NCT00532155|CompletedPhase 3ResultsDMC

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

VITAL

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

Sanofi ClinicalTrials.gov

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2 other identifiers

EFC10261EudraCT 2007-000819-29

Study Type

interventional

Target

913

Locations

30 countries

Sites

Timeline

RegisteredSep 2007

StartedSep 2007

CompletionOct 2011

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

913

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Sep 2007

Typical duration for phase_3

Geographic Reach

30 countries

30 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.1 years study duration

Study Start

First participant enrolled

September 1, 2007

Completed

18 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

September 20, 2007

Completed

3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

January 1, 2013

Completed

Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

3.3 years

First QC Date

September 19, 2007

Results QC Date

August 17, 2012

Last Update Submit

September 8, 2025

Conditions

Carcinoma Non Small Cell Lung

Keywords

lung cancerangiogenesis inhibitorchemotherapy

Outcome Measures

Primary Outcomes (1)

Overall Survival (OS)
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.
Baseline to the date when 687 deaths occurred (26 January 2011)

Secondary Outcomes (4)

Progression Free Survival (PFS)
Baseline to data cut-off (26 January 2011)
Overall Response (OR) Rate as Per Response Evaluation Criteria in Solid Tumours (RECIST) Criteria
Baseline to data cut-off (26 January 2011)
Health Related Quality of Life (HRQL) Assessed by the Lung Cancer Symptom Scale (LCSS)
Baseline (prior to first dose), at cycles 2 and 4 and at the end of study therapy.
Health Related Quality of Life (HRQL) Assessed by the Average Symptom Burden Index (ASBI)
Baseline (prior to first dose), at cycles 2 and 4 and at the end of study therapy.

Study Arms (2)

Aflibercept/Docetaxel

EXPERIMENTAL

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.

Drug: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)Drug: Docetaxel (Taxotere®)Drug: Dexamethasone (pre- and post-medication for docetaxel)

Placebo/Docetaxel

PLACEBO COMPARATOR

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.

Drug: PlaceboDrug: Docetaxel (Taxotere®)Drug: Dexamethasone (pre- and post-medication for docetaxel)

Interventions

Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)DRUG

6 mg/kg Aflibercept administered intravenously (IV) over 1 hour once on Day 1, every 3 weeks.

Aflibercept/Docetaxel

PlaceboDRUG

Matching placebo to Aflibercept administered intravenously (IV) over 1 hour once on Day 1, every 3 weeks.

Placebo/Docetaxel

Docetaxel (Taxotere®)DRUG

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.

Aflibercept/DocetaxelPlacebo/Docetaxel

Dexamethasone (pre- and post-medication for docetaxel)DRUG

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).

Aflibercept/DocetaxelPlacebo/Docetaxel

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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.

Contact the study team to confirm eligibility.