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RecruitingNCT03191149Updated Sep 24, 2026

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

A Phase 2 interventional study of Biospecimen Collection and Computed Tomography with Contrast in Advanced Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma and Stage IIIB Lung Non-Small Cell Cancer AJCC v7, sponsored by National Cancer Institute (NCI). Recruiting at 345 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
46
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

PRIMARY OBJECTIVE:

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

SECONDARY OBJECTIVES:

I. 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:

I. 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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
46 participants (estimated)

Study 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.

    Procedure: Biospecimen Collection · Procedure: Computed Tomography with Contrast · Procedure: Echocardiography Test · Procedure: Magnetic Resonance Imaging · Procedure: Multigated Acquisition Scan · Drug: Osimertinib

Interventions

  • ProcedureBiospecimen Collection

    Undergo collection of blood samples

    Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

  • ProcedureComputed Tomography with Contrast

    Undergo CT with contrast

    Also known as: Contrast Enhanced Computed Tomography, CONTRAST ENHANCED CT SCAN, Contrast-enhanced Computed Tomography, CT Scan With Contrast, CT with Contrast

  • ProcedureEchocardiography Test

    Undergo ECHO

    Also known as: EC, Echocardiography

  • ProcedureMagnetic Resonance Imaging

    Undergo MRI

    Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

  • ProcedureMultigated Acquisition Scan

    Undergo MUGA

    Also known as: Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan, MUGA, MUGA Scan, Multi-Gated Acquisition Scan, Radionuclide Ventriculogram Scan, Radionuclide Ventriculography, RNV Scan, RNVG, SYMA Scanning, Synchronized Multigated Acquisition Scanning

  • DrugOsimertinib

    Given PO

    Also known as: AZD 9291, AZD-9291, AZD9291, Mereletinib

05

What researchers measure

Primary outcomes

  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.

    Time frame: Up to 5 years

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Up to 5 years

Other outcomes

  1. Characterization of molecular markers of response to treatment in circulating tumor deoxyribonucleic acid (ctDNA)

    Initial analyses of data will utilize tests for association comparing the frequency of a particular genomic aberration at baseline and at progression (for example, using McNemar's test) and association between alterations and baseline characteristics (for example, using Fisher's exact test). More sophisticated analyses may include multivariable logistic regression modeling and/or competing risks analysis, however it is expected that analyzable results will not be obtained from 100% of patients (either due to things like assay failure, inability to biopsy at progression due to poor patient health, etc).

    Time frame: Baseline up to 5 years

  2. Biomarkers of response to treatment through retrospective analyses of pre-treatment tumor tissue

    The rate of change in allelic fraction at a particular time point may be compared to baseline measures of ctDNA and that measure will be analyzed for association with patient demographics and/or disease characteristics using the Kruskal Wallis test. Landmark analyses of PFS and OS in which the landmark time is defined by the ctDNA measurements at a particular time point, may be used as well.

    Time frame: Baseline up to 5 years

  3. Identification of resistance mechanisms to osimertinib through post-progression tumor biopsies and ctDNA

    Presence or absence of mutations in plasma will be analyzed for association with other variables using Fisher's exact test. To account for the repeated measures of plasma over time, we may potentially use these data as time varying covariates in multivariable Cox models to study their impact on outcomes like PFS and OS.

    Time frame: Up to 5 years

06

Study locations

212 of 345 sites recruiting
  • Anchorage Associates in Radiation Medicine
    Anchorage, Alaska 98508, United States
    Active, not recruiting
  • Anchorage Radiation Therapy Center
    Anchorage, Alaska 99504, United States
    Active, not recruiting
  • Alaska Breast Care and Surgery LLC
    Anchorage, Alaska 99508, United States
    Active, not recruiting
  • Alaska Oncology and Hematology LLC
    Anchorage, Alaska 99508, United States
    Active, not recruiting
  • Alaska Women's Cancer Care
    Anchorage, Alaska 99508, United States
    Active, not recruiting
  • Anchorage Oncology Centre
    Anchorage, Alaska 99508, United States
    Active, not recruiting
  • Katmai Oncology Group
    Anchorage, Alaska 99508, United States
    Active, not recruiting
  • Providence Alaska Medical Center
    Anchorage, Alaska 99508, United States
    Active, not recruiting
  • Fairbanks Memorial Hospital
    Fairbanks, Alaska 99701, United States
    Recruiting
  • Mercy Hospital Fort Smith
    Fort Smith, Arkansas 72903, United States
    • Site Public Contact · Contact · 800-378-9373
    • Jay W. Carlson · Principal investigator
    Recruiting
  • CARTI Cancer Center
    Little Rock, Arkansas 72205, United States
    • Site Public Contact · Contact · Research@CARTI.com · 501-906-4199
    • Jay W. Carlson · Principal investigator
    Recruiting
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
    Burbank, California 91505, United States
    Active, not recruiting
  • MedStar Georgetown University Hospital
    Washington D.C., District of Columbia 20007, United States
    • Site Public Contact · Contact · 202-444-2223
    • Chul Kim · Principal investigator
    Recruiting
  • Holy Cross Hospital
    Fort Lauderdale, Florida 33308, United States
    Recruiting
  • Emory University Hospital Midtown
    Atlanta, Georgia 30308, United States
    • Site Public Contact · Contact · 888-946-7447
    • Ticiana A. Leal · Principal investigator
    Recruiting
  • Emory University Hospital/Winship Cancer Institute
    Atlanta, Georgia 30322, United States
    • Site Public Contact · Contact · 404-778-1868
    • Ticiana A. Leal · Principal investigator
    Recruiting
  • Emory Saint Joseph's Hospital
    Atlanta, Georgia 30342, United States
    • Site Public Contact · Contact · 404-851-7115
    • Ticiana A. Leal · Principal investigator
    Recruiting
  • Saint Alphonsus Cancer Care Center-Boise
    Boise, Idaho 83706, United States
    Recruiting
  • Saint Luke's Cancer Institute - Boise
    Boise, Idaho 83712, United States
    Active, not recruiting
  • Saint Alphonsus Cancer Care Center-Caldwell
    Caldwell, Idaho 83605, United States
    Recruiting
  • Kootenai Health - Coeur d'Alene
    Coeur d'Alene, Idaho 83814, United States
    • Site Public Contact · Contact · mccinfo@mtcancer.org · 406-969-6060
    • John M. Schallenkamp · Principal investigator
    Recruiting
  • Walter Knox Memorial Hospital
    Emmett, Idaho 83617, United States
    Suspended
  • Saint Luke's Cancer Institute - Fruitland
    Fruitland, Idaho 83619, United States
    Active, not recruiting
  • Idaho Urologic Institute-Meridian
    Meridian, Idaho 83642, United States
    Recruiting
  • Saint Luke's Cancer Institute - Meridian
    Meridian, Idaho 83642, United States
    Active, not recruiting
  • Saint Alphonsus Cancer Care Center-Nampa
    Nampa, Idaho 83687, United States
    • Site Public Contact · Contact · mccinfo@mtcancer.org · 406-969-6060
    • Christopher M. Reynolds · Principal investigator
    Recruiting
  • Saint Luke's Cancer Institute - Nampa
    Nampa, Idaho 83687, United States
    Active, not recruiting
  • Kootenai Clinic Cancer Services - Post Falls
    Post Falls, Idaho 83854, United States
    • Site Public Contact · Contact · mccinfo@mtcancer.org · 406-969-6060
    • John M. Schallenkamp · Principal investigator
    Recruiting
  • Kootenai Clinic Cancer Services - Sandpoint
    Sandpoint, Idaho 83864, United States
    • Site Public Contact · Contact · mccinfo@mtcancer.org · 406-969-6060
    • John M. Schallenkamp · Principal investigator
    Recruiting
  • Saint Luke's Cancer Institute - Twin Falls
    Twin Falls, Idaho 83301, United States
    Active, not recruiting
  • OSF Saint Anthony's Health Center
    Alton, Illinois 62002, United States
    • Site Public Contact · Contact · 618-463-5623
    • Jay W. Carlson · Principal investigator
    Recruiting
  • Rush-Copley Medical Center
    Aurora, Illinois 60504, United States
    Recruiting
  • Illinois CancerCare-Bloomington
    Bloomington, Illinois 61704, United States
    Recruiting
  • Illinois CancerCare-Canton
    Canton, Illinois 61520, United States
    Recruiting
  • Memorial Hospital of Carbondale
    Carbondale, Illinois 62902, United States
    Recruiting
  • SIH Cancer Institute
    Carterville, Illinois 62918, United States
    Recruiting
  • Illinois CancerCare-Carthage
    Carthage, Illinois 62321, United States
    Recruiting
  • Centralia Oncology Clinic
    Centralia, Illinois 62801, United States
    Recruiting
  • Saint Mary's Hospital
    Centralia, Illinois 62801, United States
    Suspended
  • Carle at The Riverfront
    Danville, Illinois 61832, United States
    • Site Public Contact · Contact · Research@Carle.com · 800-446-5532
    • Priyank P. Patel · Principal investigator
    Recruiting
  • Cancer Care Specialists of Illinois - Decatur
    Decatur, Illinois 62526, United States
    Recruiting
  • Decatur Memorial Hospital
    Decatur, Illinois 62526, United States
    Recruiting
  • Illinois CancerCare-Dixon
    Dixon, Illinois 61021, United States
    • Site Public Contact · Contact · 815-285-7800
    • Bryan A. Faller · Principal investigator
    Recruiting
  • Carle Physician Group-Effingham
    Effingham, Illinois 62401, United States
    • Site Public Contact · Contact · Research@carle.com · 800-446-5532
    • Priyank P. Patel · Principal investigator
    Recruiting
  • Crossroads Cancer Center
    Effingham, Illinois 62401, United States
    Recruiting
  • Illinois CancerCare-Eureka
    Eureka, Illinois 61530, United States
    Recruiting
  • NorthShore University HealthSystem-Evanston Hospital
    Evanston, Illinois 60201, United States
    Active, not recruiting
  • Illinois CancerCare-Galesburg
    Galesburg, Illinois 61401, United States
    Recruiting
  • Western Illinois Cancer Treatment Center
    Galesburg, Illinois 61401, United States
    Suspended
  • NorthShore University HealthSystem-Glenbrook Hospital
    Glenview, Illinois 60026, United States
    Active, not recruiting
  • NorthShore University HealthSystem-Highland Park Hospital
    Highland Park, Illinois 60035, United States
    Active, not recruiting
  • Illinois CancerCare-Kewanee Clinic
    Kewanee, Illinois 61443, United States
    Recruiting
  • Illinois CancerCare-Macomb
    Macomb, Illinois 61455, United States
    Recruiting
  • Carle Physician Group-Mattoon/Charleston
    Mattoon, Illinois 61938, United States
    • Site Public Contact · Contact · Research@carle.com · 800-446-5532
    • Priyank P. Patel · Principal investigator
    Recruiting
  • SSM Health Good Samaritan
    Mount Vernon, Illinois 62864, United States
    Recruiting
  • Cancer Care Center of O'Fallon
    O'Fallon, Illinois 62269, United States
    Recruiting
  • HSHS Saint Elizabeth's Hospital
    O'Fallon, Illinois 62269, United States
    Recruiting
  • Illinois CancerCare-Ottawa Clinic
    Ottawa, Illinois 61350, United States
    Recruiting
  • Illinois CancerCare-Pekin
    Pekin, Illinois 61554, United States
    Recruiting
  • Illinois CancerCare-Peoria
    Peoria, Illinois 61615, United States
    Recruiting
  • Methodist Medical Center of Illinois
    Peoria, Illinois 61636, United States
    Recruiting
  • Illinois CancerCare-Peru
    Peru, Illinois 61354, United States
    Recruiting
  • Valley Radiation Oncology
    Peru, Illinois 61354, United States
    • Site Public Contact · Contact · 815-664-4141
    • Bryan A. Faller · Principal investigator
    Recruiting
  • Illinois CancerCare-Princeton
    Princeton, Illinois 61356, United States
    Recruiting
  • North Shore Medical Center
    Skokie, Illinois 60076, United States
    Active, not recruiting
  • Southern Illinois University School of Medicine
    Springfield, Illinois 62702, United States
    • Site Public Contact · Contact · 217-545-7929
    • Bryan A. Faller · Principal investigator
    Recruiting
  • Springfield Clinic
    Springfield, Illinois 62702, United States
    • Site Public Contact · Contact · 800-444-7541
    • Bryan A. Faller · Principal investigator
    Recruiting
  • Springfield Memorial Hospital
    Springfield, Illinois 62781, United States
    Recruiting
  • Southwest Illinois Health Services LLP
    Swansea, Illinois 62226, United States
    Suspended
  • Carle Cancer Center
    Urbana, Illinois 61801, United States
    • Site Public Contact · Contact · Research@carle.com · 800-446-5532
    • Priyank P. Patel · Principal investigator
    Recruiting
  • The Carle Foundation Hospital
    Urbana, Illinois 61801, United States
    • Site Public Contact · Contact · Research@carle.com · 800-446-5532
    • Priyank P. Patel · Principal investigator
    Recruiting
  • Illinois CancerCare - Washington
    Washington, Illinois 61571, United States
    Recruiting
  • Rush-Copley Healthcare Center
    Yorkville, Illinois 60560, United States
    Recruiting
  • Midwestern Regional Medical Center
    Zion, Illinois 60099, United States
    Active, not recruiting
  • Reid Health
    Richmond, Indiana 47374, United States
    Active, not recruiting
  • Heartland Oncology and Hematology LLP
    Council Bluffs, Iowa 51503, United States
    Active, not recruiting
  • Methodist Jennie Edmundson Hospital
    Council Bluffs, Iowa 51503, United States
    Active, not recruiting
  • Nebraska Cancer Specialists/Oncology Hematology West PC - MEJ
    Council Bluffs, Iowa 51503, United States
    Active, not recruiting
  • Iowa Methodist Medical Center
    Des Moines, Iowa 50309, United States
    Active, not recruiting
  • UI Health Care Mission Cancer and Blood - Des Moines Clinic
    Des Moines, Iowa 50309, United States
    Active, not recruiting
  • Broadlawns Medical Center
    Des Moines, Iowa 50314, United States
    Active, not recruiting
  • Iowa Lutheran Hospital
    Des Moines, Iowa 50316, United States
    Active, not recruiting
  • UI Healthcare Mission Cancer and Blood - Fort Dodge
    Fort Dodge, Iowa 50501, United States
    Active, not recruiting
  • Methodist West Hospital
    West Des Moines, Iowa 50266-7700, United States
    Active, not recruiting
  • Central Care Cancer Center - Garden City
    Garden City, Kansas 67846, United States
    • Site Public Contact · Contact · aroland@kccop.org · 913-948-5588
    • Jay W. Carlson · Principal investigator
    Recruiting
  • Central Care Cancer Center - Great Bend
    Great Bend, Kansas 67530, United States
    • Site Public Contact · Contact · aroland@kccop.org · 913-948-5588
    • Jay W. Carlson · Principal investigator
    Recruiting
  • Mercy Hospital Pittsburg
    Pittsburg, Kansas 66762, United States
    • Site Public Contact · Contact · 888-446-3729
    • Jay W. Carlson · Principal investigator
    Recruiting
  • Ochsner Health Center-Summa
    Baton Rouge, Louisiana 70809, United States
    Active, not recruiting
  • Medical Center of Baton Rouge
    Baton Rouge, Louisiana 70816, United States
    Active, not recruiting
  • Ochsner High Grove
    Baton Rouge, Louisiana 70836, United States
    Active, not recruiting
  • Ochsner Medical Center Jefferson
    New Orleans, Louisiana 70121, United States
    Active, not recruiting
  • MedStar Franklin Square Medical Center/Weinberg Cancer Institute
    Baltimore, Maryland 21237, United States
    Active, not recruiting
  • Johns Hopkins University/Sidney Kimmel Cancer Center
    Baltimore, Maryland 21287, United States
    Active, not recruiting
  • Massachusetts General Hospital Cancer Center
    Boston, Massachusetts 02114, United States
    • Site Public Contact · Contact · 877-726-5130
    • Zofia Piotrowska · Principal investigator
    Recruiting
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
    Suspended
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
    Suspended
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02215, United States
    Suspended
  • Mercy Medical Center
    Springfield, Massachusetts 01104, United States
    Suspended
  • MyMichigan Medical Center Gratiot
    Alma, Michigan 48801, United States
    Recruiting
  • MyMichigan Medical Center Alpena
    Alpena, Michigan 49707, United States
    Recruiting

Showing the first 100 of 345 sites.

07

Registry details

Key details

Study ID
NCT03191149
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jun 19, 2017
Start date
Apr 25, 2018
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Sep 24, 2026

Study contacts

Zofia Piotrowska
principal investigator · ECOG-ACRIN Cancer Research Group

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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