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

NCT ID: NCT00257608

Last Updated: 2016-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1145 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2014-11-30

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.

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Group Type: EXPERIMENTAL

bevacizumab

Intervention Type: DRUG

Intravenous repeating dose

erlotinib HCl

Intervention Type: DRUG

Oral repeating dose

2

Group Type: PLACEBO_COMPARATOR

bevacizumab

Intervention Type: DRUG

Intravenous repeating dose

placebo

Intervention Type: DRUG

Oral repeating dose

Interventions

bevacizumab

Intravenous repeating dose

Intervention Type: DRUG

placebo

Oral repeating dose

Intervention Type: DRUG

erlotinib HCl

Oral repeating dose

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Donald Strickland, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

Sacred Heart Medical Onc Group

Mobile, Alabama, United States

St. Edward Mercy Medical Ctr

Fort Smith, Arizona, United States

Mayo Clinic

Scottsdale, Arizona, United States

Arizona Cancer Center

Tucson, Arizona, United States

Central Hem/Onc Medical Group

Alhambra, California, United States

Comp Blood & Cancer Center

Bakersfield, California, United States

South Bay Oncology

Campbell, California, United States

Bay Area Cancer Research Grp

Concord, California, United States

Pacific Onc & Hem Assoc

Encinitas, California, United States

Pacific Coast Hem/Onc

Fountain Valley, California, United States

Cancer Care Associates

Fresno, California, United States

St. Jude Heritage Med Group

Fullerton, California, United States

Ronald H. Yanagihara

Gilroy, California, United States

Glendale Adventist Medical Ctr

Glendale, California, United States

Scipps Clinic

La Jolla, California, United States

Loma Linda Univ Medical Center

Loma Linda, California, United States

Pacific Shores Medical Group

Long Beach, California, United States

Kenmar Research Institute LLC

Los Angeles, California, United States

UCLA Medical Ctr

Los Angeles, California, United States

Sutter Gould Med Foundation

Modesto, California, United States

North Valley Hem Onc Med Grp

Northridge, California, United States

Hem Onc Med Grp Orange Cty

Orange, California, United States

Medical Oncology Care Assoc

Orange, California, United States

Ventura Co Hem-Onc Specialists

Oxnard, California, United States

Wilshire Oncology Medical Grp

Pomona, California, United States

Sutter Cancer Center

Sacramento, California, United States

Mercy General Hospital

Sacramento, California, United States

Los Palos Oncology & Hem

Salinas, California, United States

Kaiser Permanente

San Diego, California, United States

Naval Medical Center

San Diego, California, United States

Pacific Hematology Oncology

San Francisco, California, United States

Kaiser Permanente Santa Teresa

San Jose, California, United States

Sansum Medical Clinic, Inc.

Santa Barbara, California, United States

Santa Barbara Hem Onc Med Grp

Santa Barbara, California, United States

Central Coast Medical Oncology

Santa Maria, California, United States

The Angeles Clinic

Santa Monica, California, United States

Redwood Regional Med Grp

Santa Rosa, California, United States

Cancer Care Associates

Torrance, California, United States

Mile High Oncology

Denver, Colorado, United States

Front Range Cancer Specialists

Fort Collins, Colorado, United States

Washington Onc Hem Center PC

Washington D.C., District of Columbia, United States

Center for Hematology-Oncology

Boca Raton, Florida, United States

Halifax Medical Center

Daytona Beach, Florida, United States

Florida Wellcare Alliance

Inverness, Florida, United States

Baptist Cancer Institute

Jacksonville, Florida, United States

Jackson Memorial Hospital

Miami, Florida, United States

Mid-Florida Hem Oncology Ctr

Orange City, Florida, United States

Integrated Comm Onc Network

Orange Park, Florida, United States

Hematology Onc Treasure Coast

Port Saint Lucie, Florida, United States

Phoebe Putney Cancer Center

Albany, Georgia, United States

Northeast Georgia Cancer Care

Athens, Georgia, United States

Suburban Hem-Onc Associates

Lawrenceville, Georgia, United States

Northwest Georgia Onc Centers

Marietta, Georgia, United States

Chicagoland Hematology Onc

Arlington Heights, Illinois, United States

Weiss-Strauss Oncology Center

Chicago, Illinois, United States

LaGrange Oncology Associates

Geneva, Illinois, United States

La Grange Oncology Associates

LaGrange, Illinois, United States

Associates in Medical Oncology

Oak Lawn, Illinois, United States

Onc Hem Assoc of Central IL

Peoria, Illinois, United States

West Suburban Cancer Center

River Forest, Illinois, United States

OSF St. Anthony Med Ctr

Rockford, Illinois, United States

Community Hospital

Munster, Indiana, United States

Providence Medical Group

Terre Haute, Indiana, United States

Hematology Oncology Associates

Bettendorf, Iowa, United States

Siouxland Hem-Onc Assoc LLP

Sioux City, Iowa, United States

Covenant Clinic

Waterloo, Iowa, United States

Gajera & Patel, PLLC

Hopkinsville, Kentucky, United States

Kentuckiana Cancer Center

Louisville, Kentucky, United States

University of Louisville

Louisville, Kentucky, United States

Consultants in Blood Disorders

Louisville, Kentucky, United States

Owensboro Medical Health Sys

Owensboro, Kentucky, United States

Willis-Knighton Cancer Center

Shreveport, Louisiana, United States

H&J Weinberg Cancer Institute

Baltimore, Maryland, United States

Oncology Hematology Associates

Clinton, Maryland, United States

Maryland Oncology/Hema PA

Columbia, Maryland, United States

Frederick Memorial Hospital

Frederick, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Caritas St. Elizabeth Med Ctr

Boston, Massachusetts, United States

Lahey Clinic Med Ctr

Burlington, Massachusetts, United States

Metrowest Cancer Center

Framingham, Massachusetts, United States

Baystate Medical Center

Springfield, Massachusetts, United States

Spectrum Health

Grand Rapids, Michigan, United States

Kalamazoo Hem & Onc

Kalamazoo, Michigan, United States

Marquette General Health Sys

Marquette, Michigan, United States

St. Joseph Mercy Oakland

Pontiac, Michigan, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

Virginia Piper Cancer Inst

Minneapolis, Minnesota, United States

Ellis Fischel Cancer Center

Columbia, Missouri, United States

Freeman Cancer Institute

Joplin, Missouri, United States

Missouri Cancer Center, PC

Saint Charles, Missouri, United States

St. Louis Univ Care Center

St Louis, Missouri, United States

Arch Medical Services

Washington, Missouri, United States

Billings Clinic

Billings, Montana, United States

Big Sky Oncology

Great Falls, Montana, United States

Montana Cancer Specialists

Missoula, Montana, United States

NE Hematology Oncology, PC

Lincoln, Nebraska, United States

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Comp Cancer Centers of Nevada

Las Vegas, Nevada, United States

Ctr for Cancer & Hem Disease

Cherry Hill, New Jersey, United States

Forte, Attas & Schleider

Englewood, New Jersey, United States

Hunterdon Medical Center

Flemington, New Jersey, United States

Central State Medical Center

Freehold, New Jersey, United States

St. Barnabas Health Care Sys

Livingston, New Jersey, United States

Mountainside Hospital

Montclair, New Jersey, United States

Morristown Memorial Hospital

Morristown, New Jersey, United States

Hematology Oncology Assoc SJ

Mount Holly, New Jersey, United States

Jersey Shore Medical Center

Neptune City, New Jersey, United States

Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

The Valley Hospital

Paramus, New Jersey, United States

Overlook Hospital

Summit, New Jersey, United States

Holy Name Hospital

Teaneck, New Jersey, United States

San Juan Onco Assoc

Farmington, New Mexico, United States

Zale P Bernstein MD - PP

Buffalo, New York, United States

Bassett Cancer Center

Cooperstown, New York, United States

Adriondack Cancer Care

Glen Falls, New York, United States

BRANY

Great Neck, New York, United States

Queens Cancer Center

Jamaica, New York, United States

Crystal Run Health Care

Middletown, New York, United States

NYU Medical Center

New York, New York, United States

Mem Sloan Kettering Cancer Ctr

New York, New York, United States

SUNY Upstate

Syracuse, New York, United States

Presbyterian Hospital

Charlotte, North Carolina, United States

NorthEast Medical Center

Concord, North Carolina, United States

Moses Cone Reg Cncr Ctr

Greensboro, North Carolina, United States

Emerywood Hematology Oncology

High Point, North Carolina, United States

Carolina BioOncology Institute

Huntersville, North Carolina, United States

Kinston Medical Specialists

Kinston, North Carolina, United States

Beaufort County Hospital

Washington, North Carolina, United States

Summa Health System

Akron, Ohio, United States

Akron General Medical Center

Akron, Ohio, United States

Aultman Hospital

Canton, Ohio, United States

Gabrail Cancer Center

Canton, Ohio, United States

Onc/Hem Care Clin Trials LLC

Cincinnati, Ohio, United States

MetroHealth Medical Center

Cleveland, Ohio, United States

Mid Ohio Onc Hematology Inc

Columbus, Ohio, United States

Riverside Methodist Hospital

Columbus, Ohio, United States

Dayton Clinical Oncology Prog

Dayton, Ohio, United States

Ohio Cancer Specialists

Mansfield, Ohio, United States

Signal Point Hem/Oncology Inc

Middletown, Ohio, United States

Toledo Community Hospital

Toledo, Ohio, United States

Forum Health Cancer Care Ctr

Youngstown, Ohio, United States

Providence Portland Med Center

Portland, Oregon, United States

Ephrata Cancer Center

Ephrata, Pennsylvania, United States

Armstrong County Memorial Hosp

Kittanning, Pennsylvania, United States

Hem Onc Assoc Phys Lancaster

Lancaster, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Scranton Hematology Oncology

Scranton, Pennsylvania, United States

Assoc in Hematology Oncology

Upland, Pennsylvania, United States

Lankenau Medical Office Bldg

Wynnewood, Pennsylvania, United States

Charleston Cancer Center

Charleston, South Carolina, United States

Palmetto Hematology Oncology

Spartanburg, South Carolina, United States

Erlanger Health Systems

Chattanooga, Tennessee, United States

The Jones Clinic

Germantown, Tennessee, United States

Jackson-Madsion County Hosp

Jackson, Tennessee, United States

Clopton Clinic

Memphis, Tennessee, United States

Sarah Cannon Cancer Center

Nashville, Tennessee, United States

Vanderbilt University Medical

Nashville, Tennessee, United States

Lone Star Oncology Consultants

Austin, Texas, United States

Coastal Bend Cancer Center

Corpus Christi, Texas, United States

Texas Cancer Associates

Dallas, Texas, United States

Texas Hematology Oncology

Dallas, Texas, United States

JPS Center for Cancer Care

Fort Worth, Texas, United States

Univ of Texas Medical Branch

Galveston, Texas, United States

Wilford Hall Medical Center

Lackland Air Force Base, Texas, United States

SW Vermont Healthcare Onc Asoc

Bennington, Vermont, United States

Vermont Ctr Cancer Medicine

Colchester, Vermont, United States

Community Cancer Center

Rutland, Vermont, United States

Peninsula Cancer Institute

Newport News, Virginia, United States

SW Virginia Hem Onc

Roanoke, Virginia, United States

Cascade Cancer Center

Kirkland, Washington, United States

Northwest Medical Specialists

Tacoma, Washington, United States

Univ Physicians Internal Med

Huntington, West Virginia, United States

West Virginia University

Morgantown, West Virginia, United States

Oncology Alliance

Glendale, Wisconsin, United States

Dean Clinic

Madison, Wisconsin, United States

Medical Consultants LTD

Milwaukee, Wisconsin, United States

All Saints Cancer Center

Racine, Wisconsin, United States

Hospital Pirovano

Buenos Aires, , Argentina

Hospital Britanico

Buenos Aires, , Argentina

Hospital Toru

Buenos Aires, , Argentina

CEMIC

Buenos Aires, , Argentina

Centro Oncologico de Cordoba

Córdoba, , Argentina

COIR

Mendoza, , Argentina

Instituto Medico Privado

Resistencia, , Argentina

Clinica Oncologica de Rosario

Rosario, , Argentina

ISIS Clinica Especializada

Sante Fe, , Argentina

Holy Spirit Hospital Northside

Chermside, QLD, , Australia

Sunshine Coast Cancer Centre

Nambour, QLD, , Australia

Sir Charles Gairdner Hospital

Nedlands, WA, , Australia

Burnside War Memorial Hospital

Toorak Gardens, SA, , Australia

Cliniques Univ St Luc

Brussels, , Belgium

CHR Citadelle Liege

Liège, , Belgium

Instituto de cancer Arnaldo

São Paulo, São Paulo, Brazil

Instituto Nacional do Cancer

Rio de Janeiro, , Brazil

Hospital Das Clinicas

São Paulo, , Brazil

Regional Oncodispensary

Plovdiv, , Bulgaria

Regional Oncodispensary

Rousse, , Bulgaria

Regional Oncodispensary

Shumen, , Bulgaria

Regional Oncodispensary

Sofia, , Bulgaria

UMHAT "Queen Joanna"

Sofia, , Bulgaria

National Specialized Hospital

Sofia, , Bulgaria

Regional Oncodispensary

Stara Zagora, , Bulgaria

MHAT "St Marina"

Varna, , Bulgaria

Regional Oncodispensary

Veliko Tarnovo, , 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, , Israel

Sourasky Medical Center

Tel Aviv, , Israel

Sheba Medical Center

Tel Litwinsky, , Israel

Azienda Ospedaliera Univ

Genova, , Italy

Ist Nazion per Ricerca Cancro

Genova, , Italy

Univ degli Studi di Napoli

Napoli, , Italy

Azienda Ospedaliera

Parma, , Italy

Azienda Osper di Perugia

Perugia, , Italy

Divisione Onc Med dell'Azienda

Udine, , Italy

Torre Medica Cristobal Colon

Acapulco, , Mexico

Inst Nacional de Cancerologia

Distrito Federal, , Mexico

ISSSTE Merida

Mérida, , Mexico

Hospital de Especialidades

Torreon, Coahuila, , Mexico

Philippine General Hospital

Manila, Luzon, Philippines

The Medical City

Pasig, Luzon, Philippines

Veterans Memorial Medical Ctr

Quezon City, Luzon, Philippines

Perpetual Succour Hospital

Cebu City, Visayas, Philippines

Univ of Santo Tomas Hospital

Manila, , Philippines

St Luke's Medical Center

Quezon City, , Philippines

Centrul de Onc Medical Lasi

Iași, , Romania

Spitalul Clinic Judetean Sibiu

Sibiu, , Romania

Spitalul Judetean de Urgente

Suceava, , Romania

National Cancer Center

Singapore, , Singapore

Corporacio Sanitaria Parc

Sabadell, Barcelona, Spain

Hospital de Cruces

Barakaldo, , Spain

Hospital del Mar

Barcelona, , Spain

Hospital Clinic i Provincial

Barcelona, , Spain

Hospital Universitario

San Cristóbal de La Laguna, , Spain

Instituto Valenciano Oncologia

Valencia, , Spain

Hospital Clinico Universitario

Valencia, , Spain

Taichung Veterans Gen Hosp

Dawan, , Taiwan

China Medical Univ Hosp

Taichung, , Taiwan

National Taiwan University

Taipei, , Taiwan

Bumrungrad International Hosp

Bangkok, , Thailand

National Cancer Institute

Bangkok, , Thailand

Pramongkutklao Hospital

Bangkok, , Thailand

Siriraj Hospital

Bangkok, , Thailand

Maharaj Nakorn Chiang Mai Hosp

Chiang Mai, , Thailand

Bristol Heamatology & Onc Ctr

Bristol, , United Kingdom

Countries

United States; Argentina; Australia; Belgium; Brazil; Bulgaria; Hong Kong; Israel; Italy; Mexico; Philippines; Romania; Singapore; Spain; Taiwan; Thailand; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 24101054 (View on PubMed)

Other Identifiers

BO20800

Identifier Type: OTHER

Identifier Source: secondary_id

AVF3671g

Identifier Type: -

Identifier Source: org_study_id