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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
EudraCT 2007-000819-29
Secondary ID [2] 0 0
EFC10261
Universal Trial Number (UTN)
Trial acronym
VITAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma 0 0
Non Small Cell Lung 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
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).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Baseline to the date when 687 deaths occurred (26 January 2011)
Secondary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
Baseline to data cut-off (26 January 2011)
Secondary outcome [2] 0 0
Overall Response (OR) Rate as Per Response Evaluation Criteria in Solid Tumours (RECIST) Criteria
Timepoint [2] 0 0
Baseline to data cut-off (26 January 2011)
Secondary outcome [3] 0 0
Health Related Quality of Life (HRQL) Assessed by the Lung Cancer Symptom Scale (LCSS)
Timepoint [3] 0 0
Baseline (prior to first dose), at cycles 2 and 4 and at the end of study therapy.
Secondary outcome [4] 0 0
Health Related Quality of Life (HRQL) Assessed by the Average Symptom Burden Index (ASBI)
Timepoint [4] 0 0
Baseline (prior to first dose), at cycles 2 and 4 and at the end of study therapy.

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2011
Sample size
Target
Accrual to date
Final
913
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
sanofi-aventis Australia & New Zealand administrative office - Macquarie Park
Recruitment postcode(s) [1] 0 0
- Macquarie Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Austria
State/province [3] 0 0
Wien
Country [4] 0 0
Brazil
State/province [4] 0 0
Sao Paulo
Country [5] 0 0
Bulgaria
State/province [5] 0 0
Sofia
Country [6] 0 0
Canada
State/province [6] 0 0
Laval
Country [7] 0 0
Chile
State/province [7] 0 0
Santiago
Country [8] 0 0
China
State/province [8] 0 0
Shangai
Country [9] 0 0
Czech Republic
State/province [9] 0 0
Praha
Country [10] 0 0
Estonia
State/province [10] 0 0
Tallinn
Country [11] 0 0
Finland
State/province [11] 0 0
Helsinki
Country [12] 0 0
France
State/province [12] 0 0
Paris
Country [13] 0 0
Germany
State/province [13] 0 0
Berlin
Country [14] 0 0
Greece
State/province [14] 0 0
Athens
Country [15] 0 0
Hong Kong
State/province [15] 0 0
Causeway Bay
Country [16] 0 0
Hungary
State/province [16] 0 0
Budapest
Country [17] 0 0
India
State/province [17] 0 0
Mumbai
Country [18] 0 0
Italy
State/province [18] 0 0
Milano
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Seoul
Country [20] 0 0
Malaysia
State/province [20] 0 0
Kuala Lumpur
Country [21] 0 0
Netherlands
State/province [21] 0 0
Gouda
Country [22] 0 0
Poland
State/province [22] 0 0
Warszawa
Country [23] 0 0
Portugal
State/province [23] 0 0
Porto Salvo
Country [24] 0 0
Romania
State/province [24] 0 0
Bucuresti
Country [25] 0 0
Russian Federation
State/province [25] 0 0
Moscow
Country [26] 0 0
Singapore
State/province [26] 0 0
Singapore
Country [27] 0 0
Spain
State/province [27] 0 0
Barcelona
Country [28] 0 0
Sweden
State/province [28] 0 0
Bromma
Country [29] 0 0
Taiwan
State/province [29] 0 0
Taipei
Country [30] 0 0
Turkey
State/province [30] 0 0
Istanbul
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Guildford Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Regeneron Pharmaceuticals
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Ramlau R, Gorbunova V, Ciuleanu TE, Novello S, Ozg... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT00532155