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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non Small Cell Lung

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Trial Information

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


The study included:

- 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)


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 was not intended to contain all considerations relevant to
participation in a clinical trial.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall Survival (OS)

Outcome Description:

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.

Outcome Time Frame:

Baseline to the date when 687 deaths occurred (26 January 2011)

Safety Issue:

No

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

EFC10261

NCT ID:

NCT00532155

Start Date:

September 2007

Completion Date:

October 2011

Related Keywords:

  • Carcinoma
  • Non Small Cell Lung
  • lung cancer
  • angiogenesis inhibitor
  • chemotherapy
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Sanofi-Aventis Administrative OfficeBridgewater, New Jersey  08807