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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00532155
Registration number
NCT00532155
Ethics application status
Date submitted
19/09/2007
Date registered
20/09/2007
Date last updated
7/06/2016
Titles & IDs
Public title
A Study of Aflibercept Versus Placebo in Patients With Second-Line Docetaxel for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer
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Scientific title
A Multinational, Randomized, Double-Blind Study Comparing Aflibercept Versus Placebo in Patients Treated With Second-Line Docetaxel After Failure of One Platinum Based Therapy for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer
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Secondary ID [1]
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EudraCT 2007-000819-29
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Secondary ID [2]
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EFC10261
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Universal Trial Number (UTN)
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Trial acronym
VITAL
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Carcinoma
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Non Small Cell Lung
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
Treatment: Drugs - Placebo
Treatment: Drugs - Docetaxel (Taxotere®)
Treatment: Drugs - Dexamethasone (pre- and post-medication for docetaxel)
Experimental: 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 Comparator: 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.
Treatment: Drugs: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
6 mg/kg Aflibercept administered intravenously (IV) over 1 hour once on Day 1, every 3 weeks.
Treatment: Drugs: Placebo
Matching placebo to Aflibercept administered intravenously (IV) over 1 hour once on Day 1, every 3 weeks.
Treatment: Drugs: 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.
Treatment: Drugs: 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).
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS was time interval from the date of randomization to the date of death due to any cause. If death was not observed during the study, overall survival time was censored at the last date the participant was known to be alive, or the study cutoff date, whichever was earlier. The cut-off date for the OS was date when 687 deaths were observed.
OS was estimated from Kaplan-Meier Curves.
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Timepoint [1]
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Baseline to the date when 687 deaths occurred (26 January 2011)
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Secondary outcome [1]
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Progression Free Survival (PFS)
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Assessment method [1]
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PFS was defined as the time interval between the date of randomization and the time of occurrence of the first radiological tumor progression detected by a computer tomography (CT) scan and /or by Magnetic Resonance Imaging (MRI); or death due to any cause; whichever was earlier. Participants without disease progression were censored at the earliest date between their last valid tumour assessment and the data cutoff date.
PFS was estimated from Kaplan-Meier Curves.
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Timepoint [1]
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Baseline to data cut-off (26 January 2011)
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Secondary outcome [2]
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Overall Response (OR) Rate as Per Response Evaluation Criteria in Solid Tumours (RECIST) Criteria
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Assessment method [2]
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Participants with OR were those who had a confirmed complete response [CR] or a confirmed partial response [PR], based on RECIST criteria, in which
CR refected the disappearance of all tumor lesions (with no new tumors)
PR reflected a pre-defined decrease in tumor burden - a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD
OR was CR + PR The response rate was the percent of participants with a response.
To determine a response, tumors were assessed by the investigators using Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and an observed response was confirmed by repeated imaging after 4 - 6 weeks.
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Timepoint [2]
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Baseline to data cut-off (26 January 2011)
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Secondary outcome [3]
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Health Related Quality of Life (HRQL) Assessed by the Lung Cancer Symptom Scale (LCSS)
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Assessment method [3]
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HRQL assessments were performed by participants using a self-administered LCSS questionnaire. LCSS is a 9-item questionnaire, six measuring major symptoms for lung malignancies (appetite, fatigue, cough, dyspnea, hemoptysis and pain), and 3 summation items related to total symptomatic distress, activity status and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-mm lines. The LCSS total score was defined as the mean of the 9 items of the scale, each scored between 0 (for best outcome) to 100 (for worst outcome).
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Timepoint [3]
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Baseline (prior to first dose), at cycles 2 and 4 and at the end of study therapy.
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Secondary outcome [4]
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Health Related Quality of Life (HRQL) Assessed by the Average Symptom Burden Index (ASBI)
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Assessment method [4]
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HRQL assessments were performed by participants using a self-administered LCSS questionnaire. LCSS is a 9-item questionnaire, six measuring major symptoms for lung malignancies, and 3 summation items related to total symptomatic distress, activity status and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-mm lines. ABSI was the mean score for the six major lung cancer symptoms (appetite, fatigue, cough, dyspnea, hemoptysis and pain), each scored between 0 (for best outcome) to 100 (for worst outcome).
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Timepoint [4]
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Baseline (prior to first dose), at cycles 2 and 4 and at the end of study therapy.
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Eligibility
Key inclusion criteria
- Histological/cytological proven locally advanced or metastatic non-small cell lung
cancer
- 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Squamous histology/cytology
- 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2011
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Sample size
Target
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Accrual to date
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Final
913
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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sanofi-aventis Australia & New Zealand administrative office - Macquarie Park
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Recruitment postcode(s) [1]
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- Macquarie Park
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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New Jersey
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Argentina
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Buenos Aires
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Austria
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Wien
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Brazil
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Sao Paulo
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Bulgaria
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Sofia
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Canada
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Laval
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Chile
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Santiago
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China
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Shangai
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Czech Republic
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Praha
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Estonia
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Tallinn
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Finland
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Helsinki
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France
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Paris
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Germany
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Berlin
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Greece
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Athens
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Hong Kong
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Causeway Bay
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Hungary
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Budapest
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India
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Mumbai
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Italy
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Milano
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Korea, Republic of
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Seoul
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Malaysia
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Kuala Lumpur
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Netherlands
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Gouda
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Poland
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Warszawa
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Portugal
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Porto Salvo
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Romania
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Bucuresti
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Russian Federation
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Moscow
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Singapore
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Singapore
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Spain
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Barcelona
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Sweden
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Bromma
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Taiwan
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Taipei
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Turkey
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Istanbul
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United Kingdom
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Guildford Surrey
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Sanofi
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Regeneron Pharmaceuticals
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objective of the study was to demonstrate overall survival improvement for
aflibercept + docetaxel compared to docetaxel + placebo as second line treatment for
participants with locally advanced or metastatic non-small cell lung cancer (NSCLC).
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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Trial website
https://clinicaltrials.gov/ct2/show/NCT00532155
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Clinical Sciences & Operations
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Address
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Sanofi
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00532155
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