written informed consent Age > 18 Histological diagnosis of non small-cell lung cancer (NSCLC) Stage III B or Stage IV disease Contraindications to platinum based therapy (age > 70 or age < 70 with ECOG performance status 2) At least one site of metastasis (target or non-target) Life expectancy of at least 3 months ECOG <3 Neutrophils > 1500/mm3, platelets > 100,000/mm3, hemoglobin > 9g/dl Bilirubin < 1.5 x the upper normal limit SGOT and SGPT < 2.5 x the upper normal limits (< 5 x the upper normal limit in the presence of hepatic metastasis) Creatinine < 1.5 x the upper normal limit Adequate method of contraception (male and female), when there is risk of conception. Exclusion Criteria: Symptomatic cerebral metastasis Previous chemotherapy for advanced disease Adjuvant chemotherapy within the previous 6 months Radiation therapy within previous 4 weeks Any experimental drug therapy within the previous 4 weeks Previous exposure to monoclonal antibodies, signal transduction inhibitors or EGFR targeting therapy Clinically relevant cardiopathy or myocardial infarct within the last 12 months Acute or subacute intestinal occlusion or history of inflammatory bowel disease Known allergy to one or more of the experimental treatments Known alcohol or substance abuse Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or give informed consent Pregnant or breastfeeding females History of malignant neoplasm within the previous 5 years (not including non-melanoma skin carcinoma and in-situ carcinoma of the uterine cervix, provided they are being adequately treated)