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

May 15, 2026 updated by: National Cancer Institute (NCI)

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alaska
      • Anchorage, Alaska, United States, 98508
        • Active, not recruiting
        • Anchorage Associates in Radiation Medicine
      • Anchorage, Alaska, United States, 99504
        • Active, not recruiting
        • Anchorage Radiation Therapy Center
      • Anchorage, Alaska, United States, 99508
        • Active, not recruiting
        • Alaska Breast Care and Surgery LLC
      • Anchorage, Alaska, United States, 99508
        • Active, not recruiting
        • Alaska Oncology and Hematology LLC
      • Anchorage, Alaska, United States, 99508
        • Active, not recruiting
        • Alaska Women's Cancer Care
      • Anchorage, Alaska, United States, 99508
        • Active, not recruiting
        • Anchorage Oncology Centre
      • Anchorage, Alaska, United States, 99508
        • Active, not recruiting
        • Katmai Oncology Group
      • Anchorage, Alaska, United States, 99508
        • Active, not recruiting
        • Providence Alaska Medical Center
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
        • Recruiting
        • Mercy Hospital Fort Smith
        • Contact:
          • Site Public Contact
          • Phone Number: 800-378-9373
        • Principal Investigator:
          • Jay W. Carlson
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • CARTI Cancer Center
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
    • California
      • Burbank, California, United States, 91505
        • Active, not recruiting
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Recruiting
        • MedStar Georgetown University Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 202-444-2223
        • Principal Investigator:
          • Chul Kim
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Recruiting
        • Holy Cross Hospital
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital/Winship Cancer Institute
        • Principal Investigator:
          • Ticiana A. Leal
        • Contact:
          • Site Public Contact
          • Phone Number: 404-778-1868
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University Hospital Midtown
        • Contact:
          • Site Public Contact
          • Phone Number: 888-946-7447
        • Principal Investigator:
          • Ticiana A. Leal
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Emory Saint Joseph's Hospital
        • Principal Investigator:
          • Ticiana A. Leal
        • Contact:
          • Site Public Contact
          • Phone Number: 404-851-7115
    • Idaho
      • Boise, Idaho, United States, 83706
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Boise
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Boise, Idaho, United States, 83712
        • Active, not recruiting
        • Saint Luke's Cancer Institute - Boise
      • Caldwell, Idaho, United States, 83605
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Caldwell
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Coeur d'Alene, Idaho, United States, 83814
        • Recruiting
        • Kootenai Health - Coeur d'Alene
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Emmett, Idaho, United States, 83617
        • Suspended
        • Walter Knox Memorial Hospital
      • Fruitland, Idaho, United States, 83619
        • Active, not recruiting
        • Saint Luke's Cancer Institute - Fruitland
      • Meridian, Idaho, United States, 83642
        • Recruiting
        • Idaho Urologic Institute-Meridian
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Meridian, Idaho, United States, 83642
        • Active, not recruiting
        • Saint Luke's Cancer Institute - Meridian
      • Nampa, Idaho, United States, 83687
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Nampa
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Nampa, Idaho, United States, 83687
        • Active, not recruiting
        • Saint Luke's Cancer Institute - Nampa
      • Post Falls, Idaho, United States, 83854
        • Recruiting
        • Kootenai Clinic Cancer Services - Post Falls
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Sandpoint, Idaho, United States, 83864
        • Recruiting
        • Kootenai Clinic Cancer Services - Sandpoint
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Twin Falls, Idaho, United States, 83301
        • Active, not recruiting
        • Saint Luke's Cancer Institute - Twin Falls
    • Illinois
      • Alton, Illinois, United States, 62002
        • Recruiting
        • OSF Saint Anthony's Health Center
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 618-463-5623
      • Aurora, Illinois, United States, 60504
        • Recruiting
        • Rush-Copley Medical Center
        • Principal Investigator:
          • Priyank P. Patel
        • Contact:
      • Bloomington, Illinois, United States, 61704
        • Recruiting
        • Illinois CancerCare-Bloomington
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Canton, Illinois, United States, 61520
        • Recruiting
        • Illinois CancerCare-Canton
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Carbondale, Illinois, United States, 62902
        • Recruiting
        • Memorial Hospital of Carbondale
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Carterville, Illinois, United States, 62918
        • Recruiting
        • SIH Cancer Institute
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Carthage, Illinois, United States, 62321
        • Recruiting
        • Illinois CancerCare-Carthage
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Centralia, Illinois, United States, 62801
        • Recruiting
        • Centralia Oncology Clinic
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Centralia, Illinois, United States, 62801
        • Suspended
        • Saint Mary's Hospital
      • Danville, Illinois, United States, 61832
        • Recruiting
        • Carle at The Riverfront
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Cancer Care Specialists of Illinois - Decatur
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Decatur Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Dixon, Illinois, United States, 61021
        • Recruiting
        • Illinois CancerCare-Dixon
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 815-285-7800
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Carle Physician Group-Effingham
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Crossroads Cancer Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Eureka, Illinois, United States, 61530
        • Recruiting
        • Illinois CancerCare-Eureka
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Evanston, Illinois, United States, 60201
        • Active, not recruiting
        • NorthShore University HealthSystem-Evanston Hospital
      • Galesburg, Illinois, United States, 61401
        • Recruiting
        • Illinois CancerCare-Galesburg
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Galesburg, Illinois, United States, 61401
        • Suspended
        • Western Illinois Cancer Treatment Center
      • Glenview, Illinois, United States, 60026
        • Active, not recruiting
        • NorthShore University HealthSystem-Glenbrook Hospital
      • Highland Park, Illinois, United States, 60035
        • Active, not recruiting
        • NorthShore University HealthSystem-Highland Park Hospital
      • Kewanee, Illinois, United States, 61443
        • Recruiting
        • Illinois CancerCare-Kewanee Clinic
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Macomb, Illinois, United States, 61455
        • Recruiting
        • Illinois CancerCare-Macomb
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Mattoon, Illinois, United States, 61938
        • Recruiting
        • Carle Physician Group-Mattoon/Charleston
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
      • Mount Vernon, Illinois, United States, 62864
        • Recruiting
        • SSM Health Good Samaritan
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • Cancer Care Center of O'Fallon
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • HSHS Saint Elizabeth's Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Ottawa, Illinois, United States, 61350
        • Recruiting
        • Illinois CancerCare-Ottawa Clinic
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Pekin, Illinois, United States, 61554
        • Recruiting
        • Illinois CancerCare-Pekin
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peoria, Illinois, United States, 61615
        • Recruiting
        • Illinois CancerCare-Peoria
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peoria, Illinois, United States, 61636
        • Recruiting
        • Methodist Medical Center of Illinois
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peru, Illinois, United States, 61354
        • Recruiting
        • Illinois CancerCare-Peru
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peru, Illinois, United States, 61354
        • Recruiting
        • Valley Radiation Oncology
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 815-664-4141
      • Princeton, Illinois, United States, 61356
        • Recruiting
        • Illinois CancerCare-Princeton
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Skokie, Illinois, United States, 60076
        • Active, not recruiting
        • North Shore Medical Center
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Southern Illinois University School of Medicine
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 217-545-7929
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Springfield Clinic
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 800-444-7541
      • Springfield, Illinois, United States, 62781
        • Recruiting
        • Springfield Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Swansea, Illinois, United States, 62226
        • Suspended
        • Southwest Illinois Health Services LLP
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Cancer Center
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • The Carle Foundation Hospital
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
      • Washington, Illinois, United States, 61571
        • Recruiting
        • Illinois CancerCare - Washington
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Yorkville, Illinois, United States, 60560
        • Recruiting
        • Rush-Copley Healthcare Center
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
      • Zion, Illinois, United States, 60099
        • Active, not recruiting
        • Midwestern Regional Medical Center
    • Indiana
      • Richmond, Indiana, United States, 47374
        • Active, not recruiting
        • Reid Health
    • Iowa
      • Council Bluffs, Iowa, United States, 51503
        • Recruiting
        • Heartland Oncology and Hematology LLP
        • Principal Investigator:
          • Robert M. Langdon
        • Contact:
          • Site Public Contact
          • Phone Number: 712-322-4136
      • Council Bluffs, Iowa, United States, 51503
        • Recruiting
        • Methodist Jennie Edmundson Hospital
        • Principal Investigator:
          • Robert M. Langdon
        • Contact:
      • Council Bluffs, Iowa, United States, 51503
        • Recruiting
        • Nebraska Cancer Specialists/Oncology Hematology West PC - MEJ
        • Principal Investigator:
          • Robert M. Langdon
        • Contact:
      • Des Moines, Iowa, United States, 50314
        • Active, not recruiting
        • Broadlawns Medical Center
      • Des Moines, Iowa, United States, 50309
        • Active, not recruiting
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, United States, 50316
        • Active, not recruiting
        • Iowa Lutheran Hospital
      • Des Moines, Iowa, United States, 50309
        • Active, not recruiting
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
      • Fort Dodge, Iowa, United States, 50501
        • Active, not recruiting
        • UI Healthcare Mission Cancer and Blood - Fort Dodge
      • West Des Moines, Iowa, United States, 50266-7700
        • Active, not recruiting
        • Methodist West Hospital
    • Kansas
      • Garden City, Kansas, United States, 67846
        • Recruiting
        • Central Care Cancer Center - Garden City
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Great Bend, Kansas, United States, 67530
        • Recruiting
        • Central Care Cancer Center - Great Bend
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Pittsburg, Kansas, United States, 66762
        • Recruiting
        • Mercy Hospital Pittsburg
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 888-446-3729
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Active, not recruiting
        • Ochsner Health Center-Summa
      • Baton Rouge, Louisiana, United States, 70816
        • Active, not recruiting
        • Medical Center of Baton Rouge
      • Baton Rouge, Louisiana, United States, 70836
        • Active, not recruiting
        • Ochsner High Grove
      • New Orleans, Louisiana, United States, 70121
        • Active, not recruiting
        • Ochsner Medical Center Jefferson
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Active, not recruiting
        • Johns Hopkins University/Sidney Kimmel Cancer Center
      • Baltimore, Maryland, United States, 21237
        • Active, not recruiting
        • MedStar Franklin Square Medical Center/Weinberg Cancer Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 877-726-5130
        • Principal Investigator:
          • Zofia Piotrowska
      • Boston, Massachusetts, United States, 02215
        • Suspended
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Suspended
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02215
        • Suspended
        • Dana-Farber Cancer Institute
      • Springfield, Massachusetts, United States, 01104
        • Suspended
        • Mercy Medical Center
    • Michigan
      • Alma, Michigan, United States, 48801
        • Recruiting
        • MyMichigan Medical Center Gratiot
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Alpena, Michigan, United States, 49707
        • Recruiting
        • MyMichigan Medical Center Alpena
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Ann Arbor, Michigan, United States, 48106
        • Recruiting
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Battle Creek, Michigan, United States, 49017
        • Recruiting
        • Bronson Battle Creek
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Brighton, Michigan, United States, 48114
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Brighton, Michigan, United States, 48114
        • Recruiting
        • Trinity Health Medical Center - Brighton
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Canton, Michigan, United States, 48188
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Canton, Michigan, United States, 48188
        • Recruiting
        • Trinity Health Medical Center - Canton
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Caro, Michigan, United States, 48723
        • Suspended
        • Caro Cancer Center
      • Chelsea, Michigan, United States, 48118
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Chelsea, Michigan, United States, 48118
      • Clarkston, Michigan, United States, 48346
        • Recruiting
        • Hematology Oncology Consultants-Clarkston
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Clarkston, Michigan, United States, 48346
        • Recruiting
        • Newland Medical Associates-Clarkston
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Contact:
        • Principal Investigator:
          • Adam M. Forman
      • Detroit, Michigan, United States, 48236
        • Recruiting
        • Henry Ford Health Saint John Hospital
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • East China Township, Michigan, United States, 48054
        • Recruiting
        • Henry Ford River District Hospital
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Genesee Hematology Oncology PC
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Genesys Hurley Cancer Institute
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Hurley Medical Center
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Cancer Hematology Centers - Flint
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Gladwin, Michigan, United States, 48624
        • Recruiting
        • MyMichigan Medical Center Gladwin
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Trinity Health Grand Rapids Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Recruiting
        • Henry Ford Saint John Hospital - Breast
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Recruiting
        • Henry Ford Saint John Hospital - Academic
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Recruiting
        • Henry Ford Saint John Hospital - Van Elslander
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • Bronson Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • West Michigan Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Kalamazoo, Michigan, United States, 49009
        • Recruiting
        • Beacon Kalamazoo Cancer Center
        • Principal Investigator:
          • Kathleen Y. Butler
        • Contact:
          • Site Public Contact
          • Phone Number: 574-647-7370
      • Kalamazoo, Michigan, United States, 49048
        • Recruiting
        • Beacon Kalamazoo
        • Principal Investigator:
          • Kathleen Y. Butler
        • Contact:
          • Site Public Contact
          • Phone Number: 574-647-7370
      • Lansing, Michigan, United States, 48912
        • Recruiting
        • University of Michigan Health - Sparrow Lansing
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Livonia, Michigan, United States, 48154
        • Suspended
        • Hope Cancer Clinic
      • Livonia, Michigan, United States, 48154
        • Recruiting
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Macomb, Michigan, United States, 48044
        • Recruiting
        • Henry Ford Warren Hospital - Breast Macomb
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Macomb, Michigan, United States, 48044
        • Recruiting
        • Henry Ford Saint John Hospital - Macomb Medical
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Marlette, Michigan, United States, 48453
        • Suspended
        • Saint Mary's Oncology/Hematology Associates of Marlette
      • Midland, Michigan, United States, 48670
        • Recruiting
        • MyMichigan Medical Center Midland
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Mount Pleasant, Michigan, United States, 48858
        • Recruiting
        • MyMichigan Medical Center Mount Pleasant
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Muskegon, Michigan, United States, 49444
        • Recruiting
        • Trinity Health Muskegon Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Niles, Michigan, United States, 49120
        • Recruiting
        • Corewell Health Lakeland Hospitals - Niles Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 616-391-1230
        • Principal Investigator:
          • Kathleen Y. Butler
      • Norton Shores, Michigan, United States, 49444
        • Recruiting
        • Cancer and Hematology Centers of Western Michigan - Norton Shores
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Novi, Michigan, United States, 48374
        • Recruiting
        • Henry Ford Health Providence Novi Hospital
        • Principal Investigator:
          • Susan E. Lyons
        • Contact:
      • Pontiac, Michigan, United States, 48341
      • Pontiac, Michigan, United States, 48341
        • Recruiting
        • Newland Medical Associates-Pontiac
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Pontiac, Michigan, United States, 48341
        • Recruiting
        • Trinity Health Saint Joseph Mercy Oakland Hospital
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Pontiac, Michigan, United States, 48341
        • Recruiting
        • Michigan Healthcare Professionals Pontiac
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Reed City, Michigan, United States, 49677
        • Recruiting
        • Corewell Health Reed City Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Rochester Hills, Michigan, United States, 48309
        • Suspended
        • Henry Ford Rochester Hospital
      • Saginaw, Michigan, United States, 48604
        • Suspended
        • Oncology Hematology Associates of Saginaw Valley PC
      • Saginaw, Michigan, United States, 48601
        • Recruiting
        • MyMichigan Medical Center Saginaw
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Saint Joseph, Michigan, United States, 49085
        • Recruiting
        • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Saint Joseph, Michigan, United States, 49085
        • Recruiting
        • Corewell Health Lakeland Hospitals - Saint Joseph Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Southfield, Michigan, United States, 48075
        • Recruiting
        • Henry Ford Health Providence Southfield Hospital
        • Principal Investigator:
          • Susan E. Lyons
        • Contact:
      • Sterling Heights, Michigan, United States, 48312
        • Suspended
        • Bhadresh Nayak MD PC-Sterling Heights
      • Tawas City, Michigan, United States, 48764
        • Recruiting
        • MyMichigan Medical Center Tawas
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Traverse City, Michigan, United States, 49684
        • Recruiting
        • Munson Medical Center
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Warren, Michigan, United States, 48088
        • Suspended
        • Advanced Breast Care Center PLLC
      • Warren, Michigan, United States, 48093
        • Suspended
        • Macomb Hematology Oncology PC
      • Warren, Michigan, United States, 48093
        • Recruiting
        • Henry Ford Madison Heights Hospital - Breast
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Warren, Michigan, United States, 48093
        • Recruiting
        • Henry Ford Health Warren Hospital
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Warren, Michigan, United States, 48093
        • Recruiting
        • Henry Ford Warren Hospital - GLCMS
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • West Branch, Michigan, United States, 48661
        • Suspended
        • Saint Mary's Oncology/Hematology Associates of West Branch
      • Wyoming, Michigan, United States, 49519
        • Recruiting
        • University of Michigan Health - West
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Ypsilanti, Michigan, United States, 48106
      • Ypsilanti, Michigan, United States, 48197
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Recruiting
        • Minnesota Oncology - Burnsville
        • Contact:
        • Principal Investigator:
          • David M. King
      • Burnsville, Minnesota, United States, 55337
        • Suspended
        • Fairview Ridges Hospital
      • Cambridge, Minnesota, United States, 55008
        • Recruiting
        • Cambridge Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Chaska, Minnesota, United States, 55318
        • Recruiting
        • Minnesota Oncology Hematology PA-Chaska
        • Contact:
        • Principal Investigator:
          • David M. King
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Mercy Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Minnesota Oncology - Coon Rapids
        • Contact:
        • Principal Investigator:
          • David M. King
      • Edina, Minnesota, United States, 55435
        • Recruiting
        • Fairview Southdale Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Edina, Minnesota, United States, 55435
        • Recruiting
        • Minnesota Oncology - Edina
        • Contact:
        • Principal Investigator:
          • David M. King
      • Fridley, Minnesota, United States, 55432
        • Active, not recruiting
        • Unity Hospital
      • Maple Grove, Minnesota, United States, 55369
        • Recruiting
        • Fairview Clinics and Surgery Center Maple Grove
        • Contact:
        • Principal Investigator:
          • David M. King
      • Maple Grove, Minnesota, United States, 55369
        • Recruiting
        • Minnesota Oncology - Maple Grove
        • Principal Investigator:
          • David M. King
        • Contact:
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Minnesota Oncology Hematology PA-Maplewood
        • Contact:
        • Principal Investigator:
          • David M. King
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Saint John's Hospital - Healtheast
        • Contact:
        • Principal Investigator:
          • David M. King
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Abbott-Northwestern Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Minneapolis, Minnesota, United States, 55454
        • Recruiting
        • Health Partners Inc
        • Contact:
        • Principal Investigator:
          • David M. King
      • Monticello, Minnesota, United States, 55362
        • Recruiting
        • Monticello Cancer Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • New Ulm, Minnesota, United States, 56073
        • Recruiting
        • New Ulm Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Princeton, Minnesota, United States, 55371
        • Recruiting
        • Fairview Northland Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Robbinsdale, Minnesota, United States, 55422
        • Recruiting
        • North Memorial Medical Health Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Saint Louis Park, Minnesota, United States, 55416
        • Recruiting
        • Park Nicollet Clinic - Saint Louis Park
        • Contact:
        • Principal Investigator:
          • David M. King
      • Saint Paul, Minnesota, United States, 55101
        • Recruiting
        • Regions Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Saint Paul, Minnesota, United States, 55102
        • Recruiting
        • United Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Shakopee, Minnesota, United States, 55379
        • Recruiting
        • Saint Francis Regional Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Stillwater, Minnesota, United States, 55082
        • Recruiting
        • Lakeview Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Waconia, Minnesota, United States, 55387
        • Recruiting
        • Ridgeview Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Willmar, Minnesota, United States, 56201
        • Recruiting
        • Rice Memorial Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Woodbury, Minnesota, United States, 55125
        • Recruiting
        • Minnesota Oncology Hematology PA-Woodbury
        • Contact:
        • Principal Investigator:
          • David M. King
      • Wyoming, Minnesota, United States, 55092
        • Recruiting
        • Fairview Lakes Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
    • Missouri
      • Ballwin, Missouri, United States, 63011
        • Recruiting
        • Mercy Oncology and Hematology - Clayton-Clarkson
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 888-446-3729
      • Bolivar, Missouri, United States, 65613
        • Recruiting
        • Central Care Cancer Center - Bolivar
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Bonne Terre, Missouri, United States, 63628
        • Suspended
        • Parkland Health Center-Bonne Terre
      • Branson, Missouri, United States, 65616
        • Recruiting
        • Cox Cancer Center Branson
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • Cape Girardeau, Missouri, United States, 63703
        • Recruiting
        • Saint Francis Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 573-334-2230
          • Email: sfmc@sfmc.net
      • Cape Girardeau, Missouri, United States, 63703
        • Recruiting
        • Mercy Cancer Center - Cape Girardeau
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 888-446-3729
      • Farmington, Missouri, United States, 63640
        • Recruiting
        • Parkland Health Center - Farmington
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Jefferson City, Missouri, United States, 65109
        • Suspended
        • MU Health Care Goldschmidt Cancer Center
      • Joplin, Missouri, United States, 64804
        • Recruiting
        • Freeman Health System
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Joplin, Missouri, United States, 64804
        • Recruiting
        • Mercy Hospital Joplin
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Osage Beach, Missouri, United States, 65065
        • Recruiting
        • Lake Regional Hospital
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Rolla, Missouri, United States, 65401
        • Recruiting
        • Mercy Clinic-Rolla-Cancer and Hematology
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 573-458-6379
      • Rolla, Missouri, United States, 65401
        • Recruiting
        • Phelps Health Delbert Day Cancer Institute
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Saint Joseph, Missouri, United States, 64506
        • Recruiting
        • Heartland Regional Medical Center
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Sainte Genevieve, Missouri, United States, 63670
        • Recruiting
        • Sainte Genevieve County Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Springfield, Missouri, United States, 65804
        • Recruiting
        • Mercy Hospital Springfield
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • Springfield, Missouri, United States, 65807
        • Recruiting
        • CoxHealth South Hospital
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • St Louis, Missouri, United States, 63128
        • Recruiting
        • Mercy Hospital South
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Hospital Saint Louis
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-251-7066
      • St Louis, Missouri, United States, 63131
        • Recruiting
        • Missouri Baptist Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • St Louis, Missouri, United States, 63109
        • Recruiting
        • Mercy Infusion Center - Chippewa
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 888-446-3729
      • Sullivan, Missouri, United States, 63080
        • Recruiting
        • Missouri Baptist Sullivan Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Sunset Hills, Missouri, United States, 63127
        • Recruiting
        • BJC Outpatient Center at Sunset Hills
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Washington, Missouri, United States, 63090
        • Recruiting
        • Mercy Hospital Washington
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 636-390-1600
    • Montana
      • Anaconda, Montana, United States, 59711
        • Recruiting
        • Community Hospital of Anaconda
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Billings, Montana, United States, 59101
        • Recruiting
        • Billings Clinic Cancer Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Bozeman, Montana, United States, 59715
        • Recruiting
        • Bozeman Health Deaconess Hospital
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Great Falls Clinic
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Benefis Sletten Cancer Institute
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Havre, Montana, United States, 59501
        • Recruiting
        • Hi-Line Sletten Cancer Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Helena, Montana, United States, 59601
        • Suspended
        • Saint Peter's Community Hospital
      • Helena, Montana, United States, 59601
        • Recruiting
        • Benefis Helena Specialty Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Kalispell, Montana, United States, 59901
        • Recruiting
        • Logan Health Medical Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Missoula, Montana, United States, 59804
        • Recruiting
        • Community Medical Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Missoula, Montana, United States, 59802
        • Active, not recruiting
        • Saint Patrick Hospital - Community Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
        • Principal Investigator:
          • Robert M. Langdon
        • Contact:
          • Site Public Contact
          • Phone Number: 402-334-4773
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Nebraska Methodist Hospital
        • Principal Investigator:
          • Robert M. Langdon
        • Contact:
          • Site Public Contact
          • Phone Number: 402-354-5144
      • Omaha, Nebraska, United States, 68114
        • Suspended
        • Oncology Associates PC
    • New York
      • Buffalo, New York, United States, 14263
        • Active, not recruiting
        • Roswell Park Cancer Institute
      • Middletown, New York, United States, 10940
        • Suspended
        • Garnet Health Medical Center
      • White Plains, New York, United States, 10601
        • Active, not recruiting
        • Dickstein Cancer Treatment Center
    • North Carolina
      • Hendersonville, North Carolina, United States, 28791
        • Active, not recruiting
        • Margaret R Pardee Memorial Hospital
      • Pinehurst, North Carolina, United States, 28374
        • Recruiting
        • FirstHealth of the Carolinas-Moore Regional Hospital
        • Contact:
        • Principal Investigator:
          • Charles S. Kuzma
    • Ohio
      • Beavercreek, Ohio, United States, 45431
        • Active, not recruiting
        • Indu and Raj Soin Medical Center
      • Boardman, Ohio, United States, 44512
        • Active, not recruiting
        • Saint Elizabeth Boardman Hospital
      • Centerville, Ohio, United States, 45459
        • Active, not recruiting
        • Miami Valley Hospital South
      • Centerville, Ohio, United States, 45459
        • Active, not recruiting
        • Dayton Physicians LLC-Miami Valley South
      • Cincinnati, Ohio, United States, 45236
        • Active, not recruiting
        • Oncology Hematology Care Inc-Kenwood
      • Cleveland, Ohio, United States, 44109
        • Active, not recruiting
        • MetroHealth Medical Center
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Regan M. Memmott
      • Dayton, Ohio, United States, 45406
        • Suspended
        • Good Samaritan Hospital - Dayton
      • Dayton, Ohio, United States, 45409
        • Active, not recruiting
        • Miami Valley Hospital
      • Dayton, Ohio, United States, 45415
        • Active, not recruiting
        • Miami Valley Hospital North
      • Dayton, Ohio, United States, 45415
        • Active, not recruiting
        • Dayton Physician LLC - Englewood
      • Findlay, Ohio, United States, 45840
        • Active, not recruiting
        • Armes Family Cancer Center
      • Findlay, Ohio, United States, 45840
        • Active, not recruiting
        • Blanchard Valley Hospital
      • Findlay, Ohio, United States, 45840
        • Active, not recruiting
        • Orion Cancer Care
      • Franklin, Ohio, United States, 45005-1066
        • Active, not recruiting
        • Atrium Medical Center-Middletown Regional Hospital
      • Franklin, Ohio, United States, 45005
        • Active, not recruiting
        • Dayton Physicians LLC-Atrium
      • Greenville, Ohio, United States, 45331
        • Active, not recruiting
        • Dayton Physicians LLC-Wayne
      • Greenville, Ohio, United States, 45331
        • Active, not recruiting
        • Wayne Hospital
      • Kettering, Ohio, United States, 45409
        • Active, not recruiting
        • Greater Dayton Cancer Center
      • Kettering, Ohio, United States, 45420
        • Active, not recruiting
        • First Dayton Cancer Care
      • Kettering, Ohio, United States, 45429
        • Active, not recruiting
        • Kettering Medical Center
      • Springfield, Ohio, United States, 45504
        • Active, not recruiting
        • Springfield Regional Cancer Center
      • Springfield, Ohio, United States, 45504
        • Active, not recruiting
        • Springfield Regional Medical Center
      • Troy, Ohio, United States, 45373
        • Active, not recruiting
        • Upper Valley Medical Center
      • Troy, Ohio, United States, 45373
        • Active, not recruiting
        • Dayton Physicians LLC - Troy
      • Warren, Ohio, United States, 44484
        • Active, not recruiting
        • Saint Joseph Warren Hospital
      • Youngstown, Ohio, United States, 44501
        • Active, not recruiting
        • Saint Elizabeth Youngstown Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Raid Aljumaily
      • Oklahoma City, Oklahoma, United States, 73120
        • Recruiting
        • Mercy Hospital Oklahoma City
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 405-752-3402
    • Oregon
      • Baker City, Oregon, United States, 97814
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Baker City
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Bend, Oregon, United States, 97701
        • Active, not recruiting
        • Saint Charles Health System
      • Clackamas, Oregon, United States, 97015
        • Active, not recruiting
        • Clackamas Radiation Oncology Center
      • Clackamas, Oregon, United States, 97015
        • Active, not recruiting
        • Providence Cancer Institute Clackamas Clinic
      • Coos Bay, Oregon, United States, 97420
        • Active, not recruiting
        • Bay Area Hospital
      • Corvallis, Oregon, United States, 97330
        • Recruiting
        • Good Samaritan Hospital
        • Contact:
        • Principal Investigator:
          • John Strother
      • Newberg, Oregon, United States, 97132
        • Active, not recruiting
        • Providence Newberg Medical Center
      • Ontario, Oregon, United States, 97914
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Ontario
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Oregon City, Oregon, United States, 97045
        • Active, not recruiting
        • Providence Willamette Falls Medical Center
      • Portland, Oregon, United States, 97213
        • Active, not recruiting
        • Providence Portland Medical Center
      • Portland, Oregon, United States, 97225
        • Active, not recruiting
        • Providence Saint Vincent Medical Center
      • Redmond, Oregon, United States, 97756
        • Active, not recruiting
        • Saint Charles Health System-Redmond
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Recruiting
        • Lehigh Valley Hospital-Cedar Crest
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Bethlehem, Pennsylvania, United States, 18017
        • Recruiting
        • Lehigh Valley Hospital - Muhlenberg
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Recruiting
        • Bryn Mawr Hospital
        • Contact:
        • Principal Investigator:
          • Paul B. Gilman
      • Collegeville, Pennsylvania, United States, 19426
        • Suspended
        • Main Line Health Center-Collegeville
      • East Stroudsburg, Pennsylvania, United States, 18301
        • Recruiting
        • Pocono Medical Center
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Exton, Pennsylvania, United States, 19341
        • Suspended
        • Main Line Health Center-Exton
      • Hazleton, Pennsylvania, United States, 18201
        • Recruiting
        • Lehigh Valley Hospital-Hazleton
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Media, Pennsylvania, United States, 19063
        • Recruiting
        • Riddle Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Paul B. Gilman
      • Newtown Square, Pennsylvania, United States, 19073
        • Suspended
        • Bryn Mawr Health Center
      • Paoli, Pennsylvania, United States, 19301
        • Recruiting
        • Paoli Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Paul B. Gilman
      • Philadelphia, Pennsylvania, United States, 19111
        • Active, not recruiting
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19140
        • Active, not recruiting
        • Temple University Hospital
      • Reading, Pennsylvania, United States, 19605
        • Suspended
        • Penn State Health Saint Joseph Medical Center
      • Wynnewood, Pennsylvania, United States, 19096
        • Recruiting
        • Lankenau Medical Center
        • Contact:
        • Principal Investigator:
          • Paul B. Gilman
    • Virginia
      • Charlottesville, Virginia, United States, 22908
    • Washington
      • Aberdeen, Washington, United States, 98520
        • Active, not recruiting
        • Providence Regional Cancer System-Aberdeen
      • Bellingham, Washington, United States, 98225
        • Active, not recruiting
        • PeaceHealth Saint Joseph Medical Center
      • Centralia, Washington, United States, 98531
        • Active, not recruiting
        • Providence Regional Cancer System-Centralia
      • Edmonds, Washington, United States, 98026
        • Active, not recruiting
        • Swedish Cancer Institute-Edmonds
      • Everett, Washington, United States, 98201
        • Active, not recruiting
        • Providence Regional Cancer Partnership
      • Issaquah, Washington, United States, 98029
        • Active, not recruiting
        • Swedish Cancer Institute-Issaquah
      • Kennewick, Washington, United States, 99336
        • Active, not recruiting
        • Kadlec Clinic Hematology and Oncology
      • Lacey, Washington, United States, 98503
        • Active, not recruiting
        • Providence Regional Cancer System-Lacey
      • Longview, Washington, United States, 98632
        • Active, not recruiting
        • PeaceHealth Saint John Medical Center
      • Seattle, Washington, United States, 98104
        • Suspended
        • Pacific Gynecology Specialists
      • Seattle, Washington, United States, 98112
        • Active, not recruiting
        • Kaiser Permanente Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington Medical Center - Montlake
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-8824
        • Principal Investigator:
          • Christina S. Baik
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-8824
        • Principal Investigator:
          • Christina S. Baik
      • Seattle, Washington, United States, 98122
        • Active, not recruiting
        • Swedish Medical Center-First Hill
      • Seattle, Washington, United States, 98107
        • Active, not recruiting
        • Swedish Medical Center-Ballard Campus
      • Seattle, Washington, United States, 98122-5711
        • Active, not recruiting
        • Swedish Medical Center-Cherry Hill
      • Sedro-Woolley, Washington, United States, 98284
        • Active, not recruiting
        • PeaceHealth United General Medical Center
      • Shelton, Washington, United States, 98584
        • Active, not recruiting
        • Providence Regional Cancer System-Shelton
      • Vancouver, Washington, United States, 98664
        • Active, not recruiting
        • PeaceHealth Southwest Medical Center
      • Walla Walla, Washington, United States, 99362
        • Active, not recruiting
        • Providence Saint Mary Regional Cancer Center
      • Yelm, Washington, United States, 98597
        • Active, not recruiting
        • Providence Regional Cancer System-Yelm
    • Wisconsin
      • Burlington, Wisconsin, United States, 53105
        • Recruiting
        • Aurora Cancer Care-Southern Lakes VLCC
        • Contact:
        • Principal Investigator:
          • Shamsuddin Virani
      • Chippewa Falls, Wisconsin, United States, 54729
      • Cudahy, Wisconsin, United States, 53110
        • Recruiting
        • Aurora Saint Luke's South Shore
        • Contact:
        • Principal Investigator:
          • Shamsuddin Virani
      • Eau Claire, Wisconsin, United States, 54701
      • Fond du Lac, Wisconsin, United States, 54937
        • Recruiting
        • Aurora Health Center-Fond du Lac
        • Contact:
        • Principal Investigator:
          • Shamsuddin Virani
      • Germantown, Wisconsin, United States, 53022
        • Recruiting
        • Aurora Health Care Germantown Health Center
        • Contact:
        • Principal Investigator:
          • Shamsuddin Virani
      • Grafton, Wisconsin, United States, 53024
        • Recruiting
        • Aurora Cancer Care-Grafton
        • Contact:
        • Principal Investigator:
          • Shamsuddin Virani
      • Green Bay, Wisconsin, United States, 54311
        • Recruiting
        • Aurora BayCare Medical Center
        • Contact:
        • Principal Investigator:
          • Shamsuddin Virani
      • Kenosha, Wisconsin, United States, 53142
        • Recruiting
        • Aurora Cancer Care-Kenosha South
        • Contact:
        • Principal Investigator:
          • Shamsuddin Virani
      • La Crosse, Wisconsin, United States, 54601
        • Recruiting
        • Gundersen Lutheran Medical Center
        • Contact:
        • Principal Investigator:
          • Kurt Oettel
      • Ladysmith, Wisconsin, United States, 54848
      • Marinette, Wisconsin, United States, 54143
        • Recruiting
        • Aurora Bay Area Medical Group-Marinette
        • Contact:
        • Principal Investigator:
          • Shamsuddin Virani
      • Marshfield, Wisconsin, United States, 54449
      • Milwaukee, Wisconsin, United States, 53209
        • Recruiting
        • Aurora Cancer Care-Milwaukee
        • Contact:
        • Principal Investigator:
          • Shamsuddin Virani
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Aurora Saint Luke's Medical Center
        • Contact:
        • Principal Investigator:
          • Shamsuddin Virani
      • Milwaukee, Wisconsin, United States, 53233
        • Recruiting
        • Aurora Sinai Medical Center
        • Contact:
        • Principal Investigator:
          • Shamsuddin Virani
      • Minocqua, Wisconsin, United States, 54548
      • New Richmond, Wisconsin, United States, 54017
        • Recruiting
        • Cancer Center of Western Wisconsin
        • Contact:
        • Principal Investigator:
          • David M. King
      • Oshkosh, Wisconsin, United States, 54904
        • Recruiting
        • Vince Lombardi Cancer Clinic - Oshkosh
        • Contact:
        • Principal Investigator:
          • Shamsuddin Virani
      • Racine, Wisconsin, United States, 53406
        • Recruiting
        • Aurora Cancer Care-Racine
        • Contact:
        • Principal Investigator:
          • Shamsuddin Virani
      • Rice Lake, Wisconsin, United States, 54868
      • Sheboygan, Wisconsin, United States, 53081
        • Recruiting
        • Vince Lombardi Cancer Clinic-Sheboygan
        • Contact:
        • Principal Investigator:
          • Shamsuddin Virani
      • Stevens Point, Wisconsin, United States, 54482
      • Summit, Wisconsin, United States, 53066
        • Recruiting
        • Aurora Medical Center in Summit
        • Contact:
        • Principal Investigator:
          • Shamsuddin Virani
      • Two Rivers, Wisconsin, United States, 54241
        • Recruiting
        • Vince Lombardi Cancer Clinic-Two Rivers
        • Contact:
        • Principal Investigator:
          • Shamsuddin Virani
      • Wausau, Wisconsin, United States, 54401
      • Wauwatosa, Wisconsin, United States, 53226
        • Recruiting
        • Aurora Cancer Care-Milwaukee West
        • Contact:
        • Principal Investigator:
          • Shamsuddin Virani
      • West Allis, Wisconsin, United States, 53227
        • Recruiting
        • Aurora West Allis Medical Center
        • Contact:
        • Principal Investigator:
          • Shamsuddin Virani
      • Weston, Wisconsin, United States, 54476
      • Wisconsin Rapids, Wisconsin, United States, 54494
    • Wyoming
      • Cheyenne, Wyoming, United States, 82001
        • Recruiting
        • Memorial Hospital of Laramie County
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Cody, Wyoming, United States, 82414
        • Recruiting
        • Billings Clinic-Cody
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Sheridan, Wyoming, United States, 82801
        • Suspended
        • Welch Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants must have a pathologically-confirmed diagnosis of non-small cell lung cancer (NSCLC)
  • Participants must have advanced disease - either stage IV disease, stage IIIB disease not amenable to definitive multi-modality therapy, or recurrent disease after a prior diagnosis of stage I-III disease. All staging is via the American Joint Committee on Cancer (AJCC)/International Association for the Study of Lung Cancer (IASLC) 7th edition staging criteria

  • An EGFR exon 20 insertion mutation must be detected in the tumor tissue. Patients may be enrolled in the study based on an exon 20 insertion EGFR mutation detected by any Clinical Laboratory Improvement Act (CLIA)-certified tissue assay

    • NOTE: Testing results are to be submitted via Medidata Rave and the study chair or delegate will review the reports
  • Patients must have measurable disease; baseline measurements and ALL sites of disease must be obtained within 4 weeks to registration
  • Patients must have previously received at least one line of therapy for their advanced lung cancer; there are no restrictions on the maximum number of prior therapies allowed
  • Participants must not have previously received osimertinib
  • Participants must have not previously received therapies targeting PDL1, PD1 or CTLA4 within 6 months (180 days) prior to registration
  • Age >= 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 1
  • Hemoglobin >= 9.0 g/L (within 4 weeks before registration)
  • Leukocytes/white blood cells >= 3,000/mcL (within 4 weeks before registration)
  • Absolute neutrophil count >= 1,500/mcL (within 4 weeks before registration)
  • Platelets >= 100,000/mcL (within 4 weeks before registration)
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) if no liver metastases or =< 3 times ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases (within 4 weeks before registration)
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional upper limit of normal; for patients with known hepatic metastases AST and/or ALT =< 5 x ULN (within 4 weeks before registration)
  • Creatinine =< 1.5 x institutional upper limit of normal (within 4 weeks before registration)
  • Participants may not have clinically active or symptomatic interstitial lung disease or interstitial pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention), or a history of clinically significant interstitial lung disease or radiation pneumonitis
  • Participants may not have had radiation to the lung fields within four weeks (28 days) of starting treatment. For patients receiving palliative radiation to thoracic vertebrae, ribs or other sites where the radiation field includes the lungs, radiation must be completed at least two weeks before starting treatment. For all palliative radiation to all other sites, at least 7 days must have elapsed prior to starting treatment. At least six months (180 days) must have elapsed prior to starting treatment for radiation given with curative intent. Palliative radiotherapy to control symptoms (including gamma knife technique) is permitted. For stereotactic radiosurgery (SRS) to central nervous system (CNS) lesions, osimertinib can be held on the day of radiation only. For palliative radiotherapy (RT) to other sites of disease outside of the thorax osimertinib (osi) should be held for a minimum of 3 days before radiation and 3 days after RT is completed, but the duration of washout can be adjusted at the investigator's discretion with the approval of the study principal investigator (PI). For thoracic radiation, a 7-10 day washout period before the procedure and one week period after procedure before restarting osimertinib is advised to minimize the risk of pneumonitis. All radiotherapy related toxicities should be managed and ideally resolved before restarting osimertinib. Investigators should consider the radiotherapy when assessing causality if there are any localized adverse events (AEs) following the procedure
  • Participants may not have clinically symptomatic brain metastases, leptomeningeal disease, or spinal cord compression. Patients may be on a stable dose of corticosteroids to control brain metastases if they have been on a stable dose for two weeks (14 days) prior to study treatment and are clinically asymptomatic
  • Patients must have an ECHO or a nuclear study (MUGA or first pass) within 4 weeks (28 days) prior to registration to treatment and must not have a left ventricular ejection fraction (LVEF) < institutional lower limit of normal (LLN). If the LLN is not defined at a site, the LVEF must be >= 50% for the patient to be eligible

  • Participants may not have any of the following cardiac criteria:

    • Mean resting corrected QT interval (QTc) >= 470 msec obtained from 3 electrocardiograms (ECGs) using the screening clinic ECG machine-derived QTc value
    • No history of QT prolongation associated with other medications that required discontinuation of that medication
    • Patient must not be receiving any concomitant medications that are known to be associated with Torsades de Pointes
    • Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g., complete left bundle branch block, third degree heart block, second degree heart block, any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, electrolyte abnormalities (including: serum/plasma potassium < LLN; serum/plasma magnesium < LLN; serum/plasma calcium < LLN), congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval
    • Symptomatic heart failure - New York Heart Association (NYHA) grade II-IV
  • Participants may not have a second, clinically active, cancer. Patients with second cancers which have been treated with curative intent and/or are currently inactive are allowed
  • Participants may not be receiving any other investigational agents. Patients previously treated with investigational agents must complete a washout period of at least two weeks or five half-lives, whichever is longer, before starting treatment
  • Participants may not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients must have no history of hypersensitivity active or inactive excipients of osimertinib (AZD9291) or drugs with a similar chemical structure or class to osimertinib (AZD9291)
  • Patients must not currently be receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4 (at least 3 week prior). All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYP3A4

  • If medically feasible, patients taking regular medication, with the exception of potent inducers of CYP3A4, should be maintained on it throughout the study period. Patients taking concomitant medications whose disposition is dependent upon breast cancer resistance protein (BCRP) or P-glycoprotein (Pgp) and which have a narrow therapeutic index should be closely monitored for signs of changed tolerability as a result of increased exposure of the concomitant medication whilst receiving osimertinib (AZD9291)

    • NOTE: Use of St John's wort is a contra-indication for osimertinib (AZD9291) use
  • If applicable, it is recommended that the starting and maintenance dose of rosuvastatin (due to BCRP inhibition by AZD9291 [osimertinib]) should be as low as possible and should be guided by the statin label. Monitoring of low-density lipoprotein (LDL) cholesterol levels is advised. If the subject experiences any potentially relevant adverse events suggestive of muscle toxicity including unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever, the statin should be stopped, creatine kinase (CK) levels should be checked, and any appropriate further management should be taken
  • Subjects taking warfarin should be monitored regularly for changes in prothrombin time or international normalized ratio (INR)
  • No unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment, with the exception of alopecia and grade 2, prior platinum-therapy-related neuropathy
  • Patients with refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib (AZD9291) are ineligible
  • Women must not be pregnant or breast-feeding because osimertinib (AZD9291) has been shown to cause fetal harm in animal models. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  • Women of childbearing potential (WOCBP) and sexually active males must use an accepted and effective method of contraception while receiving protocol treatment or abstain from sexual intercourse for the duration of their participation in the study. WOCBP must use birth control for two weeks prior to the start of the treatment and continue for 6 weeks after the last dose of the study drug. Sexually active male patients must use effective contraception from day 1 of treatment and continue for 4 months after the last dose of the study drug
  • Other anticancer agents and investigational agents should not be given while the subject is on study treatment
  • Supportive care and other medications that are considered necessary for the subject's wellbeing may be given at the discretion of the investigator
  • A guidance regarding potential interactions with concomitant medications is provided

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Osimertinib
Given PO
Other Names:
  • AZD-9291
  • AZD9291
  • Mereletinib
  • AZD 9291
Procedure: Biospecimen Collection
Undergo collection of blood samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
  • Sample Collection
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Procedure: Computed Tomography with Contrast
Undergo CT with contrast
Other Names:
  • Contrast Enhanced Computed Tomography
  • CONTRAST ENHANCED CT SCAN
  • Contrast-enhanced Computed Tomography
  • CT Scan With Contrast
  • CT with Contrast
Procedure: Multigated Acquisition Scan
Undergo MUGA
Other Names:
  • Blood Pool Scan
  • Equilibrium Radionuclide Angiography
  • Gated Blood Pool Imaging
  • MUGA
  • Radionuclide Ventriculography
  • RNVG
  • SYMA Scanning
  • Synchronized Multigated Acquisition Scanning
  • MUGA Scan
  • Multi-Gated Acquisition Scan
  • Radionuclide Ventriculogram Scan
  • Gated Heart Pool Scan
  • RNV Scan
Procedure: Echocardiography Test
Undergo ECHO
Other Names:
  • Echocardiography
  • EC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best objective response
Time Frame: Up to 5 years
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.
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
From registration to documented disease progression or death from any cause, whichever occurs first, assessed up to 5 years
Overall survival (OS)
Time Frame: From registration to death from any cause, assessed up to 5 years
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.
From registration to death from any cause, assessed up to 5 years
Incidence of adverse events
Time Frame: Up to 5 years
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.
Up to 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterization of molecular markers of response to treatment in circulating tumor deoxyribonucleic acid (ctDNA)
Time Frame: Baseline up to 5 years
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).
Baseline up to 5 years
Biomarkers of response to treatment through retrospective analyses of pre-treatment tumor tissue
Time Frame: Baseline up to 5 years
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.
Baseline up to 5 years
Identification of resistance mechanisms to osimertinib through post-progression tumor biopsies and ctDNA
Time Frame: Up to 5 years
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.
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Zofia Piotrowska, ECOG-ACRIN Cancer Research Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2018

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

June 16, 2017

First Submitted That Met QC Criteria

June 16, 2017

First Posted (Actual)

June 19, 2017

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2017-01017 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • U10CA180820 (U.S. NIH Grant/Contract)
  • EA5162 (Other Identifier: CTEP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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