A Trial of Carboplatin and Gemcitabine Versus Gemcitabine Alone in Patients With Non-Small-Cell Lung Cancer

Inclusion Criteria: * Histologic or cytologic new diagnosis of NSCLC, Stage IIIB with a cytologically positive pleural or pericardial effusion or Stage IV. * No prior chemotherapy, including adjuvant or neoadjuvant therapy, for the treatment of NSCLC. * ECOG Performance Status of 2 . * Patients must be at least 3 weeks since major surgery. Patients must be at least 1 week since surgery, such as mediastinoscopy, pleuroscopy, or thoracostomy. * Patients must have measurable disease, defined as lesions that can be accurately measured in at least 1 dimension (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques or as greater than 10 mm with spiral CT scan. Exclusion Criteria: * Any prior radiation therapy to the thoracic area. * Active and ongoing systemic infection. * Prior radiation to greater than 25% of the bone marrow. * ECOG PS other than 2 * Patients with a known hypersensitivity to gemcitabine and carboplatin.