Trial record 1 of 1 for:    mo22097
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A Study of Avastin (Bevacizumab) in Combination With Standard of Care Treatment in Patients With Lung Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01351415
First received: May 9, 2011
Last updated: August 13, 2013
Last verified: August 2013

May 9, 2011
August 13, 2013
June 2011
January 2016   (final data collection date for primary outcome measure)
Overall survival [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01351415 on ClinicalTrials.gov Archive Site
  • Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Disease control rate according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Duration of response according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Safety (incidence of adverse events) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Avastin (Bevacizumab) in Combination With Standard of Care Treatment in Patients With Lung Cancer
An Open-label, Randomized, Phase IIIb Trial Evaluating the Efficacy and Safety of Standard of Care +/- Continuous Bevacizumab Treatment Beyond Progression of Disease (PD) in Patients With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC) After First (1st)-Line Treatment With Bevacizumab Plus a Platinum Doublet-containing Chemotherapy

This open-label, randomized, multicenter study will evaluate the efficacy and safety of Avastin (bevacizumab) in combination with standard of care treatment in patients with advanced non-squamous non-small cell lung cancer (NSCLC). Patients will be enrolled at documentation of progression of disease (PD) after 4-6 cycles of first-line treatment with Avastin plus a platinum doublet-containing therapy and a minimum of two cycles of Avastin maintenance treatment prior to PD. Patients will be randomly assigned to one of two treatment arms to receive either Avastin plus standard of care treatment or standard of care treatment alone.

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]
    7.5 or 15 mg/kg intravenously on Day 1 every 21 days until unacceptable toxicity or withdrawal of consent
  • Drug: Standard of care treatment
    Investigator's choice of standard of care treatment on Day 1 every 21 days until unacceptable toxicity or withdrawal of consent
  • Experimental: A
    Interventions:
    • Drug: bevacizumab [Avastin]
    • Drug: Standard of care treatment
  • Active Comparator: B
    Intervention: Drug: Standard of care treatment
Gridelli C, Bennouna J, de Castro J, Dingemans AM, Griesinger F, Grossi F, Rossi A, Thatcher N, Wong EK, Langer C. Randomized phase IIIb trial evaluating the continuation of bevacizumab beyond disease progression in patients with advanced non-squamous non-small-cell lung cancer after first-line treatment with bevacizumab plus platinum-based chemotherapy: treatment rationale and protocol dynamics of the AvaALL (MO22097) trial. Clin Lung Cancer. 2011 Nov;12(6):407-11. Epub 2011 Jun 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
January 2016
January 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, age >/=18 years
  • Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC)
  • Documented progression of disease (locally recurrent or metastatic) per investigator assessment following first-line treatment 4-6 cycles of Avastin plus a platinum doublet-containing chemotherapy regimen and a minimum of 2 cycles of Avastin (monotherapy) maintenance treatment prior to first progression of disease
  • No treatment interruption of Avastin treatment greater than 2 consecutive cycles (42 days) between the start of first-line treatment to start of Cycle 1 of second line treatment
  • Randomization within 4 weeks of progression of disease
  • At least one unidimensionally measurable lesion meeting RECIST criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:

  • Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
  • History of hemoptysis >/=grade 2 within 3 months of randomization
  • Major cardiac disease
Both
18 Years and older
No
Contact: Reference Study ID Number: MO22097 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
United States,   Argentina,   Austria,   Belgium,   Brazil,   Denmark,   France,   Germany,   Greece,   Italy,   Japan,   Jordan,   Lebanon,   Mexico,   Netherlands,   Oman,   Slovakia,   Spain,   United Arab Emirates
 
NCT01351415
MO22097
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2013

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