Inclusion Criteria

Inclusion Criteria

1. Patients must have a histologically or cytologically confirmed diagnosis of NSCLC and
must not have had chemotherapy or biological therapy for their disease.

2. Stage IIIB (N3 and/or pleural or pericardial effusion) or IV disease that is not
amenable to either surgery or radiation therapy of curative intent.

3. Life expectancy of ≥ 12 weeks

4. If patient has had prior radiation therapy: lesion(s) used for determination of
response was not previously irradiated or has increased in size since the completion
of radiotherapy; and patient has recovered from any toxicity from the radiotherapy.

5. Radiotherapy to lesion(s) used for determination of response was completed at least 6
weeks prior to treatment; radiotherapy to other sites was completed at least 2 weeks
prior to treatment.

6. At least one unidimensionally measurable lesion meeting Response Evaluation Criteria
in Solid Tumors [RECIST] (at least 10 mm in longest diameter by spiral computed
tomography [CT] scan, or at least 20 mm by standard techniques).

7. ECOG status must be ≤ 1

Exclusion Criteria

1. Prior chemotherapy or biological therapy (approved or experimental) for NSCLC,
including adjuvant and neoadjuvant treatment.

2. Presence of central nervous system (CNS) metastases, unless the patient has completed
successful local therapy for CNS metastases, with the exception of leptomeningeal
disease for which patients will be excluded. Patients must be off corticosteroids for
at least 21 days prior to starting treatment.

3. Second primary malignancy (except in situ carcinoma of the cervix, adequately treated
non-melanomatous skin cancers, clinically localized prostate cancer, superficial
bladder cancer or other malignancy treated at least 3 years previously with no
evidence of recurrence).

4. Patients eligible for combined modality therapy with curative intent as defined by
the combination of chemotherapy, radiation therapy and/or surgery. (This criteria is
intended to exclude patients with stage IIIB disease, as defined by the presence of
N3 nodal status, who have been reported to have cure rates as high as 10% when
treated with combined modality therapy.)