Erlotinib hydrochlorid a kabozantinib-s-malát samostatně nebo v kombinaci jako terapie druhé nebo třetí linie při léčbě pacientů s nemalobuněčným karcinomem plic stadia IV
10. listopadu 2026 aktualizováno: National Cancer Institute (NCI)
Randomizovaná studie fáze II s Erlotinibem, Cabozantinibem nebo Erlotinibem Plus Cabozantinib jako terapie 2. nebo 3. linie u pacientů s EGFR NSCLC divokého typu
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.
Přehled studie
Postavení
Aktivní, ne nábor
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
125
Fáze
- Fáze 2
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Arizona
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Scottsdale, Arizona, Spojené státy, 85259
- Mayo Clinic in Arizona
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California
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Modesto, California, Spojené státy, 95355
- Memorial Medical Center
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Monterey, California, Spojené státy, 93940
- Community Hospital of Monterey Peninsula
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Palo Alto, California, Spojené státy, 94304
- VA Palo Alto Health Care System
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Palo Alto, California, Spojené státy, 94304
- Stanford Cancer Institute Palo Alto
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Rancho Mirage, California, Spojené státy, 92270
- Eisenhower Medical Center
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Colorado
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Aurora, Colorado, Spojené státy, 80012
- The Medical Center of Aurora
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Boulder, Colorado, Spojené státy, 80303
- Boulder Community Foothills Hospital
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Boulder, Colorado, Spojené státy, 80304
- Rocky Mountain Cancer Centers-Boulder
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Colorado Springs, Colorado, Spojené státy, 80907
- Penrose-Saint Francis Healthcare
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Colorado Springs, Colorado, Spojené státy, 80907
- Rocky Mountain Cancer Centers-Penrose
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Denver, Colorado, Spojené státy, 80218
- Presbyterian - Saint Lukes Medical Center - Health One
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Denver, Colorado, Spojené státy, 80220
- Rose Medical Center
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Denver, Colorado, Spojené státy, 80218
- Rocky Mountain Cancer Centers-Midtown
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Denver, Colorado, Spojené státy, 80220
- Rocky Mountain Cancer Centers-Rose
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Denver, Colorado, Spojené státy, 80218
- Colorado Blood Cancer Institute
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Denver, Colorado, Spojené státy, 80222
- Western States Cancer Research NCORP
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Denver, Colorado, Spojené státy, 80218
- Saint Joseph Hospital - Cancer Centers of Colorado
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Denver, Colorado, Spojené státy, 80210
- AdventHealth Porter
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Durango, Colorado, Spojené státy, 81301
- Mercy Medical Center
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Englewood, Colorado, Spojené státy, 80113
- Mountain Blue Cancer Care Center - Swedish
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Englewood, Colorado, Spojené státy, 80113
- Swedish Medical Center
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Golden, Colorado, Spojené státy, 80401
- Mountain Blue Cancer Care Center
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Greeley, Colorado, Spojené státy, 80631
- Banner North Colorado Medical Center
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Greenwood Village, Colorado, Spojené státy, 80111
- Rocky Mountain Cancer Centers-Greenwood Village
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Lakewood, Colorado, Spojené státy, 80228
- Rocky Mountain Cancer Centers-Lakewood
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Lakewood, Colorado, Spojené státy, 80228
- CommonSpirit Saint Anthony Hospital Cancer Center
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Littleton, Colorado, Spojené státy, 80122
- AdventHealth Littleton
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Lone Tree, Colorado, Spojené státy, 80124
- Sky Ridge Medical Center
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Lone Tree, Colorado, Spojené státy, 80124
- Rocky Mountain Cancer Centers-Sky Ridge
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Longmont, Colorado, Spojené státy, 80501
- Longmont United Hospital
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Longmont, Colorado, Spojené státy, 80501
- Rocky Mountain Cancer Centers-Longmont
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Loveland, Colorado, Spojené státy, 80539
- Banner North Colorado Medical Center - Loveland Campus
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Parker, Colorado, Spojené státy, 80138
- Rocky Mountain Cancer Centers-Parker
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Parker, Colorado, Spojené státy, 80138
- AdventHealth Parker
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Pueblo, Colorado, Spojené státy, 81004
- Saint Mary Corwin Medical Center
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Pueblo, Colorado, Spojené státy, 81008
- Rocky Mountain Cancer Centers - Pueblo
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Wheat Ridge, Colorado, Spojené státy, 80401
- Intermountain Health Lutheran Hospital
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Connecticut
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Hartford, Connecticut, Spojené státy, 06105
- Smilow Cancer Hospital Care Center at Saint Francis
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New Britain, Connecticut, Spojené státy, 06050
- The Hospital of Central Connecticut
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Delaware
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Lewes, Delaware, Spojené státy, 19958
- Beebe Medical Center
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Newark, Delaware, Spojené státy, 19713
- Helen F Graham Cancer Center
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Newark, Delaware, Spojené státy, 19713
- Delaware Clinical and Laboratory Physicians PA
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Newark, Delaware, Spojené státy, 19713
- Medical Oncology Hematology Consultants PA
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Newark, Delaware, Spojené státy, 19718
- Christiana Care Health System-Christiana Hospital
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Rehoboth Beach, Delaware, Spojené státy, 19971
- Beebe Health Campus
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Seaford, Delaware, Spojené státy, 19973
- TidalHealth Nanticoke / Allen Cancer Center
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Wilmington, Delaware, Spojené státy, 19801
- Christiana Care Health System-Wilmington Hospital
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Florida
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Miami, Florida, Spojené státy, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
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Georgia
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Atlanta, Georgia, Spojené státy, 30322
- Emory University Hospital/Winship Cancer Institute
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Atlanta, Georgia, Spojené státy, 30342
- Emory Saint Joseph's Hospital
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Decatur, Georgia, Spojené státy, 30033
- Atlanta VA Medical Center
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Macon, Georgia, Spojené státy, 31201
- Atrium Health Navicent
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Savannah, Georgia, Spojené státy, 31405
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
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Idaho
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Boise, Idaho, Spojené státy, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Illinois
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Aurora, Illinois, Spojené státy, 60504
- Rush-Copley Medical Center
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Bloomington, Illinois, Spojené státy, 61704
- Illinois CancerCare-Bloomington
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Bloomington, Illinois, Spojené státy, 61701
- OSF Saint Joseph Medical Center
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Canton, Illinois, Spojené státy, 61520
- Illinois CancerCare-Canton
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Carthage, Illinois, Spojené státy, 62321
- Illinois CancerCare-Carthage
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Centralia, Illinois, Spojené státy, 62801
- Centralia Oncology Clinic
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Chicago, Illinois, Spojené státy, 60611
- Northwestern University
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Danville, Illinois, Spojené státy, 61832
- Carle at The Riverfront
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Decatur, Illinois, Spojené státy, 62526
- Decatur Memorial Hospital
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Decatur, Illinois, Spojené státy, 62526
- Cancer Care Specialists of Illinois - Decatur
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Decatur, Illinois, Spojené státy, 62526
- Heartland Cancer Research NCORP
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Effingham, Illinois, Spojené státy, 62401
- Crossroads Cancer Center
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Effingham, Illinois, Spojené státy, 62401
- Carle Physician Group-Effingham
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Eureka, Illinois, Spojené státy, 61530
- Illinois CancerCare-Eureka
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Evanston, Illinois, Spojené státy, 60201
- NorthShore University HealthSystem-Evanston Hospital
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Galesburg, Illinois, Spojené státy, 61401
- Illinois CancerCare-Galesburg
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Glenview, Illinois, Spojené státy, 60026
- NorthShore University HealthSystem-Glenbrook Hospital
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Harvey, Illinois, Spojené státy, 60426
- Ingalls Memorial Hospital
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Highland Park, Illinois, Spojené státy, 60035
- NorthShore University HealthSystem-Highland Park Hospital
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Highland Park, Illinois, Spojené státy, 60035
- Hematology Oncology Associates of Illinois-Highland Park
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Kankakee, Illinois, Spojené státy, 60901
- Presence Saint Mary's Hospital
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Kewanee, Illinois, Spojené státy, 61443
- Illinois CancerCare-Kewanee Clinic
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Libertyville, Illinois, Spojené státy, 60048
- AMG Libertyville - Oncology
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Macomb, Illinois, Spojené státy, 61455
- Illinois CancerCare-Macomb
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Mattoon, Illinois, Spojené státy, 61938
- Carle Physician Group-Mattoon/Charleston
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Moline, Illinois, Spojené státy, 61265
- Garneau, Stewart C MD (UIA Investigator)
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Moline, Illinois, Spojené státy, 61265
- Porubcin, Michael MD (UIA Investigator)
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Moline, Illinois, Spojené státy, 61265
- Spector, David MD (UIA Investigator)
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Moline, Illinois, Spojené státy, 61265
- Trinity Medical Center
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Monmouth, Illinois, Spojené státy, 61462
- Illinois CancerCare-Monmouth
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Niles, Illinois, Spojené státy, 60714
- Illinois Cancer Specialists-Niles
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Normal, Illinois, Spojené státy, 61761
- Carle Cancer Institute Normal
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Ottawa, Illinois, Spojené státy, 61350
- Illinois CancerCare-Ottawa Clinic
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Ottawa, Illinois, Spojené státy, 61350
- Ottawa Regional Hospital and Healthcare Center
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Pekin, Illinois, Spojené státy, 61554
- Illinois CancerCare-Pekin
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Pekin, Illinois, Spojené státy, 61554
- OSF Saint Francis Radiation Oncology at Pekin
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Peoria, Illinois, Spojené státy, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Spojené státy, 61637
- OSF Saint Francis Medical Center
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Peoria, Illinois, Spojené státy, 61615
- Illinois CancerCare-Peoria
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Peoria, Illinois, Spojené státy, 61614
- Proctor Hospital
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Peru, Illinois, Spojené státy, 61354
- Illinois CancerCare-Peru
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Peru, Illinois, Spojené státy, 61354
- Illinois Valley Hospital
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Princeton, Illinois, Spojené státy, 61356
- Illinois CancerCare-Princeton
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Rockford, Illinois, Spojené státy, 61104
- Swedish American Hospital
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Rockford, Illinois, Spojené státy, 61114
- UW Health Carbone Cancer Center Rockford
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Skokie, Illinois, Spojené státy, 60076
- Hematology Oncology Associates of Illinois - Skokie
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Springfield, Illinois, Spojené státy, 62781
- Springfield Memorial Hospital
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Urbana, Illinois, Spojené státy, 61801
- Carle Cancer Center
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Urbana, Illinois, Spojené státy, 61801
- The Carle Foundation Hospital
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Yorkville, Illinois, Spojené státy, 60560
- Rush-Copley Healthcare Center
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Indiana
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Bloomington, Indiana, Spojené státy, 47408
- IU Health Bloomington
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Elkhart, Indiana, Spojené státy, 46515
- Elkhart General Hospital
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Elkhart, Indiana, Spojené státy, 46514
- Michiana Hematology Oncology PC-Elkhart
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Elkhart, Indiana, Spojené státy, 46514-2098
- Elkhart Clinic
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Indianapolis, Indiana, Spojené státy, 46202
- Indiana University/Melvin and Bren Simon Cancer Center
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Indianapolis, Indiana, Spojené státy, 46219
- IU Health Central Indiana Cancer Centers-East
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Kokomo, Indiana, Spojené státy, 46904
- Community Howard Regional Health
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La Porte, Indiana, Spojené státy, 46350
- IU Health La Porte Hospital
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Michigan City, Indiana, Spojené státy, 46360
- Franciscan Saint Anthony Health-Michigan City
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Michigan City, Indiana, Spojené státy, 46360
- Woodland Cancer Care Center
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Mishawaka, Indiana, Spojené státy, 46545
- Michiana Hematology Oncology PC-Mishawaka
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Mishawaka, Indiana, Spojené státy, 46545
- Saint Joseph Regional Medical Center-Mishawaka
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Muncie, Indiana, Spojené státy, 47303
- IU Health Ball Memorial Hospital
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Plymouth, Indiana, Spojené státy, 46563
- Michiana Hematology Oncology PC-Plymouth
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South Bend, Indiana, Spojené státy, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, Spojené státy, 46628
- Northern Indiana Cancer Research Consortium
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South Bend, Indiana, Spojené státy, 46617
- South Bend Clinic
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Westville, Indiana, Spojené státy, 46391
- Michiana Hematology Oncology PC-Westville
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Iowa
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Ames, Iowa, Spojené státy, 50010
- Mary Greeley Medical Center
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Ames, Iowa, Spojené státy, 50010
- McFarland Clinic - Ames
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Bettendorf, Iowa, Spojené státy, 52722
- Constantinou, Costas L MD (UIA Investigator)
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Boone, Iowa, Spojené státy, 50036
- McFarland Clinic - Boone
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Cedar Rapids, Iowa, Spojené státy, 52403
- Mercy Hospital
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Cedar Rapids, Iowa, Spojené státy, 52403
- Oncology Associates at Mercy Medical Center
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Clive, Iowa, Spojené státy, 50325
- Mercy Cancer Center-West Lakes
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Clive, Iowa, Spojené státy, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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Des Moines, Iowa, Spojené státy, 50309
- Iowa Methodist Medical Center
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Des Moines, Iowa, Spojené státy, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, Spojené státy, 50316
- Iowa Lutheran Hospital
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Des Moines, Iowa, Spojené státy, 50309
- Iowa-Wide Oncology Research Coalition NCORP
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Des Moines, Iowa, Spojené státy, 50309
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
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Des Moines, Iowa, Spojené státy, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
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Jefferson, Iowa, Spojené státy, 50129
- McFarland Clinic - Jefferson
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Marshalltown, Iowa, Spojené státy, 50158
- McFarland Clinic - Marshalltown
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Mason City, Iowa, Spojené státy, 50401
- Mercy Medical Center - North Iowa
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Sioux City, Iowa, Spojené státy, 51101
- Siouxland Regional Cancer Center
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Sioux City, Iowa, Spojené státy, 51102
- Mercy Medical Center-Sioux City
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Sioux City, Iowa, Spojené státy, 51104
- Saint Luke's Regional Medical Center
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West Des Moines, Iowa, Spojené státy, 50266
- Mercy Medical Center-West Lakes
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Kansas
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Chanute, Kansas, Spojené státy, 66720
- Cancer Center of Kansas - Chanute
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Dodge City, Kansas, Spojené státy, 67801
- Cancer Center of Kansas - Dodge City
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El Dorado, Kansas, Spojené státy, 67042
- Cancer Center of Kansas - El Dorado
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Fort Scott, Kansas, Spojené státy, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, Spojené státy, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, Spojené státy, 67068
- Cancer Center of Kansas-Kingman
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Lawrence, Kansas, Spojené státy, 66044
- Lawrence Memorial Hospital
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Liberal, Kansas, Spojené státy, 67905
- Cancer Center of Kansas-Liberal
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Manhattan, Kansas, Spojené státy, 66502
- Cancer Center of Kansas-Manhattan
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McPherson, Kansas, Spojené státy, 67460
- Cancer Center of Kansas - McPherson
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Newton, Kansas, Spojené státy, 67114
- Cancer Center of Kansas - Newton
-
Parsons, Kansas, Spojené státy, 67357
- Cancer Center of Kansas - Parsons
-
Pratt, Kansas, Spojené státy, 67124
- Cancer Center of Kansas - Pratt
-
Salina, Kansas, Spojené státy, 67401
- Cancer Center of Kansas - Salina
-
Wellington, Kansas, Spojené státy, 67152
- Cancer Center of Kansas - Wellington
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Wichita, Kansas, Spojené státy, 67214
- Ascension Via Christi Hospitals Wichita
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Wichita, Kansas, Spojené státy, 67208
- Cancer Center of Kansas-Wichita Medical Arts Tower
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Wichita, Kansas, Spojené státy, 67214
- Cancer Center of Kansas - Wichita
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Wichita, Kansas, Spojené státy, 67208
- Associates In Womens Health
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Wichita, Kansas, Spojené státy, 67214
- Wichita NCI Community Oncology Research Program
-
Winfield, Kansas, Spojené státy, 67156
- Cancer Center of Kansas - Winfield
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Louisiana
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Baton Rouge, Louisiana, Spojené státy, 70809
- Ochsner Health Center-Summa
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New Orleans, Louisiana, Spojené státy, 70121
- Ochsner Medical Center Jefferson
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New Orleans, Louisiana, Spojené státy, 70115
- Ochsner Baptist Medical Center
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Maine
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York Village, Maine, Spojené státy, 03909
- York Hospital
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Maryland
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Baltimore, Maryland, Spojené státy, 21204
- Greater Baltimore Medical Center
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Elkton, Maryland, Spojené státy, 21921
- Christiana Care - Union Hospital
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Michigan
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Adrian, Michigan, Spojené státy, 49221
- Bixby Medical Center
-
Adrian, Michigan, Spojené státy, 49221
- Hickman Cancer Center
-
Ann Arbor, Michigan, Spojené státy, 48106
- Michigan Cancer Research Consortium NCORP
-
Ann Arbor, Michigan, Spojené státy, 48106
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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Dearborn, Michigan, Spojené státy, 48124
- Corewell Health Dearborn Hospital
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Detroit, Michigan, Spojené státy, 48236
- Henry Ford Health Saint John Hospital
-
Escanaba, Michigan, Spojené státy, 49829
- OSF Saint Francis Hospital and Medical Group
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Flint, Michigan, Spojené státy, 48503
- Hurley Medical Center
-
Flint, Michigan, Spojené státy, 48503
- Genesys Hurley Cancer Institute
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Jackson, Michigan, Spojené státy, 49201
- Allegiance Health
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Kalamazoo, Michigan, Spojené státy, 49007
- West Michigan Cancer Center
-
Kalamazoo, Michigan, Spojené státy, 49007
- Bronson Methodist Hospital
-
Kalamazoo, Michigan, Spojené státy, 49048
- Beacon Kalamazoo
-
Lansing, Michigan, Spojené státy, 48912
- University of Michigan Health - Sparrow Lansing
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Livonia, Michigan, Spojené státy, 48154
- Trinity Health Saint Mary Mercy Livonia Hospital
-
Monroe, Michigan, Spojené státy, 48162
- Mercy Memorial Hospital
-
Monroe, Michigan, Spojené státy, 48162
- Toledo Clinic Cancer Centers-Monroe
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Pontiac, Michigan, Spojené státy, 48341
- Trinity Health Saint Joseph Mercy Oakland Hospital
-
Port Huron, Michigan, Spojené státy, 48060
- Lake Huron Medical Center
-
Saginaw, Michigan, Spojené státy, 48601
- MyMichigan Medical Center Saginaw
-
Saint Joseph, Michigan, Spojené státy, 49085
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
-
Saint Joseph, Michigan, Spojené státy, 49085
- Corewell Health Lakeland Hospitals - Saint Joseph Hospital
-
Warren, Michigan, Spojené státy, 48093
- Henry Ford Health Warren Hospital
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Minnesota
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Bemidji, Minnesota, Spojené státy, 56601
- Sanford Joe Lueken Cancer Center
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Burnsville, Minnesota, Spojené státy, 55337
- Fairview Ridges Hospital
-
Coon Rapids, Minnesota, Spojené státy, 55433
- Mercy Hospital
-
Edina, Minnesota, Spojené státy, 55435
- Fairview Southdale Hospital
-
Fridley, Minnesota, Spojené státy, 55432
- Unity Hospital
-
Hutchinson, Minnesota, Spojené státy, 55350
- Hutchinson Area Health Care
-
Maplewood, Minnesota, Spojené státy, 55109
- Saint John's Hospital - Healtheast
-
Maplewood, Minnesota, Spojené státy, 55109
- Minnesota Oncology Hematology PA-Maplewood
-
Minneapolis, Minnesota, Spojené státy, 55415
- Hennepin County Medical Center
-
Minneapolis, Minnesota, Spojené státy, 55407
- Abbott-Northwestern Hospital
-
New Ulm, Minnesota, Spojené státy, 56073
- New Ulm Medical Center
-
Robbinsdale, Minnesota, Spojené státy, 55422
- North Memorial Medical Health Center
-
Saint Louis Park, Minnesota, Spojené státy, 55416
- Park Nicollet Clinic - Saint Louis Park
-
Saint Louis Park, Minnesota, Spojené státy, 55416
- Metro Minnesota Community Oncology Research Consortium
-
Saint Paul, Minnesota, Spojené státy, 55101
- Regions Hospital
-
Saint Paul, Minnesota, Spojené státy, 55102
- United Hospital
-
Shakopee, Minnesota, Spojené státy, 55379
- Saint Francis Regional Medical Center
-
Stillwater, Minnesota, Spojené státy, 55082
- Lakeview Hospital
-
Waconia, Minnesota, Spojené státy, 55387
- Ridgeview Medical Center
-
Willmar, Minnesota, Spojené státy, 56201
- Rice Memorial Hospital
-
Woodbury, Minnesota, Spojené státy, 55125
- Minnesota Oncology Hematology PA-Woodbury
-
-
Missouri
-
Cape Girardeau, Missouri, Spojené státy, 63703
- Saint Francis Medical Center
-
-
Nebraska
-
Lincoln, Nebraska, Spojené státy, 68510
- Nebraska Cancer Research Center
-
Omaha, Nebraska, Spojené státy, 68124
- Alegent Health Bergan Mercy Medical Center
-
Omaha, Nebraska, Spojené státy, 68122
- Alegent Health Immanuel Medical Center
-
Omaha, Nebraska, Spojené státy, 68130
- Alegent Health Lakeside Hospital
-
Omaha, Nebraska, Spojené státy, 68106
- Missouri Valley Cancer Consortium
-
-
Nevada
-
Henderson, Nevada, Spojené státy, 89052
- Comprehensive Cancer Centers of Nevada - Henderson
-
Henderson, Nevada, Spojené státy, 89052
- Cancer and Blood Specialists-Henderson
-
Henderson, Nevada, Spojené státy, 89052
- Las Vegas Cancer Center-Henderson
-
Henderson, Nevada, Spojené státy, 89074
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
-
Henderson, Nevada, Spojené státy, 89074
- Oncology Las Vegas - Henderson
-
Las Vegas, Nevada, Spojené státy, 89106
- Radiation Oncology Centers of Nevada Central
-
Las Vegas, Nevada, Spojené státy, 89119
- Radiation Oncology Centers of Nevada Southeast
-
Las Vegas, Nevada, Spojené státy, 89128
- Comprehensive Cancer Centers of Nevada - Northwest
-
Las Vegas, Nevada, Spojené státy, 89144
- Comprehensive Cancer Centers of Nevada-Summerlin
-
Las Vegas, Nevada, Spojené státy, 89148
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Spojené státy, 89169
- Comprehensive Cancer Centers of Nevada - Central Valley
-
Las Vegas, Nevada, Spojené státy, 89102
- University Medical Center of Southern Nevada
-
Las Vegas, Nevada, Spojené státy, 89106
- Cancer and Blood Specialists-Shadow
-
Las Vegas, Nevada, Spojené státy, 89109
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
-
Las Vegas, Nevada, Spojené státy, 89113
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
-
Las Vegas, Nevada, Spojené státy, 89121
- Cancer Therapy and Integrative Medicine
-
Las Vegas, Nevada, Spojené státy, 89128
- Cancer and Blood Specialists-Tenaya
-
Las Vegas, Nevada, Spojené státy, 89128
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
-
Las Vegas, Nevada, Spojené státy, 89148-2405
- Las Vegas Cancer Center-Medical Center
-
Las Vegas, Nevada, Spojené státy, 89149
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
-
Las Vegas, Nevada, Spojené státy, 89120
- Nevada Cancer Research Foundation NCORP
-
Las Vegas, Nevada, Spojené státy, 89128
- Oncology Las Vegas - Tenaya
-
Las Vegas, Nevada, Spojené státy, 89183
- OptumCare Cancer Care at Fort Apache
-
-
New Jersey
-
Camden, New Jersey, Spojené státy, 08103
- Cooper Hospital University Medical Center
-
East Orange, New Jersey, Spojené státy, 07018-1095
- Veterans Adminstration New Jersey Health Care System
-
Hackensack, New Jersey, Spojené státy, 07601
- Hackensack University Medical Center
-
Long Branch, New Jersey, Spojené státy, 07740
- Monmouth Medical Center
-
Morristown, New Jersey, Spojené státy, 07960
- Morristown Medical Center
-
Mount Holly, New Jersey, Spojené státy, 08060
- Virtua Memorial
-
Newark, New Jersey, Spojené státy, 07101
- Rutgers New Jersey Medical School
-
Summit, New Jersey, Spojené státy, 07902
- Overlook Hospital
-
Vineland, New Jersey, Spojené státy, 08360
- Inspira Medical Center Vineland
-
-
New Mexico
-
Albuquerque, New Mexico, Spojené státy, 87106
- University of New Mexico Cancer Center
-
Las Cruces, New Mexico, Spojené státy, 88011
- Memorial Medical Center-Las Cruces
-
-
New York
-
Stony Brook, New York, Spojené státy, 11794
- Stony Brook University Medical Center
-
The Bronx, New York, Spojené státy, 10467
- Montefiore Medical Center - Moses Campus
-
The Bronx, New York, Spojené státy, 10461
- Montefiore Medical Center-Weiler Hospital
-
White Plains, New York, Spojené státy, 10601
- Dickstein Cancer Treatment Center
-
-
North Dakota
-
Fargo, North Dakota, Spojené státy, 58122
- Sanford Roger Maris Cancer Center
-
Fargo, North Dakota, Spojené státy, 58122
- Sanford Broadway Medical Center
-
-
Ohio
-
Akron, Ohio, Spojené státy, 44304
- Summa Health System - Akron Campus
-
Belpre, Ohio, Spojené státy, 45714
- Strecker Cancer Center-Belpre
-
Bowling Green, Ohio, Spojené státy, 43402
- Toledo Clinic Cancer Centers-Bowling Green
-
Canton, Ohio, Spojené státy, 44708
- Cleveland Clinic Mercy Hospital
-
Chillicothe, Ohio, Spojené státy, 45601
- Adena Regional Medical Center
-
Cleveland, Ohio, Spojené státy, 44106
- Case Western Reserve University
-
Cleveland, Ohio, Spojené státy, 44109
- MetroHealth Medical Center
-
Columbus, Ohio, Spojené státy, 43214
- Riverside Methodist Hospital
-
Columbus, Ohio, Spojené státy, 43219
- The Mark H Zangmeister Center
-
Columbus, Ohio, Spojené státy, 43214
- Columbus Oncology and Hematology Associates Inc
-
Columbus, Ohio, Spojené státy, 43228
- Doctors Hospital
-
Columbus, Ohio, Spojené státy, 43215
- Grant Medical Center
-
Columbus, Ohio, Spojené státy, 43222
- Mount Carmel Health Center West
-
Columbus, Ohio, Spojené státy, 43215
- Columbus NCI Community Oncology Research Program
-
Delaware, Ohio, Spojené státy, 43015
- Delaware Health Center-Grady Cancer Center
-
Delaware, Ohio, Spojené státy, 43015
- Delaware Radiation Oncology
-
Delaware, Ohio, Spojené státy, 43015
- Grady Memorial Hospital
-
Lancaster, Ohio, Spojené státy, 43130
- Fairfield Medical Center
-
Lima, Ohio, Spojené státy, 45801
- Saint Rita's Medical Center
-
Lima, Ohio, Spojené státy, 45804
- Lima Memorial Hospital
-
Marietta, Ohio, Spojené státy, 45750
- Marietta Memorial Hospital
-
Maumee, Ohio, Spojené státy, 43537
- Toledo Clinic Cancer Centers-Maumee
-
Mount Vernon, Ohio, Spojené státy, 43050
- Knox Community Hospital
-
Newark, Ohio, Spojené státy, 43055
- Licking Memorial Hospital
-
Newark, Ohio, Spojené státy, 43055
- Newark Radiation Oncology
-
Oregon, Ohio, Spojené státy, 43616
- Saint Charles Hospital
-
Oregon, Ohio, Spojené státy, 43616
- Toledo Clinic Cancer Centers-Oregon
-
Portsmouth, Ohio, Spojené státy, 45662
- Southern Ohio Medical Center
-
Springfield, Ohio, Spojené státy, 45504
- Springfield Regional Medical Center
-
Sylvania, Ohio, Spojené státy, 43560
- ProMedica Flower Hospital
-
Tiffin, Ohio, Spojené státy, 44883
- Mercy Hospital of Tiffin
-
Toledo, Ohio, Spojené státy, 43606
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
-
Toledo, Ohio, Spojené státy, 43623
- Mercy Health - Saint Anne Hospital
-
Toledo, Ohio, Spojené státy, 43623
- Toledo Clinic Cancer Centers-Toledo
-
Toledo, Ohio, Spojené státy, 43614
- University of Toledo
-
Toledo, Ohio, Spojené státy, 43617
- Toledo Community Hospital Oncology Program CCOP
-
Toledo, Ohio, Spojené státy, 43608
- Mercy Health - Saint Vincent Hospital
-
Wauseon, Ohio, Spojené státy, 43567
- Fulton County Health Center
-
Westerville, Ohio, Spojené státy, 43081
- Saint Ann's Hospital
-
Zanesville, Ohio, Spojené státy, 43701
- Genesis Healthcare System Cancer Care Center
-
-
Pennsylvania
-
Bryn Mawr, Pennsylvania, Spojené státy, 19010
- Bryn Mawr Hospital
-
Danville, Pennsylvania, Spojené státy, 17822
- Geisinger Medical Center
-
Doylestown, Pennsylvania, Spojené státy, 18901
- Doylestown Hospital
-
Erie, Pennsylvania, Spojené státy, 16505
- UPMC Hillman Cancer Center Erie
-
Hazleton, Pennsylvania, Spojené státy, 18201
- Geisinger Medical Center-Cancer Center Hazleton
-
Hershey, Pennsylvania, Spojené státy, 17033-0850
- Penn State Milton S Hershey Medical Center
-
Lancaster, Pennsylvania, Spojené státy, 17602
- Lancaster General Hospital
-
Lewisburg, Pennsylvania, Spojené státy, 17837
- Geisinger Medical Oncology-Lewisburg
-
Paoli, Pennsylvania, Spojené státy, 19301
- Paoli Memorial Hospital
-
Philadelphia, Pennsylvania, Spojené státy, 19107
- Thomas Jefferson University Hospital
-
Philadelphia, Pennsylvania, Spojené státy, 19141
- Einstein Medical Center Philadelphia
-
Pottsville, Pennsylvania, Spojené státy, 17901
- Geisinger Cancer Services-Pottsville
-
Sayre, Pennsylvania, Spojené státy, 18840
- Guthrie Medical Group PC-Robert Packer Hospital
-
State College, Pennsylvania, Spojené státy, 16801
- Geisinger Medical Group
-
Wilkes-Barre, Pennsylvania, Spojené státy, 18711
- Geisinger Wyoming Valley/Henry Cancer Center
-
Wynnewood, Pennsylvania, Spojené státy, 19096
- Lankenau Medical Center
-
Wynnewood, Pennsylvania, Spojené státy, 19096
- Main Line Health NCORP
-
York, Pennsylvania, Spojené státy, 17403
- WellSpan Health-York Hospital
-
-
South Dakota
-
Sioux Falls, South Dakota, Spojené státy, 57117-5134
- Sanford USD Medical Center - Sioux Falls
-
Sioux Falls, South Dakota, Spojené státy, 57104
- Sanford Cancer Center Oncology Clinic
-
-
Texas
-
Austin, Texas, Spojené státy, 78701
- Dell Seton Medical Center at The University of Texas
-
San Antonio, Texas, Spojené státy, 78229
- University of Texas Health Science Center at San Antonio
-
Tyler, Texas, Spojené státy, 75708
- University of Texas Health Science Center at Tyler
-
-
Virginia
-
Fredericksburg, Virginia, Spojené státy, 22401
- Fredericksburg Oncology Inc
-
-
West Virginia
-
Charleston, West Virginia, Spojené státy, 25304
- Vandalia Health/CAMC Institute for Academic Medicine
-
Morgantown, West Virginia, Spojené státy, 26506
- West Virginia University Healthcare
-
Wheeling, West Virginia, Spojené státy, 26003
- Wheeling Hospital/Schiffler Cancer Center
-
-
Wisconsin
-
Chippewa Falls, Wisconsin, Spojené státy, 54729
- Marshfield Clinic-Chippewa Center
-
Eau Claire, Wisconsin, Spojené státy, 54701
- HSHS Sacred Heart Hospital
-
Eau Claire, Wisconsin, Spojené státy, 54701
- Marshfield Clinic Cancer Center at Sacred Heart
-
Green Bay, Wisconsin, Spojené státy, 54301
- Saint Vincent Hospital Cancer Center Green Bay
-
Green Bay, Wisconsin, Spojené státy, 54303
- Saint Vincent Hospital Cancer Center at Saint Mary's
-
Green Bay, Wisconsin, Spojené státy, 54301-3526
- Green Bay Oncology at Saint Vincent Hospital
-
Johnson Creek, Wisconsin, Spojené státy, 53038
- University of Wisconsin Carbone Cancer Center - Johnson Creek
-
Madison, Wisconsin, Spojené státy, 53792
- University of Wisconsin Carbone Cancer Center - University Hospital
-
Madison, Wisconsin, Spojené státy, 53715
- SSM Health Dean Medical Group - South Madison Campus
-
Manitowoc, Wisconsin, Spojené státy, 54221
- Holy Family Memorial Hospital
-
Marinette, Wisconsin, Spojené státy, 54143
- Bay Area Medical Center
-
Marshfield, Wisconsin, Spojené státy, 54449
- Marshfield Medical Center-Marshfield
-
Marshfield, Wisconsin, Spojené státy, 54449
- Marshfield Medical Center
-
Milwaukee, Wisconsin, Spojené státy, 53226
- Medical College of Wisconsin
-
Minocqua, Wisconsin, Spojené státy, 54548
- Marshfield Medical Center - Minocqua
-
New Richmond, Wisconsin, Spojené státy, 54017
- Cancer Center of Western Wisconsin
-
Oconomowoc, Wisconsin, Spojené státy, 53066
- ProHealth Oconomowoc Memorial Hospital
-
Oconto Falls, Wisconsin, Spojené státy, 54154
- Saint Vincent Hospital Cancer Center at Oconto Falls
-
Rhinelander, Wisconsin, Spojené státy, 54501
- Saint Mary's Hospital
-
Rhinelander, Wisconsin, Spojené státy, 54501
- Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
-
Rice Lake, Wisconsin, Spojené státy, 54868
- Marshfield Medical Center-Rice Lake
-
Sheboygan, Wisconsin, Spojené státy, 53081
- HSHS Saint Nicholas Hospital
-
Stevens Point, Wisconsin, Spojené státy, 54481
- Aspirus Cancer Care - Stevens Point
-
Waukesha, Wisconsin, Spojené státy, 53188
- ProHealth Waukesha Memorial Hospital
-
Wausau, Wisconsin, Spojené státy, 54401
- Marshfield Clinic-Wausau Center
-
Weston, Wisconsin, Spojené státy, 54476
- Marshfield Medical Center - Weston
-
Wisconsin Rapids, Wisconsin, Spojené státy, 54494
- Aspirus Cancer Care - Wisconsin Rapids
-
Wisconsin Rapids, Wisconsin, Spojené státy, 54494
- Marshfield Clinic - Wisconsin Rapids Center
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Arm A (erlotinib)
Patients receive erlotinib PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Correlative studies Given PO
Ostatní jména:
|
|
Experimentální: Arm B (cabozantinib)
Patients receive cabozantinib PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Correlative studies Given PO
Ostatní jména:
|
|
Experimentální: Arm C (erlotinib+cabozantinib)
Patients receive erlotinib as patients in Arm A and cabozantinib as patients in Arm B. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Correlative studies Given PO
Ostatní jména:
Given PO
Ostatní jména:
|
|
Experimentální: Arm Z (erlotinib+cabozantinib; step II)
Patients achieving disease progression in Arm A or Arm B may receive erlotinib and cabozantinib as patients in Arm C. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Correlative studies Given PO
Ostatní jména:
Given PO
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Progression-free Survival (PFS)
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Podíl pacientů s toxicitou nejhoršího stupně 3. nebo vyššího
Časové okno: Vyhodnocováno každé 4 týdny během léčby a po dobu 30 dnů po ukončení léčby
|
Vyhodnocováno každé 4 týdny během léčby a po dobu 30 dnů po ukončení léčby
|
|
|
Overall Survival (OS)
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Joel W Neal, ECOG-ACRIN Cancer Research Group
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
13. února 2013
Primární dokončení (Aktuální)
14. srpna 2015
Dokončení studie (Odhadovaný)
31. března 2027
Termíny zápisu do studia
První předloženo
15. října 2012
První předloženo, které splnilo kritéria kontroly kvality
15. října 2012
První zveřejněno (Odhadovaný)
17. října 2012
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
13. listopadu 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
10. listopadu 2026
Naposledy ověřeno
1. září 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Novotvary podle místa
- Novotvary
- Nemoci dýchacích cest
- Plicní onemocnění
- Novotvary dýchacího traktu
- Novotvary hrudníku
- Novotvary plic
- Karcinom, Bronchogenní
- Bronchiální novotvary
- Karcinom, nemalobuněčné plíce
- Heterocyklické sloučeniny
- Heterocyklické sloučeniny, 2-prsten
- Heterocyklické sloučeniny, fúzované kroužek
- Quinazoliny
- Erlotinib hydrochlorid
- Cabozantinib
Další identifikační čísla studie
- NCI-2012-01938
- U10CA180820 (Grant/smlouva NIH USA)
- U10CA021115 (Grant/smlouva NIH USA)
- NCI-2012-01938 (Identifikátor registru: CTRP (Clinical Trial Reporting Program))
- ECOG-E1512
- CDR0000741879
- E1512 (Jiný identifikátor: CTEP)
- E1512 (Jiný identifikátor: ECOG-ACRIN Cancer Research Group)
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