A Randomized Controlled Trial Comparing Safety and Efficacy of Carboplatin and Paclitaxel Plus or Minus Sorafenib (BAY 43-9006) in Chemonaive Patients With Stage IIIB-IV Non-Small Cell Lung Cancer (NSCLC)

• Status: Terminated
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

A randomized controlled trial comparing safety and efficacy of carboplatin and paclitaxel plus or minus sorafenib in chemonaive patients with stage III-IV non-small cell lung cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Niacinamide; Paclitaxel; Sorafenib

Criteria

Inclusion Criteria:

• Stage IIIB (with effusion) or Stage IV NSCLC any histology

• No prior chemotherapy

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

• Greater than or equal to 18 years of age

• Life expectancy at least 12 weeks

• Adequate bone marrow, liver and renal function

Exclusion Criteria:

• Prior systemic anti cancer therapy

• 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

• Pulmonary hemorrhage/bleeding event > Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 within 4 weeks of first dose of study drug

• Thrombotic or embolic events including Transient ischemic attack (TIA) within the past 6 months

• Uncontrolled hypertension

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

• Major surgery within 4 weeks

• Evidence or history of bleeding diathesis or coagulopathy