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)

PHASE3TerminatedINTERVENTIONAL
Enrollment

91

Participants

Timeline

Start Date

September 30, 2007

Primary Completion Date

May 31, 2008

Study Completion Date

May 31, 2008

Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
DRUG

Sorafenib + Paclitaxel + Carboplatin

Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), \[400 mg, (2 tablets x 200 mg each) orally, twice daily\] on Study Days 2-19 and paclitaxel (175 mg/m\^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.

DRUG

Placebo + Paclitaxel + Carboplatin

Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m\^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days

Trial Locations (22)

100

Taipei

500

Changhua

10330

Bangkok

100021

Beijing

100142

Beijing

100730

Beijing

110008

New Delhi

119228

Singapore

169610

Singapore

200032

Shanghai

200433

Shanghai

210003

Nanjing

310016

Hangzhou

400012

Mumbai

400038

Chongqing

510060

Guangzhou

510515

Guangzhou

Unknown

Shatin

Bangkok

(310022),

Hangzhou

410-769

Gyeonggi-do

136-705

Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY