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Erlotinib Hydrochloride og Cabozantinib-s-Malate alene eller i kombinasjon som andre eller tredje linjebehandling ved behandling av pasienter med stadium IV ikke-småcellet lungekreft

10. november 2026 oppdatert av: National Cancer Institute (NCI)

En randomisert fase II-studie av Erlotinib, Cabozantinib eller Erlotinib Plus Cabozantinib som 2. eller 3. linjebehandling hos pasienter med EGFR villtype NSCLC

This randomized phase II trial studies how well giving erlotinib hydrochloride and cabozantinib-s-malate alone or in combination works as second or third line therapy in treating patient with stage IV non-small cell lung cancer. Erlotinib hydrochloride and cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving erlotinib hydrochloride together with cabozantinib-s-malate is more effective than erlotinib hydrochloride or cabozantinib-s-malate alone in treating non-small cell lung cancer.

Studieoversikt

Detaljert beskrivelse

PRIMARY OBJECTIVES:

I. To compare the progression-free survival (PFS) associated with patients treated with erlotinib (erlotinib hydrochloride) versus (vs) erlotinib plus cabozantinib (cabozantinib-s-malate).

II. To compare the PFS associated with patients treated with erlotinib vs cabozantinib.

SECONDARY OBJECTIVES:

I. To evaluate overall survival in the three treatment arms. II. To evaluate best objective response rate in the three treatment arms. III. To define the toxicity associated with each regimen. IV. To conduct correlative science studies that will help to select predictive biomarkers of response to therapy, including mesenchymal-epidermal transition (MET) expression and potentially other tissue biomarkers, plasma biomarkers, and bone scans.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM A (erlotinib): Patients receive erlotinib orally (PO) daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM B (cabozantinib): Patients receive cabozantinib PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM C (erlotinib+cabozantinib): Patients receive erlotinib as patients in Arm A and cabozantinib as patients in Arm B. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM Z: Patients achieving disease progression in Arm A or Arm B may receive erlotinib and cabozantinib as patients in Arm C. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Studietype

Intervensjonell

Registrering (Faktiske)

125

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiesteder

    • Arizona
      • Scottsdale, Arizona, Forente stater, 85259
        • Mayo Clinic in Arizona
    • California
      • Modesto, California, Forente stater, 95355
        • Memorial Medical Center
      • Monterey, California, Forente stater, 93940
        • Community Hospital of Monterey Peninsula
      • Palo Alto, California, Forente stater, 94304
        • VA Palo Alto Health Care System
      • Palo Alto, California, Forente stater, 94304
        • Stanford Cancer Institute Palo Alto
      • Rancho Mirage, California, Forente stater, 92270
        • Eisenhower Medical Center
    • Colorado
      • Aurora, Colorado, Forente stater, 80012
        • The Medical Center of Aurora
      • Boulder, Colorado, Forente stater, 80303
        • Boulder Community Foothills Hospital
      • Boulder, Colorado, Forente stater, 80304
        • Rocky Mountain Cancer Centers-Boulder
      • Colorado Springs, Colorado, Forente stater, 80907
        • Penrose-Saint Francis Healthcare
      • Colorado Springs, Colorado, Forente stater, 80907
        • Rocky Mountain Cancer Centers-Penrose
      • Denver, Colorado, Forente stater, 80218
        • Presbyterian - Saint Lukes Medical Center - Health One
      • Denver, Colorado, Forente stater, 80220
        • Rose Medical Center
      • Denver, Colorado, Forente stater, 80218
        • Rocky Mountain Cancer Centers-Midtown
      • Denver, Colorado, Forente stater, 80220
        • Rocky Mountain Cancer Centers-Rose
      • Denver, Colorado, Forente stater, 80218
        • Colorado Blood Cancer Institute
      • Denver, Colorado, Forente stater, 80222
        • Western States Cancer Research NCORP
      • Denver, Colorado, Forente stater, 80218
        • Saint Joseph Hospital - Cancer Centers of Colorado
      • Denver, Colorado, Forente stater, 80210
        • AdventHealth Porter
      • Durango, Colorado, Forente stater, 81301
        • Mercy Medical Center
      • Englewood, Colorado, Forente stater, 80113
        • Mountain Blue Cancer Care Center - Swedish
      • Englewood, Colorado, Forente stater, 80113
        • Swedish Medical Center
      • Golden, Colorado, Forente stater, 80401
        • Mountain Blue Cancer Care Center
      • Greeley, Colorado, Forente stater, 80631
        • Banner North Colorado Medical Center
      • Greenwood Village, Colorado, Forente stater, 80111
        • Rocky Mountain Cancer Centers-Greenwood Village
      • Lakewood, Colorado, Forente stater, 80228
        • Rocky Mountain Cancer Centers-Lakewood
      • Lakewood, Colorado, Forente stater, 80228
        • CommonSpirit Saint Anthony Hospital Cancer Center
      • Littleton, Colorado, Forente stater, 80122
        • AdventHealth Littleton
      • Lone Tree, Colorado, Forente stater, 80124
        • Sky Ridge Medical Center
      • Lone Tree, Colorado, Forente stater, 80124
        • Rocky Mountain Cancer Centers-Sky Ridge
      • Longmont, Colorado, Forente stater, 80501
        • Longmont United Hospital
      • Longmont, Colorado, Forente stater, 80501
        • Rocky Mountain Cancer Centers-Longmont
      • Loveland, Colorado, Forente stater, 80539
        • Banner North Colorado Medical Center - Loveland Campus
      • Parker, Colorado, Forente stater, 80138
        • Rocky Mountain Cancer Centers-Parker
      • Parker, Colorado, Forente stater, 80138
        • AdventHealth Parker
      • Pueblo, Colorado, Forente stater, 81004
        • Saint Mary Corwin Medical Center
      • Pueblo, Colorado, Forente stater, 81008
        • Rocky Mountain Cancer Centers - Pueblo
      • Wheat Ridge, Colorado, Forente stater, 80401
        • Intermountain Health Lutheran Hospital
    • Connecticut
      • Hartford, Connecticut, Forente stater, 06105
        • Smilow Cancer Hospital Care Center at Saint Francis
      • New Britain, Connecticut, Forente stater, 06050
        • The Hospital of Central Connecticut
    • Delaware
      • Lewes, Delaware, Forente stater, 19958
        • Beebe Medical Center
      • Newark, Delaware, Forente stater, 19713
        • Helen F Graham Cancer Center
      • Newark, Delaware, Forente stater, 19713
        • Delaware Clinical and Laboratory Physicians PA
      • Newark, Delaware, Forente stater, 19713
        • Medical Oncology Hematology Consultants PA
      • Newark, Delaware, Forente stater, 19718
        • Christiana Care Health System-Christiana Hospital
      • Rehoboth Beach, Delaware, Forente stater, 19971
        • Beebe Health Campus
      • Seaford, Delaware, Forente stater, 19973
        • TidalHealth Nanticoke / Allen Cancer Center
      • Wilmington, Delaware, Forente stater, 19801
        • Christiana Care Health System-Wilmington Hospital
    • Florida
      • Miami, Florida, Forente stater, 33136
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
    • Georgia
      • Atlanta, Georgia, Forente stater, 30322
        • Emory University Hospital/Winship Cancer Institute
      • Atlanta, Georgia, Forente stater, 30342
        • Emory Saint Joseph's Hospital
      • Decatur, Georgia, Forente stater, 30033
        • Atlanta VA Medical Center
      • Macon, Georgia, Forente stater, 31201
        • Atrium Health Navicent
      • Savannah, Georgia, Forente stater, 31405
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
    • Idaho
      • Boise, Idaho, Forente stater, 83706
        • Saint Alphonsus Cancer Care Center-Boise
    • Illinois
      • Aurora, Illinois, Forente stater, 60504
        • Rush-Copley Medical Center
      • Bloomington, Illinois, Forente stater, 61704
        • Illinois CancerCare-Bloomington
      • Bloomington, Illinois, Forente stater, 61701
        • OSF Saint Joseph Medical Center
      • Canton, Illinois, Forente stater, 61520
        • Illinois CancerCare-Canton
      • Carthage, Illinois, Forente stater, 62321
        • Illinois CancerCare-Carthage
      • Centralia, Illinois, Forente stater, 62801
        • Centralia Oncology Clinic
      • Chicago, Illinois, Forente stater, 60611
        • Northwestern University
      • Danville, Illinois, Forente stater, 61832
        • Carle at The Riverfront
      • Decatur, Illinois, Forente stater, 62526
        • Decatur Memorial Hospital
      • Decatur, Illinois, Forente stater, 62526
        • Cancer Care Specialists of Illinois - Decatur
      • Decatur, Illinois, Forente stater, 62526
        • Heartland Cancer Research NCORP
      • Effingham, Illinois, Forente stater, 62401
        • Crossroads Cancer Center
      • Effingham, Illinois, Forente stater, 62401
        • Carle Physician Group-Effingham
      • Eureka, Illinois, Forente stater, 61530
        • Illinois CancerCare-Eureka
      • Evanston, Illinois, Forente stater, 60201
        • NorthShore University HealthSystem-Evanston Hospital
      • Galesburg, Illinois, Forente stater, 61401
        • Illinois CancerCare-Galesburg
      • Glenview, Illinois, Forente stater, 60026
        • NorthShore University HealthSystem-Glenbrook Hospital
      • Harvey, Illinois, Forente stater, 60426
        • Ingalls Memorial Hospital
      • Highland Park, Illinois, Forente stater, 60035
        • NorthShore University HealthSystem-Highland Park Hospital
      • Highland Park, Illinois, Forente stater, 60035
        • Hematology Oncology Associates of Illinois-Highland Park
      • Kankakee, Illinois, Forente stater, 60901
        • Presence Saint Mary's Hospital
      • Kewanee, Illinois, Forente stater, 61443
        • Illinois CancerCare-Kewanee Clinic
      • Libertyville, Illinois, Forente stater, 60048
        • AMG Libertyville - Oncology
      • Macomb, Illinois, Forente stater, 61455
        • Illinois CancerCare-Macomb
      • Mattoon, Illinois, Forente stater, 61938
        • Carle Physician Group-Mattoon/Charleston
      • Moline, Illinois, Forente stater, 61265
        • Garneau, Stewart C MD (UIA Investigator)
      • Moline, Illinois, Forente stater, 61265
        • Porubcin, Michael MD (UIA Investigator)
      • Moline, Illinois, Forente stater, 61265
        • Spector, David MD (UIA Investigator)
      • Moline, Illinois, Forente stater, 61265
        • Trinity Medical Center
      • Monmouth, Illinois, Forente stater, 61462
        • Illinois CancerCare-Monmouth
      • Niles, Illinois, Forente stater, 60714
        • Illinois Cancer Specialists-Niles
      • Normal, Illinois, Forente stater, 61761
        • Carle Cancer Institute Normal
      • Ottawa, Illinois, Forente stater, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Ottawa, Illinois, Forente stater, 61350
        • Ottawa Regional Hospital and Healthcare Center
      • Pekin, Illinois, Forente stater, 61554
        • Illinois CancerCare-Pekin
      • Pekin, Illinois, Forente stater, 61554
        • OSF Saint Francis Radiation Oncology at Pekin
      • Peoria, Illinois, Forente stater, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, Forente stater, 61637
        • OSF Saint Francis Medical Center
      • Peoria, Illinois, Forente stater, 61615
        • Illinois CancerCare-Peoria
      • Peoria, Illinois, Forente stater, 61614
        • Proctor Hospital
      • Peru, Illinois, Forente stater, 61354
        • Illinois CancerCare-Peru
      • Peru, Illinois, Forente stater, 61354
        • Illinois Valley Hospital
      • Princeton, Illinois, Forente stater, 61356
        • Illinois CancerCare-Princeton
      • Rockford, Illinois, Forente stater, 61104
        • Swedish American Hospital
      • Rockford, Illinois, Forente stater, 61114
        • UW Health Carbone Cancer Center Rockford
      • Skokie, Illinois, Forente stater, 60076
        • Hematology Oncology Associates of Illinois - Skokie
      • Springfield, Illinois, Forente stater, 62781
        • Springfield Memorial Hospital
      • Urbana, Illinois, Forente stater, 61801
        • Carle Cancer Center
      • Urbana, Illinois, Forente stater, 61801
        • The Carle Foundation Hospital
      • Yorkville, Illinois, Forente stater, 60560
        • Rush-Copley Healthcare Center
    • Indiana
      • Bloomington, Indiana, Forente stater, 47408
        • IU Health Bloomington
      • Elkhart, Indiana, Forente stater, 46515
        • Elkhart General Hospital
      • Elkhart, Indiana, Forente stater, 46514
        • Michiana Hematology Oncology PC-Elkhart
      • Elkhart, Indiana, Forente stater, 46514-2098
        • Elkhart Clinic
      • Indianapolis, Indiana, Forente stater, 46202
        • Indiana University/Melvin and Bren Simon Cancer Center
      • Indianapolis, Indiana, Forente stater, 46219
        • IU Health Central Indiana Cancer Centers-East
      • Kokomo, Indiana, Forente stater, 46904
        • Community Howard Regional Health
      • La Porte, Indiana, Forente stater, 46350
        • IU Health La Porte Hospital
      • Michigan City, Indiana, Forente stater, 46360
        • Franciscan Saint Anthony Health-Michigan City
      • Michigan City, Indiana, Forente stater, 46360
        • Woodland Cancer Care Center
      • Mishawaka, Indiana, Forente stater, 46545
        • Michiana Hematology Oncology PC-Mishawaka
      • Mishawaka, Indiana, Forente stater, 46545
        • Saint Joseph Regional Medical Center-Mishawaka
      • Muncie, Indiana, Forente stater, 47303
        • IU Health Ball Memorial Hospital
      • Plymouth, Indiana, Forente stater, 46563
        • Michiana Hematology Oncology PC-Plymouth
      • South Bend, Indiana, Forente stater, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, Forente stater, 46628
        • Northern Indiana Cancer Research Consortium
      • South Bend, Indiana, Forente stater, 46617
        • South Bend Clinic
      • Westville, Indiana, Forente stater, 46391
        • Michiana Hematology Oncology PC-Westville
    • Iowa
      • Ames, Iowa, Forente stater, 50010
        • Mary Greeley Medical Center
      • Ames, Iowa, Forente stater, 50010
        • McFarland Clinic - Ames
      • Bettendorf, Iowa, Forente stater, 52722
        • Constantinou, Costas L MD (UIA Investigator)
      • Boone, Iowa, Forente stater, 50036
        • McFarland Clinic - Boone
      • Cedar Rapids, Iowa, Forente stater, 52403
        • Mercy Hospital
      • Cedar Rapids, Iowa, Forente stater, 52403
        • Oncology Associates at Mercy Medical Center
      • Clive, Iowa, Forente stater, 50325
        • Mercy Cancer Center-West Lakes
      • Clive, Iowa, Forente stater, 50325
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
      • Des Moines, Iowa, Forente stater, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, Forente stater, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, Forente stater, 50316
        • Iowa Lutheran Hospital
      • Des Moines, Iowa, Forente stater, 50309
        • Iowa-Wide Oncology Research Coalition NCORP
      • Des Moines, Iowa, Forente stater, 50309
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
      • Des Moines, Iowa, Forente stater, 50314
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
      • Jefferson, Iowa, Forente stater, 50129
        • McFarland Clinic - Jefferson
      • Marshalltown, Iowa, Forente stater, 50158
        • McFarland Clinic - Marshalltown
      • Mason City, Iowa, Forente stater, 50401
        • Mercy Medical Center - North Iowa
      • Sioux City, Iowa, Forente stater, 51101
        • Siouxland Regional Cancer Center
      • Sioux City, Iowa, Forente stater, 51102
        • Mercy Medical Center-Sioux City
      • Sioux City, Iowa, Forente stater, 51104
        • Saint Luke's Regional Medical Center
      • West Des Moines, Iowa, Forente stater, 50266
        • Mercy Medical Center-West Lakes
    • Kansas
      • Chanute, Kansas, Forente stater, 66720
        • Cancer Center of Kansas - Chanute
      • Dodge City, Kansas, Forente stater, 67801
        • Cancer Center of Kansas - Dodge City
      • El Dorado, Kansas, Forente stater, 67042
        • Cancer Center of Kansas - El Dorado
      • Fort Scott, Kansas, Forente stater, 66701
        • Cancer Center of Kansas - Fort Scott
      • Independence, Kansas, Forente stater, 67301
        • Cancer Center of Kansas-Independence
      • Kingman, Kansas, Forente stater, 67068
        • Cancer Center of Kansas-Kingman
      • Lawrence, Kansas, Forente stater, 66044
        • Lawrence Memorial Hospital
      • Liberal, Kansas, Forente stater, 67905
        • Cancer Center of Kansas-Liberal
      • Manhattan, Kansas, Forente stater, 66502
        • Cancer Center of Kansas-Manhattan
      • McPherson, Kansas, Forente stater, 67460
        • Cancer Center of Kansas - McPherson
      • Newton, Kansas, Forente stater, 67114
        • Cancer Center of Kansas - Newton
      • Parsons, Kansas, Forente stater, 67357
        • Cancer Center of Kansas - Parsons
      • Pratt, Kansas, Forente stater, 67124
        • Cancer Center of Kansas - Pratt
      • Salina, Kansas, Forente stater, 67401
        • Cancer Center of Kansas - Salina
      • Wellington, Kansas, Forente stater, 67152
        • Cancer Center of Kansas - Wellington
      • Wichita, Kansas, Forente stater, 67214
        • Ascension Via Christi Hospitals Wichita
      • Wichita, Kansas, Forente stater, 67208
        • Cancer Center of Kansas-Wichita Medical Arts Tower
      • Wichita, Kansas, Forente stater, 67214
        • Cancer Center of Kansas - Wichita
      • Wichita, Kansas, Forente stater, 67208
        • Associates In Womens Health
      • Wichita, Kansas, Forente stater, 67214
        • Wichita NCI Community Oncology Research Program
      • Winfield, Kansas, Forente stater, 67156
        • Cancer Center of Kansas - Winfield
    • Louisiana
      • Baton Rouge, Louisiana, Forente stater, 70809
        • Ochsner Health Center-Summa
      • New Orleans, Louisiana, Forente stater, 70121
        • Ochsner Medical Center Jefferson
      • New Orleans, Louisiana, Forente stater, 70115
        • Ochsner Baptist Medical Center
    • Maine
      • York Village, Maine, Forente stater, 03909
        • York Hospital
    • Maryland
      • Baltimore, Maryland, Forente stater, 21204
        • Greater Baltimore Medical Center
      • Elkton, Maryland, Forente stater, 21921
        • Christiana Care - Union Hospital
    • Michigan
      • Adrian, Michigan, Forente stater, 49221
        • Bixby Medical Center
      • Adrian, Michigan, Forente stater, 49221
        • Hickman Cancer Center
      • Ann Arbor, Michigan, Forente stater, 48106
        • Michigan Cancer Research Consortium NCORP
      • Ann Arbor, Michigan, Forente stater, 48106
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
      • Dearborn, Michigan, Forente stater, 48124
        • Corewell Health Dearborn Hospital
      • Detroit, Michigan, Forente stater, 48236
        • Henry Ford Health Saint John Hospital
      • Escanaba, Michigan, Forente stater, 49829
        • OSF Saint Francis Hospital and Medical Group
      • Flint, Michigan, Forente stater, 48503
        • Hurley Medical Center
      • Flint, Michigan, Forente stater, 48503
        • Genesys Hurley Cancer Institute
      • Jackson, Michigan, Forente stater, 49201
        • Allegiance Health
      • Kalamazoo, Michigan, Forente stater, 49007
        • West Michigan Cancer Center
      • Kalamazoo, Michigan, Forente stater, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, Forente stater, 49048
        • Beacon Kalamazoo
      • Lansing, Michigan, Forente stater, 48912
        • University of Michigan Health - Sparrow Lansing
      • Livonia, Michigan, Forente stater, 48154
        • Trinity Health Saint Mary Mercy Livonia Hospital
      • Monroe, Michigan, Forente stater, 48162
        • Mercy Memorial Hospital
      • Monroe, Michigan, Forente stater, 48162
        • Toledo Clinic Cancer Centers-Monroe
      • Pontiac, Michigan, Forente stater, 48341
        • Trinity Health Saint Joseph Mercy Oakland Hospital
      • Port Huron, Michigan, Forente stater, 48060
        • Lake Huron Medical Center
      • Saginaw, Michigan, Forente stater, 48601
        • MyMichigan Medical Center Saginaw
      • Saint Joseph, Michigan, Forente stater, 49085
        • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
      • Saint Joseph, Michigan, Forente stater, 49085
        • Corewell Health Lakeland Hospitals - Saint Joseph Hospital
      • Warren, Michigan, Forente stater, 48093
        • Henry Ford Health Warren Hospital
    • Minnesota
      • Bemidji, Minnesota, Forente stater, 56601
        • Sanford Joe Lueken Cancer Center
      • Burnsville, Minnesota, Forente stater, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, Forente stater, 55433
        • Mercy Hospital
      • Edina, Minnesota, Forente stater, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, Forente stater, 55432
        • Unity Hospital
      • Hutchinson, Minnesota, Forente stater, 55350
        • Hutchinson Area Health Care
      • Maplewood, Minnesota, Forente stater, 55109
        • Saint John's Hospital - Healtheast
      • Maplewood, Minnesota, Forente stater, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, Forente stater, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, Forente stater, 55407
        • Abbott-Northwestern Hospital
      • New Ulm, Minnesota, Forente stater, 56073
        • New Ulm Medical Center
      • Robbinsdale, Minnesota, Forente stater, 55422
        • North Memorial Medical Health Center
      • Saint Louis Park, Minnesota, Forente stater, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Louis Park, Minnesota, Forente stater, 55416
        • Metro Minnesota Community Oncology Research Consortium
      • Saint Paul, Minnesota, Forente stater, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, Forente stater, 55102
        • United Hospital
      • Shakopee, Minnesota, Forente stater, 55379
        • Saint Francis Regional Medical Center
      • Stillwater, Minnesota, Forente stater, 55082
        • Lakeview Hospital
      • Waconia, Minnesota, Forente stater, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, Forente stater, 56201
        • Rice Memorial Hospital
      • Woodbury, Minnesota, Forente stater, 55125
        • Minnesota Oncology Hematology PA-Woodbury
    • Missouri
      • Cape Girardeau, Missouri, Forente stater, 63703
        • Saint Francis Medical Center
    • Nebraska
      • Lincoln, Nebraska, Forente stater, 68510
        • Nebraska Cancer Research Center
      • Omaha, Nebraska, Forente stater, 68124
        • Alegent Health Bergan Mercy Medical Center
      • Omaha, Nebraska, Forente stater, 68122
        • Alegent Health Immanuel Medical Center
      • Omaha, Nebraska, Forente stater, 68130
        • Alegent Health Lakeside Hospital
      • Omaha, Nebraska, Forente stater, 68106
        • Missouri Valley Cancer Consortium
    • Nevada
      • Henderson, Nevada, Forente stater, 89052
        • Comprehensive Cancer Centers of Nevada - Henderson
      • Henderson, Nevada, Forente stater, 89052
        • Cancer and Blood Specialists-Henderson
      • Henderson, Nevada, Forente stater, 89052
        • Las Vegas Cancer Center-Henderson
      • Henderson, Nevada, Forente stater, 89074
        • Comprehensive Cancer Centers of Nevada-Southeast Henderson
      • Henderson, Nevada, Forente stater, 89074
        • Oncology Las Vegas - Henderson
      • Las Vegas, Nevada, Forente stater, 89106
        • Radiation Oncology Centers of Nevada Central
      • Las Vegas, Nevada, Forente stater, 89119
        • Radiation Oncology Centers of Nevada Southeast
      • Las Vegas, Nevada, Forente stater, 89128
        • Comprehensive Cancer Centers of Nevada - Northwest
      • Las Vegas, Nevada, Forente stater, 89144
        • Comprehensive Cancer Centers of Nevada-Summerlin
      • Las Vegas, Nevada, Forente stater, 89148
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, Forente stater, 89169
        • Comprehensive Cancer Centers of Nevada - Central Valley
      • Las Vegas, Nevada, Forente stater, 89102
        • University Medical Center of Southern Nevada
      • Las Vegas, Nevada, Forente stater, 89106
        • Cancer and Blood Specialists-Shadow
      • Las Vegas, Nevada, Forente stater, 89109
        • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
      • Las Vegas, Nevada, Forente stater, 89113
        • HealthCare Partners Medical Group Oncology/Hematology-San Martin
      • Las Vegas, Nevada, Forente stater, 89121
        • Cancer Therapy and Integrative Medicine
      • Las Vegas, Nevada, Forente stater, 89128
        • Cancer and Blood Specialists-Tenaya
      • Las Vegas, Nevada, Forente stater, 89128
        • HealthCare Partners Medical Group Oncology/Hematology-Tenaya
      • Las Vegas, Nevada, Forente stater, 89148-2405
        • Las Vegas Cancer Center-Medical Center
      • Las Vegas, Nevada, Forente stater, 89149
        • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
      • Las Vegas, Nevada, Forente stater, 89120
        • Nevada Cancer Research Foundation NCORP
      • Las Vegas, Nevada, Forente stater, 89128
        • Oncology Las Vegas - Tenaya
      • Las Vegas, Nevada, Forente stater, 89183
        • OptumCare Cancer Care at Fort Apache
    • New Jersey
      • Camden, New Jersey, Forente stater, 08103
        • Cooper Hospital University Medical Center
      • East Orange, New Jersey, Forente stater, 07018-1095
        • Veterans Adminstration New Jersey Health Care System
      • Hackensack, New Jersey, Forente stater, 07601
        • Hackensack University Medical Center
      • Long Branch, New Jersey, Forente stater, 07740
        • Monmouth Medical Center
      • Morristown, New Jersey, Forente stater, 07960
        • Morristown Medical Center
      • Mount Holly, New Jersey, Forente stater, 08060
        • Virtua Memorial
      • Newark, New Jersey, Forente stater, 07101
        • Rutgers New Jersey Medical School
      • Summit, New Jersey, Forente stater, 07902
        • Overlook Hospital
      • Vineland, New Jersey, Forente stater, 08360
        • Inspira Medical Center Vineland
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87106
        • University of New Mexico Cancer Center
      • Las Cruces, New Mexico, Forente stater, 88011
        • Memorial Medical Center-Las Cruces
    • New York
      • Stony Brook, New York, Forente stater, 11794
        • Stony Brook University Medical Center
      • The Bronx, New York, Forente stater, 10467
        • Montefiore Medical Center - Moses Campus
      • The Bronx, New York, Forente stater, 10461
        • Montefiore Medical Center-Weiler Hospital
      • White Plains, New York, Forente stater, 10601
        • Dickstein Cancer Treatment Center
    • North Dakota
      • Fargo, North Dakota, Forente stater, 58122
        • Sanford Roger Maris Cancer Center
      • Fargo, North Dakota, Forente stater, 58122
        • Sanford Broadway Medical Center
    • Ohio
      • Akron, Ohio, Forente stater, 44304
        • Summa Health System - Akron Campus
      • Belpre, Ohio, Forente stater, 45714
        • Strecker Cancer Center-Belpre
      • Bowling Green, Ohio, Forente stater, 43402
        • Toledo Clinic Cancer Centers-Bowling Green
      • Canton, Ohio, Forente stater, 44708
        • Cleveland Clinic Mercy Hospital
      • Chillicothe, Ohio, Forente stater, 45601
        • Adena Regional Medical Center
      • Cleveland, Ohio, Forente stater, 44106
        • Case Western Reserve University
      • Cleveland, Ohio, Forente stater, 44109
        • MetroHealth Medical Center
      • Columbus, Ohio, Forente stater, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, Forente stater, 43219
        • The Mark H Zangmeister Center
      • Columbus, Ohio, Forente stater, 43214
        • Columbus Oncology and Hematology Associates Inc
      • Columbus, Ohio, Forente stater, 43228
        • Doctors Hospital
      • Columbus, Ohio, Forente stater, 43215
        • Grant Medical Center
      • Columbus, Ohio, Forente stater, 43222
        • Mount Carmel Health Center West
      • Columbus, Ohio, Forente stater, 43215
        • Columbus NCI Community Oncology Research Program
      • Delaware, Ohio, Forente stater, 43015
        • Delaware Health Center-Grady Cancer Center
      • Delaware, Ohio, Forente stater, 43015
        • Delaware Radiation Oncology
      • Delaware, Ohio, Forente stater, 43015
        • Grady Memorial Hospital
      • Lancaster, Ohio, Forente stater, 43130
        • Fairfield Medical Center
      • Lima, Ohio, Forente stater, 45801
        • Saint Rita's Medical Center
      • Lima, Ohio, Forente stater, 45804
        • Lima Memorial Hospital
      • Marietta, Ohio, Forente stater, 45750
        • Marietta Memorial Hospital
      • Maumee, Ohio, Forente stater, 43537
        • Toledo Clinic Cancer Centers-Maumee
      • Mount Vernon, Ohio, Forente stater, 43050
        • Knox Community Hospital
      • Newark, Ohio, Forente stater, 43055
        • Licking Memorial Hospital
      • Newark, Ohio, Forente stater, 43055
        • Newark Radiation Oncology
      • Oregon, Ohio, Forente stater, 43616
        • Saint Charles Hospital
      • Oregon, Ohio, Forente stater, 43616
        • Toledo Clinic Cancer Centers-Oregon
      • Portsmouth, Ohio, Forente stater, 45662
        • Southern Ohio Medical Center
      • Springfield, Ohio, Forente stater, 45504
        • Springfield Regional Medical Center
      • Sylvania, Ohio, Forente stater, 43560
        • ProMedica Flower Hospital
      • Tiffin, Ohio, Forente stater, 44883
        • Mercy Hospital of Tiffin
      • Toledo, Ohio, Forente stater, 43606
        • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
      • Toledo, Ohio, Forente stater, 43623
        • Mercy Health - Saint Anne Hospital
      • Toledo, Ohio, Forente stater, 43623
        • Toledo Clinic Cancer Centers-Toledo
      • Toledo, Ohio, Forente stater, 43614
        • University of Toledo
      • Toledo, Ohio, Forente stater, 43617
        • Toledo Community Hospital Oncology Program CCOP
      • Toledo, Ohio, Forente stater, 43608
        • Mercy Health - Saint Vincent Hospital
      • Wauseon, Ohio, Forente stater, 43567
        • Fulton County Health Center
      • Westerville, Ohio, Forente stater, 43081
        • Saint Ann's Hospital
      • Zanesville, Ohio, Forente stater, 43701
        • Genesis Healthcare System Cancer Care Center
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, Forente stater, 19010
        • Bryn Mawr Hospital
      • Danville, Pennsylvania, Forente stater, 17822
        • Geisinger Medical Center
      • Doylestown, Pennsylvania, Forente stater, 18901
        • Doylestown Hospital
      • Erie, Pennsylvania, Forente stater, 16505
        • UPMC Hillman Cancer Center Erie
      • Hazleton, Pennsylvania, Forente stater, 18201
        • Geisinger Medical Center-Cancer Center Hazleton
      • Hershey, Pennsylvania, Forente stater, 17033-0850
        • Penn State Milton S Hershey Medical Center
      • Lancaster, Pennsylvania, Forente stater, 17602
        • Lancaster General Hospital
      • Lewisburg, Pennsylvania, Forente stater, 17837
        • Geisinger Medical Oncology-Lewisburg
      • Paoli, Pennsylvania, Forente stater, 19301
        • Paoli Memorial Hospital
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, Forente stater, 19141
        • Einstein Medical Center Philadelphia
      • Pottsville, Pennsylvania, Forente stater, 17901
        • Geisinger Cancer Services-Pottsville
      • Sayre, Pennsylvania, Forente stater, 18840
        • Guthrie Medical Group PC-Robert Packer Hospital
      • State College, Pennsylvania, Forente stater, 16801
        • Geisinger Medical Group
      • Wilkes-Barre, Pennsylvania, Forente stater, 18711
        • Geisinger Wyoming Valley/Henry Cancer Center
      • Wynnewood, Pennsylvania, Forente stater, 19096
        • Lankenau Medical Center
      • Wynnewood, Pennsylvania, Forente stater, 19096
        • Main Line Health NCORP
      • York, Pennsylvania, Forente stater, 17403
        • WellSpan Health-York Hospital
    • South Dakota
      • Sioux Falls, South Dakota, Forente stater, 57117-5134
        • Sanford USD Medical Center - Sioux Falls
      • Sioux Falls, South Dakota, Forente stater, 57104
        • Sanford Cancer Center Oncology Clinic
    • Texas
      • Austin, Texas, Forente stater, 78701
        • Dell Seton Medical Center at The University of Texas
      • San Antonio, Texas, Forente stater, 78229
        • University of Texas Health Science Center at San Antonio
      • Tyler, Texas, Forente stater, 75708
        • University of Texas Health Science Center at Tyler
    • Virginia
      • Fredericksburg, Virginia, Forente stater, 22401
        • Fredericksburg Oncology Inc
    • West Virginia
      • Charleston, West Virginia, Forente stater, 25304
        • Vandalia Health/CAMC Institute for Academic Medicine
      • Morgantown, West Virginia, Forente stater, 26506
        • West Virginia University Healthcare
      • Wheeling, West Virginia, Forente stater, 26003
        • Wheeling Hospital/Schiffler Cancer Center
    • Wisconsin
      • Chippewa Falls, Wisconsin, Forente stater, 54729
        • Marshfield Clinic-Chippewa Center
      • Eau Claire, Wisconsin, Forente stater, 54701
        • HSHS Sacred Heart Hospital
      • Eau Claire, Wisconsin, Forente stater, 54701
        • Marshfield Clinic Cancer Center at Sacred Heart
      • Green Bay, Wisconsin, Forente stater, 54301
        • Saint Vincent Hospital Cancer Center Green Bay
      • Green Bay, Wisconsin, Forente stater, 54303
        • Saint Vincent Hospital Cancer Center at Saint Mary's
      • Green Bay, Wisconsin, Forente stater, 54301-3526
        • Green Bay Oncology at Saint Vincent Hospital
      • Johnson Creek, Wisconsin, Forente stater, 53038
        • University of Wisconsin Carbone Cancer Center - Johnson Creek
      • Madison, Wisconsin, Forente stater, 53792
        • University of Wisconsin Carbone Cancer Center - University Hospital
      • Madison, Wisconsin, Forente stater, 53715
        • SSM Health Dean Medical Group - South Madison Campus
      • Manitowoc, Wisconsin, Forente stater, 54221
        • Holy Family Memorial Hospital
      • Marinette, Wisconsin, Forente stater, 54143
        • Bay Area Medical Center
      • Marshfield, Wisconsin, Forente stater, 54449
        • Marshfield Medical Center-Marshfield
      • Marshfield, Wisconsin, Forente stater, 54449
        • Marshfield Medical Center
      • Milwaukee, Wisconsin, Forente stater, 53226
        • Medical College of Wisconsin
      • Minocqua, Wisconsin, Forente stater, 54548
        • Marshfield Medical Center - Minocqua
      • New Richmond, Wisconsin, Forente stater, 54017
        • Cancer Center of Western Wisconsin
      • Oconomowoc, Wisconsin, Forente stater, 53066
        • ProHealth Oconomowoc Memorial Hospital
      • Oconto Falls, Wisconsin, Forente stater, 54154
        • Saint Vincent Hospital Cancer Center at Oconto Falls
      • Rhinelander, Wisconsin, Forente stater, 54501
        • Saint Mary's Hospital
      • Rhinelander, Wisconsin, Forente stater, 54501
        • Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
      • Rice Lake, Wisconsin, Forente stater, 54868
        • Marshfield Medical Center-Rice Lake
      • Sheboygan, Wisconsin, Forente stater, 53081
        • HSHS Saint Nicholas Hospital
      • Stevens Point, Wisconsin, Forente stater, 54481
        • Aspirus Cancer Care - Stevens Point
      • Waukesha, Wisconsin, Forente stater, 53188
        • ProHealth Waukesha Memorial Hospital
      • Wausau, Wisconsin, Forente stater, 54401
        • Marshfield Clinic-Wausau Center
      • Weston, Wisconsin, Forente stater, 54476
        • Marshfield Medical Center - Weston
      • Wisconsin Rapids, Wisconsin, Forente stater, 54494
        • Aspirus Cancer Care - Wisconsin Rapids
      • Wisconsin Rapids, Wisconsin, Forente stater, 54494
        • Marshfield Clinic - Wisconsin Rapids 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

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

Criteria:

  • Tumor with a sensitizing mutation in epidermal growth factor receptor (EGFR), defined as follows:

    • EGFR mutation testing of tumor has been performed and did not demonstrate an EGFR tyrosine kinase inhibitor sensitizing mutation; at minimum, testing for EGFR exon 19 deletion and exon 21 L858R mutations must have been included; OR
    • EGFR mutation testing has been attempted and is inconclusive (for example, due to lack of sufficient deoxyribonucleic acid [DNA] yield); OR
    • EGFR mutation status is unknown but tumor is positive for at least one alternative driver mutation, i.e: Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation, v-raf murine sarcoma viral oncogene homolog B (BRAF) mutation, human epidermal growth factor receptor 2 (HER2) mutation, ret proto-oncogene (RET) rearrangement/fusion, or one not listed following approval by the study chair prior to registration

Inclusion Criteria:

  • INCLUSION CRITERIA STEP 1:
  • Cytologically or histologically confirmed non-small cell lung carcinoma (NSCLC)
  • Predominant non-squamous histology (patients with NSCLC not otherwise specified [NOS] are eligible); mixed tumors will be categorized by the predominant cell type; if small cell elements are present the patient is ineligible
  • Stage IV disease (includes M1a, M1b, or recurrent disease), according to the 7th edition of the lung cancer TNM classification system
  • Patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 criteria; baseline measurements and evaluation of all sites of disease must be obtained within 4 weeks prior to registration
  • Prior to registration, the investigator/site must confirm that sufficient pathology material representative of patient's cancer is available for submission for MET immunohistochemical (IHC) testing
  • Patients must have received one or two lines of prior chemotherapy (first line platinum-doublet based chemotherapy plus switch maintenance chemotherapy counts as one line of therapy); prior adjuvant chemotherapy for early stage disease does not count as one line of therapy if 12 months or greater elapsed between completion of adjuvant therapy and initiation of first-line systemic therapy; if less than 12 months elapsed, adjuvant chemotherapy counts as one line of therapy
  • Any prior chemotherapy (based on administration schedule) must have been completed in greater than or equal to the time frames specified in the protocol
  • Patients must have discontinued treatment with any other type of investigational agent >= 4 weeks prior to registration
  • Patients must have recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
  • Patients with no known brain metastasis at baseline must have baseline brain imaging within 12 weeks prior to study registration not demonstrating brain metastases; patients with brain metastases at baseline must have baseline brain imagining within 4 weeks prior to study registration and meet all of the specific criteria for brain mets listed in the protocol
  • Radiation related toxicities must have resolved to =< grade 1 prior to registration
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-2
  • Patients must have an anticipated life expectancy greater than 3 months
  • Acceptable bone marrow, renal and hepatic function within 2 weeks prior to registration as defined in the protocol
  • Patients must have corrected QT interval calculated by the Fridericia formula (QTcF) =< 500 ms within 28 days before registration
  • Patients must be able to swallow tablets
  • INCLUSION CRITERIA STEP 2:
  • Patients must have met all eligibility requirements for Step 1 at time of registration to Step 1 to be eligible for Step 2
  • Patients must have radiographic progressive disease per RECIST v1.1 criteria after >= 2 courses of therapy on Arm A or Arm B
  • Patients must be registered to Step 2 within 4 weeks of the last dose of treatment administration from Step 1
  • Patients must have an ECOG performance status between 0-2
  • Patients must have recovered to baseline (pre-Step 1) or CTCAE version 4.0 <= grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant AEs

Exclusion Criteria:

  • EXCLUSION CRITERIA STEP 1:

  • Patients without sufficient pathology material representative of the patient's cancer (tumor block or 10 unstained slides)

  • Prior erlotinib, other EGFR tyrosine kinase inhibitor therapy, vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor therapy, Met tyrosine kinase inhibitor therapy, or Met monoclonal antibody (MetMAb); prior antibody therapy such as bevacizumab or cetuximab is allowed with a washout period depending on dosing interval and investigational nature

  • Prior radiation therapy to the thoracic cavity, abdomen, or pelvis within 3 months prior to registration, to bone or brain metastasis within 14 days prior to registration, or to any other site within 28 days prior to registration

  • History of the following: Clinically-significant gastrointestinal (GI) bleeding within 6 months prior to registration; Hemoptysis of >= 0.5 teaspoon (2.5 mL) of red blood within 3 months prior to registration; Any other signs indicative of pulmonary hemorrhage within 3 months prior to registration

  • Radiographic or other evidence of the following within 28 days prior to registration: • Tumor invading the GI tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor; Cavitating pulmonary lesion(s); Tumor in contact with, invading or encasing any major blood vessels

  • Psychiatric illness/social situations that would limit compliance with study requirements

  • History of major thrombotic events (deep vein thrombosis [DVT] or pulmonary embolism [PE]) within 6 months prior to registration

  • Concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, low molecular weight heparin (LMWH), thrombin or Factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel). (low dose aspirin [=< 81 mg/day] and prophylactic LMWH are permitted)

  • Concomitant treatment of strong cytochrome P450 3A4 (CYP3A4) inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. John's wort)

  • Cardiovascular disorders including: Congestive heart failure (CHF): New York Heart Association (NYHA) class III (moderate) or class IV (severe) at the time of screening;

  • Concurrent uncontrolled hypertension; Any history of congenital long QT syndrome; Any of the following within 6 months prior to registration:

    • Unstable angina pectoris
    • Clinically-significant cardiac arrhythmias
    • Stroke (including transient ischemic attack [TIA], or other ischemic event)
    • Myocardial infarction
  • GI disorders particularly those associated with a high risk of perforation or fistula formation specified in the protocol

  • Other disorders associated with a high risk of fistula formation including percutaneous endoscopic gastrostomy (PEG) tube placement within 3 months prior to registration

  • Uncontrolled, significant, intercurrent or recent illness

  • Prior malignancy within 2 years prior to registration which required systemic treatment or is currently active

  • Pregnant or breast-feeding

  • Patients with known human immunodeficiency virus (HIV) disease taking antiretroviral therapy

  • Known chronic active hepatitis B

  • EXCLUSION CRITERIA (STEP 2):

  • Intervening anticancer treatment or major surgical procedure(s) between Step 1 and Step 2, except palliative radiation to the bone finishing >= 2 weeks prior to registration to Step 2

  • Central nervous system (CNS) progression; patients with stable CNS disease are allowed

  • Intercurrent illness or disease complication that the investigator believes would limit the ability to safely tolerate the combination of erlotinib and cabozantinib

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: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Arm A (erlotinib)

Patients receive erlotinib PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Correlative studies

Given PO

Andre navn:
  • Cp-358.774
  • Tarceva
  • OSI-774
  • CP-358
  • CP 358
  • CP358
  • OSI 774
  • OSI774
Eksperimentell: Arm B (cabozantinib)

Patients receive cabozantinib PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Correlative studies

Given PO

Andre navn:
  • BMS-907351
  • Cabometyx
  • Cometriq
  • XL-184
  • XL184
  • XL 184
Eksperimentell: Arm C (erlotinib+cabozantinib)

Patients receive erlotinib as patients in Arm A and cabozantinib as patients in Arm B. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Correlative studies

Given PO

Andre navn:
  • Cp-358.774
  • Tarceva
  • OSI-774
  • CP-358
  • CP 358
  • CP358
  • OSI 774
  • OSI774

Given PO

Andre navn:
  • BMS-907351
  • Cabometyx
  • Cometriq
  • XL-184
  • XL184
  • XL 184
Eksperimentell: Arm Z (erlotinib+cabozantinib; step II)

Patients achieving disease progression in Arm A or Arm B may receive erlotinib and cabozantinib as patients in Arm C. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Correlative studies

Given PO

Andre navn:
  • Cp-358.774
  • Tarceva
  • OSI-774
  • CP-358
  • CP 358
  • CP358
  • OSI 774
  • OSI774

Given PO

Andre navn:
  • BMS-907351
  • Cabometyx
  • Cometriq
  • XL-184
  • XL184
  • XL 184

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression-free Survival (PFS)
Tidsramme: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry, up to 5 years

PFS is defined as the time from randomization to documented disease progression or death from any cause, whichever occurred first. Patients who had not experienced an event of interest by the time of analysis were censored at the date of last disease assessment.

Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry, up to 5 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Andel pasienter med verste toksisitet av grad 3 eller høyere
Tidsramme: Vurderes hver 4. uke under behandling og i 30 dager etter avsluttet behandling
Vurderes hver 4. uke under behandling og i 30 dager etter avsluttet behandling
Overall Survival (OS)
Tidsramme: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry, up to 5 years

OS is defined as the time from randomization to death from any cause or date of last known alive.

Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry, up to 5 years
Proportion of Patients With Objective Response
Tidsramme: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry, up to 5 years

Objective response is defined as complete response (CR) or partial response (PR) evaluated using RECIST v 1.1. CR is defined as disappearance of all lesions and any pathological lymph nodes must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions and persistence of one or more non-target lesion(s).

Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry, up to 5 years
Proportion of Patients With MET Positivity
Tidsramme: Assessed at baseline

Submission of archival tissue for central MET IHC testing was required for this study, and total MET IHC testing was conducted at the Brigham and Women's Hospital using the c-Met clone CVD13 (arabbit polyclonal). Membranous and cytoplasmic staining were individually scored, and positivity was declared if MET was expressed in either the membrane or cytoplasm.

Assessed at baseline

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Hovedetterforsker: Joel W Neal, ECOG-ACRIN Cancer Research Group

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

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)

13. februar 2013

Primær fullføring (Faktiske)

14. august 2015

Studiet fullført (Antatt)

31. mars 2027

Datoer for studieregistrering

Først innsendt

15. oktober 2012

Først innsendt som oppfylte QC-kriteriene

15. oktober 2012

Først lagt ut (Antatt)

17. oktober 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. november 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • NCI-2012-01938
  • U10CA180820 (U.S. NIH-stipend/kontrakt)
  • U10CA021115 (U.S. NIH-stipend/kontrakt)
  • NCI-2012-01938 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
  • ECOG-E1512
  • CDR0000741879
  • E1512 (Annen identifikator: CTEP)
  • E1512 (Annen identifikator: ECOG-ACRIN Cancer Research Group)

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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