Clinical Trial - NCT03191149

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

Suspended

Sponsor: National Cancer Institute (NCI)

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT03191149

Protocol Info

Short Description: Phase II AZD9291 in NSCLC with Exon 20 Insertion Mutations in EGFR
Long Description: Phase II Study of AZD9291 (Osimertinib) in Advanced NSCLC Patients with Exon 20 Insertion Mutations in EGFR
MGH Status: Closed
Sponsor: Coop/ECOG
Disease Program: Thoracic

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.




Purpose

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. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Condition Title Intervention Phase
Advanced Lung Carcinoma EGFR Exon 20 Insertion Mutation Recurrent Lung Non-Small Cell Carcinoma Stage IIIB Lung Non-Small Cell Cancer AJCC v7 Stage IV Lung Non-Small Cell Cancer AJCC v7 Osimertinib Phase 2
Study Type Interventional
Official Title Phase II Study of AZD9291 (Osimertinib) in Advanced NSCLC Patients With Exon 20 Insertion Mutations in EGFR

Primary Outcome Measures

Best objective response [Time Frame: Up to 5 years] [Designated as safety issue: ]


Secondary Outcome Measures

Progression-free survival (PFS) [Time Frame: From registration to documented disease progression or death from any cause, whichever occurs first, assessed up to 5 years] [Designated as safety issue: ]

Overall survival (OS) [Time Frame: From registration to death from any cause, assessed up to 5 years] [Designated as safety issue: ]

Incidence of adverse events [Time Frame: Up to 5 years] [Designated as safety issue: ]

Estimated Enrollment: 20
Study Start Date: April 2018
Estimated Study Completion Date: July 2022
Estimated Primary Completion Date: July 2022
Arms Assigned Interventions

Experimental:Treatment (osimertinib)

Patients receive osimertinib PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug:Osimertinib
Given PO

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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 may not have received any prior treatment with therapies targeting PDL1, PD1 or CTLA4
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 1
  • Hemoglobin >= 9.0 g/L (within 4 weeks before registration)
  • Leukocytes >= 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 to treatment; at least six months (180 days) must have elapsed from radiation given with curative intent
  • Participants may not have clinically symptomatic brain metastases or leptomeningeal disease; 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, hypokalemia, 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 AZD9291 (osimertinib) or drugs with a similar chemical structure or class to AZD9291 (osimertinib)
  • 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) 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 AZD9291 (osimertinib) NOTE: Use of St John's wort is a contra-indication for AZD9291 (osimertinib) 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 AZD9291 (osimertinib) are ineligible
  • Women must not be pregnant or breast-feeding because AZD9291 (osimertinib) 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03191149

Locations

  • United States, Alaska
    • Anchorage Associates in Radiation Medicine Anchorage, Alaska, United States, 98508
    • Anchorage Radiation Therapy Center Anchorage, Alaska, United States, 99504
    • Alaska Breast Care and Surgery LLC Anchorage, Alaska, United States, 99508
    • Alaska Oncology and Hematology LLC Anchorage, Alaska, United States, 99508
    • Alaska Women's Cancer Care Anchorage, Alaska, United States, 99508
    • Anchorage Oncology Centre Anchorage, Alaska, United States, 99508
    • Katmai Oncology Group Anchorage, Alaska, United States, 99508
    • Providence Alaska Medical Center Anchorage, Alaska, United States, 99508
  • United States, Arkansas
    • Mercy Hospital Fort Smith Fort Smith, Arkansas, United States, 72903
  • United States, California
    • Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank, California, United States, 91505
  • United States, District of Columbia
    • MedStar Georgetown University Hospital Washington, District of Columbia, United States, 20007
  • United States, Georgia
    • Emory University Hospital Midtown Atlanta, Georgia, United States, 30308
    • Emory University Hospital/Winship Cancer Institute Atlanta, Georgia, United States, 30322
    • Emory Saint Joseph's Hospital Atlanta, Georgia, United States, 30342
  • United States, Idaho
    • Saint Alphonsus Cancer Care Center-Boise Boise, Idaho, United States, 83706
    • Saint Luke's Mountain States Tumor Institute Boise, Idaho, United States, 83712
    • Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho, United States, 83605
    • Kootenai Medical Center Coeur d'Alene, Idaho, United States, 83814
    • Walter Knox Memorial Hospital Emmett, Idaho, United States, 83617
    • Saint Luke's Mountain States Tumor Institute - Fruitland Fruitland, Idaho, United States, 83619
    • Idaho Urologic Institute-Meridian Meridian, Idaho, United States, 83642
    • Saint Luke's Mountain States Tumor Institute - Meridian Meridian, Idaho, United States, 83642
    • Saint Alphonsus Medical Center-Nampa Nampa, Idaho, United States, 83686
    • Saint Luke's Mountain States Tumor Institute - Nampa Nampa, Idaho, United States, 83686
    • Kootenai Cancer Center Post Falls, Idaho, United States, 83854
    • Kootenai Cancer Clinic Sandpoint, Idaho, United States, 83864
    • Saint Luke's Mountain States Tumor Institute-Twin Falls Twin Falls, Idaho, United States, 83301
  • United States, Illinois
    • Rush - Copley Medical Center Aurora, Illinois, United States, 60504
    • Illinois CancerCare-Bloomington Bloomington, Illinois, United States, 61704
    • Illinois CancerCare-Canton Canton, Illinois, United States, 61520
    • Memorial Hospital of Carbondale Carbondale, Illinois, United States, 62902
    • SIH Cancer Institute Carterville, Illinois, United States, 62918
    • Illinois CancerCare-Carthage Carthage, Illinois, United States, 62321
    • Centralia Oncology Clinic Centralia, Illinois, United States, 62801
    • Carle on Vermilion Danville, Illinois, United States, 61832
    • Cancer Care Specialists of Illinois - Decatur Decatur, Illinois, United States, 62526
    • Decatur Memorial Hospital Decatur, Illinois, United States, 62526
    • Carle Physician Group-Effingham Effingham, Illinois, United States, 62401
    • Crossroads Cancer Center Effingham, Illinois, United States, 62401
    • Illinois CancerCare-Eureka Eureka, Illinois, United States, 61530
    • NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois, United States, 60201
    • Illinois CancerCare-Galesburg Galesburg, Illinois, United States, 61401
    • Western Illinois Cancer Treatment Center Galesburg, Illinois, United States, 61401
    • NorthShore University HealthSystem-Glenbrook Hospital Glenview, Illinois, United States, 60026
    • NorthShore University HealthSystem-Highland Park Hospital Highland Park, Illinois, United States, 60035
    • Illinois CancerCare-Kewanee Clinic Kewanee, Illinois, United States, 61443
    • Illinois CancerCare-Macomb Macomb, Illinois, United States, 61455
    • Carle Physician Group-Mattoon/Charleston Mattoon, Illinois, United States, 61938
    • Good Samaritan Regional Health Center Mount Vernon, Illinois, United States, 62864
    • Illinois CancerCare-Ottawa Clinic Ottawa, Illinois, United States, 61350
    • Illinois CancerCare-Pekin Pekin, Illinois, United States, 61554
    • Illinois CancerCare-Peoria Peoria, Illinois, United States, 61615
    • Methodist Medical Center of Illinois Peoria, Illinois, United States, 61636
    • Illinois CancerCare-Peru Peru, Illinois, United States, 61354
    • Valley Radiation Oncology Peru, Illinois, United States, 61354
    • Illinois CancerCare-Princeton Princeton, Illinois, United States, 61356
    • North Shore Medical Center Skokie, Illinois, United States, 60076
    • Southern Illinois University School of Medicine Springfield, Illinois, United States, 62702
    • Springfield Clinic Springfield, Illinois, United States, 62702
    • Memorial Medical Center Springfield, Illinois, United States, 62781
    • Cancer Care Specialists of Illinois-Swansea Swansea, Illinois, United States, 62226
    • Southwest Illinois Health Services LLP Swansea, Illinois, United States, 62226
    • Carle Cancer Center Urbana, Illinois, United States, 61801
    • The Carle Foundation Hospital Urbana, Illinois, United States, 61801
    • Rush-Copley Healthcare Center Yorkville, Illinois, United States, 60560
  • United States, Indiana
    • Reid Health Richmond, Indiana, United States, 47374
  • United States, Iowa
    • Iowa Methodist Medical Center Des Moines, Iowa, United States, 50309
    • Medical Oncology and Hematology Associates-Des Moines Des Moines, Iowa, United States, 50309
    • Broadlawns Medical Center Des Moines, Iowa, United States, 50314
    • Iowa Lutheran Hospital Des Moines, Iowa, United States, 50316
    • Trinity Regional Medical Center Fort Dodge, Iowa, United States, 50501
    • Methodist West Hospital West Des Moines, Iowa, United States, 50266-7700
  • United States, Louisiana
    • Ochsner Health Center-Summa Baton Rouge, Louisiana, United States, 70809
    • Medical Center of Baton Rouge Baton Rouge, Louisiana, United States, 70816
    • Ochsner High Grove Baton Rouge, Louisiana, United States, 70836
    • Ochsner Medical Center Jefferson New Orleans, Louisiana, United States, 70121
  • United States, Maryland
    • MedStar Franklin Square Medical Center/Weinberg Cancer Institute Baltimore, Maryland, United States, 21237
    • Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland, United States, 21287
  • United States, Massachusetts
    • Massachusetts General Hospital Cancer Center Boston, Massachusetts, United States, 02114
    • Brigham and Women's Hospital Boston, Massachusetts, United States, 02115
    • Beth Israel Deaconess Medical Center Boston, Massachusetts, United States, 02215
    • Dana-Farber Cancer Institute Boston, Massachusetts, United States, 02215
    • Mercy Medical Center Springfield, Massachusetts, United States, 01104
  • United States, Michigan
    • Saint Joseph Mercy Hospital Ann Arbor, Michigan, United States, 48106
    • Bronson Battle Creek Battle Creek, Michigan, United States, 49017
    • IHA Hematology Oncology Consultants-Brighton Brighton, Michigan, United States, 48114
    • Saint Joseph Mercy Brighton Brighton, Michigan, United States, 48114
    • IHA Hematology Oncology Consultants-Canton Canton, Michigan, United States, 48188
    • Saint Joseph Mercy Canton Canton, Michigan, United States, 48188
    • Caro Cancer Center Caro, Michigan, United States, 48723
    • IHA Hematology Oncology Consultants-Chelsea Chelsea, Michigan, United States, 48118
    • Saint Joseph Mercy Chelsea Chelsea, Michigan, United States, 48118
    • Hematology Oncology Consultants-Clarkston Clarkston, Michigan, United States, 48346
    • Newland Medical Associates-Clarkston Clarkston, Michigan, United States, 48346
    • Ascension Saint John Hospital Detroit, Michigan, United States, 48236
    • Great Lakes Cancer Management Specialists-Doctors Park East China Township, Michigan, United States, 48054
    • Genesee Cancer and Blood Disease Treatment Center Flint, Michigan, United States, 48503
    • Genesee Hematology Oncology PC Flint, Michigan, United States, 48503
    • Genesys Hurley Cancer Institute Flint, Michigan, United States, 48503
    • Hurley Medical Center Flint, Michigan, United States, 48503
    • Helen DeVos Children's Hospital at Spectrum Health Grand Rapids, Michigan, United States, 49503
    • Mercy Health Saint Mary's Grand Rapids, Michigan, United States, 49503
    • Spectrum Health at Butterworth Campus Grand Rapids, Michigan, United States, 49503
    • Academic Hematology Oncology Specialists Grosse Pointe Woods, Michigan, United States, 48236
    • Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods, Michigan, United States, 48236
    • Michigan Breast Specialists-Grosse Pointe Woods Grosse Pointe Woods, Michigan, United States, 48236
    • Bronson Methodist Hospital Kalamazoo, Michigan, United States, 49007
    • West Michigan Cancer Center Kalamazoo, Michigan, United States, 49007
    • Borgess Medical Center Kalamazoo, Michigan, United States, 49048
    • Sparrow Hospital Lansing, Michigan, United States, 48912
    • Hope Cancer Clinic Livonia, Michigan, United States, 48154
    • Saint Mary Mercy Hospital Livonia, Michigan, United States, 48154
    • Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb, Michigan, United States, 48044
    • Michigan Breast Specialists-Macomb Township Macomb, Michigan, United States, 48044
    • Saint Mary's Oncology/Hematology Associates of Marlette Marlette, Michigan, United States, 48453
    • Mercy Health Mercy Campus Muskegon, Michigan, United States, 49444
    • Lakeland Hospital Niles Niles, Michigan, United States, 49120
    • 21st Century Oncology-Pontiac Pontiac, Michigan, United States, 48341
    • Hope Cancer Center Pontiac, Michigan, United States, 48341
    • Newland Medical Associates-Pontiac Pontiac, Michigan, United States, 48341
    • Saint Joseph Mercy Oakland Pontiac, Michigan, United States, 48341
    • Spectrum Health Reed City Hospital Reed City, Michigan, United States, 49677
    • Great Lakes Cancer Management Specialists-Rochester Hills Rochester Hills, Michigan, United States, 48309
    • Ascension Saint Mary's Hospital Saginaw, Michigan, United States, 48601
    • Oncology Hematology Associates of Saginaw Valley PC Saginaw, Michigan, United States, 48604
    • Lakeland Medical Center Saint Joseph Saint Joseph, Michigan, United States, 49085
    • Marie Yeager Cancer Center Saint Joseph, Michigan, United States, 49085
    • Bhadresh Nayak MD PC-Sterling Heights Sterling Heights, Michigan, United States, 48312
    • Ascension Saint Joseph Hospital Tawas City, Michigan, United States, 48764
    • Munson Medical Center Traverse City, Michigan, United States, 49684
    • Advanced Breast Care Center PLLC Warren, Michigan, United States, 48088
    • Great Lakes Cancer Management Specialists-Macomb Professional Building Warren, Michigan, United States, 48093
    • Macomb Hematology Oncology PC Warren, Michigan, United States, 48093
    • Michigan Breast Specialists-Warren Warren, Michigan, United States, 48093
    • Saint John Macomb-Oakland Hospital Warren, Michigan, United States, 48093
    • Saint Mary's Oncology/Hematology Associates of West Branch West Branch, Michigan, United States, 48661
    • Metro Health Hospital Wyoming, Michigan, United States, 49519
    • Huron Gastroenterology PC Ypsilanti, Michigan, United States, 48106
    • IHA Hematology Oncology Consultants-Ann Arbor Ypsilanti, Michigan, United States, 48197
  • United States, Minnesota
    • Fairview Ridges Hospital Burnsville, Minnesota, United States, 55337
    • Cambridge Medical Center Cambridge, Minnesota, United States, 55008
    • Mercy Hospital Coon Rapids, Minnesota, United States, 55433
    • Fairview-Southdale Hospital Edina, Minnesota, United States, 55435
    • Unity Hospital Fridley, Minnesota, United States, 55432
    • Fairview Maple Grove Medical Center Maple Grove, Minnesota, United States, 55369
    • Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota, United States, 55109
    • Saint John's Hospital - Healtheast Maplewood, Minnesota, United States, 55109
    • Abbott-Northwestern Hospital Minneapolis, Minnesota, United States, 55407
    • Health Partners Inc Minneapolis, Minnesota, United States, 55454
    • Monticello Cancer Center Monticello, Minnesota, United States, 55362
    • New Ulm Medical Center New Ulm, Minnesota, United States, 56073
    • Fairview Northland Medical Center Princeton, Minnesota, United States, 55371
    • North Memorial Medical Health Center Robbinsdale, Minnesota, United States, 55422
    • Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota, United States, 55416
    • Regions Hospital Saint Paul, Minnesota, United States, 55101
    • United Hospital Saint Paul, Minnesota, United States, 55102
    • Saint Francis Regional Medical Center Shakopee, Minnesota, United States, 55379
    • Lakeview Hospital Stillwater, Minnesota, United States, 55082
    • Ridgeview Medical Center Waconia, Minnesota, United States, 55387
    • Rice Memorial Hospital Willmar, Minnesota, United States, 56201
    • Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota, United States, 55125
    • Fairview Lakes Medical Center Wyoming, Minnesota, United States, 55092
  • United States, Missouri
    • Saint Louis Cancer and Breast Institute-Ballwin Ballwin, Missouri, United States, 63011
    • Parkland Health Center-Bonne Terre Bonne Terre, Missouri, United States, 63628
    • Cox Cancer Center Branson Branson, Missouri, United States, 65616
    • Saint Francis Medical Center Cape Girardeau, Missouri, United States, 63703
    • Southeast Cancer Center Cape Girardeau, Missouri, United States, 63703
    • Capital Region Southwest Campus Jefferson City, Missouri, United States, 65109
    • Freeman Health System Joplin, Missouri, United States, 64804
    • Mercy Hospital Joplin Joplin, Missouri, United States, 64804
    • Delbert Day Cancer Institute at PCRMC Rolla, Missouri, United States, 65401
    • Mercy Clinic-Rolla-Cancer and Hematology Rolla, Missouri, United States, 65401
    • Heartland Regional Medical Center Saint Joseph, Missouri, United States, 64507
    • Saint Louis Cancer and Breast Institute-South City Saint Louis, Missouri, United States, 63109
    • Mercy Hospital South Saint Louis, Missouri, United States, 63128
    • Missouri Baptist Medical Center Saint Louis, Missouri, United States, 63131
    • Mercy Hospital Saint Louis Saint Louis, Missouri, United States, 63141
    • Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri, United States, 63670
    • Mercy Hospital Springfield Springfield, Missouri, United States, 65804
    • CoxHealth South Hospital Springfield, Missouri, United States, 65807
    • Missouri Baptist Sullivan Hospital Sullivan, Missouri, United States, 63080
    • Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills, Missouri, United States, 63127
    • Mercy Hospital Washington Washington, Missouri, United States, 63090
  • United States, Montana
    • Community Hospital of Anaconda Anaconda, Montana, United States, 59711
    • Billings Clinic Cancer Center Billings, Montana, United States, 59101
    • Bozeman Deaconess Hospital Bozeman, Montana, United States, 59715
    • Benefis Healthcare- Sletten Cancer Institute Great Falls, Montana, United States, 59405
    • Great Falls Clinic Great Falls, Montana, United States, 59405
    • Saint Peter's Community Hospital Helena, Montana, United States, 59601
    • Kalispell Regional Medical Center Kalispell, Montana, United States, 59901
    • Saint Patrick Hospital - Community Hospital Missoula, Montana, United States, 59802
    • Community Medical Hospital Missoula, Montana, United States, 59804
  • United States, Nebraska
    • Nebraska Methodist Hospital Omaha, Nebraska, United States, 68114
  • United States, New York
    • Roswell Park Cancer Institute Buffalo, New York, United States, 14263
    • Orange Regional Medical Center Middletown, New York, United States, 10940
    • Dickstein Cancer Treatment Center White Plains, New York, United States, 10601
  • United States, North Carolina
    • Margaret R Pardee Memorial Hospital Hendersonville, North Carolina, United States, 28791
  • United States, Ohio
    • Indu and Raj Soin Medical Center Beavercreek, Ohio, United States, 45431
    • Saint Elizabeth Boardman Hospital Boardman, Ohio, United States, 44512
    • Dayton Physicians LLC-Miami Valley South Centerville, Ohio, United States, 45459
    • Miami Valley Hospital South Centerville, Ohio, United States, 45459
    • Oncology Hematology Care Inc-Kenwood Cincinnati, Ohio, United States, 45236
    • MetroHealth Medical Center Cleveland, Ohio, United States, 44109
    • Good Samaritan Hospital - Dayton Dayton, Ohio, United States, 45406
    • Miami Valley Hospital Dayton, Ohio, United States, 45409
    • Dayton Physician LLC-Miami Valley Hospital North Dayton, Ohio, United States, 45415
    • Miami Valley Hospital North Dayton, Ohio, United States, 45415
    • Armes Family Cancer Center Findlay, Ohio, United States, 45840
    • Blanchard Valley Hospital Findlay, Ohio, United States, 45840
    • Orion Cancer Care Findlay, Ohio, United States, 45840
    • Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio, United States, 45005-1066
    • Dayton Physicians LLC-Atrium Franklin, Ohio, United States, 45005
    • Dayton Physicians LLC-Wayne Greenville, Ohio, United States, 45331
    • Wayne Hospital Greenville, Ohio, United States, 45331
    • Greater Dayton Cancer Center Kettering, Ohio, United States, 45409
    • First Dayton Cancer Care Kettering, Ohio, United States, 45420
    • Kettering Medical Center Kettering, Ohio, United States, 45429
    • Springfield Regional Cancer Center Springfield, Ohio, United States, 45504
    • Springfield Regional Medical Center Springfield, Ohio, United States, 45505
    • Dayton Physicians LLC-Upper Valley Troy, Ohio, United States, 45373
    • Upper Valley Medical Center Troy, Ohio, United States, 45373
    • Saint Joseph Warren Hospital Warren, Ohio, United States, 44484
    • Saint Elizabeth Youngstown Hospital Youngstown, Ohio, United States, 44501
  • United States, Oklahoma
    • University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma, United States, 73104
    • Mercy Hospital Oklahoma City Oklahoma City, Oklahoma, United States, 73120
  • United States, Oregon
    • Saint Alphonsus Medical Center-Baker City Baker City, Oregon, United States, 97814
    • Saint Charles Health System Bend, Oregon, United States, 97701
    • Clackamas Radiation Oncology Center Clackamas, Oregon, United States, 97015
    • Providence Oncology and Hematology Care Southeast Clackamas, Oregon, United States, 97015
    • Bay Area Hospital Coos Bay, Oregon, United States, 97420
    • Good Samaritan Hospital Corvallis, Oregon, United States, 97330
    • Providence Newberg Medical Center Newberg, Oregon, United States, 97132
    • Saint Alphonsus Medical Center-Ontario Ontario, Oregon, United States, 97914
    • Providence Portland Medical Center Portland, Oregon, United States, 97213
    • Providence Saint Vincent Medical Center Portland, Oregon, United States, 97225
    • Saint Charles Health System-Redmond Redmond, Oregon, United States, 97756
  • United States, Pennsylvania
    • Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania, United States, 18103
    • Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania, United States, 18017
    • Bryn Mawr Hospital Bryn Mawr, Pennsylvania, United States, 19010
    • Main Line Health Center-Collegeville Collegeville, Pennsylvania, United States, 19426
    • Pocono Medical Center East Stroudsburg, Pennsylvania, United States, 18301
    • Main Line Health Center-Exton Exton, Pennsylvania, United States, 19341
    • Lehigh Valley Hospital-Hazleton Hazleton, Pennsylvania, United States, 18201
    • Riddle Memorial Hospital Media, Pennsylvania, United States, 19063
    • Bryn Mawr Health Center Newtown Square, Pennsylvania, United States, 19073
    • Paoli Memorial Hospital Paoli, Pennsylvania, United States, 19301
    • Fox Chase Cancer Center Philadelphia, Pennsylvania, United States, 19111
    • Temple University Hospital Philadelphia, Pennsylvania, United States, 19140
    • Penn State Health Saint Joseph Medical Center Reading, Pennsylvania, United States, 19605
    • Lankenau Medical Center Wynnewood, Pennsylvania, United States, 19096
  • United States, Virginia
    • University of Virginia Cancer Center Charlottesville, Virginia, United States, 22908
  • United States, Washington
    • Providence Regional Cancer System-Aberdeen Aberdeen, Washington, United States, 98520
    • PeaceHealth Saint Joseph Medical Center Bellingham, Washington, United States, 98225
    • Providence Regional Cancer System-Centralia Centralia, Washington, United States, 98531
    • Swedish Cancer Institute-Edmonds Edmonds, Washington, United States, 98026
    • Providence Regional Cancer Partnership Everett, Washington, United States, 98201
    • Swedish Cancer Institute-Issaquah Issaquah, Washington, United States, 98029
    • Kadlec Clinic Hematology and Oncology Kennewick, Washington, United States, 99336
    • Providence Regional Cancer System-Lacey Lacey, Washington, United States, 98503
    • PeaceHealth Saint John Medical Center Longview, Washington, United States, 98632
    • Pacific Gynecology Specialists Seattle, Washington, United States, 98104
    • Swedish Medical Center-Ballard Campus Seattle, Washington, United States, 98107
    • Kaiser Permanente Washington Seattle, Washington, United States, 98112
    • Swedish Medical Center-First Hill Seattle, Washington, United States, 98122-4307
    • Swedish Medical Center-Cherry Hill Seattle, Washington, United States, 98122-5711
    • PeaceHealth United General Medical Center Sedro-Woolley, Washington, United States, 98284
    • Providence Regional Cancer System-Shelton Shelton, Washington, United States, 98584
    • PeaceHealth Southwest Medical Center Vancouver, Washington, United States, 98664
    • Providence Saint Mary Regional Cancer Center Walla Walla, Washington, United States, 99362
    • Providence Regional Cancer System-Yelm Yelm, Washington, United States, 98597
  • United States, Wisconsin
    • Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin, United States, 53105
    • Marshfield Clinic-Chippewa Center Chippewa Falls, Wisconsin, United States, 54729
    • Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin, United States, 54701
    • Aurora Health Center-Fond du Lac Fond Du Lac, Wisconsin, United States, 54937
    • Aurora Health Care Germantown Health Center Germantown, Wisconsin, United States, 53022
    • Aurora Cancer Care-Grafton Grafton, Wisconsin, United States, 53024
    • Aurora BayCare Medical Center Green Bay, Wisconsin, United States, 54311
    • Aurora Cancer Care-Kenosha South Kenosha, Wisconsin, United States, 53142
    • Marshfield Clinic - Ladysmith Center Ladysmith, Wisconsin, United States, 54848
    • Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin, United States, 54143
    • Marshfield Medical Center-Marshfield Marshfield, Wisconsin, United States, 54449
    • Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin, United States, 53209
    • Aurora Saint Luke's Medical Center Milwaukee, Wisconsin, United States, 53215
    • Aurora Sinai Medical Center Milwaukee, Wisconsin, United States, 53233
    • Marshfield Clinic-Minocqua Center Minocqua, Wisconsin, United States, 54548
    • Cancer Center of Western Wisconsin New Richmond, Wisconsin, United States, 54017
    • Vince Lombardi Cancer Clinic - Oshkosh Oshkosh, Wisconsin, United States, 54904
    • Aurora Cancer Care-Racine Racine, Wisconsin, United States, 53406
    • Marshfield Medical Center-Rice Lake Rice Lake, Wisconsin, United States, 54868
    • Vince Lombardi Cancer Clinic-Sheboygan Sheboygan, Wisconsin, United States, 53081
    • Marshfield Clinic Stevens Point Center Stevens Point, Wisconsin, United States, 54482
    • Aurora Medical Center in Summit Summit, Wisconsin, United States, 53066
    • Vince Lombardi Cancer Clinic-Two Rivers Two Rivers, Wisconsin, United States, 54241
    • Marshfield Clinic-Wausau Center Wausau, Wisconsin, United States, 54401
    • Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin, United States, 53226
    • Aurora West Allis Medical Center West Allis, Wisconsin, United States, 53227
    • Marshfield Clinic - Weston Center Weston, Wisconsin, United States, 54476
    • Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids, Wisconsin, United States, 54494
  • United States, Wyoming
    • Billings Clinic-Cody Cody, Wyoming, United States, 82414
    • Welch Cancer Center Sheridan, Wyoming, United States, 82801

Sponsors and Collaborators

National Cancer Institute (NCI)

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT03191149
Other Study ID Numbers: NCI-2017-01017
Study First Received:
Last Updated:
Health Authority:

Additional relevant MeSH terms:

Carcinoma

Lung Neoplasms

Osimertinib

Next Steps


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ClinicalTrials.gov processed this data on July 18, 2019