A Randomized Phase III Trial of Paraplatin (Carboplatin) + Gemzar Versus Gemzar Alone in Patients With Advanced 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.