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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00806923
First received: December 10, 2008
Last updated: April 7, 2014
Last verified: April 2014

December 10, 2008
April 7, 2014
February 2005
February 2011   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00806923 on ClinicalTrials.gov Archive Site
  • Efficacy: Duration of overall survival, time to treatment failure, response rate, and duration of response. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • Safety:AEs, laboratory tests, SAEs, coagulation parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
A Randomized, Double-blind Study of the Effect of Avastin Plus Cisplatin and Gemcitabine or Placebo Plus Cisplatin and Gemcitabine on Progression-free Survival in Treatment-naïve Patients With Advanced or Recurrent Non-squamous NSCLC

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • 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
  • 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
  • Experimental: 1
    Interventions:
    • Drug: bevacizumab [Avastin]
    • Drug: Cisplatin
    • Drug: Gemcitabine
  • Experimental: 2
    Interventions:
    • Drug: bevacizumab [Avastin]
    • Drug: Cisplatin
    • Drug: Gemcitabine
  • Placebo Comparator: 3
    Interventions:
    • Drug: Cisplatin
    • Drug: Gemcitabine
    • Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1044
February 2011
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • documented inoperable, locally advanced, metastatic or recurrent non-squamous NSCLC;
  • adequate liver and kidney function;
  • women of childbearing potential must have a negative serum pregnancy test within 7 days of starting study treatment.

Exclusion Criteria:

  • prior chemotherapy or treatment with another systemic cancer therapy;
  • surgery (including open biopsy), significant traumatic injury, or radiotherapy within the last 4 weeks prior to first dose of study treatment;
  • brain metastasis or spinal cord compression;
  • fertile men, and women of childbearing potential, not using adequate contraception;
  • treatment with any other investigational agent, or participation in another clinical trial, within 30 days prior to entering the study.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Belgium,   Brazil,   Bulgaria,   Canada,   Czech Republic,   France,   Germany,   Greece,   Hong Kong,   Hungary,   Israel,   Italy,   Poland,   Russian Federation,   Spain,   Taiwan,   Thailand,   United Kingdom
 
NCT00806923
BO17704
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Chair: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP