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A Randomized, Double-Blind, Placebo-Controlled, Phase IIIb Trial Comparing Bevacizumab Therapy With or Without Erlotinib After Completion of Chemotherapy With Bevacizumab for the First-Line Treatment of Locally Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer

Phase 3
18 Years
Open (Enrolling)
Non-Small Cell Lung Cancer

Thank you

Trial Information

A Randomized, Double-Blind, Placebo-Controlled, Phase IIIb Trial Comparing Bevacizumab Therapy With or Without Erlotinib After Completion of Chemotherapy With Bevacizumab for the First-Line Treatment of Locally Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer

Inclusion Criteria:

- Signed Informed Consent Form

- Histologically or cytologically confirmed NSCLC

- Advanced NSCLC or recurrent disease

- INR no greater than 1.3 and aPTT no greater than upper limits of normal (ULN) within
28 days prior to enrollment for subjects not on low molecular weight heparin or
fondaparinux. Subjects on low molecular weight heparin or fondaparinux are not
required to meet INR or aPTT limits. Chronic full-dose anticoagulation with warfarin
is not permitted.

- 18 years of age or older

- For women of childbearing potential and sexually active men, use of an accepted and
effective method of contraception (hormonal or barrier methods, abstinence) prior to
enrollment and for the duration of the study

Exclusion Criteria:

- Prior systemic chemotherapy in the metastatic setting

- Treatment with an investigational or marketed agent that acts by either EGFR
inhibition or anti-angiogenesis mechanisms

- Pregnancy or lactation

- Any other medical condition, including mental illness or substance abuse, deemed by
the clinician to be likely to interfere with a subject's ability to provide informed
consent, cooperate, and participate in the study, or to interfere with the
interpretation of the results

- Active infection or a fever within 3 days of enrollment

- Active malignancy other than lung cancer

- Radiation therapy to sites other than whole brain within 14 days prior to enrollment

- History of gross hemoptysis within 3 months prior to enrollment

- Known hypersensitivity to any of the components of cytotoxic chemotherapy
combinations, bevacizumab, or tyrosine kinase inhibitors

- Inadequately controlled hypertension

- Unstable angina or New York Heart Association Grade II or greater CHF

- Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6
months prior to enrollment

- History of myocardial infarction within 6 months prior to enrollment

- History of stroke within 6 months prior to enrollment

- Symptomatic peripheral vascular disease within 6 months prior to enrollment

- Evidence of bleeding diathesis or coagulopathy

- Serious, non-healing wound, ulcer, or bone fracture

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to enrollment; anticipation of need for major surgical procedure during the
course of the study

- Current, recent, or planned participation in an experimental drug study other than
this Genentech-sponsored bevacizumab/erlotinib study

- Progressive neurologic symptoms in subjects with a history of brain metastases

- History of significant vascular disease (e.g., aortic aneurysm)

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

Post-chemo phase

Safety Issue:


Principal Investigator

Donald Strickland, M.D.

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

January 2006

Completion Date:

December 2013

Related Keywords:

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



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All Saints Cancer CenterRacine, Wisconsin  53405
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University of LouisvilleLouisville, Kentucky  40202
Consultants in Blood DisordersLouisville, Kentucky  40207
Sarah Cannon Cancer CenterNashville, Tennessee  37203
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Cancer Care AssociatesFresno, California  93720
Lagrange Oncology AssociatesLa Grange, Illinois  60525
Gabrail Cancer CenterCanton, Ohio  44718
Jersey Shore Medical CenterNeptune, New Jersey  07754
Frederick Memorial HospitalFrederick, Maryland  21701
Spectrum HealthGrand Rapids, Michigan  49503
Peninsula Cancer InstituteNewport News, Virginia  23601
Montana Cancer SpecialistsMissoula, Montana  59807-7877
Mile High OncologyDenver, Colorado  80210
The Jones ClinicGermantown, Tennessee  38138
West Suburban Cancer CenterRiver Forest, Illinois  60305
Billings ClinicBillings, Montana  59107-7000
Hunterdon Medical CenterFlemington, New Jersey  08822
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Scranton Hematology OncologyScranton, Pennsylvania  18510
West Virginia UniversityMorgantown, West Virginia  26506
Freeman Cancer InstituteJoplin, Missouri  64804
Florida Wellcare AllianceInverness, Florida  34452
Carolina BioOncology InstituteHuntersville, North Carolina  28078
Baptist Cancer InstituteJacksonville, Florida  32207
JPS Center for Cancer CareFort Worth, Texas  76104
Coastal Bend Cancer CenterCorpus Christi, Texas  78404
Oncology AllianceMilwaukee, Wisconsin  53215
Providence Medical GroupTerre Haute, Indiana  47802
Aultman HospitalCanton, Ohio  44710
Arch Medical ServicesSt. Louis, Missouri  63141
Vanderbilt University MedicalNashville, Tennessee  37232
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Comp Blood & Cancer CenterBakersfield, California  93309
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Bay Area Cancer Research GrpConcord, California  94598
Pacific Onc & Hem AssocEncinitas, California  92024
Pacific Coast Hem/OncFountain Valley, California  92708
St. Jude Heritage Med GroupFullerton, California  92835
Ronald H. YanagiharaGilroy, California  95020
Glendale Adventist Medical CtrGlendale, California  91206
Scipps ClinicLa Jolla, California  92037-1027
Loma Linda Univ Medical CenterLoma Linda, California  92354
Kenmar Research Institute LLCLos Angeles, California  90057
UCLA Medical CtrLos Angeles, California  90095
Sutter Gould Med FoundationModesto, California  95355
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Kaiser Permanente Santa TeresaSan Jose, California  95119
Sansum Medical Clinic, Inc.Santa Barbara, California  93105
Santa Barbara Hem Onc Med GrpSanta Barbara, California  93105
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The Angeles ClinicSanta Monica, California  90404
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Washington Onc Hem Center PCWashington, District of Columbia  20037
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Integrated Comm Onc NetworkOrange Park, Florida  32073
Hematology Onc Treasure CoastPort Saint Lucie, Florida  34952
Phoebe Putney Cancer CenterAlbany, Georgia  31701
Northeast Georgia Cancer CareAthens, Georgia  30607
Suburban Hem-Onc AssociatesLawrenceville, Georgia  30045
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Weiss-Strauss Oncology CenterChicago, Illinois  60640
Associates in Medical OncologyOak Lawn, Illinois  60453
Onc Hem Assoc of Central ILPeoria, Illinois  61615
OSF St. Anthony Med CtrRockford, Illinois  61108
Hematology Oncology AssociatesBettendorf, Iowa  52722
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Covenant ClinicWaterloo, Iowa  50702
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Owensboro Medical Health SysOwensboro, Kentucky  42303
H&J Weinberg Cancer InstituteBaltimore, Maryland  21237
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Lahey Clinic Med CtrBurlington, Massachusetts  01805
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Marquette General Health SysMarquette, Michigan  49855
Virginia Piper Cancer InstMinneapolis, Minnesota  55407
St. Louis Univ Care CenterSaint Louis, Missouri  63117
Missouri Cancer Center, PCSt Charles, Missouri  63301
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San Juan Onco AssocFarmington, New Mexico  87401
Zale P Bernstein MD - PPBuffalo, New York  14215
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Adriondack Cancer CareGlen Falls, New York  12801
BRANYGreat Neck, New York  11021
Queens Cancer CenterJamaica, New York  11432
Crystal Run Health CareMiddletown, New York  10941
Mem Sloan Kettering Cancer CtrNew York, New York  10021
SUNY UpstateSyracuse, New York  13210
Moses Cone Reg Cncr CtrGreensboro, North Carolina  27403
Emerywood Hematology OncologyHigh Point, North Carolina  27262
Beaufort County HospitalWashington, North Carolina  27889
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Ohio Cancer SpecialistsMansfield, Ohio  44907
Signal Point Hem/Oncology IncMiddletown, Ohio  45042
Toledo Community HospitalToledo, Ohio  43623
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Clopton ClinicMemphis, Tennessee  38138
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Univ of Texas Medical BranchGalveston, Texas  77555
SW Vermont Healthcare Onc AsocBennington, Vermont  05201
Vermont Ctr Cancer MedicineColchester, Vermont  05446
Community Cancer CenterRutland, Vermont  05701
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Univ Physicians Internal MedHuntington, West Virginia  25701
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