Combined Modality Therapy With Growth Factor Support in Locally Advanced Non-small Cell Lung Cancer (NSCLC)

Inclusion Criteria:

Histologically or cytologically confirmed NSCLC: Either histologic or cytologic proof of a newly diagnosed non-small cell lung cancer is required. A biopsy with histology is preferred, but cytology is allowed. Histology or cytology from involved mediastinal or supraclavicular lymph nodes alone will be allowed if a separate distal primary lesion is clearly evident on radiographs (i.e., a second biopsy will not be required).
Patients with two or more parenchymal lesions on same or opposite sides of the lung are ineligible.
Must have unresectable Stage IIIA (N2) or IIIB disease and also satisfy the following criteria:

Unresectable Stage IIIA (N2) patients:

N2 mediastinal lymph nodes must be multiple and/or bulky on CT scan or X-ray, such that, in the opinion of the treating investigator, the patient is not a candidate for induction chemotherapy or chemoradiotherapy followed by surgical resection.
N2 status must be documented by any one of the following methods:
Histologic or cytologic proof of N2 disease by exploratory thoracotomy, thoracoscopy, mediastinoscopy, mediastinotomy, Wang needle biopsy, fine needle aspiration under bronchoscopic or CT guidance or other method
Node positivity by PET scan
Nodes >2 cm on CT scan
Paralyzed left true vocal cord with separate left lung primary distinct from AP window nodes on CT Scan
Stage IIIB patients:
Pathologic documented or radiographically documented positive N3 nodes.

Patients with positive supraclavicular or scalene lymph nodes must not have disease extending up into the cervical region evidenced by one of the following:

Fine needle aspiration, core needle biopsy or excisional biopsy of supraclavicular N3 nodes
Biopsy of contralateral mediastinal N3 nodes by mediastinoscopy, mediastinotomy, or thoracotomy
Fine needle aspiration, core needle or Wang needle biopsy under CT or bronchoscopic fluoroscopic guidance of enlarged contralateral N3 mediastinal nodes
Contralateral mediastinal nodes >2 cm on CT scan
Contralateral node positivity on PET scan
Right sided primary with paralyzed left true vocal cord

Any of the following T4 lesions: Tumor of any size that invades any of the following: mediastinum, heart, great vessels, trachea, esophagus, vertebral body or carina:

Written documentation of type of T4 extent by attending surgeon if the patient has had an exploratory thoracotomy or thoracoscopy
T4 involvement of the trachea or carina by direct bronchoscopic visualization
T4 involvement of the heart, esophagus, aorta, or vertebral body documented by CT scan, MRI or transesophageal ultrasound
T4 involvement of the mediastinum may also be accepted by CT or MRI criteria if, in absence of the above organ involvement, there is a soft tissue extension directly into the mediastinal space.
Radiographic criteria for involvement of main pulmonary artery or vein is allowed only if there is a mediastinal soft tissue mass.
Age > 18 years
ECOG performance status 0 or 1
Ability to give informed consent

Adequate organ and marrow function as evidenced by the following peripheral blood counts or serum chemistries at study entry:

WBC > 4,000/µL
Absolute neutrophil count > 1,500/mm3
Platelet count > 100 x 103 cells/mm3
Bilirubin < 1.5 x institutional ULN
AST or ALT < 2.5 x institutional ULN
Alkaline Phosphatase <2.5 x institutional ULN
Serum Creatinine < 2.0mg/dL and/or adequate creatinine clearance
Adequate pulmonary function (FEV>1.5 liters, or if <1.5 liters, the predicted FEV1of the contralateral lung must be >800 cc based on the quantitative split function testing. (Predicted FEV1= FEV1 x % perfusion to uninvolved lung from quantitative lung V/Q scan report)
Must have one measurable lesion by chest X-ray or CT scan. Lesion(s) must be accurately measured in at least one dimension (longest diameter to be recorded) as >20mm with conventional techniques or as >10mm with spiral CT scan
Men and women of childbearing potential must agree to use effective contraception while on treatment and for 6 months after treatment

Exclusion Criteria:

Malignant pleural or pericardial effusion
Prior chemotherapy or radiation therapy
Pregnant or lactating females
Primary malignancy other than basal or squamous carcinoma of the skin or carcinoma in situ of the cervix, or any other cancer for which the patient has been disease free for five years. Other in situ malignancies (e.g. breast, bladder, etc) in the past 3 years are permissible
Unintentional weight loss >10% body weight within the last 3 months
Unable to provide informed consent
Any pre-malignant myeloid condition or any malignancy with myeloid characteristics
Active infection
Known hypersensitivity to E. coli-derived proteins, pegfilgrastim, Filgrastim, or any other component of the product
Significant nonmalignant disease including: documented HIV infection; uncontrolled heart disease, and poorly controlled diabetes
Treatment within the last 30 days with any experimental agent