A Trial Comparing Safety and Efficacy of Carboplatin and Paclitaxel Plus or Minus Sorafenib (BAY43-9006) in Chemonaive Patients With Stage IIIB-IV Non-Small Cell Lung Cancer (NSCLC)

Any prior systemic anticancer therapy including cytotoxic therapy, targeted agents, experimental therapy, adjuvant, or neo-adjuvant therapy for any current or prior diagnosis of NSCLC

Cardiac disease: Congestive heart failure \> class II New York Heart Association (NYHA). Patients must not have unstable angina (anginal symptoms at rest) or new-onset angina (began within the last 3 months) or myocardial infarction within the past 6 months

Known brain metastasis. Patients with neurological symptoms should undergo at Computed Tomography (CT) scan/Magnetic Resonance Imaging (MRI) of the brain to exclude brain metastasis

Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

Uncontrolled hypertension defined as systolic blood pressure \> 150 mm Hg or diastolic pressure \> 90 mm Hg, despite optimal medical management

Known human immunodeficiency virus (HIV) infection

Active clinically serious infections \> Common Terminology Criteria for Adverse Events (CTCAE) Grade 2

Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months

Pulmonary hemorrhage/bleeding event \> CTCAE Grade 2 within 4 weeks of first dose of study drug

Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug

Serious, non-healing wound, ulcer, or bone fracture

Evidence or history of bleeding diathesis or coagulopathy

Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug

Therapeutic anticoagulation with vitamin K antagonists such as warfarin, or with heparins or heparinoids. Low dose warfarin (1 mg daily, oral) is permitted if the INR remains \< 1.5. Low-dose aspirin is permitted

Known or suspected allergy to sorafenib or any agent given in the course of this trial

Cancer other than NSCLC within 5 years prior to start of study treatment, EXCEPT cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumors

Concurrent cancer that is distinct in primary site or histology from NSCLC

Substance abuse, medical, psychological or social conditions that may interfere with the patients participation in the study or evaluation of the study results

Any condition that impairs patients ability to swallow whole pills

Any malabsorption condition

Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment

Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation, including the 30 days period after last study drug dosing. The investigator should advise the patient how to achieve an adequate contraception

What this study is about