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Osimertinib i behandling av pasienter med stadium IIIB-IV eller tilbakevendende ikke-småcellet lungekreft med EGFR Exon 20-innsettingsmutasjoner

31. oktober 2026 oppdatert av: National Cancer Institute (NCI)

Fase II-studie av AZD9291 (Osimertinib) hos avanserte NSCLC-pasienter med Exon 20-innsettingsmutasjoner i 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.

Studieoversikt

Status

Status

Indikerer gjeldende rekrutteringsstatus eller utvidet tilgangsstatus.
Rekruttering

Forhold

Forhold

Sykdommen, lidelsen, syndromet, sykdommen eller skaden som studeres. På ClinicalTrials.gov kan tilstander også inkludere andre helserelaterte problemer, som levetid, livskvalitet og helserisiko.

Intervensjon / Behandling

Intervensjon / Behandling

En prosess eller handling som er fokus for en klinisk studie. Intervensjoner inkluderer legemidler, medisinsk utstyr, prosedyrer, vaksiner og andre produkter som enten er undersøkende eller allerede er tilgjengelige. Intervensjoner kan også inkludere ikke-invasive tilnærminger, som utdanning eller modifisering av kosthold og trening.

Detaljert beskrivelse

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.

Studietype

Studietype

Beskriver arten av en klinisk studie. Studietyper inkluderer intervensjonsstudier (også kalt kliniske studier), observasjonsstudier (inkludert pasientregistre) og utvidet tilgang.
Intervensjonell

Registrering (Antatt)

Registrering

Antall deltakere i en klinisk studie. Den "forventede" påmeldingen er måltallet for deltakere som forskerne trenger for studien.
46

Fase

Fase

Stadiet av en klinisk studie som studerer et medikament eller biologisk produkt, basert på definisjoner utviklet av U.S. Food and Drug Administration (FDA). Fasen er basert på studiens målsetting, antall deltakere og andre egenskaper. Det er fem faser: Tidlig fase 1 (tidligere oppført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant brukes til å beskrive studier uten FDA-definerte faser, inkludert utprøving av enheter eller atferdsintervensjoner.
  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Alaska
      • Anchorage, Alaska, Forente stater, 98508
        • Aktiv, ikke rekrutterende
        • Anchorage Associates in Radiation Medicine
      • Anchorage, Alaska, Forente stater, 99504
        • Aktiv, ikke rekrutterende
        • Anchorage Radiation Therapy Center
      • Anchorage, Alaska, Forente stater, 99508
        • Aktiv, ikke rekrutterende
        • Alaska Breast Care and Surgery LLC
      • Anchorage, Alaska, Forente stater, 99508
        • Aktiv, ikke rekrutterende
        • Alaska Oncology and Hematology LLC
      • Anchorage, Alaska, Forente stater, 99508
        • Aktiv, ikke rekrutterende
        • Alaska Women's Cancer Care
      • Anchorage, Alaska, Forente stater, 99508
        • Aktiv, ikke rekrutterende
        • Anchorage Oncology Centre
      • Anchorage, Alaska, Forente stater, 99508
        • Aktiv, ikke rekrutterende
        • Katmai Oncology Group
      • Anchorage, Alaska, Forente stater, 99508
        • Aktiv, ikke rekrutterende
        • Providence Alaska Medical Center
      • Fairbanks, Alaska, Forente stater, 99701
    • Arkansas
      • Fort Smith, Arkansas, Forente stater, 72903
        • Rekruttering
        • Mercy Hospital Fort Smith
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 800-378-9373
        • Hovedetterforsker:
          • Jay W. Carlson
      • Little Rock, Arkansas, Forente stater, 72205
        • Rekruttering
        • CARTI Cancer Center
        • Hovedetterforsker:
          • Jay W. Carlson
        • Ta kontakt med:
    • California
      • Burbank, California, Forente stater, 91505
        • Aktiv, ikke rekrutterende
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
    • District of Columbia
      • Washington D.C., District of Columbia, Forente stater, 20007
        • Rekruttering
        • MedStar Georgetown University Hospital
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          • Site Public Contact
          • Telefonnummer: 202-444-2223
        • Hovedetterforsker:
          • Chul Kim
    • Florida
      • Fort Lauderdale, Florida, Forente stater, 33308
        • Rekruttering
        • Holy Cross Hospital
        • Hovedetterforsker:
          • Christopher M. Reynolds
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    • Georgia
      • Atlanta, Georgia, Forente stater, 30322
        • Rekruttering
        • Emory University Hospital/Winship Cancer Institute
        • Hovedetterforsker:
          • Ticiana A. Leal
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 404-778-1868
      • Atlanta, Georgia, Forente stater, 30308
        • Rekruttering
        • Emory University Hospital Midtown
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          • Site Public Contact
          • Telefonnummer: 888-946-7447
        • Hovedetterforsker:
          • Ticiana A. Leal
      • Atlanta, Georgia, Forente stater, 30342
        • Rekruttering
        • Emory Saint Joseph's Hospital
        • Hovedetterforsker:
          • Ticiana A. Leal
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 404-851-7115
    • Idaho
      • Boise, Idaho, Forente stater, 83706
        • Rekruttering
        • Saint Alphonsus Cancer Care Center-Boise
        • Ta kontakt med:
        • Hovedetterforsker:
          • Christopher M. Reynolds
      • Boise, Idaho, Forente stater, 83712
        • Aktiv, ikke rekrutterende
        • Saint Luke's Cancer Institute - Boise
      • Caldwell, Idaho, Forente stater, 83605
        • Rekruttering
        • Saint Alphonsus Cancer Care Center-Caldwell
        • Ta kontakt med:
        • Hovedetterforsker:
          • Christopher M. Reynolds
      • Coeur d'Alene, Idaho, Forente stater, 83814
        • Rekruttering
        • Kootenai Health - Coeur d'Alene
        • Hovedetterforsker:
          • John M. Schallenkamp
        • Ta kontakt med:
      • Emmett, Idaho, Forente stater, 83617
        • Suspendert
        • Walter Knox Memorial Hospital
      • Fruitland, Idaho, Forente stater, 83619
        • Aktiv, ikke rekrutterende
        • Saint Luke's Cancer Institute - Fruitland
      • Meridian, Idaho, Forente stater, 83642
        • Rekruttering
        • Idaho Urologic Institute-Meridian
        • Ta kontakt med:
        • Hovedetterforsker:
          • Christopher M. Reynolds
      • Meridian, Idaho, Forente stater, 83642
        • Aktiv, ikke rekrutterende
        • Saint Luke's Cancer Institute - Meridian
      • Nampa, Idaho, Forente stater, 83687
        • Rekruttering
        • Saint Alphonsus Cancer Care Center-Nampa
        • Ta kontakt med:
        • Hovedetterforsker:
          • Christopher M. Reynolds
      • Nampa, Idaho, Forente stater, 83687
        • Aktiv, ikke rekrutterende
        • Saint Luke's Cancer Institute - Nampa
      • Post Falls, Idaho, Forente stater, 83854
        • Rekruttering
        • Kootenai Clinic Cancer Services - Post Falls
        • Hovedetterforsker:
          • John M. Schallenkamp
        • Ta kontakt med:
      • Sandpoint, Idaho, Forente stater, 83864
        • Rekruttering
        • Kootenai Clinic Cancer Services - Sandpoint
        • Hovedetterforsker:
          • John M. Schallenkamp
        • Ta kontakt med:
      • Twin Falls, Idaho, Forente stater, 83301
        • Aktiv, ikke rekrutterende
        • Saint Luke's Cancer Institute - Twin Falls
    • Illinois
      • Alton, Illinois, Forente stater, 62002
        • Rekruttering
        • OSF Saint Anthony's Health Center
        • Hovedetterforsker:
          • Jay W. Carlson
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          • Site Public Contact
          • Telefonnummer: 618-463-5623
      • Aurora, Illinois, Forente stater, 60504
        • Suspendert
        • Rush-Copley Medical Center
      • Bloomington, Illinois, Forente stater, 61704
        • Rekruttering
        • Illinois CancerCare-Bloomington
        • Ta kontakt med:
        • Hovedetterforsker:
          • Bryan A. Faller
      • Canton, Illinois, Forente stater, 61520
        • Rekruttering
        • Illinois CancerCare-Canton
        • Ta kontakt med:
        • Hovedetterforsker:
          • Bryan A. Faller
      • Carbondale, Illinois, Forente stater, 62902
        • Rekruttering
        • Memorial Hospital of Carbondale
        • Hovedetterforsker:
          • Bryan A. Faller
        • Ta kontakt med:
      • Carterville, Illinois, Forente stater, 62918
        • Rekruttering
        • SIH Cancer Institute
        • Hovedetterforsker:
          • Bryan A. Faller
        • Ta kontakt med:
      • Carthage, Illinois, Forente stater, 62321
        • Rekruttering
        • Illinois CancerCare-Carthage
        • Ta kontakt med:
        • Hovedetterforsker:
          • Bryan A. Faller
      • Centralia, Illinois, Forente stater, 62801
        • Rekruttering
        • Centralia Oncology Clinic
        • Hovedetterforsker:
          • Bryan A. Faller
        • Ta kontakt med:
      • Centralia, Illinois, Forente stater, 62801
        • Suspendert
        • Saint Mary's Hospital
      • Danville, Illinois, Forente stater, 61832
        • Rekruttering
        • Carle at The Riverfront
        • Hovedetterforsker:
          • Priyank P. Patel
        • Ta kontakt med:
      • Decatur, Illinois, Forente stater, 62526
        • Rekruttering
        • Cancer Care Specialists of Illinois - Decatur
        • Hovedetterforsker:
          • Bryan A. Faller
        • Ta kontakt med:
      • Decatur, Illinois, Forente stater, 62526
        • Rekruttering
        • Decatur Memorial Hospital
        • Hovedetterforsker:
          • Bryan A. Faller
        • Ta kontakt med:
      • Dixon, Illinois, Forente stater, 61021
        • Rekruttering
        • Illinois CancerCare-Dixon
        • Hovedetterforsker:
          • Bryan A. Faller
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 815-285-7800
      • Effingham, Illinois, Forente stater, 62401
        • Rekruttering
        • Carle Physician Group-Effingham
        • Ta kontakt med:
        • Hovedetterforsker:
          • Priyank P. Patel
      • Effingham, Illinois, Forente stater, 62401
        • Rekruttering
        • Crossroads Cancer Center
        • Hovedetterforsker:
          • Bryan A. Faller
        • Ta kontakt med:
      • Eureka, Illinois, Forente stater, 61530
        • Rekruttering
        • Illinois CancerCare-Eureka
        • Ta kontakt med:
        • Hovedetterforsker:
          • Bryan A. Faller
      • Evanston, Illinois, Forente stater, 60201
        • Aktiv, ikke rekrutterende
        • NorthShore University HealthSystem-Evanston Hospital
      • Galesburg, Illinois, Forente stater, 61401
        • Rekruttering
        • Illinois CancerCare-Galesburg
        • Ta kontakt med:
        • Hovedetterforsker:
          • Bryan A. Faller
      • Galesburg, Illinois, Forente stater, 61401
        • Suspendert
        • Western Illinois Cancer Treatment Center
      • Glenview, Illinois, Forente stater, 60026
        • Aktiv, ikke rekrutterende
        • NorthShore University HealthSystem-Glenbrook Hospital
      • Highland Park, Illinois, Forente stater, 60035
        • Aktiv, ikke rekrutterende
        • NorthShore University HealthSystem-Highland Park Hospital
      • Kewanee, Illinois, Forente stater, 61443
        • Rekruttering
        • Illinois CancerCare-Kewanee Clinic
        • Ta kontakt med:
        • Hovedetterforsker:
          • Bryan A. Faller
      • Macomb, Illinois, Forente stater, 61455
        • Rekruttering
        • Illinois CancerCare-Macomb
        • Ta kontakt med:
        • Hovedetterforsker:
          • Bryan A. Faller
      • Mattoon, Illinois, Forente stater, 61938
        • Rekruttering
        • Carle Physician Group-Mattoon/Charleston
        • Ta kontakt med:
        • Hovedetterforsker:
          • Priyank P. Patel
      • Mount Vernon, Illinois, Forente stater, 62864
        • Rekruttering
        • SSM Health Good Samaritan
        • Hovedetterforsker:
          • Jay W. Carlson
        • Ta kontakt med:
      • O'Fallon, Illinois, Forente stater, 62269
        • Rekruttering
        • Cancer Care Center of O'Fallon
        • Hovedetterforsker:
          • Bryan A. Faller
        • Ta kontakt med:
      • O'Fallon, Illinois, Forente stater, 62269
        • Rekruttering
        • HSHS Saint Elizabeth's Hospital
        • Hovedetterforsker:
          • Bryan A. Faller
        • Ta kontakt med:
      • Ottawa, Illinois, Forente stater, 61350
        • Rekruttering
        • Illinois CancerCare-Ottawa Clinic
        • Ta kontakt med:
        • Hovedetterforsker:
          • Bryan A. Faller
      • Pekin, Illinois, Forente stater, 61554
        • Rekruttering
        • Illinois CancerCare-Pekin
        • Ta kontakt med:
        • Hovedetterforsker:
          • Bryan A. Faller
      • Peoria, Illinois, Forente stater, 61615
        • Rekruttering
        • Illinois CancerCare-Peoria
        • Ta kontakt med:
        • Hovedetterforsker:
          • Bryan A. Faller
      • Peoria, Illinois, Forente stater, 61636
        • Rekruttering
        • Methodist Medical Center of Illinois
        • Ta kontakt med:
        • Hovedetterforsker:
          • Bryan A. Faller
      • Peru, Illinois, Forente stater, 61354
        • Rekruttering
        • Illinois CancerCare-Peru
        • Ta kontakt med:
        • Hovedetterforsker:
          • Bryan A. Faller
      • Peru, Illinois, Forente stater, 61354
        • Rekruttering
        • Valley Radiation Oncology
        • Hovedetterforsker:
          • Bryan A. Faller
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 815-664-4141
      • Princeton, Illinois, Forente stater, 61356
        • Rekruttering
        • Illinois CancerCare-Princeton
        • Ta kontakt med:
        • Hovedetterforsker:
          • Bryan A. Faller
      • Skokie, Illinois, Forente stater, 60076
        • Aktiv, ikke rekrutterende
        • North Shore Medical Center
      • Springfield, Illinois, Forente stater, 62702
        • Rekruttering
        • Southern Illinois University School of Medicine
        • Hovedetterforsker:
          • Bryan A. Faller
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 217-545-7929
      • Springfield, Illinois, Forente stater, 62702
        • Rekruttering
        • Springfield Clinic
        • Hovedetterforsker:
          • Bryan A. Faller
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 800-444-7541
      • Springfield, Illinois, Forente stater, 62781
        • Rekruttering
        • Springfield Memorial Hospital
        • Hovedetterforsker:
          • Bryan A. Faller
        • Ta kontakt med:
      • Swansea, Illinois, Forente stater, 62226
        • Suspendert
        • Southwest Illinois Health Services LLP
      • Urbana, Illinois, Forente stater, 61801
        • Rekruttering
        • Carle Cancer Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Priyank P. Patel
      • Urbana, Illinois, Forente stater, 61801
        • Rekruttering
        • The Carle Foundation Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Priyank P. Patel
      • Washington, Illinois, Forente stater, 61571
        • Rekruttering
        • Illinois CancerCare - Washington
        • Ta kontakt med:
        • Hovedetterforsker:
          • Bryan A. Faller
      • Yorkville, Illinois, Forente stater, 60560
        • Suspendert
        • Rush-Copley Healthcare Center
      • Zion, Illinois, Forente stater, 60099
        • Aktiv, ikke rekrutterende
        • Midwestern Regional Medical Center
    • Indiana
      • Richmond, Indiana, Forente stater, 47374
        • Aktiv, ikke rekrutterende
        • Reid Health
    • Iowa
      • Council Bluffs, Iowa, Forente stater, 51503
        • Aktiv, ikke rekrutterende
        • Heartland Oncology and Hematology LLP
      • Council Bluffs, Iowa, Forente stater, 51503
        • Aktiv, ikke rekrutterende
        • Methodist Jennie Edmundson Hospital
      • Council Bluffs, Iowa, Forente stater, 51503
        • Aktiv, ikke rekrutterende
        • Nebraska Cancer Specialists/Oncology Hematology West PC - MEJ
      • Des Moines, Iowa, Forente stater, 50314
        • Aktiv, ikke rekrutterende
        • Broadlawns Medical Center
      • Des Moines, Iowa, Forente stater, 50309
        • Aktiv, ikke rekrutterende
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, Forente stater, 50316
        • Aktiv, ikke rekrutterende
        • Iowa Lutheran Hospital
      • Des Moines, Iowa, Forente stater, 50309
        • Aktiv, ikke rekrutterende
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
      • Fort Dodge, Iowa, Forente stater, 50501
        • Aktiv, ikke rekrutterende
        • UI Healthcare Mission Cancer and Blood - Fort Dodge
      • West Des Moines, Iowa, Forente stater, 50266-7700
        • Aktiv, ikke rekrutterende
        • Methodist West Hospital
    • Kansas
      • Garden City, Kansas, Forente stater, 67846
        • Rekruttering
        • Central Care Cancer Center - Garden City
        • Hovedetterforsker:
          • Jay W. Carlson
        • Ta kontakt med:
      • Great Bend, Kansas, Forente stater, 67530
        • Rekruttering
        • Central Care Cancer Center - Great Bend
        • Hovedetterforsker:
          • Jay W. Carlson
        • Ta kontakt med:
      • Pittsburg, Kansas, Forente stater, 66762
        • Rekruttering
        • Mercy Hospital Pittsburg
        • Hovedetterforsker:
          • Jay W. Carlson
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 888-446-3729
    • Louisiana
      • Baton Rouge, Louisiana, Forente stater, 70809
        • Aktiv, ikke rekrutterende
        • Ochsner Health Center-Summa
      • Baton Rouge, Louisiana, Forente stater, 70816
        • Aktiv, ikke rekrutterende
        • Medical Center of Baton Rouge
      • Baton Rouge, Louisiana, Forente stater, 70836
        • Aktiv, ikke rekrutterende
        • Ochsner High Grove
      • New Orleans, Louisiana, Forente stater, 70121
        • Aktiv, ikke rekrutterende
        • Ochsner Medical Center Jefferson
    • Maryland
      • Baltimore, Maryland, Forente stater, 21287
        • Aktiv, ikke rekrutterende
        • Johns Hopkins University/Sidney Kimmel Cancer Center
      • Baltimore, Maryland, Forente stater, 21237
        • Aktiv, ikke rekrutterende
        • MedStar Franklin Square Medical Center/Weinberg Cancer Institute
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02114
        • Rekruttering
        • Massachusetts General Hospital Cancer Center
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 877-726-5130
        • Hovedetterforsker:
          • Zofia Piotrowska
      • Boston, Massachusetts, Forente stater, 02215
        • Suspendert
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, Forente stater, 02115
        • Suspendert
        • Brigham and Women's Hospital
      • Boston, Massachusetts, Forente stater, 02215
        • Suspendert
        • Dana-Farber Cancer Institute
      • Springfield, Massachusetts, Forente stater, 01104
        • Aktiv, ikke rekrutterende
        • Mercy Medical Center
    • Michigan
      • Alma, Michigan, Forente stater, 48801
        • Rekruttering
        • MyMichigan Medical Center Gratiot
        • Ta kontakt med:
        • Hovedetterforsker:
          • Christopher M. Reynolds
      • Alpena, Michigan, Forente stater, 49707
        • Rekruttering
        • MyMichigan Medical Center Alpena
        • Ta kontakt med:
        • Hovedetterforsker:
          • Christopher M. Reynolds
      • Ann Arbor, Michigan, Forente stater, 48106
        • Rekruttering
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
        • Ta kontakt med:
        • Hovedetterforsker:
          • Christopher M. Reynolds
      • Battle Creek, Michigan, Forente stater, 49017
        • Rekruttering
        • Bronson Battle Creek
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kathleen Y. Butler
      • Brighton, Michigan, Forente stater, 48114
        • Rekruttering
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Ta kontakt med:
        • Hovedetterforsker:
          • Christopher M. Reynolds
      • Brighton, Michigan, Forente stater, 48114
        • Rekruttering
        • Trinity Health Medical Center - Brighton
        • Ta kontakt med:
        • Hovedetterforsker:
          • Christopher M. Reynolds
      • Canton, Michigan, Forente stater, 48188
        • Rekruttering
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Ta kontakt med:
        • Hovedetterforsker:
          • Christopher M. Reynolds
      • Canton, Michigan, Forente stater, 48188
        • Rekruttering
        • Trinity Health Medical Center - Canton
        • Ta kontakt med:
        • Hovedetterforsker:
          • Christopher M. Reynolds
      • Caro, Michigan, Forente stater, 48723
        • Suspendert
        • Caro Cancer Center
      • Chelsea, Michigan, Forente stater, 48118
        • Rekruttering
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Christopher M. Reynolds
      • Chelsea, Michigan, Forente stater, 48118
      • Clarkston, Michigan, Forente stater, 48346
        • Rekruttering
        • Hematology Oncology Consultants-Clarkston
        • Ta kontakt med:
        • Hovedetterforsker:
          • Christopher M. Reynolds
      • Clarkston, Michigan, Forente stater, 48346
        • Suspendert
        • Newland Medical Associates-Clarkston
      • Clarkston, Michigan, Forente stater, 48346
        • Rekruttering
        • Trinity Health IHA Medical Group - Primary Care - Clarkston
        • Hovedetterforsker:
          • Christopher M. Reynolds
        • Ta kontakt med:
      • Detroit, Michigan, Forente stater, 48202
        • Rekruttering
        • Henry Ford Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Adam M. Forman
      • Detroit, Michigan, Forente stater, 48236
        • Rekruttering
        • Henry Ford Health Saint John Hospital
        • Hovedetterforsker:
          • Christopher M. Reynolds
        • Ta kontakt med:
      • East China Township, Michigan, Forente stater, 48054
        • Rekruttering
        • Henry Ford River District Hospital
        • Hovedetterforsker:
          • Christopher M. Reynolds
        • Ta kontakt med:
      • Flint, Michigan, Forente stater, 48503
        • Rekruttering
        • Genesee Hematology Oncology PC
        • Hovedetterforsker:
          • Christopher M. Reynolds
        • Ta kontakt med:
      • Flint, Michigan, Forente stater, 48503
        • Rekruttering
        • Genesys Hurley Cancer Institute
        • Hovedetterforsker:
          • Christopher M. Reynolds
        • Ta kontakt med:
      • Flint, Michigan, Forente stater, 48503
        • Rekruttering
        • Hurley Medical Center
        • Hovedetterforsker:
          • Christopher M. Reynolds
        • Ta kontakt med:
      • Flint, Michigan, Forente stater, 48503
        • Rekruttering
        • Cancer Hematology Centers - Flint
        • Hovedetterforsker:
          • Christopher M. Reynolds
        • Ta kontakt med:
      • Gladwin, Michigan, Forente stater, 48624
        • Rekruttering
        • MyMichigan Medical Center Gladwin
        • Ta kontakt med:
        • Hovedetterforsker:
          • Christopher M. Reynolds
      • Grand Rapids, Michigan, Forente stater, 49503
        • Rekruttering
        • Trinity Health Grand Rapids Hospital
        • Hovedetterforsker:
          • Christopher M. Reynolds
        • Ta kontakt med:
      • Grand Rapids, Michigan, Forente stater, 49503
        • Rekruttering
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kathleen Y. Butler
      • Grand Rapids, Michigan, Forente stater, 49503
        • Rekruttering
        • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kathleen Y. Butler
      • Grosse Pointe Woods, Michigan, Forente stater, 48236
        • Rekruttering
        • Henry Ford Saint John Hospital - Breast
        • Hovedetterforsker:
          • Christopher M. Reynolds
        • Ta kontakt med:
      • Grosse Pointe Woods, Michigan, Forente stater, 48236
        • Rekruttering
        • Henry Ford Saint John Hospital - Academic
        • Hovedetterforsker:
          • Christopher M. Reynolds
        • Ta kontakt med:
      • Grosse Pointe Woods, Michigan, Forente stater, 48236
        • Rekruttering
        • Henry Ford Saint John Hospital - Van Elslander
        • Hovedetterforsker:
          • Christopher M. Reynolds
        • Ta kontakt med:
      • Kalamazoo, Michigan, Forente stater, 49007
        • Rekruttering
        • Bronson Methodist Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kathleen Y. Butler
      • Kalamazoo, Michigan, Forente stater, 49007
        • Rekruttering
        • West Michigan Cancer Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kathleen Y. Butler
      • Kalamazoo, Michigan, Forente stater, 49009
        • Rekruttering
        • Beacon Kalamazoo Cancer Center
        • Hovedetterforsker:
          • Kathleen Y. Butler
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 574-647-7370
      • Kalamazoo, Michigan, Forente stater, 49048
        • Rekruttering
        • Beacon Kalamazoo
        • Hovedetterforsker:
          • Kathleen Y. Butler
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 574-647-7370
      • Lansing, Michigan, Forente stater, 48912
        • Rekruttering
        • University of Michigan Health - Sparrow Lansing
        • Hovedetterforsker:
          • Christopher M. Reynolds
        • Ta kontakt med:
      • Livonia, Michigan, Forente stater, 48154
        • Suspendert
        • Hope Cancer Clinic
      • Livonia, Michigan, Forente stater, 48154
        • Rekruttering
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Christopher M. Reynolds
      • Macomb, Michigan, Forente stater, 48044
        • Rekruttering
        • Henry Ford Warren Hospital - Breast Macomb
        • Hovedetterforsker:
          • Christopher M. Reynolds
        • Ta kontakt med:
      • Macomb, Michigan, Forente stater, 48044
        • Rekruttering
        • Henry Ford Saint John Hospital - Macomb Medical
        • Hovedetterforsker:
          • Christopher M. Reynolds
        • Ta kontakt med:
      • Marlette, Michigan, Forente stater, 48453
        • Suspendert
        • Saint Mary's Oncology/Hematology Associates of Marlette
      • Midland, Michigan, Forente stater, 48670
        • Rekruttering
        • MyMichigan Medical Center Midland
        • Ta kontakt med:
        • Hovedetterforsker:
          • Christopher M. Reynolds
      • Mount Pleasant, Michigan, Forente stater, 48858
        • Rekruttering
        • MyMichigan Medical Center Mount Pleasant
        • Ta kontakt med:
        • Hovedetterforsker:
          • Christopher M. Reynolds
      • Muskegon, Michigan, Forente stater, 49444
        • Suspendert
        • Trinity Health Muskegon Hospital
      • Niles, Michigan, Forente stater, 49120
        • Rekruttering
        • Corewell Health Lakeland Hospitals - Niles Hospital
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 616-391-1230
        • Hovedetterforsker:
          • Kathleen Y. Butler
      • Norton Shores, Michigan, Forente stater, 49444
        • Suspendert
        • Cancer and Hematology Centers of Western Michigan - Norton Shores
      • Novi, Michigan, Forente stater, 48374
        • Rekruttering
        • Henry Ford Health Providence Novi Hospital
        • Hovedetterforsker:
          • Susan E. Lyons
        • Ta kontakt med:
      • Pontiac, Michigan, Forente stater, 48341
        • Suspendert
        • Hope Cancer Center
      • Pontiac, Michigan, Forente stater, 48341
        • Rekruttering
        • Trinity Health Saint Joseph Mercy Oakland Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Christopher M. Reynolds
      • Pontiac, Michigan, Forente stater, 48341
        • Rekruttering
        • Michigan Healthcare Professionals Pontiac
        • Hovedetterforsker:
          • Christopher M. Reynolds
        • Ta kontakt med:
      • Pontiac, Michigan, Forente stater, 48341
        • Rekruttering
        • Trinity Health IHA Medical Group-Alice Gustafson Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Christopher M. Reynolds
      • Reed City, Michigan, Forente stater, 49677
        • Rekruttering
        • Corewell Health Reed City Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kathleen Y. Butler
      • Rochester Hills, Michigan, Forente stater, 48309
        • Suspendert
        • Henry Ford Rochester Hospital
      • Saginaw, Michigan, Forente stater, 48604
        • Suspendert
        • Oncology Hematology Associates of Saginaw Valley PC
      • Saginaw, Michigan, Forente stater, 48601
        • Rekruttering
        • MyMichigan Medical Center Saginaw
        • Ta kontakt med:
        • Hovedetterforsker:
          • Christopher M. Reynolds
      • Saint Joseph, Michigan, Forente stater, 49085
        • Rekruttering
        • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kathleen Y. Butler
      • Saint Joseph, Michigan, Forente stater, 49085
        • Rekruttering
        • Corewell Health Lakeland Hospitals - Saint Joseph Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kathleen Y. Butler
      • Southfield, Michigan, Forente stater, 48075
        • Rekruttering
        • Henry Ford Health Providence Southfield Hospital
        • Hovedetterforsker:
          • Susan E. Lyons
        • Ta kontakt med:
      • Sterling Heights, Michigan, Forente stater, 48312
        • Suspendert
        • Bhadresh Nayak MD PC-Sterling Heights
      • Tawas City, Michigan, Forente stater, 48764
        • Rekruttering
        • MyMichigan Medical Center Tawas
        • Ta kontakt med:
        • Hovedetterforsker:
          • Christopher M. Reynolds
      • Traverse City, Michigan, Forente stater, 49684
        • Rekruttering
        • Munson Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kathleen Y. Butler
      • Warren, Michigan, Forente stater, 48088
        • Suspendert
        • Advanced Breast Care Center PLLC
      • Warren, Michigan, Forente stater, 48093
        • Suspendert
        • Macomb Hematology Oncology PC
      • Warren, Michigan, Forente stater, 48093
        • Rekruttering
        • Henry Ford Madison Heights Hospital - Breast
        • Hovedetterforsker:
          • Christopher M. Reynolds
        • Ta kontakt med:
      • Warren, Michigan, Forente stater, 48093
        • Rekruttering
        • Henry Ford Health Warren Hospital
        • Hovedetterforsker:
          • Christopher M. Reynolds
        • Ta kontakt med:
      • Warren, Michigan, Forente stater, 48093
        • Rekruttering
        • Henry Ford Warren Hospital - GLCMS
        • Hovedetterforsker:
          • Christopher M. Reynolds
        • Ta kontakt med:
      • West Branch, Michigan, Forente stater, 48661
        • Suspendert
        • Saint Mary's Oncology/Hematology Associates of West Branch
      • Wyoming, Michigan, Forente stater, 49519
        • Rekruttering
        • University of Michigan Health - West
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kathleen Y. Butler
      • Ypsilanti, Michigan, Forente stater, 48106
        • Rekruttering
        • Huron Gastroenterology PC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Christopher M. Reynolds
      • Ypsilanti, Michigan, Forente stater, 48197
        • Rekruttering
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Ta kontakt med:
        • Hovedetterforsker:
          • Christopher M. Reynolds
    • Minnesota
      • Burnsville, Minnesota, Forente stater, 55337
        • Rekruttering
        • Minnesota Oncology - Burnsville
        • Ta kontakt med:
        • Hovedetterforsker:
          • David M. King
      • Burnsville, Minnesota, Forente stater, 55337
        • Suspendert
        • Fairview Ridges Hospital
      • Cambridge, Minnesota, Forente stater, 55008
        • Rekruttering
        • Cambridge Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • David M. King
      • Chaska, Minnesota, Forente stater, 55318
        • Rekruttering
        • Minnesota Oncology Hematology PA-Chaska
        • Ta kontakt med:
        • Hovedetterforsker:
          • David M. King
      • Coon Rapids, Minnesota, Forente stater, 55433
        • Rekruttering
        • Mercy Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • David M. King
      • Coon Rapids, Minnesota, Forente stater, 55433
        • Rekruttering
        • Minnesota Oncology - Coon Rapids
        • Ta kontakt med:
        • Hovedetterforsker:
          • David M. King
      • Edina, Minnesota, Forente stater, 55435
        • Rekruttering
        • Fairview Southdale Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • David M. King
      • Edina, Minnesota, Forente stater, 55435
        • Rekruttering
        • Minnesota Oncology - Edina
        • Ta kontakt med:
        • Hovedetterforsker:
          • David M. King
      • Fridley, Minnesota, Forente stater, 55432
        • Aktiv, ikke rekrutterende
        • Unity Hospital
      • Maple Grove, Minnesota, Forente stater, 55369
        • Rekruttering
        • Fairview Clinics and Surgery Center Maple Grove
        • Ta kontakt med:
        • Hovedetterforsker:
          • David M. King
      • Maple Grove, Minnesota, Forente stater, 55369
        • Rekruttering
        • Minnesota Oncology - Maple Grove
        • Hovedetterforsker:
          • David M. King
        • Ta kontakt med:
      • Maple Grove, Minnesota, Forente stater, 55369
        • Rekruttering
        • HealthPartners Cancer Care - Park Nicollet Maple Grove
        • Hovedetterforsker:
          • David M. King
        • Ta kontakt med:
      • Maplewood, Minnesota, Forente stater, 55109
        • Rekruttering
        • Minnesota Oncology Hematology PA-Maplewood
        • Ta kontakt med:
        • Hovedetterforsker:
          • David M. King
      • Maplewood, Minnesota, Forente stater, 55109
        • Rekruttering
        • Saint John's Hospital - Healtheast
        • Ta kontakt med:
        • Hovedetterforsker:
          • David M. King
      • Minneapolis, Minnesota, Forente stater, 55407
        • Rekruttering
        • Abbott-Northwestern Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • David M. King
      • Minneapolis, Minnesota, Forente stater, 55454
        • Rekruttering
        • Health Partners Inc
        • Ta kontakt med:
        • Hovedetterforsker:
          • David M. King
      • Monticello, Minnesota, Forente stater, 55362
        • Rekruttering
        • Monticello Cancer Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • David M. King
      • New Ulm, Minnesota, Forente stater, 56073
        • Rekruttering
        • New Ulm Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • David M. King
      • Princeton, Minnesota, Forente stater, 55371
        • Rekruttering
        • Fairview Northland Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • David M. King
      • Robbinsdale, Minnesota, Forente stater, 55422
        • Rekruttering
        • North Memorial Medical Health Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • David M. King
      • Saint Louis Park, Minnesota, Forente stater, 55416
        • Rekruttering
        • Park Nicollet Clinic - Saint Louis Park
        • Ta kontakt med:
        • Hovedetterforsker:
          • David M. King
      • Saint Paul, Minnesota, Forente stater, 55101
        • Rekruttering
        • Regions Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • David M. King
      • Saint Paul, Minnesota, Forente stater, 55102
        • Rekruttering
        • United Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • David M. King
      • Shakopee, Minnesota, Forente stater, 55379
        • Rekruttering
        • Saint Francis Regional Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • David M. King
      • Stillwater, Minnesota, Forente stater, 55082
        • Rekruttering
        • Lakeview Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • David M. King
      • Waconia, Minnesota, Forente stater, 55387
        • Rekruttering
        • Ridgeview Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • David M. King
      • Willmar, Minnesota, Forente stater, 56201
        • Rekruttering
        • Rice Memorial Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • David M. King
      • Woodbury, Minnesota, Forente stater, 55125
        • Rekruttering
        • Minnesota Oncology Hematology PA-Woodbury
        • Ta kontakt med:
        • Hovedetterforsker:
          • David M. King
      • Woodbury, Minnesota, Forente stater, 55125
        • Rekruttering
        • Fairview Cancer Center - Woodbury
        • Hovedetterforsker:
          • David M. King
        • Ta kontakt med:
      • Wyoming, Minnesota, Forente stater, 55092
        • Rekruttering
        • Fairview Lakes Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • David M. King
    • Missouri
      • Ballwin, Missouri, Forente stater, 63011
        • Rekruttering
        • Mercy Oncology and Hematology - Clayton-Clarkson
        • Hovedetterforsker:
          • Jay W. Carlson
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 888-446-3729
      • Bolivar, Missouri, Forente stater, 65613
        • Rekruttering
        • Central Care Cancer Center - Bolivar
        • Hovedetterforsker:
          • Jay W. Carlson
        • Ta kontakt med:
      • Bonne Terre, Missouri, Forente stater, 63628
        • Suspendert
        • Parkland Health Center-Bonne Terre
      • Branson, Missouri, Forente stater, 65616
        • Rekruttering
        • Cox Cancer Center Branson
        • Hovedetterforsker:
          • Jay W. Carlson
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 417-269-4520
      • Cape Girardeau, Missouri, Forente stater, 63703
        • Rekruttering
        • Saint Francis Medical Center
        • Hovedetterforsker:
          • Bryan A. Faller
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 573-334-2230
          • E-post: sfmc@sfmc.net
      • Cape Girardeau, Missouri, Forente stater, 63703
        • Rekruttering
        • Mercy Cancer Center - Cape Girardeau
        • Hovedetterforsker:
          • Jay W. Carlson
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 888-446-3729
      • Farmington, Missouri, Forente stater, 63640
        • Rekruttering
        • Parkland Health Center - Farmington
        • Hovedetterforsker:
          • Bryan A. Faller
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 314-996-5569
      • Jefferson City, Missouri, Forente stater, 65109
        • Suspendert
        • MU Health Care Goldschmidt Cancer Center
      • Joplin, Missouri, Forente stater, 64804
        • Rekruttering
        • Freeman Health System
        • Hovedetterforsker:
          • Jay W. Carlson
        • Ta kontakt med:
      • Joplin, Missouri, Forente stater, 64804
        • Rekruttering
        • Mercy Hospital Joplin
        • Hovedetterforsker:
          • Jay W. Carlson
        • Ta kontakt med:
      • Osage Beach, Missouri, Forente stater, 65065
        • Rekruttering
        • Lake Regional Hospital
        • Hovedetterforsker:
          • Jay W. Carlson
        • Ta kontakt med:
      • Rolla, Missouri, Forente stater, 65401
        • Rekruttering
        • Mercy Clinic-Rolla-Cancer and Hematology
        • Hovedetterforsker:
          • Jay W. Carlson
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 573-458-6379
      • Rolla, Missouri, Forente stater, 65401
        • Rekruttering
        • Phelps Health Delbert Day Cancer Institute
        • Hovedetterforsker:
          • Jay W. Carlson
        • Ta kontakt med:
      • Saint Joseph, Missouri, Forente stater, 64506
        • Rekruttering
        • Heartland Regional Medical Center
        • Hovedetterforsker:
          • Jay W. Carlson
        • Ta kontakt med:
      • Sainte Genevieve, Missouri, Forente stater, 63670
        • Rekruttering
        • Sainte Genevieve County Memorial Hospital
        • Hovedetterforsker:
          • Bryan A. Faller
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 314-996-5569
      • Springfield, Missouri, Forente stater, 65804
        • Rekruttering
        • Mercy Hospital Springfield
        • Hovedetterforsker:
          • Jay W. Carlson
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 417-269-4520
      • Springfield, Missouri, Forente stater, 65807
        • Rekruttering
        • CoxHealth South Hospital
        • Hovedetterforsker:
          • Jay W. Carlson
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 417-269-4520
      • St Louis, Missouri, Forente stater, 63128
        • Rekruttering
        • Mercy Hospital South
        • Hovedetterforsker:
          • Jay W. Carlson
        • Ta kontakt med:
      • St Louis, Missouri, Forente stater, 63141
        • Rekruttering
        • Mercy Hospital Saint Louis
        • Hovedetterforsker:
          • Jay W. Carlson
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 314-251-7066
      • St Louis, Missouri, Forente stater, 63131
        • Rekruttering
        • Missouri Baptist Medical Center
        • Hovedetterforsker:
          • Bryan A. Faller
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 314-996-5569
      • St Louis, Missouri, Forente stater, 63109
        • Rekruttering
        • Mercy Infusion Center - Chippewa
        • Hovedetterforsker:
          • Jay W. Carlson
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 888-446-3729
      • Sullivan, Missouri, Forente stater, 63080
        • Rekruttering
        • Missouri Baptist Sullivan Hospital
        • Hovedetterforsker:
          • Bryan A. Faller
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 314-996-5569
      • Washington, Missouri, Forente stater, 63090
        • Rekruttering
        • Mercy Hospital Washington
        • Hovedetterforsker:
          • Jay W. Carlson
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 636-390-1600
    • Montana
      • Anaconda, Montana, Forente stater, 59711
        • Rekruttering
        • Community Hospital of Anaconda
        • Hovedetterforsker:
          • John M. Schallenkamp
        • Ta kontakt med:
      • Billings, Montana, Forente stater, 59101
        • Rekruttering
        • Billings Clinic Cancer Center
        • Hovedetterforsker:
          • John M. Schallenkamp
        • Ta kontakt med:
      • Bozeman, Montana, Forente stater, 59715
        • Rekruttering
        • Bozeman Health Deaconess Hospital
        • Hovedetterforsker:
          • John M. Schallenkamp
        • Ta kontakt med:
      • Great Falls, Montana, Forente stater, 59405
        • Rekruttering
        • Great Falls Clinic
        • Hovedetterforsker:
          • John M. Schallenkamp
        • Ta kontakt med:
      • Great Falls, Montana, Forente stater, 59405
        • Rekruttering
        • Benefis Sletten Cancer Institute
        • Hovedetterforsker:
          • John M. Schallenkamp
        • Ta kontakt med:
      • Havre, Montana, Forente stater, 59501
        • Rekruttering
        • Hi-Line Sletten Cancer Center
        • Hovedetterforsker:
          • John M. Schallenkamp
        • Ta kontakt med:
      • Helena, Montana, Forente stater, 59601
        • Suspendert
        • Saint Peter's Community Hospital
      • Helena, Montana, Forente stater, 59601
        • Rekruttering
        • Benefis Helena Specialty Center
        • Hovedetterforsker:
          • John M. Schallenkamp
        • Ta kontakt med:
      • Kalispell, Montana, Forente stater, 59901
        • Rekruttering
        • Logan Health Medical Center
        • Hovedetterforsker:
          • John M. Schallenkamp
        • Ta kontakt med:
      • Missoula, Montana, Forente stater, 59804
        • Rekruttering
        • Community Medical Center
        • Hovedetterforsker:
          • John M. Schallenkamp
        • Ta kontakt med:
      • Missoula, Montana, Forente stater, 59802
        • Aktiv, ikke rekrutterende
        • Saint Patrick Hospital - Community Hospital
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68114
        • Aktiv, ikke rekrutterende
        • Nebraska Methodist Hospital
      • Omaha, Nebraska, Forente stater, 68114
        • Suspendert
        • Oncology Associates PC
      • Omaha, Nebraska, Forente stater, 68114
        • Aktiv, ikke rekrutterende
        • Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
    • New York
      • Buffalo, New York, Forente stater, 14263
        • Aktiv, ikke rekrutterende
        • Roswell Park Cancer Institute
      • Middletown, New York, Forente stater, 10940
        • Suspendert
        • Garnet Health Medical Center
      • White Plains, New York, Forente stater, 10601
        • Aktiv, ikke rekrutterende
        • Dickstein Cancer Treatment Center
    • North Carolina
      • Hendersonville, North Carolina, Forente stater, 28791
        • Aktiv, ikke rekrutterende
        • Margaret R Pardee Memorial Hospital
      • Pinehurst, North Carolina, Forente stater, 28374
        • Rekruttering
        • FirstHealth of the Carolinas-Moore Regional Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Charles S. Kuzma
    • Ohio
      • Beavercreek, Ohio, Forente stater, 45431
        • Aktiv, ikke rekrutterende
        • Indu and Raj Soin Medical Center
      • Boardman, Ohio, Forente stater, 44512
        • Aktiv, ikke rekrutterende
        • Saint Elizabeth Boardman Hospital
      • Centerville, Ohio, Forente stater, 45459
        • Aktiv, ikke rekrutterende
        • Miami Valley Hospital South
      • Centerville, Ohio, Forente stater, 45459
        • Aktiv, ikke rekrutterende
        • Dayton Physicians LLC-Miami Valley South
      • Cincinnati, Ohio, Forente stater, 45236
        • Aktiv, ikke rekrutterende
        • Oncology Hematology Care Inc-Kenwood
      • Cleveland, Ohio, Forente stater, 44109
        • Aktiv, ikke rekrutterende
        • MetroHealth Medical Center
      • Columbus, Ohio, Forente stater, 43210
        • Rekruttering
        • Ohio State University Comprehensive Cancer Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Regan M. Memmott
      • Dayton, Ohio, Forente stater, 45406
        • Suspendert
        • Good Samaritan Hospital - Dayton
      • Dayton, Ohio, Forente stater, 45409
        • Aktiv, ikke rekrutterende
        • Miami Valley Hospital
      • Dayton, Ohio, Forente stater, 45415
        • Aktiv, ikke rekrutterende
        • Miami Valley Hospital North
      • Dayton, Ohio, Forente stater, 45415
        • Aktiv, ikke rekrutterende
        • Dayton Physician LLC - Englewood
      • Findlay, Ohio, Forente stater, 45840
        • Aktiv, ikke rekrutterende
        • Armes Family Cancer Center
      • Findlay, Ohio, Forente stater, 45840
        • Aktiv, ikke rekrutterende
        • Blanchard Valley Hospital
      • Findlay, Ohio, Forente stater, 45840
        • Aktiv, ikke rekrutterende
        • Orion Cancer Care
      • Franklin, Ohio, Forente stater, 45005-1066
        • Aktiv, ikke rekrutterende
        • Atrium Medical Center-Middletown Regional Hospital
      • Franklin, Ohio, Forente stater, 45005
        • Aktiv, ikke rekrutterende
        • Dayton Physicians LLC-Atrium
      • Greenville, Ohio, Forente stater, 45331
        • Aktiv, ikke rekrutterende
        • Dayton Physicians LLC-Wayne
      • Greenville, Ohio, Forente stater, 45331
        • Aktiv, ikke rekrutterende
        • Wayne Hospital
      • Kettering, Ohio, Forente stater, 45409
        • Aktiv, ikke rekrutterende
        • Greater Dayton Cancer Center
      • Kettering, Ohio, Forente stater, 45420
        • Aktiv, ikke rekrutterende
        • First Dayton Cancer Care
      • Kettering, Ohio, Forente stater, 45429
        • Aktiv, ikke rekrutterende
        • Kettering Medical Center
      • Springfield, Ohio, Forente stater, 45504
        • Aktiv, ikke rekrutterende
        • Springfield Regional Cancer Center
      • Springfield, Ohio, Forente stater, 45504
        • Aktiv, ikke rekrutterende
        • Springfield Regional Medical Center
      • Troy, Ohio, Forente stater, 45373
        • Aktiv, ikke rekrutterende
        • Upper Valley Medical Center
      • Troy, Ohio, Forente stater, 45373
        • Aktiv, ikke rekrutterende
        • Dayton Physicians LLC - Troy
      • Warren, Ohio, Forente stater, 44484
        • Aktiv, ikke rekrutterende
        • Saint Joseph Warren Hospital
      • Youngstown, Ohio, Forente stater, 44501
        • Aktiv, ikke rekrutterende
        • Saint Elizabeth Youngstown Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73104
        • Rekruttering
        • University of Oklahoma Health Sciences Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Raid Aljumaily
      • Oklahoma City, Oklahoma, Forente stater, 73120
        • Rekruttering
        • Mercy Hospital Oklahoma City
        • Hovedetterforsker:
          • Jay W. Carlson
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 405-752-3402
    • Oregon
      • Baker City, Oregon, Forente stater, 97814
        • Rekruttering
        • Saint Alphonsus Cancer Care Center-Baker City
        • Ta kontakt med:
        • Hovedetterforsker:
          • Christopher M. Reynolds
      • Bend, Oregon, Forente stater, 97701
        • Aktiv, ikke rekrutterende
        • Saint Charles Health System
      • Clackamas, Oregon, Forente stater, 97015
        • Aktiv, ikke rekrutterende
        • Clackamas Radiation Oncology Center
      • Clackamas, Oregon, Forente stater, 97015
        • Aktiv, ikke rekrutterende
        • Providence Cancer Institute Clackamas Clinic
      • Coos Bay, Oregon, Forente stater, 97420
        • Aktiv, ikke rekrutterende
        • Bay Area Hospital
      • Corvallis, Oregon, Forente stater, 97330
        • Rekruttering
        • Good Samaritan Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • John Strother
      • Newberg, Oregon, Forente stater, 97132
        • Aktiv, ikke rekrutterende
        • Providence Newberg Medical Center
      • Ontario, Oregon, Forente stater, 97914
        • Rekruttering
        • Saint Alphonsus Cancer Care Center-Ontario
        • Ta kontakt med:
        • Hovedetterforsker:
          • Christopher M. Reynolds
      • Oregon City, Oregon, Forente stater, 97045
        • Aktiv, ikke rekrutterende
        • Providence Willamette Falls Medical Center
      • Portland, Oregon, Forente stater, 97213
        • Aktiv, ikke rekrutterende
        • Providence Portland Medical Center
      • Portland, Oregon, Forente stater, 97225
        • Aktiv, ikke rekrutterende
        • Providence Saint Vincent Medical Center
      • Redmond, Oregon, Forente stater, 97756
        • Aktiv, ikke rekrutterende
        • Saint Charles Health System-Redmond
    • Pennsylvania
      • Allentown, Pennsylvania, Forente stater, 18103
        • Rekruttering
        • Lehigh Valley Hospital-Cedar Crest
        • Hovedetterforsker:
          • Christopher M. Reynolds
        • Ta kontakt med:
      • Bethlehem, Pennsylvania, Forente stater, 18017
        • Rekruttering
        • Lehigh Valley Hospital - Muhlenberg
        • Hovedetterforsker:
          • Christopher M. Reynolds
        • Ta kontakt med:
      • Bryn Mawr, Pennsylvania, Forente stater, 19010
        • Rekruttering
        • Bryn Mawr Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Paul B. Gilman
      • Collegeville, Pennsylvania, Forente stater, 19426
        • Suspendert
        • Main Line Health Center-Collegeville
      • East Stroudsburg, Pennsylvania, Forente stater, 18301
        • Rekruttering
        • Pocono Medical Center
        • Hovedetterforsker:
          • Christopher M. Reynolds
        • Ta kontakt med:
      • Exton, Pennsylvania, Forente stater, 19341
        • Suspendert
        • Main Line Health Center-Exton
      • Hazleton, Pennsylvania, Forente stater, 18201
        • Rekruttering
        • Lehigh Valley Hospital-Hazleton
        • Hovedetterforsker:
          • Christopher M. Reynolds
        • Ta kontakt med:
      • Media, Pennsylvania, Forente stater, 19063
        • Rekruttering
        • Riddle Memorial Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Paul B. Gilman
      • Newtown Square, Pennsylvania, Forente stater, 19073
        • Suspendert
        • Bryn Mawr Health Center
      • Paoli, Pennsylvania, Forente stater, 19301
        • Rekruttering
        • Paoli Memorial Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Paul B. Gilman
      • Philadelphia, Pennsylvania, Forente stater, 19111
        • Aktiv, ikke rekrutterende
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, Forente stater, 19140
        • Aktiv, ikke rekrutterende
        • Temple University Hospital
      • Reading, Pennsylvania, Forente stater, 19605
        • Suspendert
        • Penn State Health Saint Joseph Medical Center
      • Wynnewood, Pennsylvania, Forente stater, 19096
        • Rekruttering
        • Lankenau Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Paul B. Gilman
    • Virginia
      • Charlottesville, Virginia, Forente stater, 22908
    • Washington
      • Aberdeen, Washington, Forente stater, 98520
        • Aktiv, ikke rekrutterende
        • Providence Regional Cancer System-Aberdeen
      • Bellingham, Washington, Forente stater, 98225
        • Aktiv, ikke rekrutterende
        • PeaceHealth Saint Joseph Medical Center
      • Centralia, Washington, Forente stater, 98531
        • Aktiv, ikke rekrutterende
        • Providence Regional Cancer System-Centralia
      • Edmonds, Washington, Forente stater, 98026
        • Aktiv, ikke rekrutterende
        • Swedish Cancer Institute-Edmonds
      • Everett, Washington, Forente stater, 98201
        • Aktiv, ikke rekrutterende
        • Providence Regional Cancer Partnership
      • Issaquah, Washington, Forente stater, 98029
        • Aktiv, ikke rekrutterende
        • Swedish Cancer Institute-Issaquah
      • Kennewick, Washington, Forente stater, 99336
        • Aktiv, ikke rekrutterende
        • Kadlec Clinic Hematology and Oncology
      • Lacey, Washington, Forente stater, 98503
        • Aktiv, ikke rekrutterende
        • Providence Regional Cancer System-Lacey
      • Longview, Washington, Forente stater, 98632
        • Aktiv, ikke rekrutterende
        • PeaceHealth Saint John Medical Center
      • Seattle, Washington, Forente stater, 98104
        • Suspendert
        • Pacific Gynecology Specialists
      • Seattle, Washington, Forente stater, 98112
        • Aktiv, ikke rekrutterende
        • Kaiser Permanente Washington
      • Seattle, Washington, Forente stater, 98195
        • Rekruttering
        • University of Washington Medical Center - Montlake
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 800-804-8824
        • Hovedetterforsker:
          • Christina S. Baik
      • Seattle, Washington, Forente stater, 98109
        • Rekruttering
        • Fred Hutchinson Cancer Center
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 800-804-8824
        • Hovedetterforsker:
          • Christina S. Baik
      • Seattle, Washington, Forente stater, 98122
        • Aktiv, ikke rekrutterende
        • Swedish Medical Center-First Hill
      • Seattle, Washington, Forente stater, 98107
        • Aktiv, ikke rekrutterende
        • Swedish Medical Center-Ballard Campus
      • Seattle, Washington, Forente stater, 98122-5711
        • Aktiv, ikke rekrutterende
        • Swedish Medical Center-Cherry Hill
      • Sedro-Woolley, Washington, Forente stater, 98284
        • Aktiv, ikke rekrutterende
        • PeaceHealth United General Medical Center
      • Shelton, Washington, Forente stater, 98584
        • Aktiv, ikke rekrutterende
        • Providence Regional Cancer System-Shelton
      • Vancouver, Washington, Forente stater, 98664
        • Aktiv, ikke rekrutterende
        • PeaceHealth Southwest Medical Center
      • Walla Walla, Washington, Forente stater, 99362
        • Aktiv, ikke rekrutterende
        • Providence Saint Mary Regional Cancer Center
      • Yelm, Washington, Forente stater, 98597
        • Aktiv, ikke rekrutterende
        • Providence Regional Cancer System-Yelm
    • Wisconsin
      • Burlington, Wisconsin, Forente stater, 53105
        • Rekruttering
        • Aurora Cancer Care-Southern Lakes VLCC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Shamsuddin Virani
      • Chippewa Falls, Wisconsin, Forente stater, 54729
      • Cudahy, Wisconsin, Forente stater, 53110
        • Rekruttering
        • Aurora Saint Luke's South Shore
        • Ta kontakt med:
        • Hovedetterforsker:
          • Shamsuddin Virani
      • Eau Claire, Wisconsin, Forente stater, 54701
      • Fond du Lac, Wisconsin, Forente stater, 54937
        • Rekruttering
        • Aurora Health Center-Fond du Lac
        • Ta kontakt med:
        • Hovedetterforsker:
          • Shamsuddin Virani
      • Germantown, Wisconsin, Forente stater, 53022
        • Rekruttering
        • Aurora Health Care Germantown Health Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Shamsuddin Virani
      • Grafton, Wisconsin, Forente stater, 53024
        • Rekruttering
        • Aurora Cancer Care-Grafton
        • Ta kontakt med:
        • Hovedetterforsker:
          • Shamsuddin Virani
      • Green Bay, Wisconsin, Forente stater, 54311
        • Rekruttering
        • Aurora BayCare Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Shamsuddin Virani
      • Kenosha, Wisconsin, Forente stater, 53142
        • Rekruttering
        • Aurora Cancer Care-Kenosha South
        • Ta kontakt med:
        • Hovedetterforsker:
          • Shamsuddin Virani
      • La Crosse, Wisconsin, Forente stater, 54601
        • Rekruttering
        • Gundersen Lutheran Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kurt Oettel
      • Ladysmith, Wisconsin, Forente stater, 54848
      • Marinette, Wisconsin, Forente stater, 54143
        • Rekruttering
        • Aurora Bay Area Medical Group-Marinette
        • Ta kontakt med:
        • Hovedetterforsker:
          • Shamsuddin Virani
      • Marshfield, Wisconsin, Forente stater, 54449
      • Milwaukee, Wisconsin, Forente stater, 53209
        • Rekruttering
        • Aurora Cancer Care-Milwaukee
        • Ta kontakt med:
        • Hovedetterforsker:
          • Shamsuddin Virani
      • Milwaukee, Wisconsin, Forente stater, 53215
        • Rekruttering
        • Aurora Saint Luke's Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Shamsuddin Virani
      • Milwaukee, Wisconsin, Forente stater, 53233
        • Rekruttering
        • Aurora Sinai Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Shamsuddin Virani
      • Minocqua, Wisconsin, Forente stater, 54548
      • New Richmond, Wisconsin, Forente stater, 54017
        • Rekruttering
        • Cancer Center of Western Wisconsin
        • Ta kontakt med:
        • Hovedetterforsker:
          • David M. King
      • Oshkosh, Wisconsin, Forente stater, 54904
        • Rekruttering
        • Vince Lombardi Cancer Clinic - Oshkosh
        • Ta kontakt med:
        • Hovedetterforsker:
          • Shamsuddin Virani
      • Racine, Wisconsin, Forente stater, 53406
        • Rekruttering
        • Aurora Cancer Care-Racine
        • Ta kontakt med:
        • Hovedetterforsker:
          • Shamsuddin Virani
      • Rice Lake, Wisconsin, Forente stater, 54868
      • Sheboygan, Wisconsin, Forente stater, 53081
        • Rekruttering
        • Vince Lombardi Cancer Clinic-Sheboygan
        • Ta kontakt med:
        • Hovedetterforsker:
          • Shamsuddin Virani
      • Stevens Point, Wisconsin, Forente stater, 54482
      • Summit, Wisconsin, Forente stater, 53066
        • Rekruttering
        • Aurora Medical Center in Summit
        • Ta kontakt med:
        • Hovedetterforsker:
          • Shamsuddin Virani
      • Two Rivers, Wisconsin, Forente stater, 54241
        • Rekruttering
        • Vince Lombardi Cancer Clinic-Two Rivers
        • Ta kontakt med:
        • Hovedetterforsker:
          • Shamsuddin Virani
      • Wausau, Wisconsin, Forente stater, 54401
      • Wauwatosa, Wisconsin, Forente stater, 53226
        • Rekruttering
        • Aurora Cancer Care-Milwaukee West
        • Ta kontakt med:
        • Hovedetterforsker:
          • Shamsuddin Virani
      • West Allis, Wisconsin, Forente stater, 53227
        • Rekruttering
        • Aurora West Allis Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Shamsuddin Virani
      • Weston, Wisconsin, Forente stater, 54476
      • Wisconsin Rapids, Wisconsin, Forente stater, 54494
    • Wyoming
      • Cheyenne, Wyoming, Forente stater, 82001
        • Rekruttering
        • Memorial Hospital of Laramie County
        • Hovedetterforsker:
          • John M. Schallenkamp
        • Ta kontakt med:
      • Cody, Wyoming, Forente stater, 82414
        • Rekruttering
        • Billings Clinic-Cody
        • Hovedetterforsker:
          • John M. Schallenkamp
        • Ta kontakt med:
      • Sheridan, Wyoming, Forente stater, 82801
        • Suspendert
        • Welch Cancer Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Kvalifikasjonskriterier

Nøkkelkravene som personer som ønsker å delta i en klinisk studie må oppfylle eller egenskapene de må ha. Kvalifikasjonskriterier består av både inklusjonskriterier (som kreves for at en person skal delta i studien) og eksklusjonskriterier (som hindrer en person i å delta). Typer kvalifikasjonskriterier inkluderer om en studie godtar friske frivillige, har alders- eller aldersgruppekrav, eller er begrenset av kjønn.

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm

Deltakergruppe / Arm

En gruppe eller undergruppe av deltakere i en klinisk studie som mottar en spesifikk intervensjon/behandling, eller ingen intervensjon, i henhold til studiens protokoll.
Intervensjon / Behandling

Intervensjon / Behandling

En prosess eller handling som er fokus for en klinisk studie. Intervensjoner inkluderer legemidler, medisinsk utstyr, prosedyrer, vaksiner og andre produkter som enten er undersøkende eller allerede er tilgjengelige. Intervensjoner kan også inkludere ikke-invasive tilnærminger, som utdanning eller modifisering av kosthold og trening.
Eksperimentell: 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.
Fremgangsmåte: Magnetic Resonance Imaging

Undergo MRI

Andre navn:
  • MR
  • Magnetisk resonans
  • Magnetic Resonance Imaging Scan
  • Medisinsk bildebehandling, magnetisk resonans / kjernemagnetisk resonans
  • MR Imaging
  • MR-skanning
  • NMR-avbildning
  • NMRI
  • Kjernemagnetisk resonansavbildning
  • Magnetisk resonanstomografi (MR)
  • sMRI
  • Magnetisk resonansavbildning (prosedyre)
  • MR-er
  • Strukturell MR
Fremgangsmåte: Echocardiography Test

Undergo ECHO

Andre navn:
  • Ekkokardiografi
  • EC
Fremgangsmåte: Multigated Acquisition Scan

Undergo MUGA

Andre navn:
  • Skanning av blodbasseng
  • Likevektsradionuklidangiografi
  • Gated Blood Pool Imaging
  • MUGA
  • Radionuklid ventrikulografi
  • RNVG
  • SYMA-skanning
  • Synchronized Multigated Acquisition Scanning
  • MUGA Scan
  • Multi-Gated Acquisition Scan
  • Radionuklid ventrikulogramskanning
  • Gated Heart Pool Scan
  • RNV Scan
Fremgangsmåte: Biospecimen Collection

Undergo collection of blood samples

Andre navn:
  • Biologisk prøvesamling
  • Bioprøve samlet
  • Prøvesamling
Legemiddel: Osimertinib

Given PO

Andre navn:
  • AZD-9291
  • AZD9291
  • Mereletinib
  • AZD 9291
Fremgangsmåte: Computed Tomography with Contrast

Undergo CT with contrast

Andre navn:
  • Kontrastforbedret computertomografi
  • KONTRAST FORBEDRET CT-SKANNING
  • CT-skanning med kontrast
  • CT med kontrast

Hva måler studien?

Primære resultatmål

Primære resultatmål

I en klinisk studies protokoll er det planlagte utfallsmålet som er det viktigste for å evaluere effekten av en intervensjon/behandling. De fleste kliniske studier har ett primært utfallsmål, men noen har mer enn ett.
Resultatmål
Tiltaksbeskrivelse
Tidsramme
Best objective response
Tidsramme: 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

Sekundære resultatmål

Sekundære resultatmål

I en klinisk studies protokoll, et planlagt utfallsmål som ikke er like viktig som det primære utfallsmålet for å evaluere effekten av en intervensjon, men som fortsatt er av interesse. De fleste kliniske studier har mer enn ett sekundært utfallsmål.
Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression-free survival (PFS)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Andre resultatmål

For kliniske studier, en planlagt måling beskrevet i protokollen som brukes for å bestemme effekten av en intervensjon/behandling på deltakerne. For observasjonsstudier, en måling eller observasjon som brukes til å beskrive mønstre av sykdommer eller egenskaper, eller assosiasjoner til eksponeringer, risikofaktorer eller behandling. Typer utfallsmål inkluderer primært resultatmål og sekundært resultatmål.
Resultatmål
Tiltaksbeskrivelse
Tidsramme
Characterization of molecular markers of response to treatment in circulating tumor deoxyribonucleic acid (ctDNA)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sponsor

Organisasjonen eller personen som initierer studien og som har myndighet og kontroll over studien.
National Cancer Institute (NCI)

Etterforskere

Etterforskere

En forsker involvert i en klinisk studie. Beslektede termer inkluderer stedets hovedetterforsker, stedsunderetterforsker, studieleder, studieleder og studiehovedetterforsker.
  • Hovedetterforsker: Zofia Piotrowska, ECOG-ACRIN Cancer Research Group

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

Studiestart

Den faktiske datoen da den første deltakeren ble registrert i en klinisk studie. Den "forventede" studiestartdatoen er datoen som forskerne tror vil være studiestartdatoen.
25. april 2018

Primær fullføring (Antatt)

Primær fullføring

Datoen da den siste deltakeren i en klinisk studie ble undersøkt eller mottok en intervensjon for å samle inn endelige data for det primære utfallsmålet. Hvorvidt den kliniske studien ble avsluttet i henhold til protokollen eller ble avsluttet, påvirker ikke denne datoen. For kliniske studier med mer enn ett primært utfallsmål med ulike fullføringsdatoer, refererer dette begrepet til datoen da datainnsamlingen er fullført for alle de primære utfallsmålene. Den "forventede" primære fullføringsdatoen er datoen som forskerne tror vil være den primære fullføringsdatoen for studien.
30. juni 2027

Studiet fullført (Antatt)

Studiet fullført

Datoen da den siste deltakeren i en klinisk studie ble undersøkt eller mottok en intervensjon/behandling for å samle inn endelige data for de primære utfallsmålene, sekundære utfallsmålene og uønskede hendelsene (det vil si siste deltakers siste besøk). Den "forventede" studiens fullføringsdato er datoen som forskerne tror vil være studiens fullføringsdato.
30. juni 2027

Datoer for studieregistrering

Først innsendt

Først innsendt

Datoen da studiesponsoren eller etterforskeren først sendte inn en studiepost til ClinicalTrials.gov. Det er vanligvis en forsinkelse på noen dager mellom første innsendte dato og postens tilgjengelighet på ClinicalTrials.gov (den første postedatoen).
16. juni 2017

Først innsendt som oppfylte QC-kriteriene

Først innsendt som oppfylte QC-kriteriene

Datoen da studiesponsoren eller etterforskeren først sender inn en studiepost som er i samsvar med gjennomgangskriteriene for National Library of Medicine (NLM) kvalitetskontroll (QC). Sponsoren eller etterforskeren må kanskje revidere og sende inn en studiepost én eller flere ganger før NLMs kvalitetskontrollkriterier oppfylles. Det er sponsorens eller etterforskerens ansvar å sikre at studieposten er i samsvar med NLM QC-gjennomgangskriteriene.
16. juni 2017

Først lagt ut (Faktiske)

Først lagt ut

Datoen da studieposten først var tilgjengelig på ClinicalTrials.gov etter at National Library of Medicine (NLM) kvalitetskontroll (QC) gjennomgang har konkludert. Det er vanligvis en forsinkelse på noen dager mellom datoen studiesponsoren eller etterforskeren sendte inn studieposten og den første postedatoen.
19. juni 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

Sist oppdatering lagt ut

Den siste datoen da endringer i en studiepost ble gjort tilgjengelig på ClinicalTrials.gov. Det kan være en forsinkelse mellom når endringene ble sendt til ClinicalTrials.gov av studiens sponsor eller etterforsker (datoen for siste innsending av oppdatering) og datoen for siste oppdatering.
3. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

Siste oppdatering sendt inn som oppfylte QC-kriteriene

Den siste datoen da studiesponsoren eller etterforskeren sendte inn endringer i en studiepost som er i samsvar med gjennomgangskriteriene for National Library of Medicine (NLM) kvalitetskontroll (QC). Det er sponsorens eller etterforskerens ansvar å sikre at studieposten er i samsvar med NLM QC-gjennomgangskriteriene.
31. oktober 2026

Sist bekreftet

Sist bekreftet

Den siste datoen da studiesponsoren eller etterforskeren bekreftet at informasjonen om en klinisk studie på ClinicalTrials.gov var nøyaktig og oppdatert. Hvis en studie med rekrutteringsstatus for rekruttering; ikke rekrutterer ennå; eller aktiv, ikke rekruttering har ikke blitt bekreftet de siste 2 årene, studiens rekrutteringsstatus vises som ukjent.
1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

Andre studie-ID-numre

Identifikatorer eller ID-numre andre enn NCT-nummeret som er tildelt en klinisk studie av studiens sponsor, finansierere eller andre. Disse tallene kan inkludere unike identifikatorer fra andre prøveregistre og National Institutes of Health-stipendnumre.
  • NCI-2017-01017
  • U10CA180820 (U.S. NIH-stipend/kontrakt)
  • NCI-2017-01017 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
  • EA5162 (Annen identifikator: CTEP)
  • EA5162 (Annen identifikator: ECOG-ACRIN Cancer Research Group)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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