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)

NCT00300885 | Terminated Phase 3 Results

• 2 other identifiers: 119612005-005245-19
• Study Type: interventional
• Target: 926
• Locations: 21 countries
• Sites: 202

Brief Summary

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.

Conditions

Carcinoma, Non-Small Cell Lung

Keywords

Non-Small Cell Lung Cancer; NSCLC

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS) in Patients Treated With Carboplatin, Paclitaxel and Sorafenib to OS in Patients Treated With Carboplatin, Paclitaxel and Placebo

  Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks during study treatment and every 3 months during post-treatment.

  Outcome measure was assessed every 3 weeks starting from randomization, during treatment period and every 3 months during follow-up period until death was recorded or up to data cutoff (1Oct2007) used for planned formal interim analysis

Secondary Outcomes (5)

• Progression Free Survival (PFS)

  Tumor measurements and assessments based on RECIST criteria were performed every 6 weeks for the first 18 weeks of therapy ( week 6, 12, and 18) and every 12 weeks thereafter up to data cutoff (1Oct2007) used for planned formal interim analysis

• Overall Best Response

  Tumor measurements and assessments based on RECIST criteria were performed every 6 weeks for the first 18 weeks of therapy ( week 6, 12, and 18) and every 12 weeks thereafter up to data cutoff (1Oct2007) used for planned formal interim analysis

• Duration of Response

  Tumor measurements and assessments based on RECIST criteria were performed every 6 weeks for the first 18 weeks of therapy ( week 6, 12, and 18) and every 12 weeks thereafter up to data cutoff (1Oct2007) used for planned formal interim analysis

• Patient Reported Outcome as Assessed by FACT-L Score. Change From Baseline in Total FACT-L at Cycles 3,5,7,9 and End of Treatment (EOT)

  Outcome measure was assessed on Day 1 of Cycle 1 and Day 1 of every other cycle (i.e. Cycle 3, 5, 7 etc.) during treatment and at end of treatment visit or up to data cutoff (10ct2007) used for planned formal interim analysis

• Patient Reported Outcome as Assessed by LCS Subscale Score. Change From Baseline in LCS Subscale at Cycles 2 Through 9 and at End of Treatment (EOT)

  Outcome measure was assessed on Day 1 of Cycle 1 and Day 1 of every cycle (i.e. Cycle 2, 3, 4, 5 etc.) during treatment and at end of treatment visit or up to data cutoff (10ct2007) used for planned formal interim analysis

Study Arms (2)

Sorafenib + C/P

EXPERIMENTAL

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.

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

Placebo + C/P

ACTIVE COMPARATOR

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.

Drug: Carboplatin plus Paclitaxel

Interventions

Nexavar (Sorafenib, BAY43-9006) + carboplatin + paclitaxel DRUG

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.

Sorafenib + C/P

Carboplatin plus Paclitaxel DRUG

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.

Placebo + C/P

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Bayer: lead

Study Sites (202)

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Birmingham, Alabama, 35211, United States

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Mobile, Alabama, 36608, United States

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Tucson, Arizona, 85715, United States

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Little Rock, Arkansas, 72205, United States

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Springdale, Arkansas, 72764, United States

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Anaheim, California, 92801, United States

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Beverly Hills, California, 90211-1850, United States

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Burbank, California, 91595, United States

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Corona, California, 92829, United States

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Encinitas, California, 92024, United States

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Highland, California, 92346, United States

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Los Angeles, California, 90057, United States

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Orange, California, 92868, United States

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Sacramento, California, 95817, United States

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Denver, Colorado, 80218, United States

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Lakeland, Florida, 33805, United States

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Merritt Island, Florida, 32952, United States

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Orlando, Florida, 32804, United States

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Orlando, Florida, 32806, United States

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Atlanta, Georgia, 30309, United States

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Marietta, Georgia, 30060, United States

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Savannah, Georgia, 31405, United States

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Chicago, Illinois, 60637, United States

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Skokie, Illinois, 60076, United States

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Skokie, Illinois, 60077, United States

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Fort Wayne, Indiana, 46815, United States

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Indianapolis, Indiana, 46202, United States

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Indianapolis, Indiana, 46254, United States

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Indianapolis, Indiana, 46260, United States

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Kokomo, Indiana, 46902, United States

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Sioux City, Iowa, 51101, United States

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Hutchinson, Kansas, 67502, United States

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Wichita, Kansas, 67214, United States

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Louisville, Kentucky, 40215, United States

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Baton Rouge, Louisiana, 70808, United States

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Metairie, Louisiana, 70006, United States

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Boston, Massachusetts, 02130, United States

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Pittsfield, Massachusetts, 01201, United States

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Ann Arbor, Michigan, 48106, United States

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Detroit, Michigan, 48202, United States

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Hattiesburg, Mississippi, 39401, United States

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Jefferson City, Missouri, 65109, United States

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Kansas City, Missouri, 64111, United States

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Kansas City, Missouri, 64131, United States

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St Louis, Missouri, 63141, United States

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Lincoln, Nebraska, 68510, United States

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Las Vegas, Nevada, 89102, United States

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Las Vegas, Nevada, 89106, United States

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Hackensack, New Jersey, 07601, United States

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Morristown, New Jersey, 07962-1089, United States

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New York, New York, 10029, United States

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Rochester, New York, 14622, United States

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Staten Island, New York, 10305, United States

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Bismarck, North Dakota, 58501, United States

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Fargo, North Dakota, 58122, United States

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Columbus, Ohio, 43213, United States

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Columbus, Ohio, 43235, United States

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Dayton, Ohio, 45429, United States

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Dover, Ohio, 44622, United States

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Oklahoma City, Oklahoma, 73104, United States

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Tulsa, Oklahoma, 74136, United States

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Portland, Oregon, 97213, United States

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Allentown, Pennsylvania, 18103, United States

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Bethlehem, Pennsylvania, 18015, United States

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Philadelphia, Pennsylvania, 19115, United States

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Pottsville, Pennsylvania, 17901, United States

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Sayre, Pennsylvania, 18840, United States

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Charleston, South Carolina, 29403, United States

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Greenville, South Carolina, 29615, United States

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Knoxville, Tennessee, 37920, United States

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Nashville, Tennessee, 37232-6307, United States

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Trophy Club, Texas, 76262, United States

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Salt Lake City, Utah, 84112, United States

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Abingdon, Virginia, 24211, United States

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Fairfax, Virginia, 22031, United States

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Richlands, Virginia, 24641, United States

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Richmond, Virginia, 23230, United States

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Richmond, Virginia, 23298-0037, United States

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Morgantown, West Virginia, 26505, United States

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Milwaukee, Wisconsin, 53215, United States

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El Palomar - Morón, Buenos Aires, 1684, Argentina

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La Plata, Buenos Aires, B1900AVG, Argentina

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Mar del Plata, Buenos Aires, B7602CBM, Argentina

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Buenos Aires, Ciudad Auton. de Buenos Aires, C1405DCS, Argentina

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Rosario, Santa Fe Province, 2000, Argentina

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Capital Federal-Buenos Aires, C1426ANZ, Argentina

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Santa Fé, S3000FFV, Argentina

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Port Macquarie, New South Wales, 2444, Australia

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Wollongong, New South Wales, 2500, Australia

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Brisbane, Queensland, 4029, Australia

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Adelaide, South Australia, 5065, Australia

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Frankston, Victoria, 3199, Australia

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Melbourne, Victoria, 3144, Australia

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Perth, Western Australia, 6000, Australia

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Bruxelles - Brussel, 1200, Belgium

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Charleroi, 6000, Belgium

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La Louvière, 7100, Belgium

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Liège, 4000, Belgium

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Fortaleza, Ceará, 60336-550, Brazil

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Fortaleza, Ceará, 60430-230, Brazil

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Salvador, Estado de Bahia, 40050410, Brazil

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Brasília, Federal District, 70390907, Brazil

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Goiânia, Goiás, 74605-180, Brazil

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Nova Lima, Minas Gerais, 34000000, Brazil

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Curitiba, Paraná, 80730-180, Brazil

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Porto Alegre, Rio Grande do Sul, 90619900, Brazil

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Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

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Joinville, Santa Catarina, 89202-050, Brazil

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Barretos, São Paulo, 14784400, Brazil

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Jaú, São Paulo, 17210-120, Brazil

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Ribeirão Preto, São Paulo, 14015-140, Brazil

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Santo André, São Paulo, 09090-780, Brazil

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São Paulo, São Paulo, 01331010, Brazil

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São Paulo, São Paulo, 04024-002, Brazil

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São Paulo, São Paulo, 05403-000, Brazil

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São Paulo, São Paulo, Brazil

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Sorocaba, São Paulo, 18030-510, Brazil

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Belo Horizonte, 30380490, Brazil

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North Vancouver, British Columbia, V7L 2L7, Canada

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Barrie, Ontario, L4M 6M2, Canada

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Brampton, Ontario, L6W 3X4, Canada

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Montreal, Quebec, H3T 1E2, Canada

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Regina, Saskatchewan, S4T 7T1, Canada

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Santiago, Santiago Metropolitan, 838-0455, Chile

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Santiago, 760 0448, Chile

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Santiago, 836-0156, Chile

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Santiago, Chile

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Bobigny, 93009, France

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Caen, 14073, France

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Clamart, 92140, France

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Metz, 57000, France

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Nancy, 54100, France

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Nice, 06102, France

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Strasbourg, 67100, France

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Heidelberg, Baden-Wurttemberg, 69126, Germany

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Mannheim, Baden-Wurttemberg, 68167, Germany

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Gauting, Bavaria, 82131, Germany

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München, Bavaria, 80336, Germany

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Hamburg, Hamburg, 21075, Germany

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Hofheim, Hesse, 65719, Germany

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Göttingen, Lower Saxony, 37075, Germany

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Hanover, Lower Saxony, 30625, Germany

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Oldenburg, Lower Saxony, 26121, Germany

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Essen, North Rhine-Westphalia, 45122, Germany

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Essen, North Rhine-Westphalia, 45136, Germany

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Hemer, North Rhine-Westphalia, 58675, Germany

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Leverkusen, North Rhine-Westphalia, 51375, Germany

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Mainz, Rhineland-Palatinate, 55131, Germany

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Großhansdorf, Schleswig-Holstein, 22927, Germany

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Berlin, State of Berlin, 12200, Germany

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Hong Kong, Hong Kong

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Budapest, 1529, Hungary

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Deszk, 6772, Hungary

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Gyula, 5703, Hungary

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Mátraháza, 3233, Hungary

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Törökbálint, 2045, Hungary

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Orbassano, Torino, 10043, Italy

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Bergamo, 24128, Italy

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Genova, 16132, Italy

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Milan, 20162, Italy

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Parma, 43100, Italy

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Pavia, 27100, Italy

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Perugia, 06156, Italy

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Roma, 00152, Italy

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Torino, 10126, Italy

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Eindhoven, North Brabant, 5623 EJ, Netherlands

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Zwolle, 8011 JW, Netherlands

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Gdansk, 80-952, Poland

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Krakow, 31-115, Poland

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Olsztyn, 10-228, Poland

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Otwock, 05-400, Poland

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Warsaw, 02-781, Poland

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Warsaw, 04-141, Poland

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Wroclaw, 53-439, Poland

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San Juan, 00921, Puerto Rico

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Moscow, 115478, Russia

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Moscow, 117837, Russia

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Moscow, 143423, Russia

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Saint Petersburg, 198255, Russia

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Seoul, 110-799, South Korea

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Seoul, 135710, South Korea

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Seoul, 138736, South Korea

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Alicante, Alicante, 03010, Spain

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Elche, Alicante, 03202, Spain

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Zaragoza, Aragon, 50009, Spain

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Barcelona, Barcelona, 08036, Spain

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Madrid, Madrid, 28006, Spain

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Madrid, Madrid, 28034, Spain

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Majadahonda, Madrid, 28222, Spain

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Pontevedra, Pontevedra, 36001, Spain

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Zamora, Zamora, 49021, Spain

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Gävle, 801 87, Sweden

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Stockholm, 171 76, Sweden

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Uppsala, 751 85, Sweden

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Taichung, 40705, Taiwan

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Taipei, 110, Taiwan

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Taoyuan District, 333, Taiwan

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Plymouth, Devon, PL6 8DH, United Kingdom

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Bornemouth, Dorset, BH7 7DW, United Kingdom

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Leicester, Leicestershire, LE1 5WW, United Kingdom

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London, London, SE1 9RT, United Kingdom

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Manchester, Manchester, M23 9LT, United Kingdom

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Related Publications (1)

• Scagliotti G, Novello S, von Pawel J, Reck M, Pereira JR, Thomas M, Abrao Miziara JE, Balint B, De Marinis F, Keller A, Aren O, Csollak M, Albert I, Barrios CH, Grossi F, Krzakowski M, Cupit L, Cihon F, Dimatteo S, Hanna N. Phase III study of carboplatin and paclitaxel alone or with sorafenib in advanced non-small-cell lung cancer. J Clin Oncol. 2010 Apr 10;28(11):1835-42. doi: 10.1200/JCO.2009.26.1321. Epub 2010 Mar 8.

  PMID: 20212250 RESULT

Related Links

• Click here and search for information of Bayer products for Europe

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Sorafenib; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Limitations and Caveats

Based on the results of the interim analysis, it was determined that the study would not meet its primary efficacy endpoint and the study was terminated early. The planned biomarker analysis was suspended due to early termination.

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2006
• First Posted: March 10, 2006
• Study Start: February 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: February 1, 2009
• Last Updated: November 4, 2014
• Results First Posted: September 20, 2010

Record last verified: 2014-10

Locations

GB (5); FR (7); CA (5); US (80); NL (2); HU (5); HK (1); RU (4); KR (3); ES (9); TW (3); PR (1); BR (20); CL (4); AU (7); PL (7); SE (3); BE (4); DE (16); AR (7); IT (9)