Lung Cancer

EA5162



Osimertinib in Treating Patients with Stage IIIB-IV or Recurrent Non-small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

STATUS: Active


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 (recurrent). Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
  • 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 Gilbertโ€™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 to treatment; at least six months (180 days) must have elapsed from radiation given with curative intent; palliative radiotherapy to control symptoms (including gamma knife technique) is permitted; for stereotactic radiosurgery (SRS) to CNS lesions, osimertinib can be held on the day of radiation only; for palliative RT to other sites of disease outside of the thorax, 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 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 echocardiogram (ECHO) or a nuclear study (multi-gated acquisition scan [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 < lower limit of normal [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 โ€“ 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 Johnโ€™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-therapyโ€“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 AZD9291 (osimertinib) 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 subjectโ€™s wellbeing may be given at the discretion of the investigator

  • A guidance regarding potential interactions with concomitant medications is provided

United States
AK
Anchorage
Alaska Breast Care and Surgery LLC
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Alaska Oncology and Hematology LLC
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Alaska Women's Cancer Care
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Anchorage Associates in Radiation Medicine
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Anchorage Oncology Centre
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Anchorage Radiation Therapy Center
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Katmai Oncology Group
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Providence Alaska Medical Center
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

AR
Ft. Smith
Mercy Hospital Fort Smith
Contact: Site Public Contact

CA
Burbank
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Contact: Site Public Contact
Email: Najee.Boucher@providence.org

DC
Washington
MedStar Georgetown University Hospital
Contact: Site Public Contact

GA
Atlanta
Emory Saint Joseph's Hospital
Contact: Site Public Contact

Emory University Hospital Midtown
Contact: Site Public Contact

Emory University Hospital/Winship Cancer Institute
Contact: Site Public Contact

IA
Council Bluffs
Heartland Oncology and Hematology LLP
Contact: Site Public Contact

Jennie Edmundson Memorial Hospital
Contact: Site Public Contact
Email: ctsucontact@westat.com

Des Moines
Broadlawns Medical Center
Contact: Site Public Contact

Iowa Lutheran Hospital
Contact: Site Public Contact

Iowa Methodist Medical Center
Contact: Site Public Contact

Medical Oncology and Hematology Associates-Des Moines
Contact: Site Public Contact

Fort Dodge
Trinity Regional Medical Center
Contact: Site Public Contact

West Des Moines
Methodist West Hospital
Contact: Site Public Contact

ID
Boise
Saint Alphonsus Cancer Care Center-Boise
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Saint Luke's Cancer Institute - Boise
Contact: Site Public Contact
Email: eslinget@slhs.org

Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Coeur D'Alene
Kootenai Health - Coeur d'Alene
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Emmett
Walter Knox Memorial Hospital
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Fruitland
Saint Luke's Cancer Institute - Fruitland
Contact: Site Public Contact
Email: eslinget@slhs.org

Meridian
Idaho Urologic Institute-Meridian
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Saint Luke's Cancer Institute - Meridian
Contact: Site Public Contact
Email: eslinget@slhs.org

Nampa
Saint Alphonsus Cancer Care Center-Nampa
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Saint Luke's Cancer Institute - Nampa
Contact: Site Public Contact
Email: eslinget@slhs.org

Post Falls
Kootenai Clinic Cancer Services - Post Falls
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Sandpoint
Kootenai Cancer Clinic
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Twin Falls
Saint Luke's Cancer Institute - Twin Falls
Contact: Site Public Contact
Email: eslinget@slhs.org

IL
Alton
Saint Anthony's Health
Contact: Site Public Contact

Aurora
Rush - Copley Medical Center
Contact: Site Public Contact
Email: Cancer.Research@rushcopley.com

Bloomington
Illinois CancerCare-Bloomington
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Canton
Illinois CancerCare-Canton
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Carbondale
Memorial Hospital of Carbondale
Contact: Site Public Contact
Email: clinical.research@sih.net

Carterville
SIH Cancer Institute
Contact: Site Public Contact
Email: clinical.research@sih.net

Carthage
Illinois CancerCare-Carthage
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Centralia
Centralia Oncology Clinic
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Saint Mary's Hospital
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Danville
Carle at The Riverfront
Contact: Site Public Contact
Email: Research@Carle.com

Decatur
Cancer Care Specialists of Illinois - Decatur
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Decatur Memorial Hospital
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Dixon
Illinois CancerCare-Dixon
Contact: Site Public Contact

Effingham
Carle Physician Group-Effingham
Contact: Site Public Contact
Email: Research@carle.com

Crossroads Cancer Center
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Eureka
Illinois CancerCare-Eureka
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Evanston
NorthShore University HealthSystem-Evanston Hospital
Contact: Site Public Contact

Galesburg
Illinois CancerCare-Galesburg
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Western Illinois Cancer Treatment Center
Contact: Site Public Contact

Glenview
NorthShore University HealthSystem-Glenbrook Hospital
Contact: Site Public Contact

Highland Park
NorthShore University HealthSystem-Highland Park Hospital
Contact: Site Public Contact

Kewanee
Illinois CancerCare-Kewanee Clinic
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Macomb
Illinois CancerCare-Macomb
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Mattoon
Carle Physician Group-Mattoon/Charleston
Contact: Site Public Contact
Email: Research@carle.com

Mount Vernon
Good Samaritan Regional Health Center
Contact: Site Public Contact

O'Fallon
Cancer Care Center of O'Fallon
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Ottawa
Illinois CancerCare-Ottawa Clinic
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Pekin
Illinois CancerCare-Pekin
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Peoria
Illinois CancerCare-Peoria
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Methodist Medical Center of Illinois
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Peru
Illinois CancerCare-Peru
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Valley Radiation Oncology
Contact: Site Public Contact

Princeton
Illinois CancerCare-Princeton
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Skokie
North Shore Medical Center
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Springfield
Memorial Medical Center
Contact: Site Public Contact
Email: pallante.beth@mhsil.com

Southern Illinois University School of Medicine
Contact: Site Public Contact

Springfield Clinic
Contact: Site Public Contact

Swansea
Southwest Illinois Health Services LLP
Contact: Site Public Contact
Email: lynns@thecancercenter.com

Urbana
Carle Cancer Center
Contact: Site Public Contact
Email: Research@carle.com

The Carle Foundation Hospital
Contact: Site Public Contact
Email: Research@carle.com

Washington
Illinois CancerCare - Washington
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Yorkville
Rush-Copley Healthcare Center
Contact: Site Public Contact
Email: Cancer.Research@rushcopley.com

IN
Richmond
Reid Health
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

KS
Garden City
Central Care Cancer Center - Garden City
Contact: Site Public Contact
Email: aroland@kccop.org

Great Bend
Central Care Cancer Center - Great Bend
Contact: Site Public Contact
Email: aroland@kccop.org

LA
Baton Rouge
Medical Center of Baton Rouge
Contact: Site Public Contact
Email: Camille.Beck@Ochsner.org

Ochsner Health Center-Summa
Contact: Site Public Contact
Email: Camille.Beck@Ochsner.org

Ochsner High Grove
Contact: Site Public Contact
Email: Camielle.beck@ochsner.org

New Orleans
Ochsner Medical Center Jefferson
Contact: Site Public Contact
Email: Elisemarie.curry@ochsner.org

MA
Boston
Beth Israel Deaconess Medical Center
Contact: Site Public Contact

Brigham and Women's Hospital
Contact: Site Public Contact

Dana-Farber Cancer Institute
Contact: Site Public Contact

Massachusetts General Hospital Cancer Center
Contact: Site Public Contact

Springfield
Mercy Medical Center
Contact: Site Public Contact

MD
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Contact: Site Public Contact
Email: jhcccro@jhmi.edu

MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Contact: Site Public Contact

MI
Ann Arbor
Saint Joseph Mercy Hospital
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Battle Creek
Bronson Battle Creek
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Brighton
Saint Joseph Mercy Brighton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Brighton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Canton
Saint Joseph Mercy Canton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Canton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Caro
Caro Cancer Center
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Chelsea
Saint Joseph Mercy Chelsea
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Clarkston
Hematology Oncology Consultants-Clarkston
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Newland Medical Associates-Clarkston
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Detroit
Ascension Saint John Hospital
Contact: Site Public Contact
Email: karen.forman@ascension.org

East China
Great Lakes Cancer Management Specialists-Doctors Park
Contact: Site Public Contact
Email: karen.forman@ascension.org

Flint
Genesee Cancer and Blood Disease Treatment Center
Contact: Site Public Contact
Email: wstrong@ghci.org

Genesee Hematology Oncology PC
Contact: Site Public Contact
Email: wstrong@ghci.org

Genesys Hurley Cancer Institute
Contact: Site Public Contact
Email: wstrong@ghci.org

Hurley Medical Center
Contact: Site Public Contact
Email: wstrong@ghci.org

Grand Rapids
Helen DeVos Children's Hospital at Spectrum Health
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Spectrum Health at Butterworth Campus
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Trinity Health Grand Rapids Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Grosse Pointe Woods
Academic Hematology Oncology Specialists
Contact: Site Public Contact
Email: karen.forman@ascension.org

Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Contact: Site Public Contact
Email: karen.forman@ascension.org

Michigan Breast Specialists-Grosse Pointe Woods
Contact: Site Public Contact
Email: karen.forman@ascension.org

Kalamazoo
Ascension Borgess Cancer Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Borgess Medical Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Bronson Methodist Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

West Michigan Cancer Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Lansing
Sparrow Hospital
Contact: Site Public Contact

Livonia
Hope Cancer Clinic
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Trinity Health Saint Mary Mercy Livonia Hospital
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Macomb Township
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Contact: Site Public Contact
Email: karen.forman@ascension.org

Michigan Breast Specialists-Macomb Township
Contact: Site Public Contact
Email: karen.forman@ascension.org

Marlette
Saint Mary's Oncology/Hematology Associates of Marlette
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Muskegon
Trinity Health Muskegon Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Niles
Lakeland Hospital Niles
Contact: Site Public Contact

Norton Shores
Cancer and Hematology Centers of Western Michigan - Norton Shores
Contact: Site Public Contact
Email: connie.szczepanek@crcwm.org

Novi
Ascension Providence Hospitals - Novi
Contact: Site Public Contact
Email: karen.fife@ascension.org

Pontiac
21st Century Oncology-Pontiac
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Hope Cancer Center
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Newland Medical Associates-Pontiac
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Saint Joseph Mercy Oakland
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Reed City
Spectrum Health Reed City Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Rochester Hills
Great Lakes Cancer Management Specialists-Rochester Hills
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Saginaw
Ascension Saint Mary's Hospital
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Oncology Hematology Associates of Saginaw Valley PC
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Saint Joseph
Lakeland Medical Center Saint Joseph
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Marie Yeager Cancer Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Southfield
Ascension Providence Hospitals - Southfield
Contact: Site Public Contact
Email: karen.fife@ascension.org

Sterling Heights
Bhadresh Nayak MD PC-Sterling Heights
Contact: Site Public Contact
Email: karen.forman@ascension.org

Tawas City
Ascension Saint Joseph Hospital
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Traverse City
Munson Medical Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Warren
Advanced Breast Care Center PLLC
Contact: Site Public Contact
Email: karen.forman@ascension.org

Great Lakes Cancer Management Specialists-Macomb Professional Building
Contact: Site Public Contact
Email: karen.forman@ascension.org

Macomb Hematology Oncology PC
Contact: Site Public Contact
Email: karen.forman@ascension.org

Michigan Breast Specialists-Warren
Contact: Site Public Contact
Email: karen.forman@ascension.org

Saint John Macomb-Oakland Hospital
Contact: Site Public Contact
Email: karen.forman@ascension.org

West Branch
Saint Mary's Oncology/Hematology Associates of West Branch
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Wyoming
University of Michigan Health - West
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Ypsilanti
Huron Gastroenterology PC
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

MN
Burnsville
Fairview Ridges Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Minnesota Oncology - Burnsville
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Cambridge
Cambridge Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Coon Rapids
Mercy Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Edina
Fairview Southdale Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Fridley
Unity Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Maple Grove
Fairview Clinics and Surgery Center Maple Grove
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Maplewood
Minnesota Oncology Hematology PA-Maplewood
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Saint John's Hospital - Healtheast
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Minneapolis
Abbott-Northwestern Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Health Partners Inc
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Monticello
Monticello Cancer Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

New Ulm
New Ulm Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Princeton
Fairview Northland Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Robbinsdale
North Memorial Medical Health Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Saint Paul
Regions Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

United Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Shakopee
Saint Francis Regional Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Stillwater
Lakeview Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Waconia
Ridgeview Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Willmar
Rice Memorial Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Woodbury
Minnesota Oncology Hematology PA-Woodbury
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Wyoming
Fairview Lakes Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

MO
Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
Contact: Site Public Contact

Bolivar
Central Care Cancer Center - Bolivar
Contact: Site Public Contact
Email: aroland@kccop.org

Bonne Terre
Parkland Health Center-Bonne Terre
Contact: Site Public Contact

Branson
Cox Cancer Center Branson
Contact: Site Public Contact

Cape Girardeau
Saint Francis Medical Center
Contact: Site Public Contact
Email: sfmc@sfmc.net

Southeast Cancer Center
Contact: Site Public Contact

Farmington
Parkland Health Center - Farmington
Contact: Site Public Contact

Jefferson City
Capital Region Southwest Campus
Contact: Site Public Contact
Email: swooden@mail.crmc.org

Joplin
Freeman Health System
Contact: Site Public Contact
Email: LJCrockett@freemanhealth.com

Mercy Hospital Joplin
Contact: Site Public Contact
Email: esmeralda.carrillo@mercy.net

Rolla
Delbert Day Cancer Institute at PCRMC
Contact: Site Public Contact
Email: research@phelpshealth.org

Mercy Clinic-Rolla-Cancer and Hematology
Contact: Site Public Contact

Saint Joseph
Heartland Regional Medical Center
Contact: Site Public Contact
Email: linda.schumacher@mymlc.com

Saint Louis
Mercy Hospital Saint Louis
Contact: Site Public Contact

Mercy Hospital South
Contact: Site Public Contact
Email: Danielle.Werle@mercy.net

Missouri Baptist Medical Center
Contact: Site Public Contact

Saint Louis Cancer and Breast Institute-South City
Contact: Site Public Contact

Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Contact: Site Public Contact

Springfield
CoxHealth South Hospital
Contact: Site Public Contact

Mercy Hospital Springfield
Contact: Site Public Contact

Sullivan
Missouri Baptist Sullivan Hospital
Contact: Site Public Contact

Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
Contact: Site Public Contact

Washington
Mercy Hospital Washington
Contact: Site Public Contact

MT
Anaconda
Community Hospital of Anaconda
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Billings
Billings Clinic Cancer Center
Contact: Site Public Contact
Email: research@billingsclinic.org

Bozeman
Bozeman Deaconess Hospital
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Great Falls
Benefis Healthcare- Sletten Cancer Institute
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Great Falls Clinic
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Helena
Saint Peter's Community Hospital
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Kalispell
Kalispell Regional Medical Center
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Missoula
Community Medical Hospital
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Saint Patrick Hospital - Community Hospital
Contact: Site Public Contact
Email: amy.hanneman@providence.org

NC
Hendersonville
Margaret R Pardee Memorial Hospital
Contact: Site Public Contact
Email: pardeecancerresearch@unchealth.unc.edu

NE
Omaha
Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
Contact: Site Public Contact

Nebraska Methodist Hospital
Contact: Site Public Contact

Oncology Associates PC
Contact: Site Public Contact
Email: info@oa-oc.com

NY
Buffalo
Roswell Park Cancer Institute
Contact: Site Public Contact
Email: askroswell@roswellpark.org

Middletown
Garnet Health Medical Center
Contact: Site Public Contact
Email: jgerlach@garnethealth.org

White Plains
Dickstein Cancer Treatment Center
Contact: Site Public Contact
Email: mcortese@wphospital.org

OH
Beavercreek
Indu and Raj Soin Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Boardman
Saint Elizabeth Boardman Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Centerville
Dayton Physicians LLC-Miami Valley South
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Miami Valley Hospital South
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Cincinnati
Oncology Hematology Care Inc-Kenwood
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Cleveland
MetroHealth Medical Center
Contact: Site Public Contact
Email: dstrater@metrohealth.org

Dayton
Dayton Physician LLC-Miami Valley Hospital North
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Good Samaritan Hospital - Dayton
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Miami Valley Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Miami Valley Hospital North
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Findlay
Armes Family Cancer Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Blanchard Valley Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Orion Cancer Care
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Franklin
Atrium Medical Center-Middletown Regional Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Dayton Physicians LLC-Atrium
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Greenville
Dayton Physicians LLC-Wayne
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Wayne Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Kettering
First Dayton Cancer Care
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Greater Dayton Cancer Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Kettering Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Springfield
Springfield Regional Cancer Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Springfield Regional Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Troy
Dayton Physicians LLC - Troy
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Upper Valley Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Warren
Saint Joseph Warren Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Youngstown
Saint Elizabeth Youngstown Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

OK
Oklahoma City
Mercy Hospital Oklahoma City
Contact: Site Public Contact

University of Oklahoma Health Sciences Center
Contact: Site Public Contact
Email: ou-clinical-trials@ouhsc.edu

OR
Baker City
Saint Alphonsus Medical Center-Baker City
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Bend
Saint Charles Health System
Contact: Site Public Contact
Email: nosall@stcharleshealthcare.org

Clackamas
Clackamas Radiation Oncology Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Providence Cancer Institute Clackamas Clinic
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Coos Bay
Bay Area Hospital
Contact: Site Public Contact
Email: cherie.cox@bayareahospital.org

Corvallis
Good Samaritan Hospital
Contact: Site Public Contact
Email: stmock@samhealth.org

Newberg
Providence Newberg Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Ontario
Saint Alphonsus Medical Center-Ontario
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Oregon City
Providence Willamette Falls Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Portland
Providence Portland Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Providence Saint Vincent Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Redmond
Saint Charles Health System-Redmond
Contact: Site Public Contact

PA
Allentown
Lehigh Valley Hospital-Cedar Crest
Contact: Site Public Contact
Email: Morgan_M.Horton@lvhn.org

Bethlehem
Lehigh Valley Hospital - Muhlenberg
Contact: Site Public Contact
Email: Morgan_M.Horton@lvhn.org

Bryn Mawr
Bryn Mawr Hospital
Contact: Site Public Contact
Email: turzoe@mlhs.org

Collegeville
Main Line Health Center-Collegeville
Contact: Site Public Contact
Email: turzoe@mlhs.org

East Stroudsburg
Pocono Medical Center
Contact: Site Public Contact
Email: Morgan_M.Horton@lvhn.org

Exton
Main Line Health Center-Exton
Contact: Site Public Contact
Email: turzoe@mlhs.org

Hazleton
Lehigh Valley Hospital-Hazleton
Contact: Site Public Contact
Email: Morgan_M.Horton@lvhn.org

Media
Riddle Memorial Hospital
Contact: Site Public Contact
Email: turzoe@mlhs.org

Newtown Square
Bryn Mawr Health Center
Contact: Site Public Contact
Email: turzoe@mlhs.org

Paoli
Paoli Memorial Hospital
Contact: Site Public Contact
Email: turzoe@mlhs.org

Philadelphia
Fox Chase Cancer Center
Contact: Site Public Contact

Temple University Hospital
Contact: Site Public Contact

Reading
Penn State Health Saint Joseph Medical Center
Contact: Site Public Contact
Email: dward1@pennstatehealth.psu.edu

Wynnewood
Lankenau Medical Center
Contact: Site Public Contact
Email: turzoe@mlhs.org

VA
Charlottesville
University of Virginia Cancer Center
Contact: Site Public Contact
Email: uvacancertrials@hscmail.mcc.virginia.edu

WI
Burlington
Aurora Cancer Care-Southern Lakes VLCC
Contact: Site Public Contact
Email: ncorp@aurora.org

Chippewa Falls
Marshfield Clinic-Chippewa Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Cudahy
Aurora Saint Luke's South Shore
Contact: Site Public Contact
Email: ncorp@aurora.org

Eau Claire
Marshfield Medical Center-EC Cancer Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Fond Du Lac
Aurora Health Center-Fond du Lac
Contact: Site Public Contact
Email: ncorp@aurora.org

Germantown
Aurora Health Care Germantown Health Center
Contact: Site Public Contact
Email: ncorp@aurora.org

Grafton
Aurora Cancer Care-Grafton
Contact: Site Public Contact
Email: ncorp@aurora.org

Green Bay
Aurora BayCare Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org

Kenosha
Aurora Cancer Care-Kenosha South
Contact: Site Public Contact
Email: ncorp@aurora.org

La Crosse
Gundersen Lutheran Medical Center
Contact: Site Public Contact
Email: cancerctr@gundersenhealth.org

Ladysmith
Marshfield Clinic - Ladysmith Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Marinette
Aurora Bay Area Medical Group-Marinette
Contact: Site Public Contact
Email: ncorp@aurora.org

Marshfield
Marshfield Medical Center-Marshfield
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Milwaukee
Aurora Cancer Care-Milwaukee
Contact: Site Public Contact
Email: ncorp@aurora.org

Aurora Saint Luke's Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org

Aurora Sinai Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org

Minocqua
Marshfield Clinic-Minocqua Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

New Richmond
Cancer Center of Western Wisconsin
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Oshkosh
Vince Lombardi Cancer Clinic - Oshkosh
Contact: Site Public Contact
Email: ncorp@aurora.org

Racine
Aurora Cancer Care-Racine
Contact: Site Public Contact
Email: ncorp@aurora.org

Rice Lake
Marshfield Medical Center-Rice Lake
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Sheboygan
Vince Lombardi Cancer Clinic-Sheboygan
Contact: Site Public Contact
Email: ncorp@aurora.org

Stevens Point
Marshfield Medical Center-River Region at Stevens Point
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Summit
Aurora Medical Center in Summit
Contact: Site Public Contact
Email: ncorp@aurora.org

Two Rivers
Vince Lombardi Cancer Clinic-Two Rivers
Contact: Site Public Contact
Email: ncorp@aurora.org

Wausau
Marshfield Clinic-Wausau Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Wauwatosa
Aurora Cancer Care-Milwaukee West
Contact: Site Public Contact
Email: ncorp@aurora.org

West Allis
Aurora West Allis Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org

Weston
Marshfield Medical Center - Weston
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Wisconsin Rapids
Marshfield Clinic - Wisconsin Rapids Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

WY
Cody
Billings Clinic-Cody
Contact: Site Public Contact
Email: research@billingsclinic.org

Sheridan
Welch Cancer Center
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

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 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.

Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.


The ECOG-ACRIN Cancer Research Group designed this trial and is conducting it with funding from the National Cancer Institute through its National Clinical Trials Network.


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ECOG-ACRIN Cancer Research Group