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.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: March 22, 2007
Last updated: December 1, 2015
Last verified: December 2015

March 22, 2007
December 1, 2015
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 with platinum-containing chemotherapy regimens in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC). Avastin will be given as first-line treatment in combination with platinum-based chemotherapy or in combination with any standard of care NSCLC first-line chemotherapy used in line with the licensed national prescribing information. Eligible patients will receive Avastin (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
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Squamous 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
  • 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.
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.
18 Years and older
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
Former Serbia and Montenegro,   Greece,   Jordan
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
December 2015

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