A Study of Aflibercept Versus Placebo in Patients With Second-Line Docetaxel for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (VITAL)


Tracking Information

Start Date  ICMJESeptember 2007
Estimated Primary Completion DateOctober 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: August 21, 2008)		Overall Survival [ Time Frame: Study period ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJE 
 (submitted: September 19, 2007)		Overall Survival
Change HistoryComplete list of historical versions of study NCT00532155 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: August 21, 2008)
  • Progression Free Survival [ Time Frame: Study period ] [ Designated as safety issue: No ]
  • Tumor Response Rate as per RECIST criteria (JNCI 2000) [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]
  • Health Related Quality of Life assessed by the Lung Cancer Symptom Scale [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: September 19, 2007)
  • Progression Free Survival
  • Tumor Response Rate as per RECIST criteria (JNCI 2000) [ Time Frame: every 6 weeks ]
  • Health Related Quality of Life assessed by the Lung Cancer Symptom Scale [ Time Frame: every 6 weeks ]

Descriptive Information

Brief Title  ICMJEA Study of Aflibercept Versus Placebo in Patients With Second-Line Docetaxel for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer
Official Title  ICMJEA 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
Brief Summary

The primary objective of the study is to demonstrate overall survival improvement for aflibercept + docetaxel compared to docetaxel + placebo as second line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).

The secondary objectives are 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 patient population and to determine immunogenicity of IV aflibercept (anti- aflibercept antibody detection) in all patients.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Condition  ICMJE
  • Carcinoma
  • Non Small Cell Lung
Intervention  ICMJE
  • Drug: Aflibercept (AVE0005)
    Associated to Docetaxel
  • Drug: Placebo
    Associated to Docetaxel
Study Arms / Comparison Groups
  • Arm A: Experimental
    Intervention: Drug: Aflibercept (AVE0005)
  • Arm B: Placebo Comparator
    Intervention: Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE900
Estimated Completion DateOctober 2010
Estimated Primary Completion DateOctober 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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 is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Public Registry ICDGV-Contact-us@sanofi-aventis.com
Location Countries  ICMJEUnited States,   Argentina,   Australia,   Austria,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Czech Republic,   Estonia,   Finland,   France,   Germany,   Greece,   Hong Kong,   Hungary,   India,   Italy,   Korea, Republic of,   Malaysia,   Netherlands,   Poland,   Portugal,   Romania,   Russian Federation,   Singapore,   Spain,   Sweden,   Taiwan,   Turkey,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00532155
Responsible PartyICD Study Director, sanofi-aventis
Study ID Numbers  ICMJEEFC10261, EudraCT 2007-000819-29
Study Sponsor  ICMJESanofi-Aventis
Collaborators  ICMJERegeneron Pharmaceuticals
Investigators  ICMJE
Study Director:ICDSanofi-Aventis
Information Provided BySanofi-Aventis