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Chlorhydrate d'erlotinib et cabozantinib-s-malate seuls ou en association comme traitement de deuxième ou de troisième intention dans le traitement des patients atteints d'un cancer du poumon non à petites cellules de stade IV

10 novembre 2026 mis à jour par: National Cancer Institute (NCI)

Un essai randomisé de phase II sur l'erlotinib, le cabozantinib ou l'erlotinib plus cabozantinib comme traitement de 2e ou 3e ligne chez les patients atteints d'un CPNPC de type sauvage EGFR

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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

125

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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

Autres noms:
  • CP-358,774
  • Tarceva
  • OSI-774
  • CP-358
  • CP 358
  • CP358
  • OSI774
Expérimental: 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

Autres noms:
  • BMS-907351
  • Cabométyx
  • Cométriq
  • XL-184
  • XL184
  • XL 184
Expérimental: 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

Autres noms:
  • CP-358,774
  • Tarceva
  • OSI-774
  • CP-358
  • CP 358
  • CP358
  • OSI774

Given PO

Autres noms:
  • BMS-907351
  • Cabométyx
  • Cométriq
  • XL-184
  • XL184
  • XL 184
Expérimental: 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

Autres noms:
  • CP-358,774
  • Tarceva
  • OSI-774
  • CP-358
  • CP 358
  • CP358
  • OSI774

Given PO

Autres noms:
  • BMS-907351
  • Cabométyx
  • Cométriq
  • XL-184
  • XL184
  • XL 184

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Progression-free Survival (PFS)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Proportion de patients présentant les pires toxicités de grade 3 ou plus
Délai: Évalué toutes les 4 semaines pendant le traitement et pendant 30 jours après la fin du traitement
Évalué toutes les 4 semaines pendant le traitement et pendant 30 jours après la fin du traitement
Overall Survival (OS)
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

13 février 2013

Achèvement primaire (Réel)

14 août 2015

Achèvement de l'étude (Estimé)

31 mars 2027

Dates d'inscription aux études

Première soumission

15 octobre 2012

Première soumission répondant aux critères de contrôle qualité

15 octobre 2012

Première publication (Estimé)

17 octobre 2012

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

13 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 novembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • NCI-2012-01938
  • U10CA180820 (Subvention/contrat des NIH des États-Unis)
  • U10CA021115 (Subvention/contrat des NIH des États-Unis)
  • NCI-2012-01938 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
  • ECOG-E1512
  • CDR0000741879
  • E1512 (Autre identifiant: CTEP)
  • E1512 (Autre identifiant: ECOG-ACRIN Cancer Research Group)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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