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Cloridrato de Erlotinibe e Cabozantinibe-s-Malato Isoladamente ou em Combinação como Terapia de Segunda ou Terceira Linha no Tratamento de Pacientes com Câncer de Pulmão de Células Não Pequenas Estágio IV

10 de novembro de 2026 atualizado por: National Cancer Institute (NCI)

Um estudo randomizado de fase II de Erlotinibe, Cabozantinibe ou Erlotinibe mais Cabozantinibe como terapia de 2ª ou 3ª linha em pacientes com NSCLC de tipo selvagem 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.

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

125

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Outro: Laboratory Biomarker Analysis

Correlative studies

Medicamento: Erlotinib Hydrochloride

Given PO

Outros nomes:
  • Cp-358.774
  • Tarceva
  • OSI-774
  • CP-358
  • CP358
  • OSI774
Experimental: 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.
Outro: Laboratory Biomarker Analysis

Correlative studies

Medicamento: Cabozantinib S-malate

Given PO

Outros nomes:
  • BMS-907351
  • Cabometyx
  • Cometriq
  • XL-184
  • XL184
  • GG 184
Experimental: 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.
Outro: Laboratory Biomarker Analysis

Correlative studies

Medicamento: Erlotinib Hydrochloride

Given PO

Outros nomes:
  • Cp-358.774
  • Tarceva
  • OSI-774
  • CP-358
  • CP358
  • OSI774
Medicamento: Cabozantinib S-malate

Given PO

Outros nomes:
  • BMS-907351
  • Cabometyx
  • Cometriq
  • XL-184
  • XL184
  • GG 184
Experimental: 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.
Outro: Laboratory Biomarker Analysis

Correlative studies

Medicamento: Erlotinib Hydrochloride

Given PO

Outros nomes:
  • Cp-358.774
  • Tarceva
  • OSI-774
  • CP-358
  • CP358
  • OSI774
Medicamento: Cabozantinib S-malate

Given PO

Outros nomes:
  • BMS-907351
  • Cabometyx
  • Cometriq
  • XL-184
  • XL184
  • GG 184

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Progression-free Survival (PFS)
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Proporção de pacientes com toxicidades de pior grau de grau 3 ou superior
Prazo: Avaliado a cada 4 semanas durante o tratamento e por 30 dias após o término do tratamento
Avaliado a cada 4 semanas durante o tratamento e por 30 dias após o término do tratamento
Overall Survival (OS)
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

National Cancer Institute (NCI)

Investigadores

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

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

13 de fevereiro de 2013

Conclusão Primária (Real)

14 de agosto de 2015

Conclusão do estudo (Estimado)

31 de março de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

15 de outubro de 2012

Enviado pela primeira vez que atendeu aos critérios de CQ

15 de outubro de 2012

Primeira postagem (Estimado)

17 de outubro de 2012

Atualizações de registro de estudo

Última Atualização Postada (Real)

13 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

10 de novembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • NCI-2012-01938
  • U10CA180820 (Concessão/Contrato do NIH dos EUA)
  • U10CA021115 (Concessão/Contrato do NIH dos EUA)
  • NCI-2012-01938 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
  • ECOG-E1512
  • CDR0000741879
  • E1512 (Outro identificador: CTEP)
  • E1512 (Outro identificador: ECOG-ACRIN Cancer Research Group)

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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