Study to Evaluate Palifermin in the Reduction of Dysphagia in Patients With Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria: Patients with a histologically or cytologically proven diagnosis of NSCLC Unresectable (locally advanced) stage IIIa or IIIb disease Initial radiotherapy field of treatment to encompass greater than or equal to 30% of the esophagus Life expectancy greater than or equal to 6 months Estimated weight loss less than or equal to 10% in the 3 months before study randomization Measurable disease 18 years of age or older Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 Hemoglobin (hgb) greater than or equal to 10 g/dL without transfusional support or growth factor use in the 4 weeks before study randomization Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L without growth factor use in the 2 weeks before study randomization Platelet count greater than or equal to 100 x 10^9/L Serum bilirubin less than or equal to 1.5 x institutional upper limit of normal (ULN) Serum creatinine less than or equal to 2.0 mg/dL (Note: Patients with a serum creatinine greater than or equal to 1.4 and less than or equal to 2.0 mg/dL must demonstrate a 24-hour urinary creatinine clearance greater than or equal to 50 mL/min) Females of childbearing potential: negative serum or urine pregnancy test Patient must give written informed consent before participating in any study-specific procedure, randomization, or receiving investigational product. Patients with reproductive capability must agree to practice adequate contraception methods. Exclusion Criteria: Metastatic disease (M1)/stage 4 NSCLC Pleural or pericardial effusion greater than 100 ml in volume as documented by appropriate imaging (positron emission tomography [PET], computed tomography [CT] scan or ultrasound). If an effusion greater than 100 ml is documented by cytology to be free from malignancy and the investigator feels the patient is capable of receiving chemo/radiotherapy for their primary disease/ NSCLC, the investigator should discuss the patient with the study physician at Amgen. Effusions smaller than 100 ml would be acceptable, unless the investigator suspects that the effusion is malignant, in which case the effusions should be evaluated by cytology. Sponsor approval must be obtained before patient is randomized. Plan to remove the tumor surgically before completing the protocol chemo/radiotherapy course Shielding of any part of the esophagus during radiotherapy (including posterior spinal cord shielding) Prior chemotherapy, radiotherapy, or surgery for NSCLC Prior invasive malignancy during the past 3 years other than non-melanomatous skin cancer. Note: Patients with prior surgically-cured malignancies [eg, stage I breast cancer or prostate cancer, in-situ carcinoma of the cervix, etc] are not excluded; however, sponsor approval must be obtained before patient is randomized. Presence or history of dysphagia or conditions predisposing to dysphagia (eg, uncontrolled gastroesophageal reflux disease [GERD], dyspepsia, etc) History of pancreatitis Four weeks or less since completion of treatment using an investigational product/device in another clinical study or presence of any unresolved toxicity from previous treatment Previous treatment on this study or with a fibroblast growth factor Known to be sero-positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) Pregnant or breastfeeding women Known sensitivity to E. coli derived products Compromised ability of the patient to give written informed consent and/or to comply with study procedures Refusal to sign an informed consent form to participate in this study, and sign the hospital information release form, if applicable Unwilling or unable to complete the patient reported outcome (PRO) questionnaires Psychological, social, familial, or geographical reasons that would prevent regular follow-up