Radiation Therapy and Chemotherapy in Treating Patients with Stage II-IV Non-small Cell Lung Cancer and the Effect of Treatment on Patient-Reported Outcomes

Inclusion Criteria

• Pathologically proven (either histologic or cytologic) diagnosis of non-small cell lung cancer (NSCLC) with any of the following stages (according to the American Joint Committee on Cancer [AJCC] Staging Manual, 7th edition): * Stage IIIA or IIIB * Stage II NSCLC with contraindication to curative surgical resection * Stage IV disease with solitary brain metastasis that has been treated radically (e.g.: with surgical resection and/or stereotactic radiosurgery) and thoracic disease that would be classified as stage II-III.
• Appropriate diagnostic/staging workup, including: * Complete history and physical examination * PET/computed tomography (CT) within 42 days prior to study entry demonstrating hypermetabolic pulmonary lesion(s) and/or thoracic lymph node(s). If PET/CT was obtained more than 42 days prior to study entry and is not repeated, chest CT within 28 days prior to study entry demonstrating stable disease is required. * Magnetic resonance imaging (MRI) of the brain or head CT with contrast within 42 days prior to study entry * Biopsy confirmation of suspected metastatic disease identified by PET/CT is recommended. * Pulmonary function tests (PFTs) within 6 weeks of study entry are recommended but not required.
• No prior chemotherapy or thoracic radiotherapy for lung cancer.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Able to read and write in one of the following languages, in which the Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) tool is available: English, Danish, German, Italian, Japanese, Korean, Spanish.
• Absolute neutrophil count (ANC) >= 1,500 cells/ul (within 28 days prior to study entry).
• Platelets >= 100,000 cells/ul (within 28 days prior to study entry).
• Hemoglobin >= 9.0 g/dl (within 28 days prior to study entry). (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 9.0 g/dl is acceptable.)
• Total bilirubin < 3.0 times the institutional upper limit of normal (ULN) (within 28 days prior to study entry).
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x the ULN (within 28 days prior to study entry).
• Serum creatinine =< 1.5 x ULN or calculated creatinine clearance >= 50 ml/min (by Cockcroft-Gault formula (within 28 days prior to study entry).
• Women of childbearing potential must: * Have a negative serum or urine pregnancy test within 72 hours prior to the start of study therapy * Agree to utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study therapy is completed * Be advised of the importance of avoiding pregnancy during trial participation and the potential risks of an unintentional pregnancy.
• All patients must sign study specific informed consent prior to study entry.

Exclusion Criteria

• Pleural or pericardial effusion * A patient with pleural effusion may be enrolled the effusion is sampled by thoracentesis and cytology is negative or the effusion is seen on axial imaging but not on chest x-ray and deemed too small to tap under CT or ultrasound guidance.
• Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness.
• Women who * Are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study therapy * Have a positive pregnancy test at baseline * Are pregnant or breastfeeding.
• Poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medications. Patients with diabetes will preferably be scheduled for PET/CT imaging in the morning, and instructions for fasting and use of medications will be provided in consultation with the patients’ primary physicians.