Pemetrexed Disodium, Carboplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Stage III Non-Small Cell Lung Cancer

• Histologically or cytologically documented NSCLC, including squamous cell carcinoma, adenocarcinoma including bronchoalveolar cell, and large cell anaplastic carcinoma (including giant and clear cell carcinomas)
• Eligible Disease Stages: Inoperable IIIA and Selected IIIB - Patients entered must be considered unresectable or inoperable. Patients do not need to have a mediastinoscopy.

A size of 2 cm or greater by CT is a sufficient criterion for the diagnosis of mediastinal lymph node (N2 or N3) involvement by malignancy. If the largest mediastinal lymph node is less than 2 cm in diameter, a biopsy confirmation of mediastinal nodal involvement is required.

• The following patients are eligible:
• Patients must be M0
• Patients with any T with N2 or N3 are eligible
• Patients with T3, N1-N3 disease are eligible if deemed unresectable
• Patients with T4, any N are eligible provided the T4 status is not determined because of malignant effusion
• Patients with contralateral mediastinal disease (N3) are eligible if all gross disease can be encompassed in the radiation field in accordance with the homogeneity criteria
• Patients with a pleural effusion, which is a transudate, cytologically negative and non-bloody, are eligible if the radiation oncologist feels the tumor can be encompassed within a reasonable field of radiotherapy
• If a pleural effusion can be seen on the chest CT but not on CXR and is too small to tap, the patient will be eligible. Patients who develop a new pleural effusion after thoracotomy or other invasive thoracic procedure will be eligible.
• The following patients are NOT eligible:
• Patients with T3, N0 disease
• Patients with M1 disease
• Patients with atelectasis of the entire lung
• Patients with direct invasion of vertebral body
• Patients with scalene, supraclavicular, or contralateral hilar node involvement
• Patients with exudative, bloody, or cytologically malignant effusions
• Patients must have Measurable Disease: Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥10 mm with spiral CT scan. Lesions that are not considered measurable include bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusion, abdominal masses that are not confirmed and followed by imaging techniques, cystic lesions and tumor lesions situated in a previously irradiated area.
• Prior Therapy: ≥ 2 weeks since formal exploratory thoracotomy. No prior chemotherapy for NSCLC, chest radiation therapy or therapy that specifically and directly targets the EGFR pathway
• ECOG performance status 0-1
• Positron Emission Tomography (PET) using 18 fluorodeoxyglucose (FDG) must be negative for distant metastasis. PET imaging is mandatory.
• Weight loss of ≤ 10% in the past 3 months
• No "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse.
• Non-pregnant and non-nursing because of significant risk to the fetus/infant
• Age ≥ 18 years
• No patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness.
• No HIV-positive patients receiving combination anti-retroviral therapy because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy
• No known history of hypersensitivity to carboplatin, pemetrexed or a monoclonal antibody
• Required Initial Laboratory Values:
• Granulocytes ≥ 1,500/mcl
• Platelets ≥ 100,000/mcl
• Calculated Creatinine Clearance ≥ 45 ml/min
• Bilirubin < 1.5 x ULN
• AST/ALT < 3 x ULN
• Alkaline Phosphatase < 3 x ULN