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Therapeutic Areas: Oncology | Pulmonary/Respiratory Diseases | Family Medicine
Disease Category: Lung Cancer
Location: United States, IL
Clinical Trial Details
Research Study Summary
S0819 - Phase III Intergroup A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab with or without Concurrent Cetuximab in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)
The purpose of this study is compare the effects, good and/or bad, of cetuximab on lung cancer.
Patient Inclusion Criteria:
- Patients must have histologically or cytologically proven primary non-small cell lung cancer (adenocarcinoma, large cell carcinoma, squamous or unspecified). Disease must be Stage IV, as defined in Section 4.0. Disease may be either newly diagnosed or recurrent after previous surgery and/or irradiation. Patients with additional lesions in an ipsilateral non-primary lobe without M1a or M1b disease will not be considered to have Stage IV disease and are not eligible
- Patients must have a CT or MRI scan of the brain to evaluate for CNS disease within 42 days prior to registration. Patient must not have brain metastases unless: (1) metastases have been treated and have remained controlled for at least two weeks following treatment, AND (2) patient has no residual neurological dysfunction off corticosteroids for at least 1 day
- Patients may have measurable or non-measurable disease documented by CT or MRI. The CT from a combined PET/CT may be used to document only non-measurable disease unless it is of diagnostic quality as defined in Section Measurable disease must be assessed within 28 days prior to registration. Non-measurable disease must be assessed within 42 days prior to registration
Patient Exclusion Criteria:
- Patients must not have received prior chemotherapy for any stage non-small cell lung cancer. Patients must not have received prior platinum-based chemotherapy for any purpose. Patients must not have received any cetuximab, gefitinib, erlotinib or other investigational agents that target the EGFR pathway. Patients must not have received for any purpose prior bevacizumab or other VEGF-related agents. Patients must not have received for any purpose prior chimerized or murine monoclonal antibody therapy or have documented presence of human anti-mouse antibodies (HAMA).
- Prior radiation is permitted; however, patients must have recovered from all associated toxicities at time of registration.
To Learn more
Both Male and Female
Date Last Changed:
July 17, 2013
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