A Study Comparing Bevacizumab Therapy With or Without Erlotinib for First-Line Treatment of Non-Small Cell Lung Cancer (ATLAS)
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT00257608
- Lead Sponsor
- Genentech, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1145
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 erlotinib HCl - 2 placebo - 1 bevacizumab - 2 bevacizumab -
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS) Approximately 3 years 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Chemotherapy Phase Approximately 3 years Treatment-emergent adverse events were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.. Number of participants who had Grade \>=3TEAEs of pulmonary hemorrhage, gastrointestinal (GI) perforation, arterial thromboembolic (ATE) events, proteinuria, congestive heart failure (CHF), and hypertension were presented. Data presented up to data cutoff 18 July 2008.
Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Post-Chemotherapy Phase Approximately 3 years Treatment-related adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state and are judged by the investigator to be possibly, probably or definitely related to study medication. Pulmonary hemorrhage, GI perforation, ATE events, proteinuria, CHF, and hypertension were prospectively identified TEAEs of grade \>=3. Data presented until cut-off date 28 January 2009.
Number of Participants With Any Adverse Events During Post-Chemotherapy Phase Approximately 3.5 years An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event. Data presented up to data cutoff 19 June 2009.
Incidence of Study Treatment Discontinuation for Reasons Other Than Disease Progression in Chemotherapy Phase Approximately 3 years Participants who experienced disease progression were discontinued from the study. Data presented up to data cutoff (18 July 2008).
Incidence of Study Treatment Discontinuation Approximately 3 years Participants in post-chemotherapy phase were discontinued from the study for the reasons other than disease progression. Data presented Up to data cutoff 18 July 2008.
Overall Survival Approximately 3.5 years Overall survival was defined as the length of time from randomization to death.
Trial Locations
- Locations (241)
Siouxland Hem-Onc Assoc LLP
🇺🇸Sioux City, Iowa, United States
Montana Cancer Specialists
🇺🇸Missoula, Montana, United States
Coastal Bend Cancer Center
🇺🇸Corpus Christi, Texas, United States
Ellis Fischel Cancer Center
🇺🇸Columbia, Missouri, United States
BRANY
🇺🇸Great Neck, New York, United States
Gabrail Cancer Center
🇺🇸Canton, Ohio, United States
Billings Clinic
🇺🇸Billings, Montana, United States
Sheba Medical Center
🇮🇱Tel-Hashomer, Israel
Pramongkutklao Hospital
🇹ðŸ‡Bangkok, Thailand
Torre Medica Cristobal Colon
🇲🇽Acapulco, Mexico
Hospital de Especialidades
🇲🇽Torreon, Coahuila, Mexico
Siriraj Hospital
🇹ðŸ‡Bangkok, Thailand
Maharaj Nakorn Chiang Mai Hosp
🇹ðŸ‡Chiangmai, Thailand
Inst Nacional de Cancerologia
🇲🇽Distrito Federal, Mexico
ISSSTE Merida
🇲🇽Merida, Mexico
Philippine General Hospital
🇵ðŸ‡Manila, Luzon, Philippines
The Medical City
🇵ðŸ‡Pasig City, Luzon, Philippines
Veterans Memorial Medical Ctr
🇵ðŸ‡Quezon City, Luzon, Philippines
Univ of Santo Tomas Hospital
🇵ðŸ‡Manila, Philippines
Spitalul Clinic Judetean Sibiu
🇷🇴Sibiu, Romania
Spitalul Judetean de Urgente
🇷🇴Suceava, Romania
Centrul de Onc Medical Lasi
🇷🇴Iasi, Romania
National Cancer Center
🇸🇬Singapore, Singapore
China Medical Univ Hosp
🇨🇳Taichung, Taiwan
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Caritas St. Elizabeth Med Ctr
🇺🇸Boston, Massachusetts, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
Comp Blood & Cancer Center
🇺🇸Bakersfield, California, United States
Kenmar Research Institute LLC
🇺🇸Los Angeles, California, United States
Glendale Adventist Medical Ctr
🇺🇸Glendale, California, United States
Scipps Clinic
🇺🇸La Jolla, California, United States
UCLA Medical Ctr
🇺🇸Los Angeles, California, United States
Pacific Shores Medical Group
🇺🇸Long Beach, California, United States
Medical Oncology Care Assoc
🇺🇸Orange, California, United States
Kalamazoo Hem & Onc
🇺🇸Kalamazoo, Michigan, United States
Hunterdon Medical Center
🇺🇸Flemington, New Jersey, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Ronald H. Yanagihara
🇺🇸Gilroy, California, United States
Loma Linda Univ Medical Center
🇺🇸Loma Linda, California, United States
St. Joseph Mercy Oakland
🇺🇸Pontiac, Michigan, United States
Lahey Clinic Med Ctr
🇺🇸Burlington, Massachusetts, United States
South Bay Oncology
🇺🇸Campbell, California, United States
Sutter Gould Med Foundation
🇺🇸Modesto, California, United States
Frederick Memorial Hospital
🇺🇸Frederick, Maryland, United States
Forte, Attas & Schleider
🇺🇸Englewood, New Jersey, United States
Summa Health System
🇺🇸Akron, Ohio, United States
Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
Mountainside Hospital
🇺🇸Montclair, New Jersey, United States
Zale P Bernstein MD - PP
🇺🇸Buffalo, New York, United States
Missouri Cancer Center, PC
🇺🇸St Charles, Missouri, United States
Metrowest Cancer Center
🇺🇸Framingham, Massachusetts, United States
Texas Cancer Associates
🇺🇸Dallas, Texas, United States
Clopton Clinic
🇺🇸Memphis, Tennessee, United States
Providence Medical Group
🇺🇸Terre Haute, Indiana, United States
Marquette General Health Sys
🇺🇸Marquette, Michigan, United States
Arch Medical Services
🇺🇸Washington, Missouri, United States
Ctr for Cancer & Hem Disease
🇺🇸Cherry Hill, New Jersey, United States
Freeman Cancer Institute
🇺🇸Joplin, Missouri, United States
Big Sky Oncology
🇺🇸Great Falls, Montana, United States
Central State Medical Center
🇺🇸Freehold, New Jersey, United States
The Valley Hospital
🇺🇸Paramus, New Jersey, United States
San Juan Onco Assoc
🇺🇸Farmington, New Mexico, United States
NE Hematology Oncology, PC
🇺🇸Lincoln, Nebraska, United States
St. Barnabas Health Care Sys
🇺🇸Livingston, New Jersey, United States
Moses Cone Reg Cncr Ctr
🇺🇸Greensboro, North Carolina, United States
Armstrong County Memorial Hosp
🇺🇸Kittanning, Pennsylvania, United States
Overlook Hospital
🇺🇸Summit, New Jersey, United States
Mid Ohio Onc Hematology Inc
🇺🇸Columbus, Ohio, United States
Mem Sloan Kettering Cancer Ctr
🇺🇸New York, New York, United States
Hospital del Mar
🇪🇸Barcelona, Spain
Kinston Medical Specialists
🇺🇸Kinston, North Carolina, United States
Aultman Hospital
🇺🇸Canton, Ohio, United States
Univ of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Emerywood Hematology Oncology
🇺🇸High Point, North Carolina, United States
Hem Onc Assoc Phys Lancaster
🇺🇸Lancaster, Pennsylvania, United States
Jersey Shore Medical Center
🇺🇸Neptune, New Jersey, United States
NYU Medical Center
🇺🇸New York, New York, United States
Erlanger Health Systems
🇺🇸Chattanooga, Tennessee, United States
Ephrata Cancer Center
🇺🇸Ephrata, Pennsylvania, United States
Assoc in Hematology Oncology
🇺🇸Upland, Pennsylvania, United States
The Jones Clinic
🇺🇸Germantown, Tennessee, United States
SW Virginia Hem Onc
🇺🇸Roanoke, Virginia, United States
All Saints Cancer Center
🇺🇸Racine, Wisconsin, United States
JPS Center for Cancer Care
🇺🇸Fort Worth, Texas, United States
Centro Oncologico de Cordoba
🇦🇷Cordoba, Argentina
MHAT "St Marina"
🇧🇬Varna, Bulgaria
Instituto Nacional do Cancer
🇧🇷Rio de Janeiro, Brazil
UMHAT "Queen Joanna"
🇧🇬Sofia, Bulgaria
Divisione Onc Med dell'Azienda
🇮🇹Udine, Italy
Sir Charles Gairdner Hospital
🇦🇺Nedlands, WA, Australia
Palmetto Hematology Oncology
🇺🇸Spartanburg, South Carolina, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
Queen Mary Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Hospital Britanico
🇦🇷Buenos Aires, Argentina
Jackson-Madsion County Hosp
🇺🇸Jackson, Tennessee, United States
Instituto Medico Privado
🇦🇷Resistencia, Argentina
Bristol Heamatology & Onc Ctr
🇬🇧Bristol, United Kingdom
Vermont Ctr Cancer Medicine
🇺🇸Colchester, Vermont, United States
Azienda Ospedaliera
🇮🇹Parma, Italy
Azienda Osper di Perugia
🇮🇹Perugia, Italy
Dean Clinic
🇺🇸Madison, Wisconsin, United States
Peninsula Cancer Institute
🇺🇸Newport News, Virginia, United States
Hospital Toru
🇦🇷Buenos Aires, Argentina
Burnside War Memorial Hospital
🇦🇺Toorak Gardens, SA, Australia
CEMIC
🇦🇷Buenos Aires, Argentina
COIR
🇦🇷Mendoza, Argentina
National Specialized Hospital
🇧🇬Sofia, Bulgaria
Univ degli Studi di Napoli
🇮🇹Napoli, Italy
Hadassah Medical Center
🇮🇱Jerusalem, Israel
Ist Nazion per Ricerca Cancro
🇮🇹Genova, Italy
ISIS Clinica Especializada
🇦🇷Sante Fe, Argentina
Sunshine Coast Cancer Centre
🇦🇺Nambour, QLD, Australia
Bumrungrad International Hosp
🇹ðŸ‡Bangkok, Thailand
Taichung Veterans Gen Hosp
🇨🇳Taiwan, Taiwan
National Taiwan University
🇨🇳Taipei, Taiwan
National Cancer Institute
🇹ðŸ‡Bangkok, Thailand
Hospital Clinico Universitario
🇪🇸Valencia, Spain
Comp Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Onc/Hem Care Clin Trials LLC
🇺🇸Cincinnati, Ohio, United States
Virginia Piper Cancer Inst
🇺🇸Minneapolis, Minnesota, United States
Pacific Hematology Oncology
🇺🇸San Francisco, California, United States
Sarah Cannon Cancer Center
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical
🇺🇸Nashville, Tennessee, United States
Community Cancer Center
🇺🇸Rutland, Vermont, United States
Hospital Das Clinicas
🇧🇷Sao Paulo, Brazil
Queens Cancer Center
🇺🇸Jamaica, New York, United States
Nebraska Methodist Hospital
🇺🇸Omaha, Nebraska, United States
Medical Consultants LTD
🇺🇸Milwaukee, Wisconsin, United States
Bay Area Cancer Research Grp
🇺🇸Concord, California, United States
Cancer Care Associates
🇺🇸Torrance, California, United States
Santa Barbara Hem Onc Med Grp
🇺🇸Santa Barbara, California, United States
Redwood Regional Med Grp
🇺🇸Santa Rosa, California, United States
Holy Name Hospital
🇺🇸Teaneck, New Jersey, United States
Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Beaufort County Hospital
🇺🇸Washington, North Carolina, United States
Providence Portland Med Center
🇺🇸Portland, Oregon, United States
Hem Onc Med Grp Orange Cty
🇺🇸Orange, California, United States
Ohio Cancer Specialists
🇺🇸Mansfield, Ohio, United States
Mayo Clinic
🇺🇸Scottsdale, Arizona, United States
St. Edward Mercy Medical Ctr
🇺🇸Ft Smith, Arizona, United States
St. Jude Heritage Med Group
🇺🇸Fullerton, California, United States
North Valley Hem Onc Med Grp
🇺🇸Northridge, California, United States
Wilshire Oncology Medical Grp
🇺🇸Pomona, California, United States
Kaiser Permanente
🇺🇸San Diego, California, United States
Sansum Medical Clinic, Inc.
🇺🇸Santa Barbara, California, United States
Central Coast Medical Oncology
🇺🇸Santa Maria, California, United States
The Angeles Clinic
🇺🇸Santa Monica, California, United States
Front Range Cancer Specialists
🇺🇸Fort Collins, Colorado, United States
Mile High Oncology
🇺🇸Denver, Colorado, United States
Washington Onc Hem Center PC
🇺🇸Washington, District of Columbia, United States
Center for Hematology-Oncology
🇺🇸Boca Raton, Florida, United States
Halifax Medical Center
🇺🇸Daytona Beach, Florida, United States
Jackson Memorial Hospital
🇺🇸Miami, Florida, United States
Baptist Cancer Institute
🇺🇸Jacksonville, Florida, United States
Florida Wellcare Alliance
🇺🇸Inverness, Florida, United States
Hematology Onc Treasure Coast
🇺🇸Port Saint Lucie, Florida, United States
Integrated Comm Onc Network
🇺🇸Orange Park, 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
LaGrange Oncology Associates
🇺🇸Geneva, 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
Community Hospital
🇺🇸Munster, Indiana, United States
Gajera & Patel, PLLC
🇺🇸Hopkinsville, Kentucky, United States
H&J Weinberg Cancer Institute
🇺🇸Baltimore, Maryland, United States
Willis-Knighton Cancer Center
🇺🇸Shreveport, Louisiana, United States
Owensboro Medical Health Sys
🇺🇸Owensboro, Kentucky, United States
Oncology Hematology Associates
🇺🇸Clinton, Maryland, United States
Maryland Oncology/Hema PA
🇺🇸Columbia, Maryland, United States
Adriondack Cancer Care
🇺🇸Glen Falls, New York, United States
Bassett Cancer Center
🇺🇸Cooperstown, New York, United States
Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
SUNY Upstate
🇺🇸Syracuse, New York, United States
Carolina BioOncology Institute
🇺🇸Huntersville, North Carolina, United States
Dayton Clinical Oncology Prog
🇺🇸Dayton, 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
Scranton Hematology Oncology
🇺🇸Scranton, Pennsylvania, United States
Lankenau Medical Office Bldg
🇺🇸Wynnewood, Pennsylvania, United States
Texas Hematology Oncology
🇺🇸Dallas, Texas, United States
Northwest Medical Specialists
🇺🇸Tacoma, Washington, United States
Wilford Hall Medical Center
🇺🇸Lackland AFB, Texas, United States
SW Vermont Healthcare Onc Asoc
🇺🇸Bennington, Vermont, United States
Cascade Cancer Center
🇺🇸Kirkland, Washington, United States
Univ Physicians Internal Med
🇺🇸Huntington, West Virginia, United States
Oncology Alliance
🇺🇸Glendale, Wisconsin, United States
Hospital Pirovano
🇦🇷Buenos Aires, Argentina
Clinica Oncologica de Rosario
🇦🇷Rosario, Argentina
Holy Spirit Hospital Northside
🇦🇺Chermside, QLD, Australia
CHR Citadelle Liege
🇧🇪Liege, Belgium
Cliniques Univ St Luc
🇧🇪Brussels, Belgium
Regional Oncodispensary
🇧🇬Veliko Tarnovo, Bulgaria
Instituto de cancer Arnaldo
🇧🇷Sao Paulo, Brazil
Tuen Mun Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Azienda Ospedaliera Univ
🇮🇹Genova, Italy
Sourasky Medical Center
🇮🇱Tel-Aviv, Israel
Perpetual Succour Hospital
🇵ðŸ‡Cebu City, Visayas, Philippines
St Luke's Medical Center
🇵ðŸ‡Quezon City, Philippines
Hospital Clinic i Provincial
🇪🇸Barcelona, Spain
Hospital de Cruces
🇪🇸Barakaldo, Spain
Corporacio Sanitaria Parc
🇪🇸Sabadell, Barcelona, Spain
Hospital Universitario
🇪🇸La Laguna, Spain
Instituto Valenciano Oncologia
🇪🇸Valencia, Spain
Sacred Heart Medical Onc Group
🇺🇸Mobile, Alabama, United States
OSF St. Anthony Med Ctr
🇺🇸Rockford, Illinois, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
Central Hem/Onc Medical Group
🇺🇸Alhambra, California, United States
Chicagoland Hematology Onc
🇺🇸Arlington Heights, Illinois, United States
Kaiser Permanente Santa Teresa
🇺🇸San Jose, California, United States
Pacific Coast Hem/Onc
🇺🇸Fountain Valley, California, United States
Pacific Onc & Hem Assoc
🇺🇸Encinitas, California, United States
Hematology Oncology Associates
🇺🇸Bettendorf, Iowa, United States
Ventura Co Hem-Onc Specialists
🇺🇸Oxnard, California, United States
Los Palos Oncology & Hem
🇺🇸Salinas, California, United States
Naval Medical Center
🇺🇸San Diego, California, United States
Mid-Florida Hem Oncology Ctr
🇺🇸Orange City, Florida, United States
La Grange Oncology Associates
🇺🇸Lagrange, Illinois, United States
Akron General Medical Center
🇺🇸Akron, Ohio, United States
Weiss-Strauss Oncology Center
🇺🇸Chicago, Illinois, United States
Covenant Clinic
🇺🇸Waterloo, Iowa, United States
Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
St. Louis Univ Care Center
🇺🇸Saint Louis, Missouri, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Charleston Cancer Center
🇺🇸Charleston, South Carolina, United States
Lone Star Oncology Consultants
🇺🇸Austin, Texas, United States
Sutter Cancer Center
🇺🇸Sacramento, California, United States
Mercy General Hospital
🇺🇸Sacramento, California, United States
Consultants in Blood Disorders
🇺🇸Louisville, Kentucky, United States
Kentuckiana Cancer Center
🇺🇸Louisville, Kentucky, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
Hematology Oncology Assoc SJ
🇺🇸Mount Holly, New Jersey, United States
Crystal Run Health Care
🇺🇸Middletown, New York, United States
NorthEast Medical Center
🇺🇸Concord, North Carolina, United States
Princess Margaret Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Queen Elizabeth Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong