Inclusion Criteria

- INCLUSION CRITERIA:

Histologically documented Non-small cell lung cancer and confirmed by the Laboratory of
Pathology at the Clinical Center/National Institutes of Health (NIH) or the Laboratory of
Pathology at National Naval Medical Center (NNMC).

Recurrent or progressed Non-Small Cell Lung Cancer (NSCLC).

Patients must have measurable disease, defined as at least one lesion that can be
accurately measured in at least one dimension (longest diameter to be recorded) as greater
than 20 mm with conventional techniques or as greater than 10 mm with spiral Computed
tomography (CT) scan.

Patients must have recovered from toxicity related to prior therapy to at least to grade 1
(defined by Common Terminology Criteria for Adverse Events (CTCAE) 3.0) and must not have
had prior chemotherapy within 4 weeks. Patients must be at least 28 days since any prior
radiation or major surgery.

Age greater than 18 years (males or non-pregnant females). Because no dosing or adverse
event data are currently available on the use of BAY 43-9006 in patients less than 18
years of age, children are excluded from this study but will be eligible for future
pediatric single-agent trials, if applicable.

Life expectancy of greater than 3 months.

Eastern Cooperative Oncology Group (ECOG) performance status less than 2 (Karnofsky >
60%).

Patients must have adequate organ and marrow function (as defined below). Patients must
have returned to base line or grade one from any acute toxicity related to prior therapy.

Leukocytes greater than 3,000/micro l;

Absolute neutrophil count greater than 1,200/micro l;

Platelets greater than 100,000/micro l;

International normalized ratio (INR) less than or equal to 1.2

Partial thromboplastin time (PTT) less than or equal to 36 seconds or abnormality can be
explained by the presences of lupus anticoagulant

Total bilirubin less than or equal to 1.5 times the institutional upper limits of normal;

Aspartate aminotransferase, oxaloacetic transaminase (AST,SGOT) and alanine transaminase,
serum glutamic pyruvic transaminase (ALT,SGPT) less than 2.5 times the institutional upper
limits of normal;

Creatinine or creatinine clearance less than or equal to 1.5 times the institutional upper
limits of normal or greater than 45 mL/min/1.73 m^2 for patients with creatinine levels
above institutional normal.

The effects of BAY 43-9006 on the developing human fetus at the recommended therapeutic
dose are unknown. For this reason and because kinase inhibitors are known to be
teratogenic, women of child-bearing potential and men must agree to use adequate
contraception (hormonal or barrier method of birth control; abstinence) prior to study
entry and for the duration of study participation and continue for at least 2 months after
completion. Should a woman become pregnant or suspect she is pregnant while participating
in this study, she should inform her treating physician immediately. Because there is an
unknown but potential risk for adverse events in nursing infants secondary to treatment of
the mother with BAY 43-9006, breastfeeding should be discontinued if the mother is treated
with BAY 43-9006.

Ability to comply with daily oral self administration schedule, and the ability to
understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

Patients with symptomatic brain metastases should be excluded from this clinical trial
because of their poor prognosis and because they often develop progressive neurologic
dysfunction that would confound the evaluation of neurologic and other adverse events.
However, patients who have had treatment for their brain metastases and whose brain
metastatic disease status has remained stable for at least 3 months without steroids may
be enrolled at the discretion of the principal investigator.

Uncontrolled medical illness including, but not limited to, ongoing or uncontrolled,
symptomatic congestive heart failure (American Heart Association (AHA) Class II or worse),
uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, or psychiatric
illness/social situations that would limit compliance with study requirements.

Human immunodeficiency virus (HIV)positive patients receiving combination anti-retroviral
therapy are excluded from the study because of possible pharmacokinetic interactions with
BAY 43-9006. HIV positive patients not receiving antiretroviral therapy are excluded due
to the possibility that BAY 43-9006 may worsen their condition and the likelihood that the
underlying condition may obscure the attribution of adverse events with respect to BAY
43-9006.

Patients may not be receiving any other investigational agents.

History of another invasive malignancy in the last five years. Non-invasive, non-melanoma
skin cancers will be allowed.

Patients with conditions that would impair their ability to swallow tablets are excluded.

Patients must not have any evidence of bleeding diathesis.

Patients must not be on therapeutic anticoagulation. Prophylactic anticoagulation (i.e.
low dose warfarin) of venous or arterial access devices is allowed provided that the
requirements for prothrombin time (PT), international normalized ratio (INR) or partial
thromboplastin time (PTT) are met.

Both men and women and members of all races and ethnic groups are eligible for this trial.
Every effort will be made to recruit women and minorities in this study.