Recruiting
Phase 2

Osimertinib

Sponsor:

National Cancer Institute (NCI)

Code:

NCT03191149

Conditions

Advanced Lung Non-Small Cell Carcinoma

Recurrent Lung Non-Small Cell Carcinoma

Stage IIIB Lung Non-Small Cell Cancer AJCC v7

Stage IV Lung Non-Small Cell Cancer AJCC v7

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Computed Tomography with Contrast

Echocardiography Test

Magnetic Resonance Imaging

Multigated Acquisition Scan

Study Details

Brief 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). Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Conditions

Advanced Lung Non-Small Cell Carcinoma

Recurrent Lung Non-Small Cell Carcinoma

Stage IIIB Lung Non-Small Cell Cancer AJCC v7

Stage IV Lung Non-Small Cell Cancer AJCC v7

Study ID

NCT03191149

Start date

Apr 25, 2018

Status verified date

Apr, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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
  • 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

Study Design

Enrollment

46 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (osimertinib)

Patients 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.

Interventions

Biospecimen Collection

Undergo collection of blood samples

Computed Tomography with Contrast

Undergo CT with contrast

Echocardiography Test

Undergo ECHO

Magnetic Resonance Imaging

Undergo MRI

Multigated Acquisition Scan

Undergo MUGA

Osimertinib

Given PO

Primary outcome measure

  • Best objective response [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Locations

Fairbanks Memorial Hospital

Recruiting

Fairbanks, Alaska, United States, 99701

Contacts

Principal Investigator:

John M. Schallenkamp

Mercy Hospital Fort Smith

Recruiting

Fort Smith, Arkansas, United States, 72903

Contacts

Site Public Contact

800-378-9373

Principal Investigator:

Jay W. Carlson

CARTI Cancer Center

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Principal Investigator:

Jay W. Carlson

MedStar Georgetown University Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20007

Contacts

Site Public Contact

202-444-2223

Principal Investigator:

Chul Kim

Holy Cross Hospital

Recruiting

Fort Lauderdale, Florida, United States, 33308

Contacts

Site Public Contact

eileen.georgi@holy-cross.com

Principal Investigator:

Christopher M. Reynolds

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Site Public Contact

888-946-7447

Principal Investigator:

Ticiana A. Leal

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Site Public Contact

404-778-1868

Principal Investigator:

Ticiana A. Leal

Emory Saint Joseph's Hospital

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Site Public Contact

404-851-7115

Principal Investigator:

Ticiana A. Leal

Saint Alphonsus Cancer Care Center-Boise

Recruiting

Boise, Idaho, United States, 83706

Contacts

Principal Investigator:

Christopher M. Reynolds

Saint Alphonsus Cancer Care Center-Caldwell

Recruiting

Caldwell, Idaho, United States, 83605

Contacts

Principal Investigator:

Christopher M. Reynolds

Kootenai Health - Coeur d'Alene

Recruiting

Coeur d'Alene, Idaho, United States, 83814

Contacts

Principal Investigator:

John M. Schallenkamp

Idaho Urologic Institute-Meridian

Recruiting

Meridian, Idaho, United States, 83642

Contacts

Principal Investigator:

Christopher M. Reynolds

Saint Alphonsus Cancer Care Center-Nampa

Recruiting

Nampa, Idaho, United States, 83687

Contacts

Principal Investigator:

Christopher M. Reynolds

Kootenai Clinic Cancer Services - Post Falls

Recruiting

Post Falls, Idaho, United States, 83854

Contacts

Principal Investigator:

John M. Schallenkamp

Kootenai Clinic Cancer Services - Sandpoint

Recruiting

Sandpoint, Idaho, United States, 83864

Contacts

Principal Investigator:

John M. Schallenkamp

OSF Saint Anthony's Health Center

Recruiting

Alton, Illinois, United States, 62002

Contacts

Site Public Contact

618-463-5623

Principal Investigator:

Jay W. Carlson

Rush-Copley Medical Center

Recruiting

Aurora, Illinois, United States, 60504

Contacts

Principal Investigator:

Priyank P. Patel

Illinois CancerCare-Bloomington

Recruiting

Bloomington, Illinois, United States, 61704

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Canton

Recruiting

Canton, Illinois, United States, 61520

Contacts

Principal Investigator:

Bryan A. Faller

Memorial Hospital of Carbondale

Recruiting

Carbondale, Illinois, United States, 62902

Contacts

Principal Investigator:

Bryan A. Faller

SIH Cancer Institute

Recruiting

Carterville, Illinois, United States, 62918

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Carthage

Recruiting

Carthage, Illinois, United States, 62321

Contacts

Principal Investigator:

Bryan A. Faller

Centralia Oncology Clinic

Recruiting

Centralia, Illinois, United States, 62801

Contacts

Principal Investigator:

Bryan A. Faller

Carle at The Riverfront

Recruiting

Danville, Illinois, United States, 61832

Contacts

Principal Investigator:

Priyank P. Patel

Cancer Care Specialists of Illinois - Decatur

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Principal Investigator:

Bryan A. Faller

Decatur Memorial Hospital

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Dixon

Recruiting

Dixon, Illinois, United States, 61021

Contacts

Site Public Contact

815-285-7800

Principal Investigator:

Bryan A. Faller

Carle Physician Group-Effingham

Recruiting

Effingham, Illinois, United States, 62401

Contacts

Principal Investigator:

Priyank P. Patel

Crossroads Cancer Center

Recruiting

Effingham, Illinois, United States, 62401

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Eureka

Recruiting

Eureka, Illinois, United States, 61530

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Galesburg

Recruiting

Galesburg, Illinois, United States, 61401

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Kewanee Clinic

Recruiting

Kewanee, Illinois, United States, 61443

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Macomb

Recruiting

Macomb, Illinois, United States, 61455

Contacts

Principal Investigator:

Bryan A. Faller

Carle Physician Group-Mattoon/Charleston

Recruiting

Mattoon, Illinois, United States, 61938

Contacts

Principal Investigator:

Priyank P. Patel

SSM Health Good Samaritan

Recruiting

Mount Vernon, Illinois, United States, 62864

Contacts

Principal Investigator:

Jay W. Carlson

Cancer Care Center of O'Fallon

Recruiting

O'Fallon, Illinois, United States, 62269

Contacts

Principal Investigator:

Bryan A. Faller

HSHS Saint Elizabeth's Hospital

Recruiting

O'Fallon, Illinois, United States, 62269

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Ottawa Clinic

Recruiting

Ottawa, Illinois, United States, 61350

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Pekin

Recruiting

Pekin, Illinois, United States, 61554

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Peoria

Recruiting

Peoria, Illinois, United States, 61615

Contacts

Principal Investigator:

Bryan A. Faller

Methodist Medical Center of Illinois

Recruiting

Peoria, Illinois, United States, 61636

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Peru

Recruiting

Peru, Illinois, United States, 61354

Contacts

Principal Investigator:

Bryan A. Faller

Valley Radiation Oncology

Recruiting

Peru, Illinois, United States, 61354

Contacts

Site Public Contact

815-664-4141

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Princeton

Recruiting

Princeton, Illinois, United States, 61356

Contacts

Principal Investigator:

Bryan A. Faller

Southern Illinois University School of Medicine

Recruiting

Springfield, Illinois, United States, 62702

Contacts

Site Public Contact

217-545-7929

Principal Investigator:

Bryan A. Faller

Springfield Clinic

Recruiting

Springfield, Illinois, United States, 62702

Contacts

Site Public Contact

800-444-7541

Principal Investigator:

Bryan A. Faller

Springfield Memorial Hospital

Recruiting

Springfield, Illinois, United States, 62781

Contacts

Principal Investigator:

Bryan A. Faller

Carle Cancer Center

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Principal Investigator:

Priyank P. Patel

The Carle Foundation Hospital

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Principal Investigator:

Priyank P. Patel

Illinois CancerCare - Washington

Recruiting

Washington, Illinois, United States, 61571

Contacts

Principal Investigator:

Bryan A. Faller

Rush-Copley Healthcare Center

Recruiting

Yorkville, Illinois, United States, 60560

Contacts

Principal Investigator:

Priyank P. Patel

Central Care Cancer Center - Garden City

Recruiting

Garden City, Kansas, United States, 67846

Contacts

Principal Investigator:

Jay W. Carlson

Central Care Cancer Center - Great Bend

Recruiting

Great Bend, Kansas, United States, 67530

Contacts

Principal Investigator:

Jay W. Carlson

Mercy Hospital Pittsburg

Recruiting

Pittsburg, Kansas, United States, 66762

Contacts

Site Public Contact

888-446-3729

Principal Investigator:

Jay W. Carlson

Massachusetts General Hospital Cancer Center

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Site Public Contact

877-726-5130

Principal Investigator:

Zofia Piotrowska

MyMichigan Medical Center Gratiot

Recruiting

Alma, Michigan, United States, 48801

Contacts

Principal Investigator:

Christopher M. Reynolds

MyMichigan Medical Center Alpena

Recruiting

Alpena, Michigan, United States, 49707

Contacts

Principal Investigator:

Christopher M. Reynolds

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Recruiting

Ann Arbor, Michigan, United States, 48106

Contacts

Principal Investigator:

Christopher M. Reynolds

Bronson Battle Creek

Recruiting

Battle Creek, Michigan, United States, 49017

Contacts

Principal Investigator:

Kathleen Y. Butler

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Recruiting

Brighton, Michigan, United States, 48114

Contacts

Principal Investigator:

Christopher M. Reynolds

Trinity Health Medical Center - Brighton

Recruiting

Brighton, Michigan, United States, 48114

Contacts

Principal Investigator:

Christopher M. Reynolds

Trinity Health IHA Medical Group Hematology Oncology - Canton

Recruiting

Canton, Michigan, United States, 48188

Contacts

Principal Investigator:

Christopher M. Reynolds

Trinity Health Medical Center - Canton

Recruiting

Canton, Michigan, United States, 48188

Contacts

Principal Investigator:

Christopher M. Reynolds

Chelsea Hospital

Recruiting

Chelsea, Michigan, United States, 48118

Contacts

Principal Investigator:

Christopher M. Reynolds

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Recruiting

Chelsea, Michigan, United States, 48118

Contacts

Principal Investigator:

Christopher M. Reynolds

Hematology Oncology Consultants-Clarkston

Recruiting

Clarkston, Michigan, United States, 48346

Contacts

Principal Investigator:

Christopher M. Reynolds

Trinity Health IHA Medical Group - Primary Care - Clarkston

Recruiting

Clarkston, Michigan, United States, 48346

Contacts

Principal Investigator:

Christopher M. Reynolds

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Principal Investigator:

Adam M. Forman

Henry Ford Health Saint John Hospital

Recruiting

Detroit, Michigan, United States, 48236

Contacts

Principal Investigator:

Christopher M. Reynolds

Henry Ford River District Hospital

Recruiting

East China Township, Michigan, United States, 48054

Contacts

Principal Investigator:

Christopher M. Reynolds

Cancer Hematology Centers - Flint

Recruiting

Flint, Michigan, United States, 48503

Contacts

Principal Investigator:

Christopher M. Reynolds

Genesee Hematology Oncology PC

Recruiting

Flint, Michigan, United States, 48503

Contacts

Principal Investigator:

Christopher M. Reynolds

Genesys Hurley Cancer Institute

Recruiting

Flint, Michigan, United States, 48503

Contacts

Principal Investigator:

Christopher M. Reynolds

Hurley Medical Center

Recruiting

Flint, Michigan, United States, 48503

Contacts

Principal Investigator:

Christopher M. Reynolds

MyMichigan Medical Center Gladwin

Recruiting

Gladwin, Michigan, United States, 48624

Contacts

Principal Investigator:

Christopher M. Reynolds

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Principal Investigator:

Kathleen Y. Butler

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

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Principal Investigator:

Kathleen Y. Butler

Henry Ford Saint John Hospital - Academic

Recruiting

Grosse Pointe Woods, Michigan, United States, 48236

Contacts

Principal Investigator:

Christopher M. Reynolds

Henry Ford Saint John Hospital - Breast

Recruiting

Grosse Pointe Woods, Michigan, United States, 48236

Contacts

Principal Investigator:

Christopher M. Reynolds

Henry Ford Saint John Hospital - Van Elslander

Recruiting

Grosse Pointe Woods, Michigan, United States, 48236

Contacts

Principal Investigator:

Christopher M. Reynolds

Bronson Methodist Hospital

Recruiting

Kalamazoo, Michigan, United States, 49007

Contacts

Principal Investigator:

Kathleen Y. Butler

West Michigan Cancer Center

Recruiting

Kalamazoo, Michigan, United States, 49007

Contacts

Principal Investigator:

Kathleen Y. Butler

University of Michigan Health - Sparrow Lansing

Recruiting

Lansing, Michigan, United States, 48912

Contacts

Principal Investigator:

Christopher M. Reynolds

Trinity Health Saint Mary Mercy Livonia Hospital

Recruiting

Livonia, Michigan, United States, 48154

Contacts

Principal Investigator:

Christopher M. Reynolds

Henry Ford Saint John Hospital - Macomb Medical

Recruiting

Macomb, Michigan, United States, 48044

Contacts

Principal Investigator:

Christopher M. Reynolds

Henry Ford Warren Hospital - Breast Macomb

Recruiting

Macomb, Michigan, United States, 48044

Contacts

Principal Investigator:

Christopher M. Reynolds

MyMichigan Medical Center Midland

Recruiting

Midland, Michigan, United States, 48670

Contacts

Principal Investigator:

Christopher M. Reynolds

MyMichigan Medical Center Mount Pleasant

Recruiting

Mount Pleasant, Michigan, United States, 48858

Contacts

Principal Investigator:

Christopher M. Reynolds

Corewell Health Lakeland Hospitals - Niles Hospital

Recruiting

Niles, Michigan, United States, 49120

Contacts

Site Public Contact

616-391-1230

Principal Investigator:

Kathleen Y. Butler

Henry Ford Health Providence Novi Hospital

Recruiting

Novi, Michigan, United States, 48374

Contacts

Site Public Contact

248-849-5332kfife3@hfhs.org

Principal Investigator:

Susan E. Lyons

Michigan Healthcare Professionals Pontiac

Recruiting

Pontiac, Michigan, United States, 48341

Contacts

Principal Investigator:

Christopher M. Reynolds

Newland Medical Associates-Pontiac

Recruiting

Pontiac, Michigan, United States, 48341

Contacts

Principal Investigator:

Christopher M. Reynolds

Trinity Health Saint Joseph Mercy Oakland Hospital

Recruiting

Pontiac, Michigan, United States, 48341

Contacts

Principal Investigator:

Christopher M. Reynolds

Corewell Health Reed City Hospital

Recruiting

Reed City, Michigan, United States, 49677

Contacts

Principal Investigator:

Kathleen Y. Butler

MyMichigan Medical Center Saginaw

Recruiting

Saginaw, Michigan, United States, 48601

Contacts

Principal Investigator:

Christopher M. Reynolds

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Recruiting

Saint Joseph, Michigan, United States, 49085

Contacts

Principal Investigator:

Kathleen Y. Butler

Corewell Health Lakeland Hospitals - Saint Joseph Hospital

Recruiting

Saint Joseph, Michigan, United States, 49085

Contacts

Principal Investigator:

Kathleen Y. Butler

Henry Ford Health Providence Southfield Hospital

Recruiting

Southfield, Michigan, United States, 48075

Contacts

Site Public Contact

248-849-5332kfife3@hfhs.org

Principal Investigator:

Susan E. Lyons

MyMichigan Medical Center Tawas

Recruiting

Tawas City, Michigan, United States, 48764

Contacts

Principal Investigator:

Christopher M. Reynolds

Munson Medical Center

Recruiting

Traverse City, Michigan, United States, 49684

Contacts

Principal Investigator:

Kathleen Y. Butler

Henry Ford Health Warren Hospital

Recruiting

Warren, Michigan, United States, 48093

Contacts

Principal Investigator:

Christopher M. Reynolds

Henry Ford Madison Heights Hospital - Breast

Recruiting

Warren, Michigan, United States, 48093

Contacts

Principal Investigator:

Christopher M. Reynolds

Henry Ford Warren Hospital - GLCMS

Recruiting

Warren, Michigan, United States, 48093

Contacts

Principal Investigator:

Christopher M. Reynolds

University of Michigan Health - West

Recruiting

Wyoming, Michigan, United States, 49519

Contacts

Principal Investigator:

Kathleen Y. Butler

Huron Gastroenterology PC

Recruiting

Ypsilanti, Michigan, United States, 48106

Contacts

Principal Investigator:

Christopher M. Reynolds

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Recruiting

Ypsilanti, Michigan, United States, 48197

Contacts

Principal Investigator:

Christopher M. Reynolds

Minnesota Oncology - Burnsville

Recruiting

Burnsville, Minnesota, United States, 55337

Contacts

Principal Investigator:

David M. King

Cambridge Medical Center

Recruiting

Cambridge, Minnesota, United States, 55008

Contacts

Principal Investigator:

David M. King

Minnesota Oncology Hematology PA-Chaska

Recruiting

Chaska, Minnesota, United States, 55318

Contacts

Principal Investigator:

David M. King

Mercy Hospital

Recruiting

Coon Rapids, Minnesota, United States, 55433

Contacts

Principal Investigator:

David M. King

Minnesota Oncology - Coon Rapids

Recruiting

Coon Rapids, Minnesota, United States, 55433

Contacts

Principal Investigator:

David M. King

Fairview Southdale Hospital

Recruiting

Edina, Minnesota, United States, 55435

Contacts

Principal Investigator:

David M. King

Minnesota Oncology - Edina

Recruiting

Edina, Minnesota, United States, 55435

Contacts

Principal Investigator:

David M. King

Fairview Clinics and Surgery Center Maple Grove

Recruiting

Maple Grove, Minnesota, United States, 55369

Contacts

Principal Investigator:

David M. King

HealthPartners Cancer Care - Park Nicollet Maple Grove

Recruiting

Maple Grove, Minnesota, United States, 55369

Contacts

Principal Investigator:

David M. King

Minnesota Oncology - Maple Grove

Recruiting

Maple Grove, Minnesota, United States, 55369

Contacts

Principal Investigator:

David M. King

Minnesota Oncology Hematology PA-Maplewood

Recruiting

Maplewood, Minnesota, United States, 55109

Contacts

Principal Investigator:

David M. King

Saint John's Hospital - Healtheast

Recruiting

Maplewood, Minnesota, United States, 55109

Contacts

Principal Investigator:

David M. King

Abbott-Northwestern Hospital

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Principal Investigator:

David M. King

Health Partners Inc

Recruiting

Minneapolis, Minnesota, United States, 55454

Contacts

Principal Investigator:

David M. King

Monticello Cancer Center

Recruiting

Monticello, Minnesota, United States, 55362

Contacts

Principal Investigator:

David M. King

New Ulm Medical Center

Recruiting

New Ulm, Minnesota, United States, 56073

Contacts

Principal Investigator:

David M. King

Fairview Northland Medical Center

Recruiting

Princeton, Minnesota, United States, 55371

Contacts

Principal Investigator:

David M. King

North Memorial Medical Health Center

Recruiting

Robbinsdale, Minnesota, United States, 55422

Contacts

Principal Investigator:

David M. King

Park Nicollet Clinic - Saint Louis Park

Recruiting

Saint Louis Park, Minnesota, United States, 55416

Contacts

Principal Investigator:

David M. King

Regions Hospital

Recruiting

Saint Paul, Minnesota, United States, 55101

Contacts

Principal Investigator:

David M. King

United Hospital

Recruiting

Saint Paul, Minnesota, United States, 55102

Contacts

Principal Investigator:

David M. King

Saint Francis Regional Medical Center

Recruiting

Shakopee, Minnesota, United States, 55379

Contacts

Principal Investigator:

David M. King

Lakeview Hospital

Recruiting

Stillwater, Minnesota, United States, 55082

Contacts

Principal Investigator:

David M. King

Ridgeview Medical Center

Recruiting

Waconia, Minnesota, United States, 55387

Contacts

Principal Investigator:

David M. King

Rice Memorial Hospital

Recruiting

Willmar, Minnesota, United States, 56201

Contacts

Principal Investigator:

David M. King

Minnesota Oncology Hematology PA-Woodbury

Recruiting

Woodbury, Minnesota, United States, 55125

Contacts

Principal Investigator:

David M. King

Fairview Lakes Medical Center

Recruiting

Wyoming, Minnesota, United States, 55092

Contacts

Principal Investigator:

David M. King

Mercy Oncology and Hematology - Clayton-Clarkson

Recruiting

Ballwin, Missouri, United States, 63011

Contacts

Site Public Contact

888-446-3729

Principal Investigator:

Jay W. Carlson

Central Care Cancer Center - Bolivar

Recruiting

Bolivar, Missouri, United States, 65613

Contacts

Principal Investigator:

Jay W. Carlson

Cox Cancer Center Branson

Recruiting

Branson, Missouri, United States, 65616

Contacts

Site Public Contact

417-269-4520

Principal Investigator:

Jay W. Carlson

Mercy Cancer Center - Cape Girardeau

Recruiting

Cape Girardeau, Missouri, United States, 63703

Contacts

Site Public Contact

888-446-3729

Principal Investigator:

Jay W. Carlson

Saint Francis Medical Center

Recruiting

Cape Girardeau, Missouri, United States, 63703

Contacts

Site Public Contact

573-334-2230sfmc@sfmc.net

Principal Investigator:

Bryan A. Faller

Parkland Health Center - Farmington

Recruiting

Farmington, Missouri, United States, 63640

Contacts

Site Public Contact

314-996-5569

Principal Investigator:

Bryan A. Faller

Freeman Health System

Recruiting

Joplin, Missouri, United States, 64804

Contacts

Principal Investigator:

Jay W. Carlson

Mercy Hospital Joplin

Recruiting

Joplin, Missouri, United States, 64804

Contacts

Principal Investigator:

Jay W. Carlson

Lake Regional Hospital

Recruiting

Osage Beach, Missouri, United States, 65065

Contacts

Principal Investigator:

Jay W. Carlson

Mercy Clinic-Rolla-Cancer and Hematology

Recruiting

Rolla, Missouri, United States, 65401

Contacts

Site Public Contact

573-458-6379

Principal Investigator:

Jay W. Carlson

Phelps Health Delbert Day Cancer Institute

Recruiting

Rolla, Missouri, United States, 65401

Contacts

Principal Investigator:

Jay W. Carlson

Heartland Regional Medical Center

Recruiting

Saint Joseph, Missouri, United States, 64506

Contacts

Principal Investigator:

Jay W. Carlson

Sainte Genevieve County Memorial Hospital

Recruiting

Sainte Genevieve, Missouri, United States, 63670

Contacts

Site Public Contact

314-996-5569

Principal Investigator:

Bryan A. Faller

Mercy Hospital Springfield

Recruiting

Springfield, Missouri, United States, 65804

Contacts

Site Public Contact

417-269-4520

Principal Investigator:

Jay W. Carlson

CoxHealth South Hospital

Recruiting

Springfield, Missouri, United States, 65807

Contacts

Site Public Contact

417-269-4520

Principal Investigator:

Jay W. Carlson

Mercy Infusion Center - Chippewa

Recruiting

St Louis, Missouri, United States, 63109

Contacts

Site Public Contact

888-446-3729

Principal Investigator:

Jay W. Carlson

Mercy Hospital South

Recruiting

St Louis, Missouri, United States, 63128

Contacts

Principal Investigator:

Jay W. Carlson

Missouri Baptist Medical Center

Recruiting

St Louis, Missouri, United States, 63131

Contacts

Site Public Contact

314-996-5569

Principal Investigator:

Bryan A. Faller

Mercy Hospital Saint Louis

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Site Public Contact

314-251-7066

Principal Investigator:

Jay W. Carlson

Missouri Baptist Sullivan Hospital

Recruiting

Sullivan, Missouri, United States, 63080

Contacts

Site Public Contact

314-996-5569

Principal Investigator:

Bryan A. Faller

Mercy Hospital Washington

Recruiting

Washington, Missouri, United States, 63090

Contacts

Site Public Contact

636-390-1600

Principal Investigator:

Jay W. Carlson

Community Hospital of Anaconda

Recruiting

Anaconda, Montana, United States, 59711

Contacts

Principal Investigator:

John M. Schallenkamp

Billings Clinic Cancer Center

Recruiting

Billings, Montana, United States, 59101

Contacts

Principal Investigator:

John M. Schallenkamp

Bozeman Health Deaconess Hospital

Recruiting

Bozeman, Montana, United States, 59715

Contacts

Principal Investigator:

John M. Schallenkamp

Benefis Sletten Cancer Institute

Recruiting

Great Falls, Montana, United States, 59405

Contacts

Principal Investigator:

John M. Schallenkamp

Great Falls Clinic

Recruiting

Great Falls, Montana, United States, 59405

Contacts

Principal Investigator:

John M. Schallenkamp

Hi-Line Sletten Cancer Center

Recruiting

Havre, Montana, United States, 59501

Contacts

Site Public Contact

ecog.rss@jimmy.harvard.edu

Principal Investigator:

John M. Schallenkamp

Benefis Helena Specialty Center

Recruiting

Helena, Montana, United States, 59601

Contacts

Principal Investigator:

John M. Schallenkamp

Logan Health Medical Center

Recruiting

Kalispell, Montana, United States, 59901

Contacts

Principal Investigator:

John M. Schallenkamp

Community Medical Center

Recruiting

Missoula, Montana, United States, 59804

Contacts

Principal Investigator:

John M. Schallenkamp

FirstHealth of the Carolinas-Moore Regional Hospital

Recruiting

Pinehurst, North Carolina, United States, 28374

Contacts

Principal Investigator:

Charles S. Kuzma

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Regan M. Memmott

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Principal Investigator:

Raid Aljumaily

Mercy Hospital Oklahoma City

Recruiting

Oklahoma City, Oklahoma, United States, 73120

Contacts

Site Public Contact

405-752-3402

Principal Investigator:

Jay W. Carlson

Saint Alphonsus Cancer Care Center-Baker City

Recruiting

Baker City, Oregon, United States, 97814

Contacts

Principal Investigator:

Christopher M. Reynolds

Good Samaritan Hospital

Recruiting

Corvallis, Oregon, United States, 97330

Contacts

Principal Investigator:

John Strother

Saint Alphonsus Cancer Care Center-Ontario

Recruiting

Ontario, Oregon, United States, 97914

Contacts

Principal Investigator:

Christopher M. Reynolds

Lehigh Valley Hospital-Cedar Crest

Recruiting

Allentown, Pennsylvania, United States, 18103

Contacts

Principal Investigator:

Christopher M. Reynolds

Lehigh Valley Hospital - Muhlenberg

Recruiting

Bethlehem, Pennsylvania, United States, 18017

Contacts

Principal Investigator:

Christopher M. Reynolds

Bryn Mawr Hospital

Recruiting

Bryn Mawr, Pennsylvania, United States, 19010

Contacts

Site Public Contact

484-476-2649turzoe@mlhs.org

Principal Investigator:

Paul B. Gilman

Pocono Medical Center

Recruiting

East Stroudsburg, Pennsylvania, United States, 18301

Contacts

Principal Investigator:

Christopher M. Reynolds

Lehigh Valley Hospital-Hazleton

Recruiting

Hazleton, Pennsylvania, United States, 18201

Contacts

Principal Investigator:

Christopher M. Reynolds

Riddle Memorial Hospital

Recruiting

Media, Pennsylvania, United States, 19063

Contacts

Site Public Contact

484-476-2649turzoe@mlhs.org

Principal Investigator:

Paul B. Gilman

Paoli Memorial Hospital

Recruiting

Paoli, Pennsylvania, United States, 19301

Contacts

Site Public Contact

484-476-2649turzoe@mlhs.org

Principal Investigator:

Paul B. Gilman

Lankenau Medical Center

Recruiting

Wynnewood, Pennsylvania, United States, 19096

Contacts

Site Public Contact

484-476-2649turzoe@mlhs.org

Principal Investigator:

Paul B. Gilman

University of Virginia Cancer Center

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Principal Investigator:

Richard D. Hall

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

Site Public Contact

800-804-8824

Principal Investigator:

Christina S. Baik

University of Washington Medical Center - Montlake

Recruiting

Seattle, Washington, United States, 98195

Contacts

Site Public Contact

800-804-8824

Principal Investigator:

Christina S. Baik

Aurora Cancer Care-Southern Lakes VLCC

Recruiting

Burlington, Wisconsin, United States, 53105

Contacts

Principal Investigator:

Shamsuddin Virani

Marshfield Clinic-Chippewa Center

Recruiting

Chippewa Falls, Wisconsin, United States, 54729

Contacts

Principal Investigator:

Chady A. Leon

Aurora Saint Luke's South Shore

Recruiting

Cudahy, Wisconsin, United States, 53110

Contacts

Principal Investigator:

Shamsuddin Virani

Marshfield Medical Center-EC Cancer Center

Recruiting

Eau Claire, Wisconsin, United States, 54701

Contacts

Principal Investigator:

Chady A. Leon

Aurora Health Center-Fond du Lac

Recruiting

Fond du Lac, Wisconsin, United States, 54937

Contacts

Principal Investigator:

Shamsuddin Virani

Aurora Health Care Germantown Health Center

Recruiting

Germantown, Wisconsin, United States, 53022

Contacts

Principal Investigator:

Shamsuddin Virani

Aurora Cancer Care-Grafton

Recruiting

Grafton, Wisconsin, United States, 53024

Contacts

Principal Investigator:

Shamsuddin Virani

Aurora BayCare Medical Center

Recruiting

Green Bay, Wisconsin, United States, 54311

Contacts

Principal Investigator:

Shamsuddin Virani

Aurora Cancer Care-Kenosha South

Recruiting

Kenosha, Wisconsin, United States, 53142

Contacts

Principal Investigator:

Shamsuddin Virani

Gundersen Lutheran Medical Center

Recruiting

La Crosse, Wisconsin, United States, 54601

Contacts

Principal Investigator:

Kurt Oettel

Marshfield Medical Center - Ladysmith

Recruiting

Ladysmith, Wisconsin, United States, 54848

Contacts

Principal Investigator:

Chady A. Leon

Aurora Bay Area Medical Group-Marinette

Recruiting

Marinette, Wisconsin, United States, 54143

Contacts

Principal Investigator:

Shamsuddin Virani

Marshfield Medical Center-Marshfield

Recruiting

Marshfield, Wisconsin, United States, 54449

Contacts

Principal Investigator:

Chady A. Leon

Aurora Cancer Care-Milwaukee

Recruiting

Milwaukee, Wisconsin, United States, 53209

Contacts

Principal Investigator:

Shamsuddin Virani

Aurora Saint Luke's Medical Center

Recruiting

Milwaukee, Wisconsin, United States, 53215

Contacts

Principal Investigator:

Shamsuddin Virani

Aurora Sinai Medical Center

Recruiting

Milwaukee, Wisconsin, United States, 53233

Contacts

Principal Investigator:

Shamsuddin Virani

Marshfield Medical Center - Minocqua

Recruiting

Minocqua, Wisconsin, United States, 54548

Contacts

Principal Investigator:

Chady A. Leon

Cancer Center of Western Wisconsin

Recruiting

New Richmond, Wisconsin, United States, 54017

Contacts

Principal Investigator:

David M. King

Vince Lombardi Cancer Clinic - Oshkosh

Recruiting

Oshkosh, Wisconsin, United States, 54904

Contacts

Principal Investigator:

Shamsuddin Virani

Aurora Cancer Care-Racine

Recruiting

Racine, Wisconsin, United States, 53406

Contacts

Principal Investigator:

Shamsuddin Virani

Marshfield Medical Center-Rice Lake

Recruiting

Rice Lake, Wisconsin, United States, 54868

Contacts

Principal Investigator:

Chady A. Leon

Vince Lombardi Cancer Clinic-Sheboygan

Recruiting

Sheboygan, Wisconsin, United States, 53081

Contacts

Principal Investigator:

Shamsuddin Virani

Marshfield Medical Center-River Region at Stevens Point

Recruiting

Stevens Point, Wisconsin, United States, 54482

Contacts

Principal Investigator:

Chady A. Leon

Aurora Medical Center in Summit

Recruiting

Summit, Wisconsin, United States, 53066

Contacts

Principal Investigator:

Shamsuddin Virani

Vince Lombardi Cancer Clinic-Two Rivers

Recruiting

Two Rivers, Wisconsin, United States, 54241

Contacts

Principal Investigator:

Shamsuddin Virani

Marshfield Clinic-Wausau Center

Recruiting

Wausau, Wisconsin, United States, 54401

Contacts

Principal Investigator:

Chady A. Leon

Aurora Cancer Care-Milwaukee West

Recruiting

Wauwatosa, Wisconsin, United States, 53226

Contacts

Principal Investigator:

Shamsuddin Virani

Aurora West Allis Medical Center

Recruiting

West Allis, Wisconsin, United States, 53227

Contacts

Principal Investigator:

Shamsuddin Virani

Marshfield Medical Center - Weston

Recruiting

Weston, Wisconsin, United States, 54476

Contacts

Principal Investigator:

Chady A. Leon

Marshfield Clinic - Wisconsin Rapids Center

Recruiting

Wisconsin Rapids, Wisconsin, United States, 54494

Contacts

Principal Investigator:

Chady A. Leon

Memorial Hospital of Laramie County

Recruiting

Cheyenne, Wyoming, United States, 82001

Contacts

Site Public Contact

ecog.rss@jimmy.harvard.edu

Principal Investigator:

John M. Schallenkamp

Billings Clinic-Cody

Recruiting

Cody, Wyoming, United States, 82414

Contacts

Principal Investigator:

John M. Schallenkamp

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Oct 6, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-10-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.