Spots Global Cancer Trial Database for 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)
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Trial Identification
Brief Title: 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)
Official Title: A Randomized Controlled 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)
Study ID: NCT00558636
Conditions
Study Description
Brief Summary: The purpose of this study conducted in Asia-Pacific was to evaluate the efficacy and safety of Sorafenib in combination with paclitaxel and carboplatin versus placebo in combination with paclitaxel and carboplatin for chemonaive patients with unresectable stage IIIB (with effusion) or stage IV NSCLC. However, as indicated below, the study was terminated prematurely when the results from Study 11961 (NCT00300885), an earlier Phase 3 study of similar design in subjects with advanced NSCLC, showed an overall lack of efficacy and increased mortality in subjects with squamous subtype. The data available is presented as descriptive analyses, due to the limitations of implementing the statistical analysis plan.
Detailed Description: The study was terminated early when the results from Study 11961 (NCT00300885), an earlier Phase 3 study evaluating the effects of Sorafenib in combination with paclitaxel and carboplatin in subjects with advanced NSCLC, showed an overall lack of efficacy of Sorafenib in combination with paclitaxel and carboplatin in NSCLC and increased mortality in subjects with squamous subtype.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Guangzhou, Guangdong, China
, Guangzhou, Guangdong, China
, Shatin, Hong Kong, China
, Nanjing, Jiangsu, China
, Hangzhou, Zhejiang, China
, Hangzhou, Zhejiang, China
, Beijing, , China
, Beijing, , China
, Beijing, , China
, Chongqing, , China
, Shanghai, , China
, Shanghai, , China
, Mumbai, Maharashtra, India
, New- Delhi, , India
, Gyeonggi-do, , Korea, Republic of
, Seoul, , Korea, Republic of
, Singapore, , Singapore
, Singapore, , Singapore
, Changhua, , Taiwan
, Taipei, , Taiwan
, Bangkok, , Thailand
, Bangkok, , Thailand
Contact Details
Name: Bayer Study Director
Affiliation: Bayer
Role: STUDY_DIRECTOR
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