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Erlotinibhydrochloride en cabozantinib-s-malaat alleen of in combinatie als tweede- of derdelijnstherapie bij de behandeling van patiënten met stadium IV niet-kleincellige longkanker

10 november 2026 bijgewerkt door: National Cancer Institute (NCI)

Een gerandomiseerde fase II-studie van erlotinib, cabozantinib of erlotinib plus cabozantinib als 2e of 3e lijnstherapie bij patiënten met EGFR Wild-Type NSCLC

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

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

PRIMARY OBJECTIVES:

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

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

SECONDARY OBJECTIVES:

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

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

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

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

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

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

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

Studietype

Ingrijpend

Inschrijving (Werkelijk)

125

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Ander: Laboratory Biomarker Analysis

Correlative studies

Geneesmiddel: Erlotinib Hydrochloride

Given PO

Andere namen:
  • CP-358.774
  • Tarceva
  • OSI-774
  • CP-358
  • CP358
  • OSI 774
  • OSI774
Experimenteel: 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.
Ander: Laboratory Biomarker Analysis

Correlative studies

Geneesmiddel: Cabozantinib S-malate

Given PO

Andere namen:
  • BMS-907351
  • Cabometyx
  • Cometriq
  • XL-184
  • XL184
Experimenteel: 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.
Ander: Laboratory Biomarker Analysis

Correlative studies

Geneesmiddel: Erlotinib Hydrochloride

Given PO

Andere namen:
  • CP-358.774
  • Tarceva
  • OSI-774
  • CP-358
  • CP358
  • OSI 774
  • OSI774
Geneesmiddel: Cabozantinib S-malate

Given PO

Andere namen:
  • BMS-907351
  • Cabometyx
  • Cometriq
  • XL-184
  • XL184
Experimenteel: 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.
Ander: Laboratory Biomarker Analysis

Correlative studies

Geneesmiddel: Erlotinib Hydrochloride

Given PO

Andere namen:
  • CP-358.774
  • Tarceva
  • OSI-774
  • CP-358
  • CP358
  • OSI 774
  • OSI774
Geneesmiddel: Cabozantinib S-malate

Given PO

Andere namen:
  • BMS-907351
  • Cabometyx
  • Cometriq
  • XL-184
  • XL184

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression-free Survival (PFS)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage patiënten met toxiciteit van de slechtste graad van graad 3 of hoger
Tijdsspanne: Elke 4 weken beoordeeld tijdens de behandeling en gedurende 30 dagen na het einde van de behandeling
Elke 4 weken beoordeeld tijdens de behandeling en gedurende 30 dagen na het einde van de behandeling
Overall Survival (OS)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Cancer Institute (NCI)

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

13 februari 2013

Primaire voltooiing (Werkelijk)

14 augustus 2015

Studie voltooiing (Geschat)

31 maart 2027

Studieregistratiedata

Eerst ingediend

15 oktober 2012

Eerst ingediend dat voldeed aan de QC-criteria

15 oktober 2012

Eerst geplaatst (Geschat)

17 oktober 2012

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 november 2026

Laatste update ingediend die voldeed aan QC-criteria

10 november 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • NCI-2012-01938
  • U10CA180820 (Subsidie/contract van de Amerikaanse NIH)
  • U10CA021115 (Subsidie/contract van de Amerikaanse NIH)
  • NCI-2012-01938 (Register-ID: CTRP (Clinical Trial Reporting Program))
  • ECOG-E1512
  • CDR0000741879
  • E1512 (Andere identificatie: CTEP)
  • E1512 (Andere identificatie: ECOG-ACRIN Cancer Research Group)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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