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)

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

Official Title

Conditions

• Non-Small Cell Lung Cancer (NSCLC)

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Study Start

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

Inclusion Criteria:

• Stage IIIB (with effusion) or Stage IV NSCLC any histology
• No prior chemotherapy
• 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 CT scan/MRI of the brain to exclude brain metastasis
• Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug
• Thrombotic or embolic events inclduign 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

Total Enrolment

Contact Details

Bayer Clinical Trial Contact clinical-trials-contact@bayerhealthcare.com