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)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Carcinoma, Non-Small Cell Lung

In brief

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.

Key facts

Study ID

NCT00300885

Run by

Bayer

People needed

926

Starts

2006-02-01

Expected to finish

2009-02-01

Last updated by the study team

2014-11-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Tucson, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Springdale, Arkansas, United States
• Study site — Anaheim, California, United States
• Study site — Beverly Hills, California, United States
• Study site — Burbank, California, United States
• Study site — Corona, California, United States
• Study site — Encinitas, California, United States
• Study site — Highland, California, United States
• Study site — Los Angeles, California, United States
• Study site — Orange, California, United States
• Study site — Sacramento, California, United States
• Study site — Denver, Colorado, United States
• Study site — Lakeland, Florida, United States
• Study site — Merritt Island, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Marietta, Georgia, United States
• Study site — Savannah, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Skokie, Illinois, United States
• Study site — Skokie, Illinois, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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