A Study of Avastin (Bevacizumab) in Combination With Platinum-Containing Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00451906
First received: March 22, 2007
Last updated: October 20, 2014
Last verified: October 2014

March 22, 2007
October 20, 2014
October 2006
June 2009   (final data collection date for primary outcome measure)
AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Safety: AEs, laboratory tests.
Complete list of historical versions of study NCT00451906 on ClinicalTrials.gov Archive Site
Duration of survival; time to disease progression. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Efficacy: Duration of survival; time to disease progression
Not Provided
Not Provided
 
A Study of Avastin (Bevacizumab) in Combination With Platinum-Containing Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.
Open Label Study of Avastin in Combination With Platinum-containing Chemotherapy as 1st Line Treatment in Patients With Stage IIIb/IV Non-squamous NSCLC

This single arm study will assess the safety and efficacy of Avastin combined wi th platinum-containing chemotherapy regimens in patients with advanced or recurr ent non-squamous non-small cell lung cancer (NSCLC). Avastin will be given as fi rst-line treatment in combination with platinum-based chemotherapy or in combina tion with any standard of care NSCLC first-line chemotherapy used in line with t he licensed national prescribing information. Eligible patients will receive Av astin (15mg/kg iv on day 1 of each 3 week cycle) concomitantly with chemotherapy Avastin treatment will continue after completion of chemotherapy cycles until disease progression, and the target sample size is 500+ individuals.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • Drug: Platinum-based chemotherapy
    As prescribed
  • Drug: bevacizumab [Avastin]
    15mg/kg iv on day 1 of each 3 week cycle
Experimental: 1
Interventions:
  • Drug: Platinum-based chemotherapy
  • Drug: bevacizumab [Avastin]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2118
June 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • histologically or cytologically documented inoperable, locally advanced ( stage III), metastatic (stage IV) or recurrent NSCLC other than squamous cell (tumors of mixed histology should be categorized by the predominant cell type);
  • ECOG PS status 0-2;
  • life expectancy >= 12weeks;
  • adequate renal, liver and hematological function.

Exclusion Criteria:

  • mixed, non-small and small cell tumors, or mixed adenosquamous carcinomas with a predominant squamous component;
  • hemoptysis (>=1/2 teaspoon of bright red blood) in previous 3 months;
  • evidence of tumor invading major blood vessels on imaging;
  • evidence of CNS metastases, even if previously treated.
  • major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrolment, or anticipation of need for major surgery during study treatment;
  • prior chemotherapy for stage IIIb/IV disease.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Austria,   Bosnia and Herzegovina,   Brazil,   Canada,   China,   Colombia,   Czech Republic,   Denmark,   Ecuador,   Egypt,   Estonia,   Finland,   France,   Germany,   Hong Kong,   Hungary,   Iceland,   Israel,   Italy,   Latvia,   Lebanon,   Lithuania,   Mexico,   Netherlands,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Slovakia,   Slovenia,   Spain,   Sweden,   Switzerland,   Taiwan,   Turkey,   United Kingdom,   Venezuela
 
NCT00451906
MO19390
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2014

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