A Study Comparing Bevacizumab Therapy With or Without Erlotinib for First-Line Treatment of Non-Small Cell Lung Cancer (ATLAS)
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
2 other identifiers
interventional
1,145
17 countries
247
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 nonsmall-cell-lung-cancer
Started Jan 2006
Longer than P75 for phase_3 nonsmall-cell-lung-cancer
247 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2005
CompletedFirst Posted
Study publicly available on registry
November 23, 2005
CompletedStudy Start
First participant enrolled
January 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedResults Posted
Study results publicly available
March 15, 2016
CompletedApril 18, 2016
March 1, 2016
8.8 years
November 21, 2005
November 9, 2015
March 18, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS)
PFS was defined as the length of time from randomization until documented disease progression or death from any cause, whichever occurred earlier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Data presented until cut-off date 18 July 2008.
Approximately 3 years
Secondary Outcomes (6)
Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Chemotherapy Phase
Approximately 3 years
Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Post-Chemotherapy Phase
Approximately 3 years
Number of Participants With Any Adverse Events During Post-Chemotherapy Phase
Approximately 3.5 years
Incidence of Study Treatment Discontinuation for Reasons Other Than Disease Progression in Chemotherapy Phase
Approximately 3 years
Incidence of Study Treatment Discontinuation
Approximately 3 years
- +1 more secondary outcomes
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
- 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
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (247)
Sacred Heart Medical Onc Group
Mobile, Alabama, 36608, United States
St. Edward Mercy Medical Ctr
Fort Smith, Arizona, 72917, United States
Mayo Clinic
Scottsdale, Arizona, 85259, United States
Arizona Cancer Center
Tucson, Arizona, 85724, United States
Central Hem/Onc Medical Group
Alhambra, California, 91801, United States
Comp Blood & Cancer Center
Bakersfield, California, 93309, United States
South Bay Oncology
Campbell, California, 95008, United States
Bay Area Cancer Research Grp
Concord, California, 94598, United States
Pacific Onc & Hem Assoc
Encinitas, California, 92024, United States
Pacific Coast Hem/Onc
Fountain Valley, California, 92708, United States
Cancer Care Associates
Fresno, California, 93720, United States
St. Jude Heritage Med Group
Fullerton, California, 92835, United States
Ronald H. Yanagihara
Gilroy, California, 95020, United States
Glendale Adventist Medical Ctr
Glendale, California, 91206, United States
Scipps Clinic
La Jolla, California, 92037-1027, United States
Loma Linda Univ Medical Center
Loma Linda, California, 92354, United States
Pacific Shores Medical Group
Long Beach, California, 90813, United States
Kenmar Research Institute LLC
Los Angeles, California, 90057, United States
UCLA Medical Ctr
Los Angeles, California, 90095, United States
Sutter Gould Med Foundation
Modesto, California, 95355, United States
North Valley Hem Onc Med Grp
Northridge, California, 91325, United States
Hem Onc Med Grp Orange Cty
Orange, California, 92868, United States
Medical Oncology Care Assoc
Orange, California, 92868, United States
Ventura Co Hem-Onc Specialists
Oxnard, California, 93030, United States
Wilshire Oncology Medical Grp
Pomona, California, 91767, United States
Sutter Cancer Center
Sacramento, California, 95816, United States
Mercy General Hospital
Sacramento, California, 95819, United States
Los Palos Oncology & Hem
Salinas, California, 93901, United States
Kaiser Permanente
San Diego, California, 92120, United States
Naval Medical Center
San Diego, California, 92134, United States
Pacific Hematology Oncology
San Francisco, California, 94115, United States
Kaiser Permanente Santa Teresa
San Jose, California, 95119, United States
Sansum Medical Clinic, Inc.
Santa Barbara, California, 93105, United States
Santa Barbara Hem Onc Med Grp
Santa Barbara, California, 93105, United States
Central Coast Medical Oncology
Santa Maria, California, 93454, United States
The Angeles Clinic
Santa Monica, California, 90404, United States
Redwood Regional Med Grp
Santa Rosa, California, 95403, United States
Cancer Care Associates
Torrance, California, 90505, United States
Mile High Oncology
Denver, Colorado, 80210, United States
Front Range Cancer Specialists
Fort Collins, Colorado, 80524, United States
Washington Onc Hem Center PC
Washington D.C., District of Columbia, 20037, United States
Center for Hematology-Oncology
Boca Raton, Florida, 33486, United States
Halifax Medical Center
Daytona Beach, Florida, 32115, United States
Florida Wellcare Alliance
Inverness, Florida, 34452, United States
Baptist Cancer Institute
Jacksonville, Florida, 32207, United States
Jackson Memorial Hospital
Miami, Florida, 33136, United States
Mid-Florida Hem Oncology Ctr
Orange City, Florida, 32763, United States
Integrated Comm Onc Network
Orange Park, Florida, 32073, United States
Hematology Onc Treasure Coast
Port Saint Lucie, Florida, 34952, United States
Phoebe Putney Cancer Center
Albany, Georgia, 31701, United States
Northeast Georgia Cancer Care
Athens, Georgia, 30607, United States
Suburban Hem-Onc Associates
Lawrenceville, Georgia, 30045, United States
Northwest Georgia Onc Centers
Marietta, Georgia, 30060, United States
Chicagoland Hematology Onc
Arlington Heights, Illinois, 60005, United States
Weiss-Strauss Oncology Center
Chicago, Illinois, 60640, United States
LaGrange Oncology Associates
Geneva, Illinois, 54301, United States
La Grange Oncology Associates
LaGrange, Illinois, 60525, United States
Associates in Medical Oncology
Oak Lawn, Illinois, 60453, United States
Onc Hem Assoc of Central IL
Peoria, Illinois, 61615, United States
West Suburban Cancer Center
River Forest, Illinois, 60305, United States
OSF St. Anthony Med Ctr
Rockford, Illinois, 61108, United States
Community Hospital
Munster, Indiana, 46321, United States
Providence Medical Group
Terre Haute, Indiana, 47802, United States
Hematology Oncology Associates
Bettendorf, Iowa, 52722, United States
Siouxland Hem-Onc Assoc LLP
Sioux City, Iowa, 51101, United States
Covenant Clinic
Waterloo, Iowa, 50702, United States
Gajera & Patel, PLLC
Hopkinsville, Kentucky, 42240, United States
Kentuckiana Cancer Center
Louisville, Kentucky, 40202, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Consultants in Blood Disorders
Louisville, Kentucky, 40207, United States
Owensboro Medical Health Sys
Owensboro, Kentucky, 42303, United States
Willis-Knighton Cancer Center
Shreveport, Louisiana, 71103, United States
H&J Weinberg Cancer Institute
Baltimore, Maryland, 21237, United States
Oncology Hematology Associates
Clinton, Maryland, 20735, United States
Maryland Oncology/Hema PA
Columbia, Maryland, 21044, United States
Frederick Memorial Hospital
Frederick, Maryland, 21701, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Caritas St. Elizabeth Med Ctr
Boston, Massachusetts, 02135, United States
Lahey Clinic Med Ctr
Burlington, Massachusetts, 01805, United States
Metrowest Cancer Center
Framingham, Massachusetts, 01702, United States
Baystate Medical Center
Springfield, Massachusetts, 01107, United States
Spectrum Health
Grand Rapids, Michigan, 49503, United States
Kalamazoo Hem & Onc
Kalamazoo, Michigan, 49048, United States
Marquette General Health Sys
Marquette, Michigan, 49855, United States
St. Joseph Mercy Oakland
Pontiac, Michigan, 48341, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Virginia Piper Cancer Inst
Minneapolis, Minnesota, 55407, United States
Ellis Fischel Cancer Center
Columbia, Missouri, 65203, United States
Freeman Cancer Institute
Joplin, Missouri, 64804, United States
Missouri Cancer Center, PC
Saint Charles, Missouri, 63301, United States
St. Louis Univ Care Center
St Louis, Missouri, 63117, United States
Arch Medical Services
Washington, Missouri, 63090, United States
Billings Clinic
Billings, Montana, 59101, United States
Big Sky Oncology
Great Falls, Montana, 59405, United States
Montana Cancer Specialists
Missoula, Montana, 59802, United States
NE Hematology Oncology, PC
Lincoln, Nebraska, 68506, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Comp Cancer Centers of Nevada
Las Vegas, Nevada, 89109, United States
Ctr for Cancer & Hem Disease
Cherry Hill, New Jersey, 08003, United States
Forte, Attas & Schleider
Englewood, New Jersey, 07631, United States
Hunterdon Medical Center
Flemington, New Jersey, 08822, United States
Central State Medical Center
Freehold, New Jersey, 07728, United States
St. Barnabas Health Care Sys
Livingston, New Jersey, 07039, United States
Mountainside Hospital
Montclair, New Jersey, 07042, United States
Morristown Memorial Hospital
Morristown, New Jersey, 07962, United States
Hematology Oncology Assoc SJ
Mount Holly, New Jersey, 08060, United States
Jersey Shore Medical Center
Neptune City, New Jersey, 07754, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
The Valley Hospital
Paramus, New Jersey, 07652, United States
Overlook Hospital
Summit, New Jersey, 07902, United States
Holy Name Hospital
Teaneck, New Jersey, 07666, United States
San Juan Onco Assoc
Farmington, New Mexico, 87401, United States
Zale P Bernstein MD - PP
Buffalo, New York, 14215, United States
Bassett Cancer Center
Cooperstown, New York, 13326, United States
Adriondack Cancer Care
Glen Falls, New York, 12801, United States
BRANY
Great Neck, New York, 11021, United States
Queens Cancer Center
Jamaica, New York, 11432, United States
Crystal Run Health Care
Middletown, New York, 10941, United States
NYU Medical Center
New York, New York, 10016, United States
Mem Sloan Kettering Cancer Ctr
New York, New York, 10021, United States
SUNY Upstate
Syracuse, New York, 13210, United States
Presbyterian Hospital
Charlotte, North Carolina, 28204, United States
NorthEast Medical Center
Concord, North Carolina, 28025, United States
Moses Cone Reg Cncr Ctr
Greensboro, North Carolina, 27403, United States
Emerywood Hematology Oncology
High Point, North Carolina, 27262, United States
Carolina BioOncology Institute
Huntersville, North Carolina, 28078, United States
Kinston Medical Specialists
Kinston, North Carolina, 28501, United States
Beaufort County Hospital
Washington, North Carolina, 27889, United States
Summa Health System
Akron, Ohio, 44304, United States
Akron General Medical Center
Akron, Ohio, 44307, United States
Aultman Hospital
Canton, Ohio, 44710, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Onc/Hem Care Clin Trials LLC
Cincinnati, Ohio, 45242, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Mid Ohio Onc Hematology Inc
Columbus, Ohio, 43213, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Dayton Clinical Oncology Prog
Dayton, Ohio, 45429, United States
Ohio Cancer Specialists
Mansfield, Ohio, 44907, United States
Signal Point Hem/Oncology Inc
Middletown, Ohio, 45042, United States
Toledo Community Hospital
Toledo, Ohio, 43623, United States
Forum Health Cancer Care Ctr
Youngstown, Ohio, 44501, United States
Providence Portland Med Center
Portland, Oregon, 97213, United States
Ephrata Cancer Center
Ephrata, Pennsylvania, 17543, United States
Armstrong County Memorial Hosp
Kittanning, Pennsylvania, 16201, United States
Hem Onc Assoc Phys Lancaster
Lancaster, Pennsylvania, 17604, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Scranton Hematology Oncology
Scranton, Pennsylvania, 18510, United States
Assoc in Hematology Oncology
Upland, Pennsylvania, 19013, United States
Lankenau Medical Office Bldg
Wynnewood, Pennsylvania, 19096, United States
Charleston Cancer Center
Charleston, South Carolina, 29406, United States
Palmetto Hematology Oncology
Spartanburg, South Carolina, 29303, United States
Erlanger Health Systems
Chattanooga, Tennessee, 37403, United States
The Jones Clinic
Germantown, Tennessee, 38138, United States
Jackson-Madsion County Hosp
Jackson, Tennessee, 38301, United States
Clopton Clinic
Memphis, Tennessee, 38138, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203-1632, United States
Vanderbilt University Medical
Nashville, Tennessee, 37232, United States
Lone Star Oncology Consultants
Austin, Texas, 78759, United States
Coastal Bend Cancer Center
Corpus Christi, Texas, 78404, United States
Texas Cancer Associates
Dallas, Texas, 75231, United States
Texas Hematology Oncology
Dallas, Texas, 75234, United States
JPS Center for Cancer Care
Fort Worth, Texas, 76104, United States
Univ of Texas Medical Branch
Galveston, Texas, 77555, United States
Wilford Hall Medical Center
Lackland Air Force Base, Texas, 78236, United States
SW Vermont Healthcare Onc Asoc
Bennington, Vermont, 05201, United States
Vermont Ctr Cancer Medicine
Colchester, Vermont, 05446, United States
Community Cancer Center
Rutland, Vermont, 05701, United States
Peninsula Cancer Institute
Newport News, Virginia, 23606, United States
SW Virginia Hem Onc
Roanoke, Virginia, 24014, United States
Cascade Cancer Center
Kirkland, Washington, 98034, United States
Northwest Medical Specialists
Tacoma, Washington, 98405, United States
Univ Physicians Internal Med
Huntington, West Virginia, 25701, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
Oncology Alliance
Glendale, Wisconsin, 53212, United States
Dean Clinic
Madison, Wisconsin, 53715, United States
Medical Consultants LTD
Milwaukee, Wisconsin, 53215, United States
All Saints Cancer Center
Racine, Wisconsin, 53405, United States
Hospital Pirovano
Buenos Aires, 1430, Argentina
Hospital Britanico
Buenos Aires, C1284AEB, Argentina
Hospital Toru
Buenos Aires, C1427ARN, Argentina
CEMIC
Buenos Aires, C1431FWO, Argentina
Centro Oncologico de Cordoba
Córdoba, X5000AAI, Argentina
COIR
Mendoza, 5500, Argentina
Instituto Medico Privado
Resistencia, 3900, Argentina
Clinica Oncologica de Rosario
Rosario, S2000dsk, Argentina
ISIS Clinica Especializada
Sante Fe, S3000FFU, Argentina
Holy Spirit Hospital Northside
Chermside, QLD, 4032, Australia
Sunshine Coast Cancer Centre
Nambour, QLD, 4560, Australia
Sir Charles Gairdner Hospital
Nedlands, WA, 6009, Australia
Burnside War Memorial Hospital
Toorak Gardens, SA, 5065, Australia
Cliniques Univ St Luc
Brussels, 1200, Belgium
CHR Citadelle Liege
Liège, 4000, Belgium
Instituto de cancer Arnaldo
São Paulo, São Paulo, 01221-020, Brazil
Instituto Nacional do Cancer
Rio de Janeiro, 20-231-050, Brazil
Hospital Das Clinicas
São Paulo, 05403-01, Brazil
Regional Oncodispensary
Plovdiv, 4004, Bulgaria
Regional Oncodispensary
Rousse, 7000, Bulgaria
Regional Oncodispensary
Shumen, 9700, Bulgaria
Regional Oncodispensary
Sofia, 1233, Bulgaria
UMHAT "Queen Joanna"
Sofia, 1527, Bulgaria
National Specialized Hospital
Sofia, 1756, Bulgaria
Regional Oncodispensary
Stara Zagora, 6003, Bulgaria
MHAT "St Marina"
Varna, 9010, Bulgaria
Regional Oncodispensary
Veliko Tarnovo, 5000, Bulgaria
Princess Margaret Hospital
Hong Kong, Hong Kong
Queen Elizabeth Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Tuen Mun Hospital
Hong Kong, Hong Kong
Hadassah Medical Center
Jerusalem, 91120, Israel
Sourasky Medical Center
Tel Aviv, 64239, Israel
Sheba Medical Center
Tel Litwinsky, 52621, Israel
Azienda Ospedaliera Univ
Genova, 16132, Italy
Ist Nazion per Ricerca Cancro
Genova, 16132, Italy
Univ degli Studi di Napoli
Napoli, 80131, Italy
Azienda Ospedaliera
Parma, 43100, Italy
Azienda Osper di Perugia
Perugia, 06159, Italy
Divisione Onc Med dell'Azienda
Udine, 33100, Italy
Torre Medica Cristobal Colon
Acapulco, 39670, Mexico
Inst Nacional de Cancerologia
Distrito Federal, 14080, Mexico
ISSSTE Merida
Mérida, 97500, Mexico
Hospital de Especialidades
Torreon, Coahuila, 27200, Mexico
Philippine General Hospital
Manila, Luzon, 1000, Philippines
The Medical City
Pasig, Luzon, 1605, Philippines
Veterans Memorial Medical Ctr
Quezon City, Luzon, 1114, Philippines
Perpetual Succour Hospital
Cebu City, Visayas, 6000, Philippines
Univ of Santo Tomas Hospital
Manila, 1008, Philippines
St Luke's Medical Center
Quezon City, 1102, Philippines
Centrul de Onc Medical Lasi
Iași, 700106, Romania
Spitalul Clinic Judetean Sibiu
Sibiu, 550245, Romania
Spitalul Judetean de Urgente
Suceava, 720237, Romania
National Cancer Center
Singapore, 169610, Singapore
Corporacio Sanitaria Parc
Sabadell, Barcelona, 08208, Spain
Hospital de Cruces
Barakaldo, 48903, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Clinic i Provincial
Barcelona, 08036, Spain
Hospital Universitario
San Cristóbal de La Laguna, 38320, Spain
Instituto Valenciano Oncologia
Valencia, 46009, Spain
Hospital Clinico Universitario
Valencia, 46010, Spain
Taichung Veterans Gen Hosp
Dawan, 407, Taiwan
China Medical Univ Hosp
Taichung, 404, Taiwan
National Taiwan University
Taipei, 112, Taiwan
Bumrungrad International Hosp
Bangkok, 10110, Thailand
National Cancer Institute
Bangkok, 10400, Thailand
Pramongkutklao Hospital
Bangkok, 10400, Thailand
Siriraj Hospital
Bangkok, 10700, Thailand
Maharaj Nakorn Chiang Mai Hosp
Chiang Mai, 50200, Thailand
Bristol Heamatology & Onc Ctr
Bristol, BS2 8ED, United Kingdom
Related Publications (1)
Johnson BE, Kabbinavar F, Fehrenbacher L, Hainsworth J, Kasubhai S, Kressel B, Lin CY, Marsland T, Patel T, Polikoff J, Rubin M, White L, Yang JC, Bowden C, Miller V. ATLAS: randomized, double-blind, placebo-controlled, phase IIIB trial comparing bevacizumab therapy with or without erlotinib, after completion of chemotherapy, with bevacizumab for first-line treatment of advanced non-small-cell lung cancer. J Clin Oncol. 2013 Nov 1;31(31):3926-34. doi: 10.1200/JCO.2012.47.3983. Epub 2013 Oct 7.
PMID: 24101054DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Roche Trial Information Hotline
- Organization
- F. Hoffmann-La Roche AG
Study Officials
- STUDY DIRECTOR
Donald Strickland, M.D.
Genentech, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2005
First Posted
November 23, 2005
Study Start
January 1, 2006
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
April 18, 2016
Results First Posted
March 15, 2016
Record last verified: 2016-03