Patients with a history of a curatively treated malignancy must be disease-free for at least two years except for carcinoma in situ of cervix and/or non-melanomatous skin cancer; patients must not have received chemotherapy or investigational therapy within two years of surgical resection of the primary tumor Curatively treated non-melanoma skin malignancy History of a second primary cancer with the exception of ) curatively treated non-melanomatous skin cancer, ) curatively treated cervical or breast carcinoma in situ, or ) other malignancy with no known active disease present and no treatment administered during the last years. Curatively resected non-melanoma skin cancer; No prior systemic treatment (chemotherapy or biologic/molecular targeted therapy) or radiation treatment for head and neck cancer\r\n* Patients may have received chemotherapy or radiation for a previous, curatively treated non-HNSCC malignancy, provided at least years have elapsed\r\n* Patients must be untreated with radiation above the clavicles\r\n* Patients with a history of curatively-treated non-HNSCC malignancy must be disease-free for at least years except for carcinoma-in-situ of cervix, non-melanomatous skin cancer, or T-, N, M resected differentiated thyroid carcinoma History of another malignancy within the previous years with > % probability of relapse other than curatively treated non-melanomatous skin cancer curatively treated non-melanomatous skin cancer No active malignancy except for nonmelanoma skin cancer or in situ cervical cancer; patients surviving a cancer that was curatively treated and without evidence of disease for more than years before the trial are allowed Has a diagnosed additional malignancy within years prior to first dose of study treatment with the exception of curatively treated in-situ cancer Patients with a history of prior malignancy within years of study entry with the exception of curatively treated non-melanomatous skin cancer or carcinoma in situ of the cervix or breast Other malignancy within years, except curatively treated non-melanomatous skin cancer, curatively treated carcinoma in situ of the uterine cervix, or early stage (stage I or IIa) prostate cancer History of another malignancy within the previous years other than curatively treated non-melanoma skin cancer History of another primary cancer within the last years with the exception of non-melanoma skin cancer or curatively-treated cervical carcinoma in-situ History of another primary cancer within the last years that required treatment, with the exception of non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in situ. a) Curatively treated non-melanoma skin cancer or Past or current history of neoplasm other than Non-small Cell Lung Cancer (NSCLC), except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer curatively treated and with no evidence of disease for at least years Curatively resected nonmelanomatous skin cancer Other malignancy curatively treated with no known active disease present and no systemic treatment administered for years before the first dose of study drug Patients with a history of a curatively treated malignancy must be disease-free for at least two years except for carcinoma in situ of cervix, melanoma in-situ (if fully resected), and/or non-melanomatous skin cancer History of another primary cancer within the last years with the exception of non-melanoma skin cancer, early state prostate cancer, or curatively-treated cervical cancer in-situ. History of another primary malignancy, with the exception of (i) curatively resected non-melanoma skin cancer, (ii) curatively treated in situ cervical cancer, or (iii) other malignancy curatively treated with no evidence of disease and no anticancer therapy administered for years prior to randomization, with the exception of adjuvant hormonal therapy for breast cancer History of another primary cancer within years prior to enrollment with the exception of curatively treated skin cancer (other than melanoma) or curatively treated cervical carcinoma in-situ History of another primary cancer within years prior to day with the exception of curatively treated skin cancer (other than melanoma) or curatively treated cervical carcinoma in-situ Diagnosis of another malignancy, unless the patient was diagnosed at least years earlier and has been disease-free for at least months following the completion of curative intent therapy, specifics as follows:\r\n* Curatively resected non-melanomatous skin cancer \r\n* Curatively treated cervical carcinoma in situ\r\n* Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed.\r\n* Other primary solid tumor curatively treated with no known active disease present and no treatment administered for the last years History of another invasive malignancy within years except for curatively resected nonmelanoma skin cancer or carcinoma in situ of the cervix The patient has history of another primary malignancy, with the exception of\r\n* Curatively treated non-melanomatous skin cancer;\r\n* Curatively treated cervical carcinoma in situ; \r\n* Non-metastatic prostate cancer\r\n* Other primary non-hematologic malignancies or solid tumor treated with curative intent, no known active disease, and no treatment administered during the last years prior to registration History of another primary cancer, except:\r\n* Curatively treated cervical carcinoma in situ, or\r\n* Curatively resected non-melanomatous skin cancer, or\r\n* Other primary solid tumor curatively treated with no known active disease present and no treatment administered for >= years prior to enrollment Concurrent malignancy, unless ) the subject has been curatively treated and disease free for >= years, or ) the cancer was non-melanoma skin cancer or early cervical cancer History of another primary cancer within the last years that required treatment, with the exception of non-melanoma skin cancer, early stage prostate cancer, or curatively treated cervical carcinoma in situ. History of or current neoplasm other than gastric adenocarcinoma, except for curatively treated nonmelanoma skin cancer or in situ carcinoma of the cervix uteri. History of or current neoplasm other than gastric adenocarcinoma, except for curatively treated nonmelanoma skin cancer or in situ carcinoma of the cervix uteri. Curatively resected non-melanomatous skin cancer; History of second or other primary cancer with the exception of: ) curatively treated non-melanomatous skin cancer; ) curatively treated cervical or breast carcinoma in situ; or ) other primary solid tumor treated with curative intent and no known active disease present and no treatment administered during the last years. Curatively resected non-melanomatous skin cancer; Curatively resected non melanoma skin cancer. A history of another invasive malignancy (other than non-melanoma skin cancer or curatively treated in situ carcinoma) with evidence of disease within the past years The participant has a history of another primary cancer, with the exception of the following: curatively resected nonmelanomatous skin cancer, curatively treated carcinoma in situ, or other primary solid tumor treated with curative intent and no known active disease present and no treatment administered during the last years. The participant has a history of another primary cancer, with the exception of: a) curatively resected nonmelanomatous skin cancer; b) curatively treated cervical carcinoma in-situ; or c) other primary solid tumor curatively resected or treated with no known active disease present and no treatment administered for the last years Patient must not have a history of other malignancy that has not been in remission for at least years, with the exception of basal non-melanoma skin cancer which were treated with local resection only or intraepithelial lesions or carcinoma in situ of the cervix or prostate that has been curatively treated History of, or current active cancer other than NSCLC, with the exception of curatively resected non-melanomatous skin cancer, curatively treated cervical carcinoma in situ, or other primary solid tumors curatively treated with no known active disease present and no curative treatment administered for the last years. History of another malignancy within the previous years other than curatively treated non-melanoma skin cancer