A Study of Aflibercept Versus Placebo in Patients With Second-Line Docetaxel for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer
NCT ID: NCT00532155
Last Updated: 2025-09-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
913 participants
INTERVENTIONAL
2007-09-30
2011-10-31
Brief Summary
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The secondary objectives were to compare other efficacy parameters, to assess the overall safety of the two treatment arms, to assess the pharmacokinetics of intravenous (IV) aflibercept in this participant population and to determine immunogenicity of IV aflibercept in all participants.
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Detailed Description
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* A screening visit of up to 21 days prior to randomization
* Randomization at baseline (Treatment was initiated with 3 days of randomization)
* A treatment period with 3-week treatment cycles until the participant met the following discontinuation criteria: had progressive disease, had unacceptable toxicity, or refused further study treatment
* A post study treatment follow-up period (a visit was scheduled every 8 weeks until death or end of study)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Aflibercept/Docetaxel
Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
6 mg/kg Aflibercept administered intravenously (IV) over 1 hour once on Day 1, every 3 weeks.
Docetaxel (Taxotere®)
75 mg/m² docetaxel in 250 mL dextrose 5% or NaCl 0.9% administered intravenously (IV) over 1 hour, on Day 1 every 3 weeks.
Dexamethasone (pre- and post-medication for docetaxel)
As a pre- and post-medication for docetaxel, 8 mg dexamethasone was administered orally, the evening before Day 1, on Day 1 (early morning, 1 hour before docetaxel treatment, and evening) and on Day 2 (morning and evening).
Placebo/Docetaxel
Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
Placebo
Matching placebo to Aflibercept administered intravenously (IV) over 1 hour once on Day 1, every 3 weeks.
Docetaxel (Taxotere®)
75 mg/m² docetaxel in 250 mL dextrose 5% or NaCl 0.9% administered intravenously (IV) over 1 hour, on Day 1 every 3 weeks.
Dexamethasone (pre- and post-medication for docetaxel)
As a pre- and post-medication for docetaxel, 8 mg dexamethasone was administered orally, the evening before Day 1, on Day 1 (early morning, 1 hour before docetaxel treatment, and evening) and on Day 2 (morning and evening).
Interventions
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Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
6 mg/kg Aflibercept administered intravenously (IV) over 1 hour once on Day 1, every 3 weeks.
Placebo
Matching placebo to Aflibercept administered intravenously (IV) over 1 hour once on Day 1, every 3 weeks.
Docetaxel (Taxotere®)
75 mg/m² docetaxel in 250 mL dextrose 5% or NaCl 0.9% administered intravenously (IV) over 1 hour, on Day 1 every 3 weeks.
Dexamethasone (pre- and post-medication for docetaxel)
As a pre- and post-medication for docetaxel, 8 mg dexamethasone was administered orally, the evening before Day 1, on Day 1 (early morning, 1 hour before docetaxel treatment, and evening) and on Day 2 (morning and evening).
Eligibility Criteria
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Inclusion Criteria
* Disease progression during or after one, and only one, prior anticancer therapy which is platinum-based for advanced or metastatic disease
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
* Adequate renal, liver and bone marrow functions
Exclusion Criteria
* Less than 28 days elapsed from prior treatment with radiotherapy, surgery, or chemotherapy to the time of randomization
* Prior isotope therapy, whole pelvic radiotherapy, or radiotherapy to \> 25% of bone marrow
* Prior docetaxel treatment
* Uncontrolled hypertension
The above information was not intended to contain all considerations relevant to participation in a clinical trial.
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
Buenos Aires, , Argentina
sanofi-aventis Australia & New Zealand administrative office
Macquarie Park, New South Wales, Australia
Sanofi-Aventis Administrative Office
Vienna, , Austria
Sanofi-Aventis Administrative Office
São Paulo, , Brazil
Sanofi-Aventis Administrative Office
Sofia, , Bulgaria
Sanofi-Aventis Administrative Office
Laval, , Canada
Sanofi-Aventis Administrative Office
Santiago, , Chile
Sanofi-Aventis Administrative Office
Shanghai, , China
Sanofi-Aventis Administrative Office
Prague, , Czechia
Sanofi-Aventis Administrative Office
Tallinn, , Estonia
Sanofi-Aventis Administrative Office
Helsinki, , Finland
Sanofi-Aventis Administrative Office
Paris, , France
Sanofi-Aventis Administrative Office
Berlin, , Germany
Sanofi-Aventis Administrative Office
Athens, , Greece
Sanofi-Aventis Administrative Office
Causeway Bay, , Hong Kong
Sanofi-Aventis Administrative Office
Budapest, , Hungary
Sanofi-Aventis Administrative Office
Mumbai, , India
Sanofi-Aventis Administrative Office
Milan, , Italy
Sanofi-Aventis Administrative Office
Kuala Lumpur, , Malaysia
Sanofi-Aventis Administrative Office
Gouda, , Netherlands
Sanofi-Aventis Administrative Office
Warsaw, , Poland
Sanofi-Aventis Administrative Office
Porto Salvo, , Portugal
Sanofi-Aventis Administrative Office
Bucharest, , Romania
Sanofi-Aventis Administrative Office
Moscow, , Russia
Sanofi-Aventis Administrative Office
Singapore, , Singapore
Sanofi-Aventis Administrative Office
Seoul, , South Korea
Sanofi-Aventis Administrative Office
Barcelona, , Spain
Sanofi-Aventis Administrative Office
Bromma, , Sweden
Sanofi-Aventis Administrative Office
Taipei, , Taiwan
Sanofi-Aventis Administraive Office
Istanbul, , Turkey (Türkiye)
Sanofi-Aventis Admnistrative Office
Guildford Surrey, , United Kingdom
Countries
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References
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Ramlau R, Gorbunova V, Ciuleanu TE, Novello S, Ozguroglu M, Goksel T, Baldotto C, Bennouna J, Shepherd FA, Le-Guennec S, Rey A, Miller V, Thatcher N, Scagliotti G. Aflibercept and Docetaxel versus Docetaxel alone after platinum failure in patients with advanced or metastatic non-small-cell lung cancer: a randomized, controlled phase III trial. J Clin Oncol. 2012 Oct 10;30(29):3640-7. doi: 10.1200/JCO.2012.42.6932. Epub 2012 Sep 10.
Other Identifiers
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EudraCT 2007-000819-29
Identifier Type: -
Identifier Source: secondary_id
EFC10261
Identifier Type: -
Identifier Source: org_study_id
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