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       
    

NCT00094861_exc_T1
Condition
Metastatic disease NSCLC
NCT00094861_exc_T2
Condition
(M1)/stage 4
NCT00094861_exc_T3
Condition
Pleural effusion
NCT00094861_exc_T4
Condition
pericardial effusion
NCT00094861_exc_T5
Value
greater than 100 ml in volume
NCT00094861_exc_T6
Measurement
positron emission tomography
NCT00094861_exc_T7
Measurement
computed tomography scan
NCT00094861_exc_T8
Measurement
PET
NCT00094861_exc_T9
Measurement
CT
NCT00094861_exc_T10
Measurement
ultrasound
NCT00094861_exc_T11
Scope
positron emission tomography [PET], computed tomography [CT] scan or ultrasound
NCT00094861_exc_T13
Temporal
before completing the protocol chemo/radiotherapy course
NCT00094861_exc_T14
Observation
Plan to remove the tumor surgically
NCT00094861_exc_T15
Qualifier
esophagus
NCT00094861_exc_T16
Multiplier
any part of
NCT00094861_exc_T17
Procedure
radiotherapy
NCT00094861_exc_T18
Procedure
Shielding
NCT00094861_exc_T19
Procedure
posterior spinal cord shielding
NCT00094861_exc_T20
Drug
chemotherapy
NCT00094861_exc_T21
Procedure
radiotherapy
NCT00094861_exc_T22
Procedure
surgery
NCT00094861_exc_T23
Condition
NSCLC
NCT00094861_exc_T24
Temporal
Prior
NCT00094861_exc_T25
Scope
chemotherapy, radiotherapy, or surgery
NCT00094861_exc_T26
Condition
malignancy
NCT00094861_exc_T27
Qualifier
invasive
NCT00094861_exc_T29
Temporal
during the past 3 years
NCT00094861_exc_T28
Negation
other than
NCT00094861_exc_T30
Condition
non-melanomatous skin cancer
NCT00094861_exc_T31
Negation
are not
NCT00094861_exc_T32
Condition
surgically-cured malignancies
NCT00094861_exc_T34
Condition
dysphagia
NCT00094861_exc_T35
Condition
conditions predisposing to dysphagia
NCT00094861_exc_T36
Condition
gastroesophageal reflux disease
NCT00094861_exc_T37
Qualifier
uncontrolled
NCT00094861_exc_T38
Condition
GERD
NCT00094861_exc_T39
Condition
dyspepsia
NCT00094861_exc_T40
Scope
uncontrolled gastroesophageal reflux disease [GERD], dyspepsia
NCT00094861_exc_T41
Scope
dysphagia or conditions predisposing to dysphagia
NCT00094861_exc_T42
Condition
pancreatitis
NCT00094861_exc_T43
Observation
History of
NCT00094861_exc_T44
Temporal
Four weeks or less since completion of treatment
NCT00094861_exc_T45
Reference_point
completion of treatment
NCT00094861_exc_T46
Procedure
treatment
NCT00094861_exc_T47
Drug
investigational product
NCT00094861_exc_T48
Device
investigational device
NCT00094861_exc_T49
Qualifier
unresolved
NCT00094861_exc_T50
Condition
toxicity
NCT00094861_exc_T52
Temporal
previous
NCT00094861_exc_T53
Procedure
treatment
NCT00094861_exc_T54
Scope
investigational product/device
NCT00094861_exc_T55
Observation
history of
NCT00094861_exc_T56
Temporal
Prior
NCT00094861_exc_T57
Temporal
Previous
NCT00094861_exc_T58
Procedure
treatment
NCT00094861_exc_T59
Drug
fibroblast growth factor
NCT00094861_exc_T60
Value
sero-positive
NCT00094861_exc_T61
Measurement
human immunodeficiency virus (HIV)
NCT00094861_exc_T62
Condition
sero-positive for human immunodeficiency virus (HIV)
NCT00094861_exc_T63
Condition
sero-positive for hepatitis C virus (HCV)
NCT00094861_exc_T64
Condition
sero-positive for hepatitis B virus (HBV)
NCT00094861_exc_T65
Measurement
hepatitis C virus (HCV)
NCT00094861_exc_T66
Measurement
hepatitis B virus (HBV)
NCT00094861_exc_T67
Condition
Pregnant
NCT00094861_exc_T68
Condition
breastfeeding
NCT00094861_exc_T69
Person
women
NCT00094861_exc_T70
Condition
sensitivity
NCT00094861_exc_T71
Qualifier
E. coli derived
NCT00094861_exc_T72
Drug
products
NCT00094861_exc_T73
Condition
Compromised ability
NCT00094861_exc_T76
Scope
give written informed consent and/or to comply with study procedures
NCT00094861_exc_T78
Observation
Refusal to