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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

Approximately 3 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Spain: Agencia EspaƱola de Medicamentos y Productos Sanitarios

Study ID:

MO22097

NCT ID:

NCT01351415

Start Date:

June 2011

Completion Date:

January 2016

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Hinsdale, Illinois  60521
New Britain, Connecticut  06052
Bettendorf, Iowa  52722
Alexandria, Minnesota  56308
Albany, Georgia  31701
Birmingham, Alabama  35294
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
Louisville, Kentucky  40207
McLean, Virginia  22101
Little Rock, Arkansas  72205-7199
Kansas City, Kansas  66160
Scarborough, Maine  04074
Metairie, Louisiana  70006
Baltimore, Maryland  21287
Boston, Massachusetts  
Charlotte, North Carolina  
Eugene, Oregon  
Milwaukee, Wisconsin  
Indianapolis, Indiana  
Providence, Rhode Island  02908
Coeur D'alene, Idaho  83814