Advanced Lung Non-Squamous Non-Small Cell CarcinomaPhase 3NCT04181060
Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer
A Phase 3 study testing Bevacizumab, Biospecimen Collection and Computed Tomography in people with Advanced Lung Non-Squamous Non-Small Cell Carcinoma and Metastatic Lung Non-Squamous Non-Small Cell Carcinoma, run by National Cancer Institute (NCI) at 604 sites in United States.
Trial summary
This phase III trial compares the effect of bevacizumab and osimertinib combination vs. osimertinib alone for the treatment of non-small cell lung cancer that has spread outside of the lungs (stage IIIB-IV) and has a change (mutation) in a gene called EGFR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Lung Non-Squamous Non-Small Cell Carcinoma, Metastatic Lung Non-Squamous Non-Small Cell Carcinoma, Recurrent Lung Non-Squamous Non-Small Cell Carcinoma
- What is being tested?
- Bevacizumab, Biospecimen Collection and Computed Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 604 sitesUnited States
- Study dates
- 28 Dec 2020to 30 Jun 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Patient must have a pathologically-confirmed diagnosis of non-squamous, non-small cell lung cancer (NSCLC)
- Patient must have advanced disease, defined as - either stage IV disease, stage IIIB disease not amenable to definitive multi-modality therapy, or recurrent disease after a prior diagnosis of stage I-III disease. All staging is via the American Joint Committee on Cancer (AJCC)/International Association for the Study of Lung Cancer (IASLC) 8th edition staging criteria
- Patient must have somatic activating sensitizing mutation in EGFR (e.g. but not limited to Exon 19 deletion, L858R, E709X, G719X, exon 19 insertions, L861Q, S768I). Patients with non-sensitizing mutations in EGFR (EGFR exon 20 insertions) are not eligible. Test results originating from a Clinical Laboratory Improvement Act (CLIA)-certified or similarly accredited laboratory are acceptable; no specific assay is mandated. Plasma, cytology, or tumor tissue can be utilized for mutation testing
- Patient must not have received any prior treatment with an anti-VEGF agent
- NOTE: Prior treatment with an EGFR TKI is not allowed, however if a candidate for this study has already started osimertinib within 21 days prior to randomization, the exact osimertinib start date is known, and the patient had the required study baseline imaging completed prior to the osimertinib start date, the patient will be eligible
- Patients that have received prior radiation therapy are eligible. Radiation (limited field stereotactic radiation or conventional radiation) must have been completed at least one week prior to study drug initiation and more extensive field radiation (i.e., whole-brain radiotherapy [WBRT]) must have been completed at least two weeks prior to drug initiation
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- Patient must not have any risk factors for anti-VEGF administration, specifically, hemoptysis, active cardiovascular disease, uncontrolled hypertension, significant proteinuria (screening urinalysis > 300 mg/dl) and tumor invading major blood vessels
- Patient must have measurable disease. Baseline measurements of sites of disease must be obtained within 4 weeks prior to study randomization. If a potential target lesion is previously irradiated without subsequent growth and/or is radiated after the imaging from which baseline measurements are obtained, they cannot be included as target lesions, and additional target lesions are required to meet criteria for measurable disease
- Patient must not have had any prior systemic treatment for metastatic disease
- Patient must be ≥ 18 years of age
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used
- All females of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy
- A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
- Patient of childbearing potential and sexually active males must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for 2 weeks prior to the start of treatment, while on study treatment, and for
- 6 weeks after the last dose of protocol treatment for female patients on the osimertinib (AZD9291) alone arm
- 4 months after the last dose of protocol treatment for male patients on osimertinib (AZD9291) alone arm
- 6 months after the last dose of protocol treatment for all patients on osimertinib (AZD9291) plus bevacizumab combination arm
- NOTE: Female patients should also not breastfeed while on treatment and for 6 months after the last dose bevacizumab
- Leukocytes >= 3,000/mcL (obtained =< 14 days prior to randomization)
- Absolute neutrophil count >= 1,500/mcL (obtained =< 14 days prior to randomization)
- Platelets >= 100,000/mcL (obtained =< 14 days prior to randomization)
- Hemoglobin >= 9 g/dL (obtained =< 14 days prior to randomization)
- Total bilirubin and creatinine =< 1.5 x institutional upper limit of normal (ULN) (obtained =< 14 days prior to randomization)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (obtained =< 14 days prior to randomization)
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- Patients with treated brain metastases are eligible if neurologically stable without glucocorticoid therapy after the stated washout period from radiation therapy (RT) or surgery provided the metastatic lesions are non-hemorrhagic
- Patients with untreated brain metastases or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required provided the metastatic lesions are non-hemorrhagic and are neurologically stable without glucocorticoid therapy
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- Patients with known history or current symptoms of cardiac disease, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
- Patient must have the ability to understand and the willingness to sign a written informed consent document and comply with study requirements
- Patient must not have had treatment with any investigational drug within five half-lives or 3 months (whichever is greater), prior to study initiation
- Patient must not be currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of CYP3A4. For any patient currently receiving such inducers of CYP3A4, they must discontinue use prior to first dose of study treatment. All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYP3A4
- Patient must not have any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of randomization, with the exception of alopecia and grade 2 prior platinum-therapy-related neuropathy
- Patient must not have any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it challenging for the patient to participate in the study. Screening for chronic conditions is not required
- Patient must not have refractory nausea and vomiting, chronic gastrointestinal diseases, the inability to swallow the osimertinib tablets or previous significant bowel resection that would preclude adequate absorption of osimertinib
- Patient must not have a medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease
- Patient must not have a history of hypersensitivity to active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib
- Patient must not have mean resting corrected QT interval (QTc) > 470 msec obtained from 3 electrocardiograms (ECGs), using the screening clinic ECG machine derived QTc value (using Bazett's correction)
- Patient must not have any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block, third degree heart block and second-degree heart block
- Patient must not have any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, electrolyte abnormalities (including: potassium < lower limit of normal [LLN]; magnesium < LLN; calcium < LLN), congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval and cause torsades de pointes
Who cannot join
None listed.
Trial locations and contacts
604 sites in 1 country. Contact the study team or a site near you to ask about taking part.
300 sites in 1 country
United States300 sites, 155 recruiting
- Active, not recruiting
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, 96701
- Active, not recruiting
Pali Momi Medical Center
‘Aiea, Hawaii, 96701
- Active, not recruiting
Queen's Cancer Center - Pearlridge
‘Aiea, Hawaii, 96701
- Active, not recruiting
The Cancer Center of Hawaii-Pali Momi
‘Aiea, Hawaii, 96701
- Suspended
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, 98520
- Suspended
Hickman Cancer Center
Adrian, Michigan, 49221
- Recruiting
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu
Martha Mapalo
- Suspended
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, 87109
- Recruiting
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Elie G. Dib
- Suspended
OSF Saint Anthony's Health Center
Alton, Illinois, 62002
- Recruiting
Mary Greeley Medical Center
Ames, Iowa, 50010
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Recruiting
McFarland Clinic - Ames
Ames, Iowa, 50010
Site Public Contact, 515-239-4734, ksoder@mcfarlandclinic.com
Joseph J. Merchant
- Recruiting
Community Hospital of Anaconda
Anaconda, Montana, 59711
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Suspended
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508
- Suspended
Anchorage Radiation Therapy Center
Anchorage, Alaska, 99504
- Suspended
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508
- Suspended
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
- Suspended
Alaska Women's Cancer Care
Anchorage, Alaska, 99508
- Suspended
Anchorage Oncology Centre
Anchorage, Alaska, 99508
- Recruiting
Katmai Oncology Group
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Alison K. Conlin
- Suspended
Providence Alaska Medical Center
Anchorage, Alaska, 99508
- Recruiting
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, 94531
Site Public Contact, 877-642-4691, Kpoct@kp.org
Jennifer M. Suga
- Recruiting
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
Site Public Contact, 920-364-3604, ResearchDept@thedacare.org
Matthias Weiss
- Suspended
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, 93420
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Site Public Contact, 888-946-7447
Ticiana A. Leal
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Site Public Contact, 404-778-1868
Ticiana A. Leal
- Recruiting
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, 80012
Site Public Contact, 303-777-2663, info@westernstatesncorp.org
Nicholas J. DiBella
- Suspended
The Medical Center of Aurora
Aurora, Colorado, 80012
- Suspended
Rush-Copley Medical Center
Aurora, Illinois, 60504
- Recruiting
UH Seidman Cancer Center at UH Avon Health Center
Avon, Ohio, 44011
Site Public Contact, 800-641-2422
Melinda L. Hsu
- Suspended
Saint Alphonsus Cancer Care Center-Baker City
Baker City, Oregon, 97814
- Suspended
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri, 63011
- Suspended
CommonSpirit Saint Joseph Hospital - Bardstown
Bardstown, Kentucky, 40004
- Recruiting
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Site Public Contact, 212-639-7592
Helena A. Yu
- Recruiting
Houston Methodist San Jacinto Hospital
Baytown, Texas, 77521
Site Public Contact, 888-823-5923, ctsucontact@westat.com
Jun Zhang
- Recruiting
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122
Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org
Melinda L. Hsu
- Suspended
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431
- Suspended
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
- Recruiting
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714
Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Aruna C. Gowda
- Active, not recruiting
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
- Recruiting
Saint Charles Health System
Bend, Oregon, 97701
Site Public Contact, 541-706-2909, nosall@stcharleshealthcare.org
Alison K. Conlin
- Recruiting
ThedaCare Cancer Care - Berlin
Berlin, Wisconsin, 54923
Site Public Contact, 920-364-3605, ResearchDept@thedacare.org
Matthias Weiss
- Suspended
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
- Recruiting
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Elie G. Dib
- Active, not recruiting
Beverly Hospital
Beverly, Massachusetts, 01915
- Recruiting
Billings Clinic Cancer Center
Billings, Montana, 59101
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- Active, not recruiting
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
- Recruiting
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Suspended
Saint Elizabeth Boardman Hospital
Boardman, Ohio, 44512
- Recruiting
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
Elie G. Dib
- Recruiting
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Site Public Contact, 208-381-2774, eslinget@slhs.org
Alison K. Conlin
- Suspended
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613
- Suspended
McFarland Clinic - Boone
Boone, Iowa, 50036
- Suspended
Boulder Community Foothills Hospital
Boulder, Colorado, 80303
- Recruiting
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304
Site Public Contact, 303-777-2663, info@westernstatesncorp.org
Nicholas J. DiBella
- Recruiting
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Suspended
Saint Joseph Regional Cancer Center
Bryan, Texas, 77802
- Recruiting
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
Site Public Contact, 484-476-2649, turzoe@mlhs.org
Paul B. Gilman
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Site Public Contact, 800-767-9355, askroswell@roswellpark.org
Edwin H. Yau
- Suspended
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505
- Suspended
Saint Anne Hospital
Burien, Washington, 98166
- Recruiting
UCSF Cancer Center Burlingame
Burlingame, California, 94010
Site Public Contact, Niloufar.Abdollahi@ucsf.edu
Sirisha Tummala
- Active, not recruiting
Lahey Clinic
Burlington, Massachusetts, 01805
- Suspended
Fairview Ridges Hospital
Burnsville, Minnesota, 55337
- Recruiting
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
Elie G. Dib
- Suspended
Cambridge Medical Center
Cambridge, Minnesota, 55008
- Recruiting
Illinois CancerCare-Canton
Canton, Illinois, 61520
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Trinity Health Medical Center - Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Suspended
Mercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri, 63703
- Recruiting
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Site Public Contact, 573-334-2230, sfmc@sfmc.net
Bryan A. Faller
- Suspended
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902
- Suspended
Caro Cancer Center
Caro, Michigan, 48723
- Recruiting
Saint Anthony Regional Hospital
Carroll, Iowa, 51401
Site Public Contact, 515-689-7658, sbenson@iora.org
Seema Harichand-Herdt
- Suspended
SIH Cancer Institute
Carterville, Illinois, 62918
- Recruiting
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Suspended
Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado, 80112
- Suspended
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459
- Recruiting
Miami Valley Hospital South
Centerville, Ohio, 45459
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Centralia Oncology Clinic
Centralia, Illinois, 62801
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Suspended
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531
- Active, not recruiting
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317
- Suspended
Chambersburg Hospital
Chambersburg, Pennsylvania, 17201
- Recruiting
WellSpan Medical Oncology and Hematology
Chambersburg, Pennsylvania, 17201
Site Public Contact, 717-217-6020
Joseph Kannarkatt
- Active, not recruiting
Geauga Hospital
Chardon, Ohio, 44024
- Active, not recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
- Recruiting
Vandalia Health/CAMC Institute for Academic Medicine
Charleston, West Virginia, 25304
Site Public Contact, 304-388-9944, CAMCClinicalTrials@vandaliahealth.org
Ahmed A. Khalid
- Recruiting
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204
Site Public Contact, 980-201-6360, kashah@novanthealth.org
Alfred J. Newman
- Recruiting
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
Site Public Contact, 434-243-6303, uvacancertrials@hscmail.mcc.virginia.edu
Richard D. Hall
- Recruiting
Chelsea Hospital
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Saint Luke's Hospital
Chesterfield, Missouri, 63017
Site Public Contact, 314-205-6936
Meera Rana
- Suspended
Cheyenne Regional Medical Center-West
Cheyenne, Wyoming, 82001
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Site Public Contact, 312-695-1301, cancer@northwestern.edu
Nisha A. Mohindra
- Active, not recruiting
Jesse Brown Veterans Affairs Medical Center
Chicago, Illinois, 60612
- Recruiting
University of Illinois
Chicago, Illinois, 60612
Site Public Contact, 312-355-3046
Frank Weinberg
- Suspended
Swedish Covenant Hospital
Chicago, Illinois, 60625
- Recruiting
Adena Regional Medical Center
Chillicothe, Ohio, 45601
Site Public Contact, 877-779-7585, Jeffh@columbusccop.org
Aruna C. Gowda
- Recruiting
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219
Site Public Contact, 513-584-7698, cancer@uchealth.com
Kerri McGovern
- Suspended
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
- Suspended
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236
- Suspended
Bethesda North Hospital
Cincinnati, Ohio, 45242
- Suspended
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, 45247
- Suspended
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio, 45255
- Suspended
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
- Suspended
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015
- Recruiting
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan, 48346
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Suspended
Newland Medical Associates-Clarkston
Clarkston, Michigan, 48346
- Recruiting
Case Western Reserve University
Cleveland, Ohio, 44106
Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org
Melinda L. Hsu
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Site Public Contact, 866-223-8100, TaussigResearch@ccf.org
Khaled A. Hassan
- Recruiting
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, 28328
Site Public Contact, 919-587-9084, jfields@cancersmoc.com
Samer S. Kasbari
- Suspended
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325
- Recruiting
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Suspended
Billings Clinic-Cody
Cody, Wyoming, 82414
- Recruiting
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Suspended
Main Line Health Center-Collegeville
Collegeville, Pennsylvania, 19426
- Recruiting
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, 38017
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Philip E. Lammers
- Suspended
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907
- Suspended
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907
- Recruiting
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, 39705
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Philip E. Lammers
- Suspended
Mount Carmel East Hospital
Columbus, Ohio, 43213
- Recruiting
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, 43214
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Shakir Sarwar
- Suspended
Riverside Methodist Hospital
Columbus, Ohio, 43214
- Recruiting
Grant Medical Center
Columbus, Ohio, 43215
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Shakir Sarwar
- Recruiting
The Mark H Zangmeister Center
Columbus, Ohio, 43219
Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Aruna C. Gowda
- Suspended
Mount Carmel Health Center West
Columbus, Ohio, 43222
- Recruiting
Doctors Hospital
Columbus, Ohio, 43228
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Shakir Sarwar
- Recruiting
Memorial Sloan Kettering Commack
Commack, New York, 11725
Site Public Contact, 212-639-7592
Helena A. Yu
- Recruiting
Mercy Hospital
Coon Rapids, Minnesota, 55433
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Suspended
Bay Area Hospital
Coos Bay, Oregon, 97420
- Suspended
Commonwealth Cancer Center-Corbin
Corbin, Kentucky, 40701
- Suspended
Alegent Health Mercy Hospital
Council Bluffs, Iowa, 51503
- Active, not recruiting
Greater Regional Medical Center
Creston, Iowa, 50801
- Recruiting
Northwest Cancer Center - Crown Point
Crown Point, Indiana, 46307
Site Public Contact, 219-836-6879, CancerResearch@powershealth.org
Vamsi K. Vasireddy
- Recruiting
Houston Methodist Cypress Hospital
Cypress, Texas, 77429
Site Public Contact, 346-356-1413, irb@houstonmethodist.org
Jun Zhang
- Recruiting
Parkland Memorial Hospital
Dallas, Texas, 75235
Site Public Contact, 214-590-5582, canceranswerline@UTSouthwestern.edu
Sheena Bhalla
- Recruiting
UT Southwestern Simmons Cancer Center - RedBird
Dallas, Texas, 75237
Site Public Contact, 214-648-7097, canceranswerline@utsouthwestern.edu
Sheena Bhalla
- Recruiting
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu
Sheena Bhalla
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
Site Public Contact, 800-446-5532, Research@Carle.com
Vamsi K. Vasireddy
- Recruiting
Miami Valley Hospital
Dayton, Ohio, 45409
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Premier Blood and Cancer Center
Dayton, Ohio, 45409
Site Public Contact, 937-276-8320
Tarek M. Sabagh
- Suspended
Dayton Physician LLC - Englewood
Dayton, Ohio, 45415
- Recruiting
Miami Valley Hospital North
Dayton, Ohio, 45415
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Corewell Health Dearborn Hospital
Dearborn, Michigan, 48124
Site Public Contact, 248-551-7695
Andrew A. Muskovitz
- Recruiting
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Suspended
Decatur Memorial Hospital
Decatur, Illinois, 62526
- Recruiting
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Nisha A. Mohindra
- Recruiting
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Shakir Sarwar
- Suspended
Grady Memorial Hospital
Delaware, Ohio, 43015
- Recruiting
Kaiser Permanente-Franklin
Denver, Colorado, 80205
Site Public Contact, 303-817-9295, KPCOIHRClinicalResearch@kp.org
Matthew J. Eadens
- Suspended
The Women's Imaging Center
Denver, Colorado, 80209
- Suspended
AdventHealth Porter
Denver, Colorado, 80210
- Suspended
Colorado Blood Cancer Institute
Denver, Colorado, 80218
- Suspended
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218
- Suspended
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, 80218
- Suspended
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, 80220
- Active, not recruiting
Rose Medical Center
Denver, Colorado, 80220
- Suspended
Western Surgical Care
Denver, Colorado, 80220
- Recruiting
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, 06418
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Sarah B. Goldberg
- Recruiting
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Site Public Contact, 515-241-6727
Seema Harichand-Herdt
- Recruiting
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Broadlawns Medical Center
Des Moines, Iowa, 50314
Site Public Contact, 515-282-2200
Seema Harichand-Herdt
- Suspended
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
- Recruiting
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Suspended
Iowa Lutheran Hospital
Des Moines, Iowa, 50316
- Recruiting
Henry Ford Health Saint John Hospital
Detroit, Michigan, 48236
Site Public Contact, 313-343-3166, Kkeenan1@hfhs.org
Elie G. Dib
- Recruiting
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
Site Public Contact, 815-285-7800
Bryan A. Faller
- Recruiting
Kaiser Permanente Dublin
Dublin, California, 94568
Site Public Contact, 877-642-4691
Jennifer M. Suga
- Suspended
Dublin Methodist Hospital
Dublin, Ohio, 43016
- Suspended
CommonSpirit Cancer Center Mercy
Durango, Colorado, 81301
- Suspended
Mercy Medical Center
Durango, Colorado, 81301
- Recruiting
Northwest Oncology LLC
Dyer, Indiana, 46311
Site Public Contact, 219-924-8178
Vamsi K. Vasireddy
- Recruiting
Henry Ford River District Hospital
East China Township, Michigan, 48054
Site Public Contact, 313-343-3166, kforman1@hfhs.org
Elie G. Dib
- Recruiting
The Cancer Institute at Saint Francis Hospital
East Hills, New York, 11548
Site Public Contact, 516-325-7514, Stephanie.Solito@chsli.org
Bhoomi Mehrotra
- Suspended
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301
- Recruiting
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Kareem H. Abdelhadi
- Recruiting
Fairview Southdale Hospital
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Minnesota Oncology - Edina
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Suspended
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
- Recruiting
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Site Public Contact, 800-446-5532, Research@carle.com
Vamsi K. Vasireddy
- Recruiting
Crossroads Cancer Center
Effingham, Illinois, 62401
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Suspended
Walter Knox Memorial Hospital
Emmett, Idaho, 83617
- Suspended
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado, 80113
- Recruiting
Rocky Mountain Cancer Centers - Swedish
Englewood, Colorado, 80113
Site Public Contact, 303-777-2663, info@westernstatesncorp.org
Nicholas J. DiBella
- Suspended
Swedish Medical Center
Englewood, Colorado, 80113
- Suspended
The Melanoma and Skin Cancer Institute
Englewood, Colorado, 80113
- Recruiting
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631
Site Public Contact, 201-894-3456
Lewis M. Attas
- Suspended
Saint Elizabeth Hospital
Enumclaw, Washington, 98022
- Recruiting
Ephrata Cancer Center
Ephrata, Pennsylvania, 17522
Site Public Contact, 717-721-4840
Joseph Kannarkatt
- Recruiting
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Suspended
Providence Regional Cancer Partnership
Everett, Washington, 98201
- Suspended
Main Line Health Center-Exton
Exton, Pennsylvania, 19341
- Recruiting
Fairbanks Memorial Hospital
Fairbanks, Alaska, 99701
Site Public Contact, 907-458-3043, Veronica.Stevenson@foundationhealth.org
John M. Schallenkamp
- Recruiting
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, 06824
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Sarah B. Goldberg
- Active, not recruiting
Sanford South University Medical Center
Fargo, North Dakota, 58103
- Active, not recruiting
Southpointe-Sanford Medical Center Fargo
Fargo, North Dakota, 58103
- Active, not recruiting
Sanford Medical Center Fargo
Fargo, North Dakota, 58104
- Active, not recruiting
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
- Active, not recruiting
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
- Recruiting
Parkland Health Center - Farmington
Farmington, Missouri, 63640
Site Public Contact, 314-996-5569
Bryan A. Faller
- Suspended
Saint Francis Hospital
Federal Way, Washington, 98003
- Suspended
Armes Family Cancer Center
Findlay, Ohio, 45840
- Suspended
Blanchard Valley Hospital
Findlay, Ohio, 45840
- Suspended
Orion Cancer Care
Findlay, Ohio, 45840
- Recruiting
Cancer Hematology Centers - Flint
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Elie G. Dib
- Suspended
Genesee Hematology Oncology PC
Flint, Michigan, 48503
- Recruiting
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Elie G. Dib
- Recruiting
Hurley Medical Center
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Elie G. Dib
- Recruiting
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Recruiting
UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge, Iowa, 50501
Site Public Contact, 515-282-2921, trials@missioncancer.com
Seema Harichand-Herdt
- Recruiting
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Site Public Contact, eileen.georgi@holy-cross.com
Elie G. Dib
- Suspended
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
- Recruiting
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas, 76104
Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu
Sheena Bhalla
- Recruiting
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Dayton Physicians LLC-Atrium
Franklin, Ohio, 45005
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Kaiser Permanente-Fremont
Fremont, California, 94538
Site Public Contact, 877-642-4691, Kpoct@kp.org
Jennifer M. Suga
- Recruiting
Washington Health
Fremont, California, 94538
Site Public Contact, 510-248-1600
Bogdan S. Eftimie
- Recruiting
Kaiser Permanente Fresno Orchard Plaza
Fresno, California, 93720
Site Public Contact, 833-574-2273
Jennifer M. Suga
- Recruiting
Kaiser Permanente-Fresno
Fresno, California, 93720
Site Public Contact, 877-642-4691, Kpoct@kp.org
Jennifer M. Suga
- Active, not recruiting
Unity Hospital
Fridley, Minnesota, 55432
- Recruiting
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
Site Public Contact, 208-381-2774, eslinget@slhs.org
Alison K. Conlin
- Suspended
Central Ohio Breast and Endocrine Surgery
Gahanna, Ohio, 43230
- Recruiting
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Suspended
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401
- Suspended
Central Care Cancer Center - Garden City
Garden City, Kansas, 67846
- Recruiting
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Nisha A. Mohindra
- Recruiting
Adams Cancer Center
Gettysburg, Pennsylvania, 17325
Site Public Contact, 877-441-7957
Joseph Kannarkatt
- Suspended
Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut, 06033
- Recruiting
Glens Falls Hospital
Glens Falls, New York, 12801
Site Public Contact, 518-926-6700
Aqeel A. Gillani
- Recruiting
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, 60026
Site Public Contact, 312-695-1102
Nisha A. Mohindra
- Active, not recruiting
Addison Gilbert Hospital
Gloucester, Massachusetts, 01930
- Recruiting
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, 27534
Site Public Contact, 919-587-9084, jfields@cancersmoc.com
Samer S. Kasbari
- Suspended
Nebraska Cancer Specialists/Oncology Hematology West PC
Grand Island, Nebraska, 68803
- Recruiting
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, 60030
Site Public Contact, 312-695-1102
Nisha A. Mohindra
- Suspended
Central Care Cancer Center - Great Bend
Great Bend, Kansas, 67530
- Recruiting
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Suspended
Great Falls Clinic
Great Falls, Montana, 59405
- Suspended
Banner North Colorado Medical Center
Greeley, Colorado, 80631
- Suspended
Dayton Physicians LLC-Wayne
Greenville, Ohio, 45331
- Recruiting
Miami Valley Cancer Care and Infusion
Greenville, Ohio, 45331
Site Public Contact, 937-569-7515
Tarek M. Sabagh
- Suspended
Wayne Hospital
Greenville, Ohio, 45331
- Recruiting
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, 06830
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Sarah B. Goldberg
- Recruiting
Baptist Cancer Center-Grenada
Grenada, Mississippi, 38901
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Philip E. Lammers
- Recruiting
Henry Ford Saint John Hospital - Academic
Grosse Pointe Woods, Michigan, 48236
Site Public Contact, 313-343-3166, kforman1@hfhs.org
Elie G. Dib
- Suspended
Henry Ford Saint John Hospital - Breast
Grosse Pointe Woods, Michigan, 48236
- Recruiting
Henry Ford Saint John Hospital - Van Elslander
Grosse Pointe Woods, Michigan, 48236
Site Public Contact, 313-343-3166, kforman1@hfhs.org
Elie G. Dib
- Suspended
Mount Carmel Grove City Hospital
Grove City, Ohio, 43123
- Recruiting
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, 06437
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Sarah B. Goldberg
- Recruiting
WellSpan Medical Oncology and Hematology
Hanover, Pennsylvania, 17331
Site Public Contact, 717-632-1559
Joseph Kannarkatt
- Recruiting
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Site Public Contact, 212-639-7592
Helena A. Yu
- Recruiting
Hartford Hospital
Hartford, Connecticut, 06102
Site Public Contact, 860-545-5363
Todd J. Alekshun
- Suspended
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105
- Recruiting
Ingalls Memorial Hospital
Harvey, Illinois, 60426
Site Public Contact, 708-915-4673, clinicaltrials@ingalls.org
James A. Wallace
- Suspended
Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania, 18201
- Recruiting
Northwest Cancer Center - Hobart
Hobart, Indiana, 46342
Site Public Contact, 219-947-1795
Vamsi K. Vasireddy
- Recruiting
Saint Mary Medical Center
Hobart, Indiana, 46342
Site Public Contact, 219-836-6875, CancerResearch@COMHS.org
Vamsi K. Vasireddy
- Active, not recruiting
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813
- Active, not recruiting
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii, 96813
- Active, not recruiting
Queen's Medical Center
Honolulu, Hawaii, 96813
- Active, not recruiting
Straub Clinic and Hospital
Honolulu, Hawaii, 96813
- Active, not recruiting
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
- Active, not recruiting
Kuakini Medical Center
Honolulu, Hawaii, 96817
- Active, not recruiting
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, 96817
- Active, not recruiting
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, 96817
- Recruiting
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819
Site Public Contact, 808-432-5195, shelley.a.clark@kp.org
Jennifer M. Suga
- Active, not recruiting
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
- Suspended
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas, 71913
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Site Public Contact, 713-790-2700
Jun Zhang
- Recruiting
Methodist Willowbrook Hospital
Houston, Texas, 77070
Site Public Contact, 888-823-5923, ctsucontact@westat.com
Jun Zhang
- Recruiting
Houston Methodist West Hospital
Houston, Texas, 77094
Site Public Contact, 832-522-2873
Jun Zhang
- Recruiting
Novant Health Cancer Institute - Huntersville
Huntersville, North Carolina, 28078
Site Public Contact, 980-201-6360, kashah@novanthealth.org
Alfred J. Newman
- Recruiting
Saint Catherine Hospital
Indianapolis, Indiana, 46312
Site Public Contact, ecog.rss@jimmy.harvard.edu
Vamsi K. Vasireddy
- Suspended
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
- Recruiting
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, 28546
Site Public Contact, 910-587-9084, jfields@cancersmoc.com
Samer S. Kasbari
- Recruiting
Mercyhealth Hospital and Cancer Center - Janesville
Janesville, Wisconsin, 53548
Site Public Contact, 608-756-6871, oncologyclinicaltrials@mhemail.org
Emily G. Robinson
- Suspended
McFarland Clinic - Jefferson
Jefferson, Iowa, 50129
- Suspended
MU Health Care Goldschmidt Cancer Center
Jefferson City, Missouri, 65109
- Recruiting
Jersey City Medical Center
Jersey City, New Jersey, 07302
Site Public Contact, ecog.rss@jimmy.harvard.edu
Missak Haigentz
- Recruiting
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, 72401
Site Public Contact, 870-936-7066, Emily.Carvell@bmhcc.org
Philip E. Lammers
- Suspended
Freeman Health System
Joplin, Missouri, 64804
- Suspended
Mercy Hospital Joplin
Joplin, Missouri, 64804
- Recruiting
Logan Health Medical Center
Kalispell, Montana, 59901
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Suspended
CHI Health Good Samaritan
Kearney, Nebraska, 68847
- Suspended
ECU Health Oncology Kenansville
Kenansville, North Carolina, 28349
- Recruiting
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336
Site Public Contact, 509-783-4637, research@kadlecmed.org
Alison K. Conlin
- Recruiting
Novant Health Cancer Institute - Kernersville
Kernersville, North Carolina, 27284
Site Public Contact, 336-718-8335, asmarrs@novanthealth.org
Garrett B. Sherwood
- Suspended
Greater Dayton Cancer Center
Kettering, Ohio, 45409
- Suspended
Kettering Medical Center
Kettering, Ohio, 45429
- Recruiting
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Suspended
ECU Health Oncology Kinston
Kinston, North Carolina, 28501
- Recruiting
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
Site Public Contact, 608-775-2385, cancerctr@gundersenhealth.org
Kurt Oettel
- Withdrawn
UC San Diego Moores Cancer Center
La Jolla, California, 92093
- Suspended
Providence Regional Cancer System-Lacey
Lacey, Washington, 98503
- Recruiting
Kaiser Permanente-Rock Creek
Lafayette, Colorado, 80026
Site Public Contact, 303-817-9295, KPCOIHRClinicalResearch@kp.org
Matthew J. Eadens
- Recruiting
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045
Site Public Contact, cancertrials@northwestern.edu
Nisha A. Mohindra
About this study
Official title: Randomized Phase III Study of Combination Osimertinib (AZD9291) and Bevacizumab Versus Osimertinib (AZD9291) Alone as First-Line Treatment for Patients With Metastatic EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC)
This phase III trial compares the effect of bevacizumab and osimertinib combination vs. osimertinib alone for the treatment of non-small cell lung cancer that has spread outside of the lungs (stage IIIB-IV) and has a change (mutation) in a gene called EGFR. The EGFR protein is involved in cell signaling pathways that control cell division and survival. Sometimes, mutations in the EGFR gene cause EGFR proteins to be made in higher than normal amounts on some types of cancer cells. This causes cancer cells to divide more rapidly. Osimertinib may stop the growth of tumor cells by blocking EGFR that is needed for cell growth in this type of cancer. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving osimertinib with bevacizumab may control cancer for longer and help patients live longer as compared to osimertinib alone.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate progression-free survival (PFS) of osimertinib (AZD9291) and bevacizumab versus osimertinib (AZD9291) alone as first-line treatment for patients with metastatic EGFR-mutant lung cancers.
SECONDARY OBJECTIVES:
- To evaluate overall survival (OS). II. To evaluate best objective response rate and duration of objective response.
III. To evaluate time to central nervous system (CNS) progression and CNS PFS. IV. To evaluate toxicity of the combination regimen.
CORRELATIVE OBJECTIVES:
- To characterize mechanisms of resistance to osimertinib (AZD9291) and osimertinib (AZD9291) with bevacizumab first-line therapy through post-progression circulating tumor-derived deoxyribonucleic acid (ctDNA).
II. To assess for ctDNA clearance on study treatment and associate ctDNA clearance with clinical outcomes.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive osimertinib orally (PO) once daily (QD) on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive osimertinib PO QD on days 1-21 and bevacizumab intravenously (IV) over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients undergo echocardiography (ECHO), multigated acquisition scan (MUGA), computed tomography (CT) and may undergo magnetic resonance imaging (MRI) and blood and urine sample collection on study.
After completion of study treatment, patients are followed up every 3 months for 10 years.
- Conditions
- Advanced Lung Non-Squamous Non-Small Cell Carcinoma, Metastatic Lung Non-Squamous Non-Small Cell Carcinoma, Recurrent Lung Non-Squamous Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8
- Being tested
- Bevacizumab, Biospecimen Collection, Computed Tomography, Echocardiography Test, Magnetic Resonance Imaging
- Medical subject headings
- Lung Neoplasms
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
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo blood and urine sample collection
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
Echocardiography TestProcedure or surgery
Also called EC, Echocardiography
Undergo ECHO
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
Multigated Acquisition ScanProcedure or surgery
Also called Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan
Undergo MUGA
OsimertinibDrug
Also called AZD 9291, AZD-9291, AZD9291, Mereletinib
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm A (osimertinib) | Active comparator | Patients receive osimertinib PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO, MUGA, CT and may undergo MRI and blood and urine sample collection on study. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Echocardiography Test; Procedure: Magnetic Resonance Imaging; Procedure: Multigated Acquisition Scan; Drug: Osimertinib |
| Arm B (osimertinib, bevacizumab) | Experimental | Patients receive osimertinib PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO, MUGA, CT and may undergo MRI and blood and urine sample collection on study. Receives: Biological: Bevacizumab; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Echocardiography Test; Procedure: Magnetic Resonance Imaging; Procedure: Multigated Acquisition Scan; Drug: Osimertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Will be estimated using the Kaplan-Meier method, and Cox proportional hazards models will be used to estimate the treatment hazard ratios. PFS will use a logrank test stratified on the randomization stratification factors with a one-sided type I error rate of 2.5%.
Measured: From randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or death from any cause, whichever occurs first, assessed up to 10 years
Secondary outcomes (5)
Overall survival (OS)
Will be estimated using the Kaplan-Meier method, and Cox proportional hazards models will be used to estimate the treatment hazard ratios. OS will be tested at the one-sided 10% level.
Measured: From randomization to death from any cause, assessed up to 10 years
Best objective response rate
Best objective response will be evaluated via RECIST 1.1 criteria. Will be compared using Fisher's exact tests with a one-sided type I error rate of 2.5%; multivariable logistic regression modeling will be used to adjust for the effect of any covariates that are associated with these categorical outcomes.
Measured: Up to 10 years
Time to central nervous system progression
Will be estimated using competing risks methodology, adjusting for death and progression as competing events. Regular central nervous system imaging will occur when patients are on treatment. After they discontinue study treatment, central nervous system imaging will be symptom-prompted during follow up.
Measured: From study randomization to evidence of central nervous system progressive disease, with death and progression as competing events, assessed up to 10 years
Central nervous system progression-free survival
Will be estimated using the Kaplan-Meier method.
Measured: From study randomization to evidence of central nervous system progressive disease or death from any cause, whichever occurs first, assessed up to 10 years
Incidence of adverse events
Toxicity will be determined using the Common Terminology Criteria for Adverse Events (CTCAE). Will be compared using Fisher's exact tests with a one-sided type I error rate of 2.5%; multivariable logistic regression modeling will be used to adjust for the effect of any covariates that are associated with these categorical outcomes.
Measured: Up to 30 days after the last administration of investigational agent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start28 Dec 2020
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Lung Non-Squamous Non-Small Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Helena A Yu, Principal investigator, ECOG-ACRIN Cancer Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181060
- Sponsor's protocol ID
- NCI-2019-07941
- Other IDs
- NCI-2019-07941, EA5182, EA5182, U10CA180820
- Status last verified
- Sep 2026
- First submitted
- 27 Nov 2019
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase III Study of Combination Osimertinib (AZD9291) and Bevacizumab Versus Osimertinib (AZD9291) Alone as First-Line Treatment for Patients With Metastatic EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT04181060
- Acronym / sponsor ID
- NCI-2019-07941
- Conditions
- Advanced Lung Non-Squamous Non-Small Cell Carcinoma, Metastatic Lung Non-Squamous Non-Small Cell Carcinoma, Recurrent Lung Non-Squamous Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 28 Dec 2020 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 29 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase III trial compares the effect of bevacizumab and osimertinib combination vs. osimertinib alone for the treatment of non-small cell lung cancer that has spread outside of the lungs (stage IIIB-IV) and has a change (mutation) in a gene called EGFR. The EGFR protein is involved in cell signaling pathways that control cell division and survival. Sometimes, mutations in the EGFR gene cause EGFR proteins to be made in higher than normal amounts on some types of cancer cells. This causes cancer cells to divide more rapidly. Osimertinib may stop the growth of tumor cells by blocking EGFR that is needed for cell growth in this type of cancer. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving osimertinib with bevacizumab may control cancer for longer and help patients live longer as compared to osimertinib alone.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate progression-free survival (PFS) of osimertinib (AZD9291) and bevacizumab versus osimertinib (AZD9291) alone as first-line treatment for patients with metastatic EGFR-mutant lung cancers.
SECONDARY OBJECTIVES:
- To evaluate overall survival (OS). II. To evaluate best objective response rate and duration of objective response.
III. To evaluate time to central nervous system (CNS) progression and CNS PFS. IV. To evaluate toxicity of the combination regimen.
CORRELATIVE OBJECTIVES:
- To characterize mechanisms of resistance to osimertinib (AZD9291) and osimertinib (AZD9291) with bevacizumab first-line therapy through post-progression circulating tumor-derived deoxyribonucleic acid (ctDNA).
II. To assess for ctDNA clearance on study treatment and associate ctDNA clearance with clinical outcomes.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive osimertinib orally (PO) once daily (QD) on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive osimertinib PO QD on days 1-21 and bevacizumab intravenously (IV) over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients undergo echocardiography (ECHO), multigated acquisition scan (MUGA), computed tomography (CT) and may undergo magnetic resonance imaging (MRI) and blood and urine sample collection on study.
After completion of study treatment, patients are followed up every 3 months for 10 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (osimertinib) | Active comparator | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Procedure: Echocardiography Test, Procedure: Magnetic Resonance Imaging, Procedure: Multigated Acquisition Scan, Drug: OsimertinibPatients receive osimertinib PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO, MUGA, CT and may undergo MRI and blood and urine sample collection on study. |
| Arm B (osimertinib, bevacizumab) | Experimental | Biological: Bevacizumab, Procedure: Biospecimen Collection, Procedure: Computed Tomography, Procedure: Echocardiography Test, Procedure: Magnetic Resonance Imaging, Procedure: Multigated Acquisition Scan, Drug: OsimertinibPatients receive osimertinib PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO, MUGA, CT and may undergo MRI and blood and urine sample collection on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (43 listed)
- Patient must have a pathologically-confirmed diagnosis of non-squamous, non-small cell lung cancer (NSCLC)
- Patient must have advanced disease, defined as - either stage IV disease, stage IIIB disease not amenable to definitive multi-modality therapy, or recurrent disease after a prior diagnosis of stage I-III disease. All staging is via the American Joint Committee on Cancer (AJCC)/International Association for the Study of Lung Cancer (IASLC) 8th edition staging criteria
- Patient must have somatic activating sensitizing mutation in EGFR (e.g. but not limited to Exon 19 deletion, L858R, E709X, G719X, exon 19 insertions, L861Q, S768I). Patients with non-sensitizing mutations in EGFR (EGFR exon 20 insertions) are not eligible. Test results originating from a Clinical Laboratory Improvement Act (CLIA)-certified or similarly accredited laboratory are acceptable; no specific assay is mandated. Plasma, cytology, or tumor tissue can be utilized for mutation testing
- Patient must not have received any prior treatment with an anti-VEGF agent
- Patients that have received prior radiation therapy are eligible. Radiation (limited field stereotactic radiation or conventional radiation) must have been completed at least one week prior to study drug initiation and more extensive field radiation (i.e., whole-brain radiotherapy [WBRT]) must have been completed at least two weeks prior to drug initiation
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabAlso: ABP 215, ABP-215, ABP215, AlymsysGiven IV | Biological | Arm B (osimertinib, bevacizumab) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen CollectionUndergo blood and urine sample collection | Procedure or surgery | Arm A (osimertinib), Arm B (osimertinib, bevacizumab) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT | Procedure or surgery | Arm A (osimertinib), Arm B (osimertinib, bevacizumab) |
| Echocardiography TestAlso: EC, EchocardiographyUndergo ECHO | Procedure or surgery | Arm A (osimertinib), Arm B (osimertinib, bevacizumab) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo MRI | Procedure or surgery | Arm A (osimertinib), Arm B (osimertinib, bevacizumab) |
| Multigated Acquisition ScanAlso: Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool ScanUndergo MUGA | Procedure or surgery | Arm A (osimertinib), Arm B (osimertinib, bevacizumab) |
| OsimertinibAlso: AZD 9291, AZD-9291, AZD9291, MereletinibGiven PO | Drug | Arm A (osimertinib), Arm B (osimertinib, bevacizumab) |
Primary outcome
Progression-free survival (PFS)
Time frame: From randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or death from any cause, whichever occurs first, assessed up to 10 years
Will be estimated using the Kaplan-Meier method, and Cox proportional hazards models will be used to estimate the treatment hazard ratios. PFS will use a logrank test stratified on the randomization stratification factors with a one-sided type I error rate of 2.5%.
5 secondary outcomes
Overall survival (OS)
Time frame: From randomization to death from any cause, assessed up to 10 years
Best objective response rate
Time frame: Up to 10 years
Time to central nervous system progression
Time frame: From study randomization to evidence of central nervous system progressive disease, with death and progression as competing events, assessed up to 10 years
Central nervous system progression-free survival
Time frame: From study randomization to evidence of central nervous system progressive disease or death from any cause, whichever occurs first, assessed up to 10 years
Incidence of adverse events
Time frame: Up to 30 days after the last administration of investigational agent
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Yes. NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katmai Oncology Group
Anchorage, United States
Fairbanks Memorial Hospital
Fairbanks, United States
Cancer Center at Saint Joseph's
Phoenix, United States
Helena A Yu principal investigator
ECOG-ACRIN Cancer Research Group
604 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bevacizumab, Biospecimen Collection and Computed Tomography in people with Advanced Lung Non-Squamous Non-Small Cell Carcinoma and Metastatic Lung Non-Squamous Non-Small Cell Carcinoma, run by National Cancer Institute (NCI) at 604 sites in United States.
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 43 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 604 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: From randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or death from any cause, whichever occurs first, assessed up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2026.