High-Dose or Standard-Dose Radiation Therapy and Chemotherapy With or Without Cetuximab in Treating Patients With Newly Diagnosed Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

Inclusion criteria

• Pathologically proven (either histologic or cytologic) diagnosis of Stage IIIA or IIIB non-small cell lung cancer (NSCLC); excluding patients with N3 disease based on supraclavicular or contralateral hilar adenopathy, [according to American Joint Committee on Cancer (AJCC) Staging, 6th edition; see appendix III] within 12 weeks of registration; patients who present with N2 or N3 disease and an undetectable NSCLC primary tumor also are eligible.
• Patients must be considered unresectable or inoperable; Note: Patients who have had a nodal recurrence after surgery for an early-stage NSCLC are eligible if the following criteria are met:
• Nodal recurrence must be N1 or N2; N3 is not eligible.
• The initial primary must have been staged as T1-2, N0, M0.
• The node must be biopsied within 12 weeks of registration.
• The node must be measurable.
• The patient must not have received prior chemotherapy or radiation for this lung cancer.
• Prior curative surgery must have been at least 6 months prior to the nodal recurrence.
• The exception to a prior invasive malignancy does not apply to the initial lung primary.
• Stage III A or B disease, including no distant metastases, based upon the following minimum diagnostic workup are acceptable:
• History/physical examination, including documentation of height, weight, body surface area (BSA), and vital signs within 8 weeks prior to registration;
• Computed tomographic (CT)/Magnetic Resonance Imaging (MRI) imaging of the lung and upper abdomen through the adrenal glands within 6 weeks prior to registration;
• An MRI of the brain with contrast (or CT with contrast if MRI is medically contraindicated) within 6 weeks prior to registration; Note: The use of intravenous contrast is required for the MRI or CT. An MRI without contrast is only permitted if the patient has a contrast allergy.
• Whole-body fluorodeoxyglucose (FDG) - Positron Emission Tomography(PET) or PET/CT or if no PET is available, a bone scan is required within 6 weeks prior to registration; Note: If a PET is done that shows clear adrenals and lungs, then a CT scan of chest only is permitted.
• If a pleural effusion is present, the following criteria must be met to exclude malignant involvement (incurable T4 disease):
• When pleural fluid is visible on both the CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative.
• Exudative pleural effusions are excluded, regardless of cytology;
• Effusions that are minimal (i.e. not visible on chest x-ray) that are too small to safely tap are eligible.
• Patients must have measurable or evaluable disease.
• Patients with post-obstructive pneumonia are eligible.
• Patients must be at least 3 weeks from prior thoracotomy (if performed).
• Zubrod Performance Status 0-1;
• Age ≥ 18;
• Pulmonary function tests (PFTs) including forced expiratory volume in one second (FEV1) within 12 weeks prior to registration; for FEV1, the best value obtained pre- or post bronchodilator must be ≥ 1.2 liters/second or ≥ 50% predicted.
• Complete blood count (CBC)/differential obtained within 2 weeks prior to registration on study, with adequate bone marrow function defined as follows:
• Absolute neutrophil count (ANC) ≥ 1, 800 cells/mm3;
• Platelets ≥ 100,000 cells/mm3;
• Hemoglobin ≥ 10.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 10.0 g/dl is acceptable.)
• Serum creatinine within normal institutional limits or creatinine clearance ≥60 ml/min;
• Bilirubin must be within or below normal institutional limits;
• Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) < 2.5 x the institutional upper limit of normal (IULN);
• Patient must sign study specific informed consent prior to study entry.

Exclusion Criteria

• N3 supraclavicular disease;
• Greater than minimal, exudative, or cytologically positive pleural effusions;
• Involved contralateral hilar nodes