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A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

NCT00806923 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1044

Last updated 2016-11-02

No results posted yet for this study

Summary

This 3 arm study will evaluate the efficacy and safety of adding Avastin versus placebo to a standard chemotherapeutic regimen in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) who have not received prior chemotherapy. The anticipated time of study treatment is until disease progression, and the target sample size is 500+ individuals.

Conditions

  • Non-Squamous Non-Small Cell Lung Cancer

Interventions

DRUG

Cisplatin

80mg/m2 iv on day 1 of each 3 week cycle, for a maximum of 6 cycles

DRUG

Gemcitabine

1250mg/m2 on days 1 and 8 of each 3 week cycle for a maximum of 6 cycles

DRUG

Placebo

iv on day 1 of each 3 week cycle until disease progression

DRUG

bevacizumab [Avastin]

15mg/kg 1v on day 1 of each 3 week cycle until disease progression

DRUG

bevacizumab [Avastin]

7.5 mg/kg iv on day 1 of each 3 week cycle until disease progression

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Czechia
  • France
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • Israel
  • Italy
  • Poland
  • Russia
  • Spain
  • Taiwan
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00806923 on ClinicalTrials.gov