AzTrials
AzTrials

Advanced Lung Non-Small Cell CarcinomaPhase 2NCT03191149

Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change

A Phase 2 study testing Biospecimen Collection, Computed Tomography with Contrast and Echocardiography Test in people with Advanced Lung Non-Small Cell Carcinoma and Recurrent Lung Non-Small Cell Carcinoma, run by National Cancer Institute (NCI) at 347 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This phase II trial studies how well osimertinib works in treating patients with non-small cell lung cancer with EGFR exon 20 insertion mutation that is stage IIIB-IV or has come back after a period of improvement (recurrent). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Computed Tomography with Contrast and Echocardiography Test
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
347 sitesUnited States
Study dates
25 Apr 2018to 30 Jun 2027
Phase
Phase 2
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

  • Participants must have a pathologically-confirmed diagnosis of non-small cell lung cancer (NSCLC)
  • Participants must have advanced disease - 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) 7th edition staging criteria
  • An EGFR exon 20 insertion mutation must be detected in the tumor tissue. Patients may be enrolled in the study based on an exon 20 insertion EGFR mutation detected by any Clinical Laboratory Improvement Act (CLIA)-certified tissue assay
  • NOTE: Testing results are to be submitted via Medidata Rave and the study chair or delegate will review the reports
  • Patients must have measurable disease; baseline measurements and ALL sites of disease must be obtained within 4 weeks to registration
  • Patients must have previously received at least one line of therapy for their advanced lung cancer; there are no restrictions on the maximum number of prior therapies allowed
Show all 43Show fewer
  • Participants must not have previously received osimertinib
  • Participants must have not previously received therapies targeting PDL1, PD1 or CTLA4 within 6 months (180 days) prior to registration
  • Age >= 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 1
  • Hemoglobin >= 9.0 g/L (within 4 weeks before registration)
  • Leukocytes/white blood cells >= 3,000/mcL (within 4 weeks before registration)
  • Absolute neutrophil count >= 1,500/mcL (within 4 weeks before registration)
  • Platelets >= 100,000/mcL (within 4 weeks before registration)
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) if no liver metastases or =< 3 times ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases (within 4 weeks before registration)
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional upper limit of normal; for patients with known hepatic metastases AST and/or ALT =< 5 x ULN (within 4 weeks before registration)
  • Creatinine =< 1.5 x institutional upper limit of normal (within 4 weeks before registration)
  • Participants may not have clinically active or symptomatic interstitial lung disease or interstitial pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention), or a history of clinically significant interstitial lung disease or radiation pneumonitis
  • Participants may not have had radiation to the lung fields within four weeks (28 days) of starting treatment. For patients receiving palliative radiation to thoracic vertebrae, ribs or other sites where the radiation field includes the lungs, radiation must be completed at least two weeks before starting treatment. For all palliative radiation to all other sites, at least 7 days must have elapsed prior to starting treatment. At least six months (180 days) must have elapsed prior to starting treatment for radiation given with curative intent. Palliative radiotherapy to control symptoms (including gamma knife technique) is permitted. For stereotactic radiosurgery (SRS) to central nervous system (CNS) lesions, osimertinib can be held on the day of radiation only. For palliative radiotherapy (RT) to other sites of disease outside of the thorax osimertinib (osi) should be held for a minimum of 3 days before radiation and 3 days after RT is completed, but the duration of washout can be adjusted at the investigator's discretion with the approval of the study principal investigator (PI). For thoracic radiation, a 7-10 day washout period before the procedure and one week period after procedure before restarting osimertinib is advised to minimize the risk of pneumonitis. All radiotherapy related toxicities should be managed and ideally resolved before restarting osimertinib. Investigators should consider the radiotherapy when assessing causality if there are any localized adverse events (AEs) following the procedure
  • Participants may not have clinically symptomatic brain metastases, leptomeningeal disease, or spinal cord compression. Patients may be on a stable dose of corticosteroids to control brain metastases if they have been on a stable dose for two weeks (14 days) prior to study treatment and are clinically asymptomatic
  • Patients must have an ECHO or a nuclear study (MUGA or first pass) within 4 weeks (28 days) prior to registration to treatment and must not have a left ventricular ejection fraction (LVEF) < institutional lower limit of normal (LLN). If the LLN is not defined at a site, the LVEF must be >= 50% for the patient to be eligible
  • Participants may not have any of the following cardiac criteria:
  • Mean resting corrected QT interval (QTc) >= 470 msec obtained from 3 electrocardiograms (ECGs) using the screening clinic ECG machine-derived QTc value
  • No history of QT prolongation associated with other medications that required discontinuation of that medication
  • Patient must not be receiving any concomitant medications that are known to be associated with Torsades de Pointes
  • Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g., complete left bundle branch block, third degree heart block, second degree heart block, any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, electrolyte abnormalities (including: serum/plasma potassium < LLN; serum/plasma magnesium < LLN; serum/plasma 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
  • Symptomatic heart failure - New York Heart Association (NYHA) grade II-IV
  • Participants may not have a second, clinically active, cancer. Patients with second cancers which have been treated with curative intent and/or are currently inactive are allowed
  • Participants may not be receiving any other investigational agents. Patients previously treated with investigational agents must complete a washout period of at least two weeks or five half-lives, whichever is longer, before starting treatment
  • Participants may not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients must have no history of hypersensitivity active or inactive excipients of osimertinib (AZD9291) or drugs with a similar chemical structure or class to osimertinib (AZD9291)
  • Patients must not currently be receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4 (at least 3 week prior). All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYP3A4
  • If medically feasible, patients taking regular medication, with the exception of potent inducers of CYP3A4, should be maintained on it throughout the study period. Patients taking concomitant medications whose disposition is dependent upon breast cancer resistance protein (BCRP) or P-glycoprotein (Pgp) and which have a narrow therapeutic index should be closely monitored for signs of changed tolerability as a result of increased exposure of the concomitant medication whilst receiving osimertinib (AZD9291)
  • NOTE: Use of St John's wort is a contra-indication for osimertinib (AZD9291) use
  • If applicable, it is recommended that the starting and maintenance dose of rosuvastatin (due to BCRP inhibition by AZD9291 [osimertinib]) should be as low as possible and should be guided by the statin label. Monitoring of low-density lipoprotein (LDL) cholesterol levels is advised. If the subject experiences any potentially relevant adverse events suggestive of muscle toxicity including unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever, the statin should be stopped, creatine kinase (CK) levels should be checked, and any appropriate further management should be taken
  • Subjects taking warfarin should be monitored regularly for changes in prothrombin time or international normalized ratio (INR)
  • No unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment, with the exception of alopecia and grade 2, prior platinum-therapy-related neuropathy
  • Patients with refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib (AZD9291) are ineligible
  • Women must not be pregnant or breast-feeding because osimertinib (AZD9291) has been shown to cause fetal harm in animal models. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  • Women of childbearing potential (WOCBP) and sexually active males must use an accepted and effective method of contraception while receiving protocol treatment or abstain from sexual intercourse for the duration of their participation in the study. WOCBP must use birth control for two weeks prior to the start of the treatment and continue for 6 weeks after the last dose of the study drug. Sexually active male patients must use effective contraception from day 1 of treatment and continue for 4 months after the last dose of the study drug
  • Other anticancer agents and investigational agents should not be given while the subject is on study treatment
  • Supportive care and other medications that are considered necessary for the subject's wellbeing may be given at the discretion of the investigator
  • A guidance regarding potential interactions with concomitant medications is provided

Who cannot join

None listed.

Trial locations and contacts

347 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, 185 recruiting

  • Providence Regional Cancer System-Aberdeen

    Aberdeen, Washington, 98520

    Active, not recruiting

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

    Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org

    Christopher M. Reynolds

    Recruiting

  • MyMichigan Medical Center Gratiot

    Alma, Michigan, 48801

    Site Public Contact, 989-631-2469, CVResearch@mymichigan.org

    Christopher M. Reynolds

    Recruiting

  • MyMichigan Medical Center Alpena

    Alpena, Michigan, 49707

    Site Public Contact, 989-631-2469, CVResearch@mymichigan.org

    Christopher M. Reynolds

    Recruiting

  • OSF Saint Anthony's Health Center

    Alton, Illinois, 62002

    Site Public Contact, 618-463-5623

    Jay W. Carlson

    Recruiting

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Anchorage Associates in Radiation Medicine

    Anchorage, Alaska, 98508

    Active, not recruiting

  • Anchorage Radiation Therapy Center

    Anchorage, Alaska, 99504

    Active, not recruiting

  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaska, 99508

    Active, not recruiting

  • Alaska Oncology and Hematology LLC

    Anchorage, Alaska, 99508

    Active, not recruiting

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

    Active, not recruiting

  • Anchorage Oncology Centre

    Anchorage, Alaska, 99508

    Active, not recruiting

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

    Active, not recruiting

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

    Active, not recruiting

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    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

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

    Site Public Contact, 404-851-7115

    Ticiana A. Leal

    Recruiting

  • Rush-Copley Medical Center

    Aurora, Illinois, 60504

    Suspended

  • Saint Alphonsus Cancer Care Center-Baker City

    Baker City, Oregon, 97814

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    Christopher M. Reynolds

    Recruiting

  • Mercy Oncology and Hematology - Clayton-Clarkson

    Ballwin, Missouri, 63011

    Site Public Contact, 888-446-3729

    Jay W. Carlson

    Recruiting

  • MedStar Franklin Square Medical Center/Weinberg Cancer Institute

    Baltimore, Maryland, 21237

    Active, not recruiting

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

    Active, not recruiting

  • Ochsner Health Center-Summa

    Baton Rouge, Louisiana, 70809

    Active, not recruiting

  • Medical Center of Baton Rouge

    Baton Rouge, Louisiana, 70816

    Active, not recruiting

  • Ochsner High Grove

    Baton Rouge, Louisiana, 70836

    Active, not recruiting

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Indu and Raj Soin Medical Center

    Beavercreek, Ohio, 45431

    Active, not recruiting

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

    Active, not recruiting

  • Saint Charles Health System

    Bend, Oregon, 97701

    Active, not recruiting

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

    Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org

    Christopher M. Reynolds

    Recruiting

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

    Site Public Contact, 800-996-2663, research@billingsclinic.org

    John M. Schallenkamp

    Recruiting

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Saint Elizabeth Boardman Hospital

    Boardman, Ohio, 44512

    Active, not recruiting

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

    Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

    Active, not recruiting

  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri, 65613

    Site Public Contact, 913-948-5588, aroland@kccop.org

    Jay W. Carlson

    Recruiting

  • Parkland Health Center-Bonne Terre

    Bonne Terre, Missouri, 63628

    Suspended

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

    Site Public Contact, 877-726-5130

    Zofia Piotrowska

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Suspended

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Suspended

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Suspended

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Cox Cancer Center Branson

    Branson, Missouri, 65616

    Site Public Contact, 417-269-4520

    Jay W. Carlson

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Trinity Health Medical Center - Brighton

    Brighton, Michigan, 48114

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    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

    Active, not recruiting

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

    Active, not recruiting

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Shamsuddin Virani

    Recruiting

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

    Suspended

  • 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

    Christopher M. Reynolds

    Recruiting

  • Cambridge Medical Center

    Cambridge, Minnesota, 55008

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    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

    Christopher M. Reynolds

    Recruiting

  • Trinity Health Medical Center - Canton

    Canton, Michigan, 48188

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Mercy Cancer Center - Cape Girardeau

    Cape Girardeau, Missouri, 63703

    Site Public Contact, 888-446-3729

    Jay W. Carlson

    Recruiting

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

    Site Public Contact, 573-334-2230, sfmc@sfmc.net

    Bryan A. Faller

    Recruiting

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

    Site Public Contact, 618-457-5200, clinical.research@sih.net

    Bryan A. Faller

    Recruiting

  • Caro Cancer Center

    Caro, Michigan, 48723

    Suspended

  • SIH Cancer Institute

    Carterville, Illinois, 62918

    Site Public Contact, 618-985-3333, clinical.research@sih.net

    Bryan A. Faller

    Recruiting

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Dayton Physicians LLC-Miami Valley South

    Centerville, Ohio, 45459

    Active, not recruiting

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

    Active, not recruiting

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Saint Mary's Hospital

    Centralia, Illinois, 62801

    Suspended

  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

    Active, not recruiting

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

    Site Public Contact, 434-243-6303, uvacancertrials@hscmail.mcc.virginia.edu

    Richard D. Hall

    Recruiting

  • Minnesota Oncology Hematology PA-Chaska

    Chaska, Minnesota, 55318

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Chelsea Hospital

    Chelsea, Michigan, 48118

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Memorial Hospital of Laramie County

    Cheyenne, Wyoming, 82001

    Site Public Contact, ecog.rss@jimmy.harvard.edu

    John M. Schallenkamp

    Recruiting

  • Marshfield Clinic-Chippewa Center

    Chippewa Falls, Wisconsin, 54729

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Chady A. Leon

    Recruiting

  • Oncology Hematology Care Inc-Kenwood

    Cincinnati, Ohio, 45236

    Active, not recruiting

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

    Active, not recruiting

  • Providence Cancer Institute Clackamas Clinic

    Clackamas, Oregon, 97015

    Active, not recruiting

  • Hematology Oncology Consultants-Clarkston

    Clarkston, Michigan, 48346

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Newland Medical Associates-Clarkston

    Clarkston, Michigan, 48346

    Suspended

  • Trinity Health IHA Medical Group - Primary Care - Clarkston

    Clarkston, Michigan, 48346

    Site Public Contact, 248-858-6215, Emily.Crofts@Trinity-Health.org

    Christopher M. Reynolds

    Recruiting

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

    Active, not recruiting

  • Billings Clinic-Cody

    Cody, Wyoming, 82414

    Site Public Contact, 800-996-2663, research@billingsclinic.org

    John M. Schallenkamp

    Recruiting

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Main Line Health Center-Collegeville

    Collegeville, Pennsylvania, 19426

    Suspended

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Site Public Contact, 800-293-5066, Jamesline@osumc.edu

    Regan M. Memmott

    Recruiting

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Minnesota Oncology - Coon Rapids

    Coon Rapids, Minnesota, 55433

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Bay Area Hospital

    Coos Bay, Oregon, 97420

    Active, not recruiting

  • Good Samaritan Hospital

    Corvallis, Oregon, 97330

    Site Public Contact, 541-768-4352, stmock@samhealth.org

    John Strother

    Recruiting

  • Heartland Oncology and Hematology LLP

    Council Bluffs, Iowa, 51503

    Active, not recruiting

  • Methodist Jennie Edmundson Hospital

    Council Bluffs, Iowa, 51503

    Active, not recruiting

  • Nebraska Cancer Specialists/Oncology Hematology West PC - MEJ

    Council Bluffs, Iowa, 51503

    Active, not recruiting

  • Aurora Saint Luke's South Shore

    Cudahy, Wisconsin, 53110

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Shamsuddin Virani

    Recruiting

  • Carle at The Riverfront

    Danville, Illinois, 61832

    Site Public Contact, 800-446-5532, Research@Carle.com

    Priyank P. Patel

    Recruiting

  • Good Samaritan Hospital - Dayton

    Dayton, Ohio, 45406

    Suspended

  • Miami Valley Hospital

    Dayton, Ohio, 45409

    Active, not recruiting

  • Dayton Physician LLC - Englewood

    Dayton, Ohio, 45415

    Active, not recruiting

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

    Active, not recruiting

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

    Active, not recruiting

  • UI Health Care Mission Cancer and Blood - Des Moines Clinic

    Des Moines, Iowa, 50309

    Active, not recruiting

  • Broadlawns Medical Center

    Des Moines, Iowa, 50314

    Active, not recruiting

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

    Active, not recruiting

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Adam M. Forman

    Recruiting

  • Henry Ford Health Saint John Hospital

    Detroit, Michigan, 48236

    Site Public Contact, 313-343-3166, Kkeenan1@hfhs.org

    Christopher M. Reynolds

    Recruiting

  • Illinois CancerCare-Dixon

    Dixon, Illinois, 61021

    Site Public Contact, 815-285-7800

    Bryan A. Faller

    Recruiting

  • Henry Ford River District Hospital

    East China Township, Michigan, 48054

    Site Public Contact, 313-343-3166, kforman1@hfhs.org

    Christopher M. Reynolds

    Recruiting

  • Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

    Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org

    Christopher M. Reynolds

    Recruiting

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Chady A. Leon

    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

    Recruiting

  • Swedish Cancer Institute-Edmonds

    Edmonds, Washington, 98026

    Active, not recruiting

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

    Site Public Contact, 800-446-5532, Research@carle.com

    Priyank P. Patel

    Recruiting

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Walter Knox Memorial Hospital

    Emmett, Idaho, 83617

    Suspended

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

    Active, not recruiting

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

    Active, not recruiting

  • Main Line Health Center-Exton

    Exton, Pennsylvania, 19341

    Suspended

  • Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701

    Site Public Contact, 907-458-3043, Veronica.Stevenson@foundationhealth.org

    John M. Schallenkamp

    Recruiting

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

    Site Public Contact, 314-996-5569

    Bryan A. Faller

    Recruiting

  • Armes Family Cancer Center

    Findlay, Ohio, 45840

    Active, not recruiting

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

    Active, not recruiting

  • Orion Cancer Care

    Findlay, Ohio, 45840

    Active, not recruiting

  • Cancer Hematology Centers - Flint

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Christopher M. Reynolds

    Recruiting

  • Genesee Hematology Oncology PC

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Christopher M. Reynolds

    Recruiting

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Christopher M. Reynolds

    Recruiting

  • Hurley Medical Center

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Christopher M. Reynolds

    Recruiting

  • Aurora Health Center-Fond du Lac

    Fond du Lac, Wisconsin, 54937

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Shamsuddin Virani

    Recruiting

  • UI Healthcare Mission Cancer and Blood - Fort Dodge

    Fort Dodge, Iowa, 50501

    Active, not recruiting

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

    Site Public Contact, eileen.georgi@holy-cross.com

    Christopher M. Reynolds

    Recruiting

  • Mercy Hospital Fort Smith

    Fort Smith, Arkansas, 72903

    Site Public Contact, 800-378-9373

    Jay W. Carlson

    Recruiting

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

    Active, not recruiting

  • Dayton Physicians LLC-Atrium

    Franklin, Ohio, 45005

    Active, not recruiting

  • Unity Hospital

    Fridley, Minnesota, 55432

    Active, not recruiting

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

    Active, not recruiting

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

    Suspended

  • Central Care Cancer Center - Garden City

    Garden City, Kansas, 67846

    Site Public Contact, 913-948-5588, aroland@kccop.org

    Jay W. Carlson

    Recruiting

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Shamsuddin Virani

    Recruiting

  • MyMichigan Medical Center Gladwin

    Gladwin, Michigan, 48624

    Site Public Contact, 989-631-2469, CVResearch@mymichigan.org

    Christopher M. Reynolds

    Recruiting

  • NorthShore University HealthSystem-Glenbrook Hospital

    Glenview, Illinois, 60026

    Active, not recruiting

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Shamsuddin Virani

    Recruiting

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

    Grand Rapids, Michigan, 49503

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Trinity Health Grand Rapids Hospital

    Grand Rapids, Michigan, 49503

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Christopher M. Reynolds

    Recruiting

  • Central Care Cancer Center - Great Bend

    Great Bend, Kansas, 67530

    Site Public Contact, 913-948-5588, aroland@kccop.org

    Jay W. Carlson

    Recruiting

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Great Falls Clinic

    Great Falls, Montana, 59405

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Shamsuddin Virani

    Recruiting

  • Dayton Physicians LLC-Wayne

    Greenville, Ohio, 45331

    Active, not recruiting

  • Wayne Hospital

    Greenville, Ohio, 45331

    Active, not recruiting

  • Henry Ford Saint John Hospital - Academic

    Grosse Pointe Woods, Michigan, 48236

    Site Public Contact, 313-343-3166, kforman1@hfhs.org

    Christopher M. Reynolds

    Recruiting

  • Henry Ford Saint John Hospital - Breast

    Grosse Pointe Woods, Michigan, 48236

    Site Public Contact, 313-343-3166, karen.forman@ascension.org

    Christopher M. Reynolds

    Recruiting

  • Henry Ford Saint John Hospital - Van Elslander

    Grosse Pointe Woods, Michigan, 48236

    Site Public Contact, 313-343-3166, kforman1@hfhs.org

    Christopher M. Reynolds

    Recruiting

  • Hi-Line Sletten Cancer Center

    Havre, Montana, 59501

    Site Public Contact, ecog.rss@jimmy.harvard.edu

    John M. Schallenkamp

    Recruiting

  • Lehigh Valley Hospital-Hazleton

    Hazleton, Pennsylvania, 18201

    Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org

    Christopher M. Reynolds

    Recruiting

  • Benefis Helena Specialty Center

    Helena, Montana, 59601

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

    Suspended

  • Margaret R Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

    Active, not recruiting

  • NorthShore University HealthSystem-Highland Park Hospital

    Highland Park, Illinois, 60035

    Active, not recruiting

  • Swedish Cancer Institute-Issaquah

    Issaquah, Washington, 98029

    Active, not recruiting

  • MU Health Care Goldschmidt Cancer Center

    Jefferson City, Missouri, 65109

    Suspended

  • Freeman Health System

    Joplin, Missouri, 64804

    Site Public Contact, 417-347-4030, LJCrockett@freemanhealth.com

    Jay W. Carlson

    Recruiting

  • Mercy Hospital Joplin

    Joplin, Missouri, 64804

    Site Public Contact, 417-556-3074, esmeralda.carrillo@mercy.net

    Jay W. Carlson

    Recruiting

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Beacon Kalamazoo Cancer Center

    Kalamazoo, Michigan, 49009

    Site Public Contact, 574-647-7370

    Kathleen Y. Butler

    Recruiting

  • Beacon Kalamazoo

    Kalamazoo, Michigan, 49048

    Site Public Contact, 574-647-7370

    Kathleen Y. Butler

    Recruiting

  • Logan Health Medical Center

    Kalispell, Montana, 59901

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336

    Active, not recruiting

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Shamsuddin Virani

    Recruiting

  • Greater Dayton Cancer Center

    Kettering, Ohio, 45409

    Active, not recruiting

  • First Dayton Cancer Care

    Kettering, Ohio, 45420

    Active, not recruiting

  • Kettering Medical Center

    Kettering, Ohio, 45429

    Active, not recruiting

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

    Site Public Contact, 608-775-2385, cancerctr@gundersenhealth.org

    Kurt Oettel

    Recruiting

  • Providence Regional Cancer System-Lacey

    Lacey, Washington, 98503

    Active, not recruiting

  • Marshfield Medical Center - Ladysmith

    Ladysmith, Wisconsin, 54848

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Chady A. Leon

    Recruiting

  • University of Michigan Health - Sparrow Lansing

    Lansing, Michigan, 48912

    Site Public Contact, 517-364-3712, harsha.trivedi@umhsparrow.org

    Christopher M. Reynolds

    Recruiting

  • CARTI Cancer Center

    Little Rock, Arkansas, 72205

    Site Public Contact, 501-906-4199, Research@CARTI.com

    Jay W. Carlson

    Recruiting

  • Hope Cancer Clinic

    Livonia, Michigan, 48154

    Suspended

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • PeaceHealth Saint John Medical Center

    Longview, Washington, 98632

    Active, not recruiting

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Henry Ford Saint John Hospital - Macomb Medical

    Macomb, Michigan, 48044

    Site Public Contact, 313-343-3166, kforman1@hfhs.org

    Christopher M. Reynolds

    Recruiting

  • Henry Ford Warren Hospital - Breast Macomb

    Macomb, Michigan, 48044

    Site Public Contact, 313-343-3166, kforman1@hfhs.org

    Christopher M. Reynolds

    Recruiting

  • Fairview Clinics and Surgery Center Maple Grove

    Maple Grove, Minnesota, 55369

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • HealthPartners Cancer Care - Park Nicollet Maple Grove

    Maple Grove, Minnesota, 55369

    Site Public Contact, 952-883-6000, CancerResearch@HealthPartners.com

    David M. King

    Recruiting

  • Minnesota Oncology - Maple Grove

    Maple Grove, Minnesota, 55369

    Site Public Contact, 952-993-1572, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Aurora Bay Area Medical Group-Marinette

    Marinette, Wisconsin, 54143

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Shamsuddin Virani

    Recruiting

  • Saint Mary's Oncology/Hematology Associates of Marlette

    Marlette, Michigan, 48453

    Suspended

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Chady A. Leon

    Recruiting

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

    Site Public Contact, 800-446-5532, Research@carle.com

    Priyank P. Patel

    Recruiting

  • Riddle Memorial Hospital

    Media, Pennsylvania, 19063

    Site Public Contact, 484-476-2649, turzoe@mlhs.org

    Paul B. Gilman

    Recruiting

  • Idaho Urologic Institute-Meridian

    Meridian, Idaho, 83642

    Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Saint Luke's Cancer Institute - Meridian

    Meridian, Idaho, 83642

    Active, not recruiting

  • Garnet Health Medical Center

    Middletown, New York, 10940

    Suspended

  • MyMichigan Medical Center Midland

    Midland, Michigan, 48670

    Site Public Contact, 989-631-2469, CVResearch@mymichigan.org

    Christopher M. Reynolds

    Recruiting

  • Aurora Cancer Care-Milwaukee

    Milwaukee, Wisconsin, 53209

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Shamsuddin Virani

    Recruiting

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Shamsuddin Virani

    Recruiting

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Shamsuddin Virani

    Recruiting

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Health Partners Inc

    Minneapolis, Minnesota, 55454

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Marshfield Medical Center - Minocqua

    Minocqua, Wisconsin, 54548

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Chady A. Leon

    Recruiting

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

    Active, not recruiting

  • Community Medical Center

    Missoula, Montana, 59804

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Monticello Cancer Center

    Monticello, Minnesota, 55362

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • MyMichigan Medical Center Mount Pleasant

    Mount Pleasant, Michigan, 48858

    Site Public Contact, 989-631-2469, CVResearch@mymichigan.org

    Christopher M. Reynolds

    Recruiting

  • SSM Health Good Samaritan

    Mount Vernon, Illinois, 62864

    Site Public Contact, 618-899-1894, gayla.hall@ssmhealth.com

    Jay W. Carlson

    Recruiting

  • Trinity Health Muskegon Hospital

    Muskegon, Michigan, 49444

    Suspended

  • Saint Alphonsus Cancer Care Center-Nampa

    Nampa, Idaho, 83687

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    Christopher M. Reynolds

    Recruiting

  • Saint Luke's Cancer Institute - Nampa

    Nampa, Idaho, 83687

    Active, not recruiting

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, 70121

    Active, not recruiting

  • Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • New Ulm Medical Center

    New Ulm, Minnesota, 56073

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Providence Newberg Medical Center

    Newberg, Oregon, 97132

    Active, not recruiting

  • Bryn Mawr Health Center

    Newtown Square, Pennsylvania, 19073

    Suspended

  • Corewell Health Lakeland Hospitals - Niles Hospital

    Niles, Michigan, 49120

    Site Public Contact, 616-391-1230

    Kathleen Y. Butler

    Recruiting

  • Cancer and Hematology Centers of Western Michigan - Norton Shores

    Norton Shores, Michigan, 49444

    Suspended

  • Henry Ford Health Providence Novi Hospital

    Novi, Michigan, 48374

    Site Public Contact, 248-849-5332, kfife3@hfhs.org

    Susan E. Lyons

    Recruiting

  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois, 62269

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • HSHS Saint Elizabeth's Hospital

    O'Fallon, Illinois, 62269

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

    Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu

    Raid Aljumaily

    Recruiting

  • Mercy Hospital Oklahoma City

    Oklahoma City, Oklahoma, 73120

    Site Public Contact, 405-752-3402

    Jay W. Carlson

    Recruiting

  • Nebraska Cancer Specialists/Oncology Hematology West PC - MECC

    Omaha, Nebraska, 68114

    Active, not recruiting

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

    Active, not recruiting

  • Oncology Associates PC

    Omaha, Nebraska, 68114

    Suspended

  • Saint Alphonsus Cancer Care Center-Ontario

    Ontario, Oregon, 97914

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    Christopher M. Reynolds

    Recruiting

  • Providence Willamette Falls Medical Center

    Oregon City, Oregon, 97045

    Active, not recruiting

  • Lake Regional Hospital

    Osage Beach, Missouri, 65065

    Site Public Contact, 573-302-2768, clinicaltrials@lakeregional.com

    Jay W. Carlson

    Recruiting

  • Vince Lombardi Cancer Clinic - Oshkosh

    Oshkosh, Wisconsin, 54904

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Shamsuddin Virani

    Recruiting

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301

    Site Public Contact, 484-476-2649, turzoe@mlhs.org

    Paul B. Gilman

    Recruiting

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Valley Radiation Oncology

    Peru, Illinois, 61354

    Site Public Contact, 815-664-4141

    Bryan A. Faller

    Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Active, not recruiting

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

    Active, not recruiting

  • FirstHealth of the Carolinas-Moore Regional Hospital

    Pinehurst, North Carolina, 28374

    Site Public Contact, 910-715-3500, jcwilliams@firsthealth.org

    Charles S. Kuzma

    Recruiting

  • Mercy Hospital Pittsburg

    Pittsburg, Kansas, 66762

    Site Public Contact, 888-446-3729

    Jay W. Carlson

    Recruiting

  • Hope Cancer Center

    Pontiac, Michigan, 48341

    Suspended

  • Michigan Healthcare Professionals Pontiac

    Pontiac, Michigan, 48341

    Site Public Contact, 248-858-6215, Emily.Crofts@trinity-health.org

    Christopher M. Reynolds

    Recruiting

  • Trinity Health IHA Medical Group-Alice Gustafson Center

    Pontiac, Michigan, 48341

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Trinity Health Saint Joseph Mercy Oakland Hospital

    Pontiac, Michigan, 48341

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Providence Portland Medical Center

    Portland, Oregon, 97213

    Active, not recruiting

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

    Active, not recruiting

  • Kootenai Clinic Cancer Services - Post Falls

    Post Falls, Idaho, 83854

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Fairview Northland Medical Center

    Princeton, Minnesota, 55371

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Aurora Cancer Care-Racine

    Racine, Wisconsin, 53406

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Shamsuddin Virani

    Recruiting

  • Penn State Health Saint Joseph Medical Center

    Reading, Pennsylvania, 19605

    Suspended

  • Saint Charles Health System-Redmond

    Redmond, Oregon, 97756

    Active, not recruiting

  • Corewell Health Reed City Hospital

    Reed City, Michigan, 49677

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin, 54868

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Chady A. Leon

    Recruiting

  • Reid Health

    Richmond, Indiana, 47374

    Active, not recruiting

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Henry Ford Rochester Hospital

    Rochester Hills, Michigan, 48309

    Suspended

  • Mercy Clinic-Rolla-Cancer and Hematology

    Rolla, Missouri, 65401

    Site Public Contact, 573-458-6379

    Jay W. Carlson

    Recruiting

  • Phelps Health Delbert Day Cancer Institute

    Rolla, Missouri, 65401

    Site Public Contact, 573-458-7504, research@phelpshealth.org

    Jay W. Carlson

    Recruiting

  • MyMichigan Medical Center Saginaw

    Saginaw, Michigan, 48601

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Oncology Hematology Associates of Saginaw Valley PC

    Saginaw, Michigan, 48604

    Suspended

  • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

    Saint Joseph, Michigan, 49085

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Corewell Health Lakeland Hospitals - Saint Joseph Hospital

    Saint Joseph, Michigan, 49085

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

    Site Public Contact, 816-271-7937, Trisha.England2@mymlc.com

    Jay W. Carlson

    Recruiting

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Regions Hospital

    Saint Paul, Minnesota, 55101

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • United Hospital

    Saint Paul, Minnesota, 55102

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Sainte Genevieve County Memorial Hospital

    Sainte Genevieve, Missouri, 63670

    Site Public Contact, 314-996-5569

    Bryan A. Faller

    Recruiting

  • Kootenai Clinic Cancer Services - Sandpoint

    Sandpoint, Idaho, 83864

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Pacific Gynecology Specialists

    Seattle, Washington, 98104

    Suspended

  • Swedish Medical Center-Ballard Campus

    Seattle, Washington, 98107

    Active, not recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Site Public Contact, 800-804-8824

    Christina S. Baik

    Recruiting

  • Kaiser Permanente Washington

    Seattle, Washington, 98112

    Active, not recruiting

  • Swedish Medical Center-Cherry Hill

    Seattle, Washington, 98122-5711

    Active, not recruiting

  • Swedish Medical Center-First Hill

    Seattle, Washington, 98122

    Active, not recruiting

  • University of Washington Medical Center - Montlake

    Seattle, Washington, 98195

    Site Public Contact, 800-804-8824

    Christina S. Baik

    Recruiting

  • PeaceHealth United General Medical Center

    Sedro-Woolley, Washington, 98284

    Active, not recruiting

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Vince Lombardi Cancer Clinic-Sheboygan

    Sheboygan, Wisconsin, 53081

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Shamsuddin Virani

    Recruiting

  • Providence Regional Cancer System-Shelton

    Shelton, Washington, 98584

    Active, not recruiting

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

    Suspended

  • North Shore Medical Center

    Skokie, Illinois, 60076

    Active, not recruiting

  • Henry Ford Health Providence Southfield Hospital

    Southfield, Michigan, 48075

    Site Public Contact, 248-849-5332, kfife3@hfhs.org

    Susan E. Lyons

    Recruiting

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

    Site Public Contact, 217-545-7929

    Bryan A. Faller

    Recruiting

  • Springfield Clinic

    Springfield, Illinois, 62702

    Site Public Contact, 800-444-7541

    Bryan A. Faller

    Recruiting

  • Springfield Memorial Hospital

    Springfield, Illinois, 62781

    Site Public Contact, 217-528-7541, pallante.beth@mhsil.com

    Bryan A. Faller

    Recruiting

  • Mercy Medical Center

    Springfield, Massachusetts, 01104

    Active, not recruiting

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

    Site Public Contact, 417-269-4520

    Jay W. Carlson

    Recruiting

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

    Site Public Contact, 417-269-4520

    Jay W. Carlson

    Recruiting

  • Springfield Regional Cancer Center

    Springfield, Ohio, 45504

    Active, not recruiting

  • Springfield Regional Medical Center

    Springfield, Ohio, 45504

    Active, not recruiting

  • Mercy Infusion Center - Chippewa

    St Louis, Missouri, 63109

    Site Public Contact, 888-446-3729

    Jay W. Carlson

    Recruiting

  • Mercy Hospital South

    St Louis, Missouri, 63128

    Site Public Contact, 314-525-6042, Danielle.Werle@mercy.net

    Jay W. Carlson

    Recruiting

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

    Site Public Contact, 314-996-5569

    Bryan A. Faller

    Recruiting

Other trials in United States

About this study

Official title: Phase II Study of Osimertinib (AZD9291) in Advanced NSCLC Patients With Exon 20 Insertion Mutations in EGFR

This phase II trial studies how well osimertinib works in treating patients with non-small cell lung cancer with EGFR exon 20 insertion mutation that is stage IIIB-IV or has come back after a period of improvement (recurrent). Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate the best objective response rate of osimertinib (AZD9291) among patients with EGFR exon 20 insertions.

SECONDARY OBJECTIVES:

  1. To determine the safety profile of 160 mg once daily (QD) dose of osimertinib (AZD9291) in patients with EGFR Exon 20 insertion mutations.

II. To determine the progression-free survival. III. To determine the overall survival.

TERTIARY OBJECTIVES:

  1. To characterize molecular markers of response to treatment in circulating tumor deoxyribonucleic acid (DNA).

II. To evaluate biomarkers of response to treatment through retrospective analyses of pre-treatment tumor tissue.

III. To identify resistance mechanisms to osimertinib (AZD9291) through post-progression tumor biopsies and circulating tumor (ct)DNA.

OUTLINE:

Patients receive osimertinib orally (PO) once daily (QD) on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography (ECHO) or multigated acquisition scan (MUGA), magnetic resonance imaging (MRI) or computed tomography (CT) with contrast, and collection of blood samples throughout the trial.

After completion of study treatment, patients are followed up at 30 days and every 3 months for up to 5 years.

Being tested
Biospecimen Collection, Computed Tomography with Contrast, Echocardiography Test, Magnetic Resonance Imaging, Multigated Acquisition Scan
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.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo collection of blood samples

  • Computed Tomography with ContrastProcedure or surgery

    Also called Contrast Enhanced Computed Tomography, CONTRAST ENHANCED CT SCAN, Contrast-enhanced Computed Tomography, CT Scan With Contrast

    Undergo CT with contrast

  • 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 groups in NCT03191149
Study groupRoleWhat they receive
Treatment (osimertinib)ExperimentalPatients receive osimertinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA, MRI or CT with contrast, and collection of blood samples throughout the trial.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography with Contrast; 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.

  1. Best objective response

    Will be evaluated via Response Evaluation Criteria in Solid Tumors 1.1 criteria. Categorical data, such as response rates (complete response + partial response), will be compared using Fisher's exact tests with a one-sided type I error rate of 10%; multivariable logistic regression modeling will be used to adjust for the effect of any covariates that are associated with these categorical outcomes. Any continuous outcomes will be analyzed using Wilcoxon rank sum test, and multivariable linear regression models may be used to adjust for multiple associations with outcome. Point estimates of all endpoints will be accompanied by the corresponding two-sided 80% confidence intervals. The method of Atkinson and Brown will be used for the estimation of the confidence interval for response.

    Measured: Up to 5 years

Secondary outcomes (3)

  1. Progression-free survival (PFS)

    Will be estimated using the Kaplan-Meier method, and Cox proportional hazards models will be used to estimate hazard ratios. Comparisons of groups will be made using the logrank test and Cox modeling. Point estimates of all endpoints will be accompanied by the corresponding two-sided 80% confidence intervals. The method of Atkinson and Brown will be used for the estimation of the confidence interval for response.

    Measured: From registration to documented disease progression or death from any cause, whichever occurs first, assessed up to 5 years

  2. Overall survival (OS)

    Will be estimated using the Kaplan-Meier method, and Cox proportional hazards models will be used to estimate hazard ratios. Comparisons of groups will be made using the logrank test and Cox modeling. Point estimates of all endpoints will be accompanied by the corresponding two-sided 80% confidence intervals. The method of Atkinson and Brown will be used for the estimation of the confidence interval for response.

    Measured: From registration to death from any cause, assessed up to 5 years

  3. Incidence of adverse events

    Will be graded according to Common Terminology Criteria for Adverse Events version 5.0. Categorical data, such as toxicity, will be compared using Fisher's exact tests with a one-sided type I error rate of 10%; multivariable logistic regression modeling will be used to adjust for the effect of any covariates that are associated with these categorical outcomes. Any continuous outcomes will be analyzed using Wilcoxon rank sum test, and multivariable linear regression models may be used to adjust for multiple associations with outcome. Point estimates of all endpoints will be accompanied by the corresponding two-sided 80% confidence intervals. The method of Atkinson and Brown will be used for the estimation of the confidence interval for response.

    Measured: Up to 5 years

Timeline

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

  1. First posted19 Jun 2017
  2. Study start25 Apr 2018
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03191149
Sponsor's protocol ID
NCI-2017-01017
Other IDs
NCI-2017-01017, EA5162, EA5162, U10CA180820
Status last verified
Oct 2026
First submitted
16 Jun 2017
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, Computed Tomography with Contrast and Echocardiography Test in people with Advanced Lung Non-Small Cell Carcinoma and Recurrent Lung Non-Small Cell Carcinoma, run by National Cancer Institute (NCI) at 347 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 3 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 347 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Best objective response (time frame: Up to 5 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 NCT03191149.

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 3 Nov 2026.

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