Intervention: Sorafenib
Trial phase: Phase 2
ATC code: L01EX02 | L01XE05
SMILES: CNC(=O)c1cc(Oc2ccc(NC(=O)Nc3ccc(Cl)c(C(F)(F)F)c3)cc2)ccn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle.

sorafenib: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient.
Eligibility criteria:
DISEASE CHARACTERISTICS:

Histologically confirmed non-small cell lung cancer

Stage IIIB or IV disease
Recurrent disease after prior surgery, chemotherapy, or radiotherapy
No squamous cell histology or mixed tumor with > 50% squamous cells
Non-smoker (smoked ≤ 100 cigarettes in lifetime) OR former light smoker (smoked > 100 cigarettes but ≤ 10 pack years AND quit smoking ≥ 1 year ago)

No known brain metastasis

Patients with neurological symptoms must undergo a CT scan or MRI of the brain to exclude brain metastasis

PATIENT CHARACTERISTICS:

ECOG(Eastern Cooperative Oncology Group)performance status 0-2
ANC (Absolute Neutrophil Count)≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
ALT (Alanine Aminotransferase Test) and AST (Aspartate Aminotransferase Test) ≤ 2.5 times upper limit of normal (ULN)
Alkaline phosphatase ≤ 2.5 times ULN
Bilirubin ≤ 1.5 mg/dL
Creatinine clearance ≥ 50 mL/min
INR (International Normalized Ratio) < 1.5 OR PT/PTT (Prothrombin time/partial thromboplastin time)normal
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective barrier contraception prior to, during, and for ≥ 3 months after completion of study treatment

No cardiac disease, including any of the following:

New York Heart Association class III-IV congestive heart failure
Unstable angina (anginal symptoms at rest)
New-onset angina within the past 3 months
Myocardial infarction within the past 6 months
No cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
No uncontrolled hypertension (i.e., systolic blood pressure [BP] > 150 mm Hg or diastolic BP > 90 mm Hg) despite optimal medical management
No thrombolic or embolic events (e.g., cerebrovascular accident, including transient ischemic attacks) within the past 6 months
No pulmonary hemorrhage or bleeding event ≥ CTCAE (Common Terminology Criteria for Adverse Events)grade 2 within the past 4 weeks
No other hemorrhage or bleeding event ≥ CTCAE grade 3 within the past 4 weeks
No active clinically serious infection > CTCAE grade 2
No serious non-healing wound, ulcer, or bone fracture
No evidence or history of bleeding diathesis or coagulopathy
No known HIV infection or chronic hepatitis B or C

No other malignancy except for any of the following:

Adequately treated basal cell or squamous cell skin cancer
In situ cervical cancer
Other cancer from which the patient has been disease-free for ≥ 5 years with a low probability of recurrence
No condition that impairs the patient's ability to swallow whole pills
No malabsorption problems
No known or suspected allergy to sorafenib tosylate or any agent given in the course of this study
No significant traumatic injury within the past 4 weeks

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

No more than one prior systemic chemotherapy treatment for metastatic disease

Prior treatment with EGFR inhibitors is not considered chemotherapy
More than 4 weeks since prior major surgery or open biopsy
No prior sorafenib tosylate
No concurrent St. John's wort or rifampin
Concurrent anticoagulation with warfarin or heparin allowed