AzTrials
AzTrials

Non-Small Cell Lung CancerPhase 3NCT00257608

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

A Phase 3 study testing bevacizumab and erlotinib HCl in people with Non-Small Cell Lung Cancer, run by Genentech, Inc. at 247 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
bevacizumab and erlotinib HCl
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,145 participants
Where
247 sitesin 17 countries
Study dates
Jan 2006to Nov 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 21Show fewer
  • 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)

Trial locations and contacts

247 sites in 17 countries.

247 sites in 17 countries

United States177 sites

  • Summa Health System

    Akron, Ohio, 44304

  • Akron General Medical Center

    Akron, Ohio, 44307

  • Phoebe Putney Cancer Center

    Albany, Georgia, 31701

  • Central Hem/Onc Medical Group

    Alhambra, California, 91801

  • Chicagoland Hematology Onc

    Arlington Heights, Illinois, 60005

  • Northeast Georgia Cancer Care

    Athens, Georgia, 30607

  • Lone Star Oncology Consultants

    Austin, Texas, 78759

  • Comp Blood & Cancer Center

    Bakersfield, California, 93309

  • H&J Weinberg Cancer Institute

    Baltimore, Maryland, 21237

  • SW Vermont Healthcare Onc Asoc

    Bennington, Vermont, 05201

  • Hematology Oncology Associates

    Bettendorf, Iowa, 52722

  • Billings Clinic

    Billings, Montana, 59101

  • Center for Hematology-Oncology

    Boca Raton, Florida, 33486

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Caritas St. Elizabeth Med Ctr

    Boston, Massachusetts, 02135

  • Zale P Bernstein MD - PP

    Buffalo, New York, 14215

  • Lahey Clinic Med Ctr

    Burlington, Massachusetts, 01805

  • South Bay Oncology

    Campbell, California, 95008

  • Aultman Hospital

    Canton, Ohio, 44710

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Charleston Cancer Center

    Charleston, South Carolina, 29406

  • Presbyterian Hospital

    Charlotte, North Carolina, 28204

  • Erlanger Health Systems

    Chattanooga, Tennessee, 37403

  • Ctr for Cancer & Hem Disease

    Cherry Hill, New Jersey, 08003

  • Weiss-Strauss Oncology Center

    Chicago, Illinois, 60640

  • Onc/Hem Care Clin Trials LLC

    Cincinnati, Ohio, 45242

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Oncology Hematology Associates

    Clinton, Maryland, 20735

  • Vermont Ctr Cancer Medicine

    Colchester, Vermont, 05446

  • Maryland Oncology/Hema PA

    Columbia, Maryland, 21044

  • Ellis Fischel Cancer Center

    Columbia, Missouri, 65203

  • Mid Ohio Onc Hematology Inc

    Columbus, Ohio, 43213

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Bay Area Cancer Research Grp

    Concord, California, 94598

  • NorthEast Medical Center

    Concord, North Carolina, 28025

  • Bassett Cancer Center

    Cooperstown, New York, 13326

  • Coastal Bend Cancer Center

    Corpus Christi, Texas, 78404

  • Texas Cancer Associates

    Dallas, Texas, 75231

  • Texas Hematology Oncology

    Dallas, Texas, 75234

  • Dayton Clinical Oncology Prog

    Dayton, Ohio, 45429

  • Halifax Medical Center

    Daytona Beach, Florida, 32115

  • Mile High Oncology

    Denver, Colorado, 80210

  • Pacific Onc & Hem Assoc

    Encinitas, California, 92024

  • Forte, Attas & Schleider

    Englewood, New Jersey, 07631

  • Ephrata Cancer Center

    Ephrata, Pennsylvania, 17543

  • San Juan Onco Assoc

    Farmington, New Mexico, 87401

  • Hunterdon Medical Center

    Flemington, New Jersey, 08822

  • Front Range Cancer Specialists

    Fort Collins, Colorado, 80524

  • St. Edward Mercy Medical Ctr

    Fort Smith, Arizona, 72917

  • JPS Center for Cancer Care

    Fort Worth, Texas, 76104

  • Pacific Coast Hem/Onc

    Fountain Valley, California, 92708

  • Metrowest Cancer Center

    Framingham, Massachusetts, 01702

  • Frederick Memorial Hospital

    Frederick, Maryland, 21701

  • Central State Medical Center

    Freehold, New Jersey, 07728

  • Cancer Care Associates

    Fresno, California, 93720

  • St. Jude Heritage Med Group

    Fullerton, California, 92835

  • Univ of Texas Medical Branch

    Galveston, Texas, 77555

  • LaGrange Oncology Associates

    Geneva, Illinois, 54301

  • The Jones Clinic

    Germantown, Tennessee, 38138

  • Ronald H. Yanagihara

    Gilroy, California, 95020

  • Adriondack Cancer Care

    Glen Falls, New York, 12801

  • Glendale Adventist Medical Ctr

    Glendale, California, 91206

  • Oncology Alliance

    Glendale, Wisconsin, 53212

  • Spectrum Health

    Grand Rapids, Michigan, 49503

  • Big Sky Oncology

    Great Falls, Montana, 59405

  • BRANY

    Great Neck, New York, 11021

  • Moses Cone Reg Cncr Ctr

    Greensboro, North Carolina, 27403

  • Emerywood Hematology Oncology

    High Point, North Carolina, 27262

  • Gajera & Patel, PLLC

    Hopkinsville, Kentucky, 42240

  • Carolina BioOncology Institute

    Huntersville, North Carolina, 28078

  • Univ Physicians Internal Med

    Huntington, West Virginia, 25701

  • Florida Wellcare Alliance

    Inverness, Florida, 34452

  • Jackson-Madsion County Hosp

    Jackson, Tennessee, 38301

  • Baptist Cancer Institute

    Jacksonville, Florida, 32207

  • Queens Cancer Center

    Jamaica, New York, 11432

  • Freeman Cancer Institute

    Joplin, Missouri, 64804

  • Kalamazoo Hem & Onc

    Kalamazoo, Michigan, 49048

  • Kinston Medical Specialists

    Kinston, North Carolina, 28501

  • Cascade Cancer Center

    Kirkland, Washington, 98034

  • Armstrong County Memorial Hosp

    Kittanning, Pennsylvania, 16201

  • Scipps Clinic

    La Jolla, California, 92037-1027

  • Wilford Hall Medical Center

    Lackland Air Force Base, Texas, 78236

  • La Grange Oncology Associates

    LaGrange, Illinois, 60525

  • Hem Onc Assoc Phys Lancaster

    Lancaster, Pennsylvania, 17604

  • Comp Cancer Centers of Nevada

    Las Vegas, Nevada, 89109

  • Suburban Hem-Onc Associates

    Lawrenceville, Georgia, 30045

  • NE Hematology Oncology, PC

    Lincoln, Nebraska, 68506

  • St. Barnabas Health Care Sys

    Livingston, New Jersey, 07039

  • Loma Linda Univ Medical Center

    Loma Linda, California, 92354

  • Pacific Shores Medical Group

    Long Beach, California, 90813

  • Kenmar Research Institute LLC

    Los Angeles, California, 90057

  • UCLA Medical Ctr

    Los Angeles, California, 90095

  • Kentuckiana Cancer Center

    Louisville, Kentucky, 40202

  • University of Louisville

    Louisville, Kentucky, 40202

  • Consultants in Blood Disorders

    Louisville, Kentucky, 40207

  • Dean Clinic

    Madison, Wisconsin, 53715

  • Ohio Cancer Specialists

    Mansfield, Ohio, 44907

  • Northwest Georgia Onc Centers

    Marietta, Georgia, 30060

  • Marquette General Health Sys

    Marquette, Michigan, 49855

  • Clopton Clinic

    Memphis, Tennessee, 38138

  • Jackson Memorial Hospital

    Miami, Florida, 33136

  • Crystal Run Health Care

    Middletown, New York, 10941

  • Signal Point Hem/Oncology Inc

    Middletown, Ohio, 45042

  • Medical Consultants LTD

    Milwaukee, Wisconsin, 53215

  • Virginia Piper Cancer Inst

    Minneapolis, Minnesota, 55407

  • Montana Cancer Specialists

    Missoula, Montana, 59802

  • Sacred Heart Medical Onc Group

    Mobile, Alabama, 36608

  • Sutter Gould Med Foundation

    Modesto, California, 95355

  • Mountainside Hospital

    Montclair, New Jersey, 07042

  • West Virginia University

    Morgantown, West Virginia, 26506

  • Morristown Memorial Hospital

    Morristown, New Jersey, 07962

  • Hematology Oncology Assoc SJ

    Mount Holly, New Jersey, 08060

  • Community Hospital

    Munster, Indiana, 46321

  • Sarah Cannon Cancer Center

    Nashville, Tennessee, 37203-1632

  • Vanderbilt University Medical

    Nashville, Tennessee, 37232

  • Jersey Shore Medical Center

    Neptune City, New Jersey, 07754

  • Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • NYU Medical Center

    New York, New York, 10016

  • Mem Sloan Kettering Cancer Ctr

    New York, New York, 10021

  • Peninsula Cancer Institute

    Newport News, Virginia, 23606

  • North Valley Hem Onc Med Grp

    Northridge, California, 91325

  • Associates in Medical Oncology

    Oak Lawn, Illinois, 60453

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Hem Onc Med Grp Orange Cty

    Orange, California, 92868

  • Medical Oncology Care Assoc

    Orange, California, 92868

  • Mid-Florida Hem Oncology Ctr

    Orange City, Florida, 32763

  • Integrated Comm Onc Network

    Orange Park, Florida, 32073

  • Owensboro Medical Health Sys

    Owensboro, Kentucky, 42303

  • Ventura Co Hem-Onc Specialists

    Oxnard, California, 93030

  • The Valley Hospital

    Paramus, New Jersey, 07652

  • Onc Hem Assoc of Central IL

    Peoria, Illinois, 61615

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Wilshire Oncology Medical Grp

    Pomona, California, 91767

  • St. Joseph Mercy Oakland

    Pontiac, Michigan, 48341

  • Hematology Onc Treasure Coast

    Port Saint Lucie, Florida, 34952

  • Providence Portland Med Center

    Portland, Oregon, 97213

  • All Saints Cancer Center

    Racine, Wisconsin, 53405

  • West Suburban Cancer Center

    River Forest, Illinois, 60305

  • SW Virginia Hem Onc

    Roanoke, Virginia, 24014

  • OSF St. Anthony Med Ctr

    Rockford, Illinois, 61108

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • Community Cancer Center

    Rutland, Vermont, 05701

  • Sutter Cancer Center

    Sacramento, California, 95816

  • Mercy General Hospital

    Sacramento, California, 95819

  • Missouri Cancer Center, PC

    Saint Charles, Missouri, 63301

  • Los Palos Oncology & Hem

    Salinas, California, 93901

  • Kaiser Permanente

    San Diego, California, 92120

  • Naval Medical Center

    San Diego, California, 92134

  • Pacific Hematology Oncology

    San Francisco, California, 94115

  • Kaiser Permanente Santa Teresa

    San Jose, California, 95119

  • Sansum Medical Clinic, Inc.

    Santa Barbara, California, 93105

  • Santa Barbara Hem Onc Med Grp

    Santa Barbara, California, 93105

  • Central Coast Medical Oncology

    Santa Maria, California, 93454

  • The Angeles Clinic

    Santa Monica, California, 90404

  • Redwood Regional Med Grp

    Santa Rosa, California, 95403

  • Mayo Clinic

    Scottsdale, Arizona, 85259

  • Scranton Hematology Oncology

    Scranton, Pennsylvania, 18510

  • Willis-Knighton Cancer Center

    Shreveport, Louisiana, 71103

  • Siouxland Hem-Onc Assoc LLP

    Sioux City, Iowa, 51101

  • Palmetto Hematology Oncology

    Spartanburg, South Carolina, 29303

  • Baystate Medical Center

    Springfield, Massachusetts, 01107

  • St. Louis Univ Care Center

    St Louis, Missouri, 63117

  • Overlook Hospital

    Summit, New Jersey, 07902

  • SUNY Upstate

    Syracuse, New York, 13210

  • Northwest Medical Specialists

    Tacoma, Washington, 98405

  • Holy Name Hospital

    Teaneck, New Jersey, 07666

  • Providence Medical Group

    Terre Haute, Indiana, 47802

  • Toledo Community Hospital

    Toledo, Ohio, 43623

  • Cancer Care Associates

    Torrance, California, 90505

  • Arizona Cancer Center

    Tucson, Arizona, 85724

  • Assoc in Hematology Oncology

    Upland, Pennsylvania, 19013

  • Arch Medical Services

    Washington, Missouri, 63090

  • Beaufort County Hospital

    Washington, North Carolina, 27889

  • Washington Onc Hem Center PC

    Washington D.C., District of Columbia, 20037

  • Covenant Clinic

    Waterloo, Iowa, 50702

  • Lankenau Medical Office Bldg

    Wynnewood, Pennsylvania, 19096

  • Forum Health Cancer Care Ctr

    Youngstown, Ohio, 44501

Other trials in United States

Argentina9 sites

  • Hospital Pirovano

    Buenos Aires, 1430

  • Hospital Britanico

    Buenos Aires, C1284AEB

  • Hospital Toru

    Buenos Aires, C1427ARN

  • CEMIC

    Buenos Aires, C1431FWO

  • Centro Oncologico de Cordoba

    Córdoba, X5000AAI

  • COIR

    Mendoza, 5500

  • Instituto Medico Privado

    Resistencia, 3900

  • Clinica Oncologica de Rosario

    Rosario, S2000dsk

  • ISIS Clinica Especializada

    Sante Fe, S3000FFU

Other trials in Argentina

Bulgaria9 sites

  • Regional Oncodispensary

    Plovdiv, 4004

  • Regional Oncodispensary

    Rousse, 7000

  • Regional Oncodispensary

    Shumen, 9700

  • Regional Oncodispensary

    Sofia, 1233

  • UMHAT "Queen Joanna"

    Sofia, 1527

  • National Specialized Hospital

    Sofia, 1756

  • Regional Oncodispensary

    Stara Zagora, 6003

  • MHAT "St Marina"

    Varna, 9010

  • Regional Oncodispensary

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Spain7 sites

  • Hospital de Cruces

    Barakaldo, 48903

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Clinic i Provincial

    Barcelona, 08036

  • Corporacio Sanitaria Parc

    Sabadell, Barcelona, 08208

  • Hospital Universitario

    San Cristóbal de La Laguna, 38320

  • Instituto Valenciano Oncologia

    Valencia, 46009

  • Hospital Clinico Universitario

    Valencia, 46010

Other trials in Spain

Italy6 sites

  • Azienda Ospedaliera Univ

    Genova, 16132

  • Ist Nazion per Ricerca Cancro

    Genova, 16132

  • Univ degli Studi di Napoli

    Naples, 80131

  • Azienda Ospedaliera

    Parma, 43100

  • Azienda Osper di Perugia

    Perugia, 06159

  • Divisione Onc Med dell'Azienda

    Udine, 33100

Other trials in Italy

Philippines6 sites

  • Perpetual Succour Hospital

    Cebu City, Visayas, 6000

  • Philippine General Hospital

    Manila, Luzon, 1000

  • Univ of Santo Tomas Hospital

    Manila, 1008

  • The Medical City

    Pasig, Luzon, 1605

  • Veterans Memorial Medical Ctr

    Quezon City, Luzon, 1114

  • St Luke's Medical Center

    Quezon City, 1102

Other trials in Philippines

Thailand5 sites

  • Bumrungrad International Hosp

    Bangkok, 10110

  • National Cancer Institute

    Bangkok, 10400

  • Pramongkutklao Hospital

    Bangkok, 10400

  • Siriraj Hospital

    Bangkok, 10700

  • Maharaj Nakorn Chiang Mai Hosp

    Chiang Mai, 50200

Other trials in Thailand

Australia4 sites

  • Holy Spirit Hospital Northside

    Chermside, QLD, 4032

  • Sunshine Coast Cancer Centre

    Nambour, QLD, 4560

  • Sir Charles Gairdner Hospital

    Nedlands, WA, 6009

  • Burnside War Memorial Hospital

    Toorak Gardens, SA, 5065

Other trials in Australia

Hong Kong4 sites

  • Princess Margaret Hospital

    Hong Kong

  • Queen Elizabeth Hospital

    Hong Kong

  • Queen Mary Hospital

    Hong Kong

  • Tuen Mun Hospital

    Hong Kong

Other trials in Hong Kong

Mexico4 sites

  • Torre Medica Cristobal Colon

    Acapulco, 39670

  • Inst Nacional de Cancerologia

    Distrito Federal, 14080

  • ISSSTE Merida

    Mérida, 97500

  • Hospital de Especialidades

    Torreon, Coahuila, 27200

Other trials in Mexico

Brazil3 sites

  • Instituto Nacional do Cancer

    Rio de Janeiro, 20-231-050

  • Instituto de cancer Arnaldo

    São Paulo, São Paulo, 01221-020

  • Hospital Das Clinicas

    São Paulo, 05403-01

Other trials in Brazil

Israel3 sites

  • Hadassah Medical Center

    Jerusalem, 91120

  • Sourasky Medical Center

    Tel Aviv, 64239

  • Sheba Medical Center

    Tel HaShomer, 52621

Other trials in Israel

Romania3 sites

  • Centrul de Onc Medical Lasi

    Iași, 700106

  • Spitalul Clinic Judetean Sibiu

    Sibiu, 550245

  • Spitalul Judetean de Urgente

    Suceava, 720237

Other trials in Romania

Taiwan3 sites

  • Taichung Veterans Gen Hosp

    Dawan, 407

  • China Medical Univ Hosp

    Taichung, 404

  • National Taiwan University

    Taipei, 112

Other trials in Taiwan

Belgium2 sites

  • Cliniques Univ St Luc

    Brussels, 1200

  • CHR Citadelle Liege

    Liège, 4000

Other trials in Belgium

Singapore1 site

  • National Cancer Center

    Singapore, 169610

Other trials in Singapore

United Kingdom1 site

  • Bristol Heamatology & Onc Ctr

    Bristol, BS2 8ED

Other trials in United Kingdom

About this study

Official title: 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.

Being tested
bevacizumab, placebo, erlotinib HCl
Keywords
NSCLC, Lung Cancer, ATLAS, Avastin, Tarceva
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bevacizumabDrug

    Intravenous repeating dose

  • placeboDrug

    Oral repeating dose

  • erlotinib HClDrug

    Oral repeating dose

Study groups in NCT00257608
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: bevacizumab; Drug: erlotinib HCl
2Placebo comparatorNot described
Receives: Drug: bevacizumab; Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Approximately 3 years

Secondary outcomes (6)

  1. Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Chemotherapy Phase

    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.

    Measured: Approximately 3 years

  2. Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Post-Chemotherapy Phase

    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.

    Measured: Approximately 3 years

  3. Number of Participants With Any Adverse Events During Post-Chemotherapy Phase

    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.

    Measured: Approximately 3.5 years

  4. Incidence of Study Treatment Discontinuation for Reasons Other Than Disease Progression in Chemotherapy Phase

    Participants who experienced disease progression were discontinued from the study. Data presented up to data cutoff (18 July 2008).

    Measured: Approximately 3 years

  5. Incidence of Study Treatment Discontinuation

    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.

    Measured: Approximately 3 years

  6. Overall Survival

    Overall survival was defined as the length of time from randomization to death.

    Measured: Approximately 3.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2005 (estimated)
  2. Study startJan 2006
  3. Primary completionNov 2014
  4. Study completionNov 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,145 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00257608
Sponsor's protocol ID
AVF3671g
Other IDs
BO20800
Status last verified
Mar 2016
First submitted
21 Nov 2005
Last updated
18 Apr 2016

Publications

  • 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.

    PubMed 24101054

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bevacizumab and erlotinib HCl in people with Non-Small Cell Lung Cancer, run by Genentech, Inc. at 247 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 247 sites in United States, Argentina, Bulgaria, Spain, Italy and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: Approximately 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00257608, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2016.

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