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

Sponsor
Hoffmann-La Roche
Study ID
NCT00806923
Phase
PHASE3
Status
Completed

Conditions

  • Non-Squamous Non-Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cisplatin — DRUG
    80mg/m2 iv on day 1 of each 3 week cycle, for a maximum of 6 cycles
  • Gemcitabine — DRUG
    1250mg/m2 on days 1 and 8 of each 3 week cycle for a maximum of 6 cycles
  • Placebo — DRUG
    iv on day 1 of each 3 week cycle until disease progression
  • bevacizumab [Avastin] — DRUG
    15mg/kg 1v on day 1 of each 3 week cycle until disease progression
  • bevacizumab [Avastin] — DRUG
    7.5 mg/kg iv on day 1 of each 3 week cycle until disease progression

Study Details

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.

Key Dates

First listed
Dec 11, 2008
Start date
Feb 28, 2005
Status verified
Nov 2016
Primary completion
Feb 28, 2011
Completion
Feb 28, 2011

Study Design

Enrollment
1,044 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
  • Experimental: 2
  • Placebo Comparator: 3

Primary Outcome Measure

Progression-free survival [ Time Frame: Event driven ]

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