AzTrials
AzTrials

Stage IB Lung Non-Small Cell Carcinoma AJCC v7Phase 3NCT00324805

Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-small Cell Lung Cancer That Was Removed By Surgery

A Phase 3 study testing Bevacizumab, Cisplatin and Docetaxel in people with Stage IB Lung Non-Small Cell Carcinoma AJCC v7 and Stage IIA Lung Non-Small Cell Carcinoma AJCC v7, run by National Cancer Institute (NCI) at 1,169 sites in 5 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 randomized phase III trial studies chemotherapy and bevacizumab to see how well they work compared to chemotherapy alone in treating patients with stage IB, stage II, or stage IIIA non-small cell lung cancer that was removed by surgery. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bevacizumab, Cisplatin and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,501 participants
Where
1,169 sitesin 5 countries
Study dates
19 Jul 2007to 31 Jan 2025
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

  • In order to be eligible for this trial, patients must have undergone complete resection of their non-small cell lung cancer (NSCLC) [stage IB (>= 4 cm)] - [IIIA (T2-3N0, T1-3N1, T1-3N2] prior to enrollment; accepted types of resection will consist of lobectomy, sleeve lobectomy, bi-lobectomy or pneumonectomy; resections by segmentectomy or wedge resection will not be accepted; mediastinal lymph node sampling at specified levels is required pre-operatively (mediastinoscopy) or intraoperatively (level 7 and 4 for right sided tumors or level 7 and 5 and/or 6 for left sided tumors)
  • Patients must be no less than 6 weeks (42 days) and no more than 12 weeks (84 days) post-thoracotomy at the time of randomization and must be adequately recovered from surgery
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Patients must not have received the following:
  • Prior systemic chemotherapy at any time; methotrexate (MTX) given in low doses for non-malignant conditions with last dose at least 2 weeks prior to date of registration will be allowed; other low dose chemotherapeutics for non-malignant conditions will be considered, but review by the study chair is required
  • Hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years of randomization; (prior surgery, biologic therapy, hormonal therapy, or radiation therapy for a malignancy over 5 years prior to enrollment that is now considered cured is acceptable)
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  • Patients must not have any history of cancer within 5 years from randomization, with the exception of in-situ carcinoma of the cervix or completely resected non-melanoma skin cancer
  • Absolute neutrophil count (ANC) >= 1500 mm^3
  • Platelets >= 100,000/mm^3
  • Prothrombin time/international normalized ratio (INR) =< 1.5
  • Or, if patient is on therapeutic anticoagulation, prothrombin time/INR =< 3.0
  • Partial thromboplastin time (PTT) =< institutional upper limit of normal (ULN) OR, if patient is on therapeutic anticoagulation, PTT must be =< 1.5 x ULN
  • Total bilirubin =< 1.5 mg/dL
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) < 5 x upper limit of normal (ULN)
  • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 5 x upper limit of normal (ULN)
  • Serum creatinine =< 1.5 x institutional upper limit of normal (ULN)
  • Urine protein should be screened by urine analysis for urine protein creatinine (UPC) ratio; for UPC ratio > 0.5, 24-hour urine protein must be obtained and the level must be < 1000 mg (1 g) for patient enrollment
  • Patients with a known history of myocardial infarction or other evidence of arterial thrombotic disease (angina) will be allowed on study only if they have had no evidence of active disease for at least 12 months prior to randomization
  • Patients with any history of cerebral vascular accident (CVA) or transient ischemic attack (TIA) will not be allowed on trial
  • Women must not be pregnant or breast-feeding
  • All females of childbearing potential must have a blood or urine test within 2 weeks prior to randomization to rule out pregnancy
  • Both fertile men and women must agree to use adequate contraceptive measures during study treatment and for at least 6 months after completion of bevacizumab
  • Patients must not have any clinically significant ongoing, active or serious infection, symptomatic or uncontrolled congestive heart failure, symptomatic or uncontrolled cardiac arrhythmia or any other medical condition or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients must have no history of bleeding diathesis or coagulopathy
  • All patients must have a documented blood pressure (BP) with systolic =< 150 and diastolic =< 90 within 28 days of registration; patients with known hypertension must be on a stable regimen of anti-hypertensive therapy
  • Patients receiving daily treatment with aspirin or non-steroidal anti-inflammatory agents (NSAIDS) are eligible; treatment with dipyridamole (Persantine), ticlopine (Ticlid), clopidogrel (Plavix) and/or cilostazol (Pletal) is not allowed; patients must have stopped taking any of these agents at least 7 days prior to randomization
  • Patients must not have serious non-healing wound, ulcer, bone fracture, or have undergone a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization OR core biopsy within 7 days prior to randomization
  • Patients must not have a history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days prior to randomization
  • Patients must not have any anticipated major surgical procedure(s) during the course of the study
  • Patients must not have known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • Patients may be on a stable regimen of therapeutic anticoagulation or may be receiving prophylactic anticoagulation of venous access devices, provided that coagulation studies meet entry criteria above; caution must be exercised for patients requiring anticoagulation, including treatment with low dose heparin or low molecular weight heparin for deep vein thrombosis (DVT) prophylaxis while on study
  • Patients with ongoing post-operative hemoptysis (defined as bright red blood of 1/2 teaspoon or more) are not eligible; patients with pre-operative hemoptysis that has resolved post-operatively are eligible
  • Patients who will receive pemetrexed (pemetrexed disodium)/cisplatin therapy must also meet the following criteria:
  • Patients assigned to pemetrexed/cisplatin therapy must NOT have squamous cell histology
  • Calculated creatinine clearance must be obtained within 2 weeks of randomization and calculated creatinine clearance (CrCl) must be >= 45 mL/min using the standard Cockcroft and Gault formula, or the measured glomerular filtration rate (GFR) using the appropriate radiolabeled method ([51]chromium-labeled ethylenediaminetetraacetic acid [51-CrEDTA] or technetium 99m diethylenetriamine-pentaacetic acid [Tc99m-DTPA]) must be used to calculate CrCl

Who cannot join

None listed.

Trial locations and contacts

1,169 sites in 5 countries.

330 sites in 5 countries

United States300 sites

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • Avera Cancer Institute-Aberdeen

    Aberdeen, South Dakota, 57401

  • Jefferson Abington Hospital

    Abington, Pennsylvania, 19001

  • Bixby Medical Center

    Adrian, Michigan, 49221

  • Hickman Cancer Center

    Adrian, Michigan, 49221

  • Summa Health System - Akron Campus

    Akron, Ohio, 44304

  • Cleveland Clinic Akron General

    Akron, Ohio, 44307

  • San Luis Valley Regional Medical Center

    Alamosa, Colorado, 81101

  • Phoebe Putney Memorial Hospital

    Albany, Georgia, 31701

  • New York Oncology Hematology PC - Albany

    Albany, New York, 12206

  • New York Oncology Hematology PC - Albany Medical Center

    Albany, New York, 12208

  • Lovelace Medical Center-Saint Joseph Square

    Albuquerque, New Mexico, 87102

  • Hematology Oncology Associates

    Albuquerque, New Mexico, 87106

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • Presbyterian Kaseman Hospital

    Albuquerque, New Mexico, 87110

  • Medini, Eitan MD (UIA Investigator)

    Alexandria, Minnesota, 56308

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • OSF Saint Anthony's Health Center

    Alton, Illinois, 62002

  • The Don and Sybil Harrington Cancer Center

    Amarillo, Texas, 79106

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

  • Cancer Care Center at Island Hospital

    Anacortes, Washington, 98221

  • Kaiser Permanente-Anaheim

    Anaheim, California, 92806

  • Alaska Regional Hospital

    Anchorage, Alaska, 99508

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • Ascension Saint Vincent Anderson

    Anderson, Indiana, 46016

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • AnMed Health Hospital

    Anderson, South Carolina, 29621

  • Michigan Cancer Research Consortium NCORP

    Ann Arbor, Michigan, 48106

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Northeast Alabama Regional Medical Center

    Anniston, Alabama, 36202

  • Hospital District Sixth of Harper County

    Anthony, Kansas, 67003

  • Kaiser Permanente-Deer Valley Medical Center

    Antioch, California, 94531

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

  • PCR Oncology

    Arroyo Grande, California, 93420

  • Randolph Hospital

    Asheboro, North Carolina, 27203

  • Mission Hospital

    Asheville, North Carolina, 28801

  • King's Daughter's Medical Center

    Ashland, Kentucky, 41101

  • Our Lady Bellefonte Hospital

    Ashland, Kentucky, 41101

  • University Cancer and Blood Center LLC

    Athens, Georgia, 30607

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Atlanta Regional CCOP

    Atlanta, Georgia, 30342

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Sturdy Memorial Hospital

    Attleboro, Massachusetts, 02703

  • MultiCare Auburn Medical Center

    Auburn, Washington, 98001

  • Augusta Oncology Associates PC-D'Antignac

    Augusta, Georgia, 30901

  • Augusta University Medical Center

    Augusta, Georgia, 30912

  • Harold Alfond Center for Cancer Care

    Augusta, Maine, 04330

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • Rocky Mountain Regional VA Medical Center

    Aurora, Colorado, 80045

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045

  • Rush - Copley Medical Center

    Aurora, Illinois, 60504

  • WellStar Cobb Hospital

    Austell, Georgia, 30106

  • Kaiser Permanente-Baldwin Park

    Baldwin Park, California, 91706

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Veterans Administration Medical Center-Baltimore

    Baltimore, Maryland, 21201

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • MedStar Franklin Square Medical Center/Weinberg Cancer Institute

    Baltimore, Maryland, 21237

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Summa Health System - Barberton Campus

    Barberton, Ohio, 44203

  • Baton Rouge General Medical Center

    Baton Rouge, Louisiana, 70806

  • Hematology/Oncology Clinic PLLC

    Baton Rouge, Louisiana, 70809

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Ochsner Health Center-Summa

    Baton Rouge, Louisiana, 70809

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • McLaren Cancer Institute-Bay City

    Bay City, Michigan, 48706

  • Cleveland Clinic Cancer Center Beachwood

    Beachwood, Ohio, 44122

  • UHHS-Chagrin Highlands Medical Center

    Beachwood, Ohio, 44122

  • Franciscan Saint Francis Health-Beech Grove

    Beech Grove, Indiana, 46107

  • UM Upper Chesapeake Medical Center

    Bel Air, Maryland, 21014

  • Mary Rutan Hospital

    Bellefontaine, Ohio, 43311

  • Overlake Medical Center

    Bellevue, Washington, 98004

  • Kaiser Permanente-Bellflower

    Bellflower, California, 90706

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

  • Saint Charles Health System

    Bend, Oregon, 97701

  • Southwestern Vermont Medical Center

    Bennington, Vermont, 05201

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

  • Central Vermont Medical Center/National Life Cancer Treatment

    Berlin Corners, Vermont, 05602

  • MacNeal Hospital and Cancer Center

    Berwyn, Illinois, 60402

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889-5600

  • Saint Luke's University Hospital-Bethlehem Campus

    Bethlehem, Pennsylvania, 18015

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

  • Constantinou, Costas L MD (UIA Investigator)

    Bettendorf, Iowa, 52722

  • University of Iowa Healthcare Cancer Services Quad Cities

    Bettendorf, Iowa, 52722

  • Beverly Hospital

    Beverly, Massachusetts, 01915

  • Spectrum Health Big Rapids Hospital

    Big Rapids, Michigan, 49307

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Montana Cancer Consortium NCORP

    Billings, Montana, 59102

  • Saint Vincent Frontier Cancer Center

    Billings, Montana, 59102

  • Mid Dakota Clinic

    Bismarck, North Dakota, 58501

  • Saint Alexius Medical Center

    Bismarck, North Dakota, 58501

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • OSF Saint Joseph Medical Center

    Bloomington, Illinois, 61701

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Lynn Regional Cancer Center - West

    Boca Raton, Florida, 33428

  • Boca Raton Comprehensive Cancer Center

    Boca Raton, Florida, 33486

  • Boca Raton Regional Hospital

    Boca Raton, Florida, 33486

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri, 65613

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Boulder Community Hospital

    Boulder, Colorado, 80301

  • Toledo Clinic Cancer Centers-Bowling Green

    Bowling Green, Ohio, 43402

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

  • Essentia Health Saint Joseph's Medical Center

    Brainerd, Minnesota, 56401

  • Cox Cancer Center Branson

    Branson, Missouri, 65616

  • Ocean University Medical Center

    Brick, New Jersey, 08724

  • Hartford HealthCare - Saint Vincent's Medical Center

    Bridgeport, Connecticut, 06606

  • Bridgeport Hospital

    Bridgeport, Connecticut, 06610

  • Steward Saint Elizabeth's Medical Center

    Brighton, Massachusetts, 02135

  • Wellmont Medical Associates Oncology and Hematology-Bristol

    Bristol, Tennessee, 37620

  • Kings County Hospital

    Brooklyn, New York, 11203

  • State University of New York Downstate Medical Center

    Brooklyn, New York, 11203

  • Veteran Affairs New York Harbor Healthcare System-Brooklyn Campus

    Brooklyn, New York, 11209

  • Maimonides Medical Center

    Brooklyn, New York, 11219

  • Coney Island Hospital

    Brooklyn, New York, 11235

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Veterans Affairs Western New York Health Care System-Buffalo

    Buffalo, New York, 14215

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • Highline Medical Center-Main Campus

    Burien, Washington, 98166

  • Mills-Peninsula Medical Center

    Burlingame, California, 94010

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

  • Cone Health Cancer Center at Alamance Regional

    Burlington, North Carolina, 27215

  • University of Vermont and State Agricultural College

    Burlington, Vermont, 05405

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Butler Memorial Hospital

    Butler, Pennsylvania, 16001

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Graham Hospital Association

    Canton, Illinois, 61520

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Cleveland Clinic Mercy Hospital

    Canton, Ohio, 44708

  • Aultman Health Foundation

    Canton, Ohio, 44710

  • Southeast Missouri Hospital

    Cape Girardeau, Missouri, 63701

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Southeast Cancer Center

    Cape Girardeau, Missouri, 63703

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Memorial Hospital

    Carthage, Illinois, 62321

  • Waverly Hematology Oncology

    Cary, North Carolina, 27518

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

  • East Bay Radiation Oncology Center

    Castro Valley, California, 94546

  • Eden Hospital Medical Center

    Castro Valley, California, 94546

  • Valley Medical Oncology Consultants-Castro Valley

    Castro Valley, California, 94546

  • Physicians' Clinic of Iowa PC

    Cedar Rapids, Iowa, 52402

  • Saint Luke's Hospital

    Cedar Rapids, Iowa, 52402

  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Geauga Hospital

    Chardon, Ohio, 44024

  • Roper Hospital

    Charleston, South Carolina, 29401

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • West Virginia University Charleston Division

    Charleston, West Virginia, 25304

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • Sentara Martha Jefferson Hospital

    Charlottesville, Virginia, 22901

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Erlanger Medical Center

    Chattanooga, Tennessee, 37403

  • Saint Luke's Hospital

    Chesterfield, Missouri, 63017

  • Mount Sinai Hospital Medical Center

    Chicago, Illinois, 60608

  • Hematology and Oncology Associates

    Chicago, Illinois, 60611

  • Northwestern University

    Chicago, Illinois, 60611

  • Jesse Brown Veterans Affairs Medical Center

    Chicago, Illinois, 60612

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Illinois

    Chicago, Illinois, 60612

  • Swedish Covenant Hospital

    Chicago, Illinois, 60625

  • Presence Resurrection Medical Center

    Chicago, Illinois, 60631

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Weiss Memorial Hospital

    Chicago, Illinois, 60640

  • UChicago Medicine Comprehensive Cancer Center - Saint Joseph Hospital

    Chicago, Illinois, 60657

  • Adventist Health Cancer Care Center Chico

    Chico, California, 95973

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Marshfield Clinic-Chippewa Center

    Chippewa Falls, Wisconsin, 54729

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • McLaren Cancer Institute-Clarkston

    Clarkston, Michigan, 48346

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • New York Oncology Hematology PC - Clifton Park

    Clifton Park, New York, 12065

  • Finger Lakes Hematology and Oncology

    Clifton Springs, New York, 14432

  • Mission Cancer and Blood - West Des Moines

    Clive, Iowa, 50325

  • Community Cancer Institute

    Clovis, California, 93611

  • North Coast Cancer Care-Clyde

    Clyde, Ohio, 43410

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • UCHealth Memorial Hospital Central

    Colorado Springs, Colorado, 80909

  • Veterans Administration

    Columbia, Missouri, 65201

  • MU Health - University Hospital/Ellis Fischel Cancer Center

    Columbia, Missouri, 65212

  • John B Amos Cancer Center

    Columbus, Georgia, 31904

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Mount Carmel East Hospital

    Columbus, Ohio, 43213

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Columbus NCI Community Oncology Research Program

    Columbus, Ohio, 43215

  • Grant Medical Center

    Columbus, Ohio, 43215

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • Doctors Hospital

    Columbus, Ohio, 43228

  • Commonwealth Hematology Oncology PC-Concord

    Concord, Massachusetts, 01742

  • New Hampshire Oncology Hematology PA-Concord

    Concord, New Hampshire, 03301

  • Atrium Health Cabarrus/LCI-Concord

    Concord, North Carolina, 28025

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Mary Imogene Bassett Hospital

    Cooperstown, New York, 13326

  • Bay Area Hospital

    Coos Bay, Oregon, 97420

  • Ochsner Health Center-Covington

    Covington, Louisiana, 70433

  • Hematology and Oncology Associates of Rhode Island Inc

    Cranston, Rhode Island, 02920

  • UPMC Western Maryland

    Cumberland, Maryland, 21502

  • Dallas VA Medical Center

    Dallas, Texas, 75216

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Texas Health Presbyterian Hospital Dallas

    Dallas, Texas, 75231

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • Clements University Hospital

    Dallas, Texas, 75390

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Mass General/North Shore Cancer Center

    Danvers, Massachusetts, 01923

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Mercy Fitzgerald Hospital

    Darby, Pennsylvania, 19023-1291

  • Genesis Medical Center - East Campus

    Davenport, Iowa, 52803

  • MercyOne Genesis Davenport Cancer Center

    Davenport, Iowa, 52804

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital - Dayton

    Dayton, Ohio, 45406

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

  • Dayton Veterans Affairs Medical Center

    Dayton, Ohio, 45428

  • Dayton NCI Community Oncology Research Program

    Dayton, Ohio, 45459

  • Halifax Health Medical Center-Centers for Oncology

    Daytona Beach, Florida, 32114

  • Florida Hospital Memorial Medical Center

    Daytona Beach, Florida, 32117

  • Corewell Health Dearborn Hospital

    Dearborn, Michigan, 48124

  • Atlanta VA Medical Center

    Decatur, Georgia, 30033

  • Emory Decatur Hospital

    Decatur, Georgia, 30033

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Heartland Cancer Research NCORP

    Decatur, Illinois, 62526

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Denver Health Medical Center

    Denver, Colorado, 80204

  • Kaiser Permanente-Franklin

    Denver, Colorado, 80205

  • AdventHealth Porter

    Denver, Colorado, 80210

  • University of Colorado

    Denver, Colorado, 80217-3364

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, 80218

  • Saint Joseph Hospital - Cancer Centers of Colorado

    Denver, Colorado, 80218

  • Rose Medical Center

    Denver, Colorado, 80220

  • Western States Cancer Research NCORP

    Denver, Colorado, 80222

  • Mercy Capitol

    Des Moines, Iowa, 50307

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Iowa-Wide Oncology Research Coalition NCORP

    Des Moines, Iowa, 50309

  • Mission Cancer and Blood - Des Moines

    Des Moines, Iowa, 50309

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Mission Cancer and Blood - Laurel

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Henry Ford Health Saint John Hospital

    Detroit, Michigan, 48236

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Bayhealth Hospital Kent Campus

    Dover, Delaware, 19901

  • Wentworth-Douglass Hospital

    Dover, New Hampshire, 03820

  • Advocate Good Samaritan Hospital

    Downers Grove, Illinois, 60515

  • Doylestown Hospital

    Doylestown, Pennsylvania, 18901

  • Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Oncology Hematology Associates of Northern Pennsylvania

    DuBois, Pennsylvania, 15801

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

  • Essentia Health Saint Mary's Medical Center

    Duluth, Minnesota, 55805

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

  • Saint Luke's Hospital of Duluth

    Duluth, Minnesota, 55805

  • Durham VA Medical Center

    Durham, North Carolina, 27705

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640

  • Michigan State University Clinical Center

    East Lansing, Michigan, 48824

  • Veterans Adminstration New Jersey Health Care System

    East Orange, New Jersey, 07018-1095

  • Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

  • Hematology Oncology Associates of Central New York-East Syracuse

    East Syracuse, New York, 13057

  • University of Maryland Shore Medical Center at Easton

    Easton, Maryland, 21601

  • Easton Hospital

    Easton, Pennsylvania, 18042

  • HSHS Sacred Heart Hospital

    Eau Claire, Wisconsin, 54701

  • Marshfield Clinic Cancer Center at Sacred Heart

    Eau Claire, Wisconsin, 54701

  • Mayo Clinic Health System-Eau Claire Clinic

    Eau Claire, Wisconsin, 54701

  • Mayo Clinic Health System Eau Claire Hospital-Luther Campus

    Eau Claire, Wisconsin, 54703

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Swedish Cancer Institute-Edmonds

    Edmonds, Washington, 98026

  • Shaw Cancer Center

    Edwards, Colorado, 81632

  • Saint Anthony Memorial Hospital

    Effingham, Illinois, 62401

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Advocate Sherman Hospital

    Elgin, Illinois, 60123

  • Ascension Alexian Brothers - Elk Grove Village

    Elk Grove Village, Illinois, 60007

Other trials in United States

Canada18 sites

  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Health Sciences North

    Greater Sudbury, Ontario, P3E 5J1

  • CSSS Champlain-Charles Le Moyne

    Greenfield Park, Quebec, J4V 2H1

  • QEII Health Sciences Centre/Nova Scotia Health Authority

    Halifax, Nova Scotia, B3H 2Y9

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • Trillium Health Partners - Mississauga Hospital

    Mississauga, Ontario, L5B 1B8

  • The Moncton Hospital

    Moncton, New Brunswick, E1C 6Z8

  • McGill University Department of Oncology

    Montreal, Quebec, H2W 1S6

  • Ottawa Hospital and Cancer Center-General Campus

    Ottawa, Ontario, K1H 8L6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Algoma District Cancer Program Sault Area Hospital

    Sault Ste. Marie, Ontario, P6B 0A8

  • Thunder Bay Regional Health Science Centre

    Thunder Bay, Ontario, P7B 6V4

  • University Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • Trillium Health Partners - Queensway Health Centre

    Toronto, Ontario, M9C 1A5

  • BCCA-Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Ireland10 sites

  • Cork University Hospital

    Cork

  • Tallaght University Hospital

    Dublin, Co Dublin, 24

  • Saint Vincent's University Hospital

    Dublin, Co Dublin, 4

  • Mater Misericordiae University Hospital

    Dublin, Co Dublin, 7

  • Mater Private Hospital

    Dublin, Co Dublin, 7

  • Beaumont Hospital

    Dublin, Co Dublin, 9

  • Saint James Hospital

    Dublin, 8

  • University College Hospital Galway

    Galway, Co Galway

  • Mid-Western Regional Hospital

    Limerick, Co Limerick, 9

  • University Hospital Waterford

    Waterford, Co Waterford, 9

Other trials in Ireland

Peru1 site

  • Instituto Nacional de Enfermedades Neoplasicas

    Lima, Lima 34

Other trials in Peru

South Africa1 site

  • University Of Pretoria

    Pretoria, 0002

Other trials in South Africa

About this study

Official title: A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (≥ 4 cm) - IIIA Non-small Cell Lung Cancer (NSCLC)

This randomized phase III trial studies chemotherapy and bevacizumab to see how well they work compared to chemotherapy alone in treating patients with stage IB, stage II, or stage IIIA non-small cell lung cancer that was removed by surgery. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab also may stop the growth of non-small cell lung cancer by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether chemotherapy is more effective with or without bevacizumab in treating non-small cell lung cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate overall survival with chemotherapy with or without bevacizumab used in the adjuvant setting in patients with resected stage IB (>= 4 cm) - IIIA non-small cell lung cancer (NSCLC).

SECONDARY OBJECTIVES:

  1. To evaluate disease-free survival and toxicity with chemotherapy with or without bevacizumab used in the adjuvant setting in patients with resected stage IB (>= 4 cm) - IIIA NSCLC.

CORRELATIVE OBJECTIVES:

  1. To perform analyses of tissue and blood to establish factors that predict clinical outcome in patients receiving chemotherapy, with or without bevacizumab, for resected early stage NSCLC.

II. To determine whether smoking status is linked to outcome for patients with resected stage IB (>= 4 cm) - IIIA NSCLC treated with chemotherapy with or without bevacizumab in the adjuvant setting.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I (adjuvant chemotherapy without bevacizumab): Patients receive 1 of 4 chemotherapy regimens.

REGIMEN 1: Patients receive vinorelbine ditartrate intravenously (IV) over 10 minutes on days 1 and 8 and cisplatin IV over 60 minutes on day 1 immediately following vinorelbine ditartrate administration.

REGIMEN 2: Patients receive docetaxel IV over 1 hour on day 1 and cisplatin over 1 hour on day 1 immediately following docetaxel administration.

REGIMEN 3: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 60 minutes on day 1 immediately following gemcitabine administration.

REGIMEN 4 (non-squamous histology only): Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 1 hour on day 1 immediately following pemetrexed disodium administration.

In all regimens, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

ARM II (adjuvant chemotherapy with bevacizumab): Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year.

After completion of study treatment, patients are followed up periodically for 10 years.

Being tested
Bevacizumab, Cisplatin, Docetaxel, Gemcitabine Hydrochloride, Laboratory Biomarker Analysis
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • BevacizumabBiological

    Also called ABP 215, ABP-215, ABP215, Alymsys

    Given IV

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Given IV

  • DocetaxelDrug

    Also called Docecad, RP 56976, RP-56976, RP56976

    Given IV

  • Gemcitabine HydrochlorideDrug

    Also called dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemcitabine HCI, Gemzar

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Pemetrexed DisodiumDrug

    Also called Alimta, Almita, LY231514, N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic Acid Disodium Salt

    Given IV

  • Questionnaire AdministrationOther

    Ancillary studies

  • Vinorelbine TartrateDrug

    Also called Biovelbin, Eunades, KW 2307, KW-2307

    Given IV

Study groups in NCT00324805
Study groupRoleWhat they receive
Arm I (chemotherapy)Active comparatorPatients receive one of the following. For all, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. REGIMEN 1: Vinorelbine ditartrate 30 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV over 60 minutes on day 1 REGIMEN 2: Docetaxel 75 mg/m2 IV and cisplastin 75 mg/m2 IV on day 1 REGIMEN 3: Gemcitabine hydrochloride 1200 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV on day 1 REGIMEN 4 (non-squamous histology only): Pemetrexed disodium 500mg/m2 IV and cisplatin 75 mg/m2 IV on day 1
Receives: Drug: Cisplatin; Drug: Docetaxel; Drug: Gemcitabine Hydrochloride; Other: Laboratory Biomarker Analysis; Drug: Pemetrexed Disodium; Other: Questionnaire Administration; Drug: Vinorelbine Tartrate
Arm II (chemotherapy, bevacizumab)ExperimentalPatients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year.
Receives: Biological: Bevacizumab; Drug: Cisplatin; Drug: Docetaxel; Drug: Gemcitabine Hydrochloride; Other: Laboratory Biomarker Analysis; Drug: Pemetrexed Disodium; Other: Questionnaire Administration; Drug: Vinorelbine Tartrate

What is being measured

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

  1. Overall Survival

    Overall survival (OS) was defined as the time from randomization to death from any cause, and patients who were thought to be alive at the time of final analysis were censored at the last date of contact. The study failed to meet its primary endpoint.

    Measured: From registration to death, up to 10 years

Secondary outcomes (1)

  1. Disease-free Survival

    Disease-free survival (DFS) was defined as the time from randomization to an event. Events include disease recurrence, new primary of lung cancer, second primaries or death, whichever occurred first; however, it should be noted that patients with new primaries at other non-lung sites should have continued followup for recurrence of the original cancer. Patients that have not had an event reported at analysis were censored at their last date of disease assessment.

    Measured: From registration to death, up to 10 years

Timeline

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

  1. First posted11 May 2006 (estimated)
  2. Study start19 Jul 2007
  3. Primary completion20 Oct 2015
  4. Study completion31 Jan 2025

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
None (open label)
Enrolment
1,501 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00324805
Sponsor's protocol ID
NCI-2009-00509
Other IDs
NCI-2009-00509, 09-0404, E1505, CDR0000475774, ECOG-E1505, E1505, E1505, U10CA180820
Status last verified
May 2026
First submitted
10 May 2006
Last updated
23 Jun 2026
Data monitoring committee
Yes

Publications

  • Wang Y, Sun Z, Sridhar A, Ramalingam SS, Wakelee HA, Gerber DE. Participation in lung cancer biospecimen studies: an analysis of the ECOG-ACRIN phase 3 E1505 and E5508 clinical trials. Lung Cancer. 2026 Apr;214:109304. doi: 10.1016/j.lungcan.2026.109304. Epub 2026 Feb 7.

    PubMed 41666849

  • Wakelee HA, Dahlberg SE, Keller SM, Tester WJ, Gandara DR, Graziano SL, Adjei AA, Leighl NB, Aisner SC, Rothman JM, Patel JD, Sborov MD, McDermott SR, Perez-Soler R, Traynor AM, Butts C, Evans T, Shafqat A, Chapman AE, Kasbari SS, Horn L, Ramalingam SS, Schiller JH; ECOG-ACRIN. Adjuvant chemotherapy with or without bevacizumab in patients with resected non-small-cell lung cancer (E1505): an open-label, multicentre, randomised, phase 3 trial. Lancet Oncol. 2017 Dec;18(12):1610-1623. doi: 10.1016/S1470-2045(17)30691-5. Epub 2017 Nov 9.

    PubMed 29129443

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bevacizumab, Cisplatin and Docetaxel in people with Stage IB Lung Non-Small Cell Carcinoma AJCC v7 and Stage IIA Lung Non-Small Cell Carcinoma AJCC v7, run by National Cancer Institute (NCI) at 1,169 sites in 5 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 35 inclusion and 0 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 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1,169 sites in United States, Canada, Ireland, Peru, South Africa. 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. 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 14 Feb 2018). 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?

Overall Survival (time frame: From registration to death, up to 10 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 NCT00324805, which also lists 2 linked publications.

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 23 Jun 2026.

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