A Study Comparing Bevacizumab Therapy With or Without Erlotinib for First-Line Treatment of Non-Small Cell Lung Cancer (ATLAS)



Status:Completed
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:January 2006
End Date:November 2014

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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

This is a Phase IIIb, multicenter, randomized, placebo-controlled trial to evaluate the
safety and efficacy of chemotherapy+bevacizumab followed by bevacizumab+erlotinib versus
bevacizumab+erlotinib placebo in subjects with locally advanced or metastatic NSCLC.


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)
We found this trial at
178
sites
8303 Dodge Street
Omaha, Nebraska 68114
(402) 354–4000
Nebraska Methodist Hospital Methodist Hospital is a general medical and surgical hospital in Omaha, NE....
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Boca Raton, Florida 33486
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301 University Blvd
Galveston, Texas 77555
(409) 772-1011
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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9801 W. Kincey Ave
Huntersville, North Carolina 28078
704-947-6599
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701 Doctors Dr
Kinston, North Carolina 28504
(252) 559-2200
Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
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1500 Northwest 12th Avenue # 106
Miami, Florida 33136
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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Akron, Ohio 44304
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1 Akron General Ave
Akron, Ohio 44307
(330) 344-6000
Akron General Medical Center It
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Albany, Georgia 31701
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Alhambra, California 91801
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Arlington Heights, Illinois 60005
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Athens, Georgia 30607
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Austin, Texas 78759
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Bakersfield, California 93309
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Baltimore, Maryland 21237
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Bennington, Vermont 05201
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Bettendorf, Iowa 52722
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801 North 29th Street
Billings, Montana 59107
406-238-2500
Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, Massachusetts 02135
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Buenos Aires,
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Buffalo, New York 14215
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Burlington, Massachusetts 01805
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Campbell, California 95008
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Canton, Ohio 44710
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4875 Higbee Ave NW
Canton, Ohio 44718
330-492-3345
Gabrail Cancer Center Since 1990, Gabrail Cancer Center has built a national reputation for excellence...
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Charleston, South Carolina
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200 Hawthorne Ln
Charlotte, North Carolina 28204
(704) 384-4000
Presbyterian Hospital At Novant Health Presbyterian Medical Center, we are welcoming a new era in...
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Chattanooga, Tennessee 37403
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Cherry Hill, New Jersey 08003
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Chicago, Illinois 60640
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Cincinnati, Ohio 45242
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2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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Clinton, Maryland 20735
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Colchester, Vermont 05446
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Columbia, Maryland 21044
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Columbia, Missouri 65203
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Columbus, Ohio 43213
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3535 Olentangy River Rd
Columbus, Ohio 43214
(614) 566-5000
Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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Concord, California 94598
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Concord, North Carolina 28025
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Cooperstown, New York 13326
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Corpus Christi, Texas 78463
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Dallas, Texas 75231
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Dallas, Texas 75234
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Dayton, Ohio 45429
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Daytona Beach, Florida 32114
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Denver, Colorado 80210
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Encinitas, California 92024
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Englewood, New Jersey 07631
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Ephrata, Pennsylvania 17522
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Farmington, New Mexico 87401
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Flemington, New Jersey 08822
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2315 E Harmony Rd #110
Fort Collins, Colorado 80528
(970) 212-7600
Front Range Cancer Specialists At Front Range Cancer Specialists, we are dedicated to providing quality...
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Fort Worth, Texas 76104
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Fountain Valley, California 92708
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Framingham, Massachusetts 01702
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Frederick, Maryland 21701
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Freehold, New Jersey 07728
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Fresno, California 93720
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Ft Smith, Arizona 72917
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Fullerton, California 92835
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Geneva, Illinois 60134
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Germantown, Tennessee 38138
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Gilroy, California 95020
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Glen Falls, New York 12801
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Glendale, California 91206
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Glendale, Wisconsin 53212
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Grand Rapids, Michigan 49503
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1117 29th St S Ste 500
Great Falls, Montana 59405
(406) 731-8100
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Great Neck, New York 11021
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Greensboro, North Carolina 27403
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High Point, North Carolina 27262
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Hopkinsville, Kentucky 42240
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Huntington, West Virginia 25701
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Inverness, Florida 34452
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Jackson, Tennessee 38301
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Jacksonville, Florida
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Jamaica, New York 11432
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Joplin, Missouri 64804
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Kalamazoo, Michigan 49048
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Kirkland, Washington 98034
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Kittanning, Pennsylvania 16201
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La Jolla, California 92037
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Lackland AFB, Texas 78236
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Lagrange, Illinois 60525
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Lancaster, Pennsylvania 17604
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Las Vegas, Nevada 89109
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Lawrenceville, Georgia 30045
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Lincoln, Nebraska 68506
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Livingston, New Jersey 07039
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11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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Long Beach, California 90813
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Los Angeles, California 90057
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757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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Louisville, Kentucky 40202
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
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Louisville, Kentucky 40207
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Madison, Wisconsin 53715
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Mansfield, Ohio 44907
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