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)

Bayer

Status and phase: Terminated; Phase 3

Conditions: Carcinoma, Non-Small Cell Lung

Treatments: Drug: Nexavar (Sorafenib, BAY43-9006) + carboplatin + paclitaxel; Drug: Carboplatin plus Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00300885

11961

2005-005245-19 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 926 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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926 participants in 2 patient groups

Sorafenib + C/P

Experimental group

Description:

Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), \[400 mg orally, twice daily\] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml\*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.

Treatment:

Drug: Nexavar (Sorafenib, BAY43-9006) + carboplatin + paclitaxel

Placebo + C/P

Active Comparator group

Description:

Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily\] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml\*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.

Treatment:

Drug: Carboplatin plus Paclitaxel