Randomized Phase II Trail of Carboplatin and Gemcitabine Untreated Stage IIIB-pleural Effusion and Stage IV Lung Cancer

Inclusion Criteria:

- Untreated, stage IIIB with pleural effusion

- Untreated, Stage IV, non-small cell lung cancer

- Recurrent after surgery if no previous radiation therapy or chemotherapy were
administered as part of their primary treatment, except for palliative radiotherapy

- 18 years of age or older

- ECOG PS 0, 1 or 2

- At Least one target lesion according to the RECIST Criteria

- Adequate organ and marrow function

Exclusion Criteria:

- Previous cancer history unless they have had curative treatment completed at least 5
years prior to entry.

- No previous radiotherapy, chemotherapy or immunotherapy for NSCLC, except for
radiation therapy to the brain to control metastasis, bone to control pain, or lung
to relieve bronchial obstruction.

- No radiation therapy for any previous cancer to more than 25% of bone marrow.

- Uncontrolled, intercurrent illness

- Non-study corticosteroids

- Pregnant women

- Peripheral neuropathy greater than grade 1

- Uncontrolled seizures, central nervous system disorders

- Major surgery within 4 weeks of the start of study treatment

- Lack of complete recovery from major surgery.

- Glaucoma

- Lack of physical integrity of upper gastrointestinal tract, inability to swallow
tablets

- Severe acquired or hereditary immunodeficiency

- Patients with brain metastases must receive definitive treatment (radiation, surgery
or both) and be clinically and radiologically stable for 4 weeks & off
corticosteroids for at least 2 weeks prior to randomization.