Erlotinib hydrochloride och Cabozantinib-s-Malate ensamma eller i kombination som andra eller tredje linjens terapi vid behandling av patienter med stadium IV icke-småcellig lungcancer
10 november 2026 uppdaterad av: National Cancer Institute (NCI)
En randomiserad fas II-studie av Erlotinib, Cabozantinib eller Erlotinib Plus Cabozantinib som 2:a eller 3:e linjens terapi hos patienter med EGFR vildtyp 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.
Studieöversikt
Status
Aktiv, inte rekryterande
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
125
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Arizona
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Scottsdale, Arizona, Förenta staterna, 85259
- Mayo Clinic in Arizona
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California
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Modesto, California, Förenta staterna, 95355
- Memorial Medical Center
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Monterey, California, Förenta staterna, 93940
- Community Hospital of Monterey Peninsula
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Palo Alto, California, Förenta staterna, 94304
- VA Palo Alto Health Care System
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Palo Alto, California, Förenta staterna, 94304
- Stanford Cancer Institute Palo Alto
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Rancho Mirage, California, Förenta staterna, 92270
- Eisenhower Medical Center
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Colorado
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Aurora, Colorado, Förenta staterna, 80012
- The Medical Center of Aurora
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Boulder, Colorado, Förenta staterna, 80303
- Boulder Community Foothills Hospital
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Boulder, Colorado, Förenta staterna, 80304
- Rocky Mountain Cancer Centers-Boulder
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Colorado Springs, Colorado, Förenta staterna, 80907
- Penrose-Saint Francis Healthcare
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Colorado Springs, Colorado, Förenta staterna, 80907
- Rocky Mountain Cancer Centers-Penrose
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Denver, Colorado, Förenta staterna, 80218
- Presbyterian - Saint Lukes Medical Center - Health One
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Denver, Colorado, Förenta staterna, 80220
- Rose Medical Center
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Denver, Colorado, Förenta staterna, 80218
- Rocky Mountain Cancer Centers-Midtown
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Denver, Colorado, Förenta staterna, 80220
- Rocky Mountain Cancer Centers-Rose
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Denver, Colorado, Förenta staterna, 80218
- Colorado Blood Cancer Institute
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Denver, Colorado, Förenta staterna, 80222
- Western States Cancer Research NCORP
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Denver, Colorado, Förenta staterna, 80218
- Saint Joseph Hospital - Cancer Centers of Colorado
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Denver, Colorado, Förenta staterna, 80210
- AdventHealth Porter
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Durango, Colorado, Förenta staterna, 81301
- Mercy Medical Center
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Englewood, Colorado, Förenta staterna, 80113
- Mountain Blue Cancer Care Center - Swedish
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Englewood, Colorado, Förenta staterna, 80113
- Swedish Medical Center
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Golden, Colorado, Förenta staterna, 80401
- Mountain Blue Cancer Care Center
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Greeley, Colorado, Förenta staterna, 80631
- Banner North Colorado Medical Center
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Greenwood Village, Colorado, Förenta staterna, 80111
- Rocky Mountain Cancer Centers-Greenwood Village
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Lakewood, Colorado, Förenta staterna, 80228
- Rocky Mountain Cancer Centers-Lakewood
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Lakewood, Colorado, Förenta staterna, 80228
- CommonSpirit Saint Anthony Hospital Cancer Center
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Littleton, Colorado, Förenta staterna, 80122
- AdventHealth Littleton
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Lone Tree, Colorado, Förenta staterna, 80124
- Sky Ridge Medical Center
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Lone Tree, Colorado, Förenta staterna, 80124
- Rocky Mountain Cancer Centers-Sky Ridge
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Longmont, Colorado, Förenta staterna, 80501
- Longmont United Hospital
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Longmont, Colorado, Förenta staterna, 80501
- Rocky Mountain Cancer Centers-Longmont
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Loveland, Colorado, Förenta staterna, 80539
- Banner North Colorado Medical Center - Loveland Campus
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Parker, Colorado, Förenta staterna, 80138
- Rocky Mountain Cancer Centers-Parker
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Parker, Colorado, Förenta staterna, 80138
- AdventHealth Parker
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Pueblo, Colorado, Förenta staterna, 81004
- Saint Mary Corwin Medical Center
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Pueblo, Colorado, Förenta staterna, 81008
- Rocky Mountain Cancer Centers - Pueblo
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Wheat Ridge, Colorado, Förenta staterna, 80401
- Intermountain Health Lutheran Hospital
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Connecticut
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Hartford, Connecticut, Förenta staterna, 06105
- Smilow Cancer Hospital Care Center at Saint Francis
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New Britain, Connecticut, Förenta staterna, 06050
- The Hospital of Central Connecticut
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Delaware
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Lewes, Delaware, Förenta staterna, 19958
- Beebe Medical Center
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Newark, Delaware, Förenta staterna, 19713
- Helen F Graham Cancer Center
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Newark, Delaware, Förenta staterna, 19713
- Delaware Clinical and Laboratory Physicians PA
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Newark, Delaware, Förenta staterna, 19713
- Medical Oncology Hematology Consultants PA
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Newark, Delaware, Förenta staterna, 19718
- Christiana Care Health System-Christiana Hospital
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Rehoboth Beach, Delaware, Förenta staterna, 19971
- Beebe Health Campus
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Seaford, Delaware, Förenta staterna, 19973
- TidalHealth Nanticoke / Allen Cancer Center
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Wilmington, Delaware, Förenta staterna, 19801
- Christiana Care Health System-Wilmington Hospital
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Florida
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Miami, Florida, Förenta staterna, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
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Georgia
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Atlanta, Georgia, Förenta staterna, 30322
- Emory University Hospital/Winship Cancer Institute
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Atlanta, Georgia, Förenta staterna, 30342
- Emory Saint Joseph's Hospital
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Decatur, Georgia, Förenta staterna, 30033
- Atlanta VA Medical Center
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Macon, Georgia, Förenta staterna, 31201
- Atrium Health Navicent
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Savannah, Georgia, Förenta staterna, 31405
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
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Idaho
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Boise, Idaho, Förenta staterna, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Illinois
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Aurora, Illinois, Förenta staterna, 60504
- Rush-Copley Medical Center
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Bloomington, Illinois, Förenta staterna, 61704
- Illinois CancerCare-Bloomington
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Bloomington, Illinois, Förenta staterna, 61701
- OSF Saint Joseph Medical Center
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Canton, Illinois, Förenta staterna, 61520
- Illinois CancerCare-Canton
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Carthage, Illinois, Förenta staterna, 62321
- Illinois CancerCare-Carthage
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Centralia, Illinois, Förenta staterna, 62801
- Centralia Oncology Clinic
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Chicago, Illinois, Förenta staterna, 60611
- Northwestern University
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Danville, Illinois, Förenta staterna, 61832
- Carle at The Riverfront
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Decatur, Illinois, Förenta staterna, 62526
- Decatur Memorial Hospital
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Decatur, Illinois, Förenta staterna, 62526
- Cancer Care Specialists of Illinois - Decatur
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Decatur, Illinois, Förenta staterna, 62526
- Heartland Cancer Research NCORP
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Effingham, Illinois, Förenta staterna, 62401
- Crossroads Cancer Center
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Effingham, Illinois, Förenta staterna, 62401
- Carle Physician Group-Effingham
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Eureka, Illinois, Förenta staterna, 61530
- Illinois CancerCare-Eureka
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Evanston, Illinois, Förenta staterna, 60201
- NorthShore University HealthSystem-Evanston Hospital
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Galesburg, Illinois, Förenta staterna, 61401
- Illinois CancerCare-Galesburg
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Glenview, Illinois, Förenta staterna, 60026
- NorthShore University HealthSystem-Glenbrook Hospital
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Harvey, Illinois, Förenta staterna, 60426
- Ingalls Memorial Hospital
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Highland Park, Illinois, Förenta staterna, 60035
- NorthShore University HealthSystem-Highland Park Hospital
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Highland Park, Illinois, Förenta staterna, 60035
- Hematology Oncology Associates of Illinois-Highland Park
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Kankakee, Illinois, Förenta staterna, 60901
- Presence Saint Mary's Hospital
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Kewanee, Illinois, Förenta staterna, 61443
- Illinois CancerCare-Kewanee Clinic
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Libertyville, Illinois, Förenta staterna, 60048
- AMG Libertyville - Oncology
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Macomb, Illinois, Förenta staterna, 61455
- Illinois CancerCare-Macomb
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Mattoon, Illinois, Förenta staterna, 61938
- Carle Physician Group-Mattoon/Charleston
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Moline, Illinois, Förenta staterna, 61265
- Garneau, Stewart C MD (UIA Investigator)
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Moline, Illinois, Förenta staterna, 61265
- Porubcin, Michael MD (UIA Investigator)
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Moline, Illinois, Förenta staterna, 61265
- Spector, David MD (UIA Investigator)
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Moline, Illinois, Förenta staterna, 61265
- Trinity Medical Center
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Monmouth, Illinois, Förenta staterna, 61462
- Illinois CancerCare-Monmouth
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Niles, Illinois, Förenta staterna, 60714
- Illinois Cancer Specialists-Niles
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Normal, Illinois, Förenta staterna, 61761
- Carle Cancer Institute Normal
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Ottawa, Illinois, Förenta staterna, 61350
- Illinois CancerCare-Ottawa Clinic
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Ottawa, Illinois, Förenta staterna, 61350
- Ottawa Regional Hospital and Healthcare Center
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Pekin, Illinois, Förenta staterna, 61554
- Illinois CancerCare-Pekin
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Pekin, Illinois, Förenta staterna, 61554
- OSF Saint Francis Radiation Oncology at Pekin
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Peoria, Illinois, Förenta staterna, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Förenta staterna, 61637
- OSF Saint Francis Medical Center
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Peoria, Illinois, Förenta staterna, 61615
- Illinois CancerCare-Peoria
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Peoria, Illinois, Förenta staterna, 61614
- Proctor Hospital
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Peru, Illinois, Förenta staterna, 61354
- Illinois CancerCare-Peru
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Peru, Illinois, Förenta staterna, 61354
- Illinois Valley Hospital
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Princeton, Illinois, Förenta staterna, 61356
- Illinois CancerCare-Princeton
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Rockford, Illinois, Förenta staterna, 61104
- Swedish American Hospital
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Rockford, Illinois, Förenta staterna, 61114
- UW Health Carbone Cancer Center Rockford
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Skokie, Illinois, Förenta staterna, 60076
- Hematology Oncology Associates of Illinois - Skokie
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Springfield, Illinois, Förenta staterna, 62781
- Springfield Memorial Hospital
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Urbana, Illinois, Förenta staterna, 61801
- Carle Cancer Center
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Urbana, Illinois, Förenta staterna, 61801
- The Carle Foundation Hospital
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Yorkville, Illinois, Förenta staterna, 60560
- Rush-Copley Healthcare Center
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Indiana
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Bloomington, Indiana, Förenta staterna, 47408
- IU Health Bloomington
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Elkhart, Indiana, Förenta staterna, 46515
- Elkhart General Hospital
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Elkhart, Indiana, Förenta staterna, 46514
- Michiana Hematology Oncology PC-Elkhart
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Elkhart, Indiana, Förenta staterna, 46514-2098
- Elkhart Clinic
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Indianapolis, Indiana, Förenta staterna, 46202
- Indiana University/Melvin and Bren Simon Cancer Center
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Indianapolis, Indiana, Förenta staterna, 46219
- IU Health Central Indiana Cancer Centers-East
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Kokomo, Indiana, Förenta staterna, 46904
- Community Howard Regional Health
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La Porte, Indiana, Förenta staterna, 46350
- IU Health La Porte Hospital
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Michigan City, Indiana, Förenta staterna, 46360
- Franciscan Saint Anthony Health-Michigan City
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Michigan City, Indiana, Förenta staterna, 46360
- Woodland Cancer Care Center
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Mishawaka, Indiana, Förenta staterna, 46545
- Michiana Hematology Oncology PC-Mishawaka
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Mishawaka, Indiana, Förenta staterna, 46545
- Saint Joseph Regional Medical Center-Mishawaka
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Muncie, Indiana, Förenta staterna, 47303
- IU Health Ball Memorial Hospital
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Plymouth, Indiana, Förenta staterna, 46563
- Michiana Hematology Oncology PC-Plymouth
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South Bend, Indiana, Förenta staterna, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, Förenta staterna, 46628
- Northern Indiana Cancer Research Consortium
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South Bend, Indiana, Förenta staterna, 46617
- South Bend Clinic
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Westville, Indiana, Förenta staterna, 46391
- Michiana Hematology Oncology PC-Westville
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Iowa
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Ames, Iowa, Förenta staterna, 50010
- Mary Greeley Medical Center
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Ames, Iowa, Förenta staterna, 50010
- McFarland Clinic - Ames
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Bettendorf, Iowa, Förenta staterna, 52722
- Constantinou, Costas L MD (UIA Investigator)
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Boone, Iowa, Förenta staterna, 50036
- McFarland Clinic - Boone
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Cedar Rapids, Iowa, Förenta staterna, 52403
- Mercy Hospital
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Cedar Rapids, Iowa, Förenta staterna, 52403
- Oncology Associates at Mercy Medical Center
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Clive, Iowa, Förenta staterna, 50325
- Mercy Cancer Center-West Lakes
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Clive, Iowa, Förenta staterna, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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Des Moines, Iowa, Förenta staterna, 50309
- Iowa Methodist Medical Center
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Des Moines, Iowa, Förenta staterna, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, Förenta staterna, 50316
- Iowa Lutheran Hospital
-
Des Moines, Iowa, Förenta staterna, 50309
- Iowa-Wide Oncology Research Coalition NCORP
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Des Moines, Iowa, Förenta staterna, 50309
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
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Des Moines, Iowa, Förenta staterna, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
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Jefferson, Iowa, Förenta staterna, 50129
- McFarland Clinic - Jefferson
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Marshalltown, Iowa, Förenta staterna, 50158
- McFarland Clinic - Marshalltown
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Mason City, Iowa, Förenta staterna, 50401
- Mercy Medical Center - North Iowa
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Sioux City, Iowa, Förenta staterna, 51101
- Siouxland Regional Cancer Center
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Sioux City, Iowa, Förenta staterna, 51102
- Mercy Medical Center-Sioux City
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Sioux City, Iowa, Förenta staterna, 51104
- Saint Luke's Regional Medical Center
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West Des Moines, Iowa, Förenta staterna, 50266
- Mercy Medical Center-West Lakes
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Kansas
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Chanute, Kansas, Förenta staterna, 66720
- Cancer Center of Kansas - Chanute
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Dodge City, Kansas, Förenta staterna, 67801
- Cancer Center of Kansas - Dodge City
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El Dorado, Kansas, Förenta staterna, 67042
- Cancer Center of Kansas - El Dorado
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Fort Scott, Kansas, Förenta staterna, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, Förenta staterna, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, Förenta staterna, 67068
- Cancer Center of Kansas-Kingman
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Lawrence, Kansas, Förenta staterna, 66044
- Lawrence Memorial Hospital
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Liberal, Kansas, Förenta staterna, 67905
- Cancer Center of Kansas-Liberal
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Manhattan, Kansas, Förenta staterna, 66502
- Cancer Center of Kansas-Manhattan
-
McPherson, Kansas, Förenta staterna, 67460
- Cancer Center of Kansas - McPherson
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Newton, Kansas, Förenta staterna, 67114
- Cancer Center of Kansas - Newton
-
Parsons, Kansas, Förenta staterna, 67357
- Cancer Center of Kansas - Parsons
-
Pratt, Kansas, Förenta staterna, 67124
- Cancer Center of Kansas - Pratt
-
Salina, Kansas, Förenta staterna, 67401
- Cancer Center of Kansas - Salina
-
Wellington, Kansas, Förenta staterna, 67152
- Cancer Center of Kansas - Wellington
-
Wichita, Kansas, Förenta staterna, 67214
- Ascension Via Christi Hospitals Wichita
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Wichita, Kansas, Förenta staterna, 67208
- Cancer Center of Kansas-Wichita Medical Arts Tower
-
Wichita, Kansas, Förenta staterna, 67214
- Cancer Center of Kansas - Wichita
-
Wichita, Kansas, Förenta staterna, 67208
- Associates In Womens Health
-
Wichita, Kansas, Förenta staterna, 67214
- Wichita NCI Community Oncology Research Program
-
Winfield, Kansas, Förenta staterna, 67156
- Cancer Center of Kansas - Winfield
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Louisiana
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Baton Rouge, Louisiana, Förenta staterna, 70809
- Ochsner Health Center-Summa
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New Orleans, Louisiana, Förenta staterna, 70121
- Ochsner Medical Center Jefferson
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New Orleans, Louisiana, Förenta staterna, 70115
- Ochsner Baptist Medical Center
-
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Maine
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York Village, Maine, Förenta staterna, 03909
- York Hospital
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Maryland
-
Baltimore, Maryland, Förenta staterna, 21204
- Greater Baltimore Medical Center
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Elkton, Maryland, Förenta staterna, 21921
- Christiana Care - Union Hospital
-
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Michigan
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Adrian, Michigan, Förenta staterna, 49221
- Bixby Medical Center
-
Adrian, Michigan, Förenta staterna, 49221
- Hickman Cancer Center
-
Ann Arbor, Michigan, Förenta staterna, 48106
- Michigan Cancer Research Consortium NCORP
-
Ann Arbor, Michigan, Förenta staterna, 48106
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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Dearborn, Michigan, Förenta staterna, 48124
- Corewell Health Dearborn Hospital
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Detroit, Michigan, Förenta staterna, 48236
- Henry Ford Health Saint John Hospital
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Escanaba, Michigan, Förenta staterna, 49829
- OSF Saint Francis Hospital and Medical Group
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Flint, Michigan, Förenta staterna, 48503
- Hurley Medical Center
-
Flint, Michigan, Förenta staterna, 48503
- Genesys Hurley Cancer Institute
-
Jackson, Michigan, Förenta staterna, 49201
- Allegiance Health
-
Kalamazoo, Michigan, Förenta staterna, 49007
- West Michigan Cancer Center
-
Kalamazoo, Michigan, Förenta staterna, 49007
- Bronson Methodist Hospital
-
Kalamazoo, Michigan, Förenta staterna, 49048
- Beacon Kalamazoo
-
Lansing, Michigan, Förenta staterna, 48912
- University of Michigan Health - Sparrow Lansing
-
Livonia, Michigan, Förenta staterna, 48154
- Trinity Health Saint Mary Mercy Livonia Hospital
-
Monroe, Michigan, Förenta staterna, 48162
- Mercy Memorial Hospital
-
Monroe, Michigan, Förenta staterna, 48162
- Toledo Clinic Cancer Centers-Monroe
-
Pontiac, Michigan, Förenta staterna, 48341
- Trinity Health Saint Joseph Mercy Oakland Hospital
-
Port Huron, Michigan, Förenta staterna, 48060
- Lake Huron Medical Center
-
Saginaw, Michigan, Förenta staterna, 48601
- MyMichigan Medical Center Saginaw
-
Saint Joseph, Michigan, Förenta staterna, 49085
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
-
Saint Joseph, Michigan, Förenta staterna, 49085
- Corewell Health Lakeland Hospitals - Saint Joseph Hospital
-
Warren, Michigan, Förenta staterna, 48093
- Henry Ford Health Warren Hospital
-
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Minnesota
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Bemidji, Minnesota, Förenta staterna, 56601
- Sanford Joe Lueken Cancer Center
-
Burnsville, Minnesota, Förenta staterna, 55337
- Fairview Ridges Hospital
-
Coon Rapids, Minnesota, Förenta staterna, 55433
- Mercy Hospital
-
Edina, Minnesota, Förenta staterna, 55435
- Fairview Southdale Hospital
-
Fridley, Minnesota, Förenta staterna, 55432
- Unity Hospital
-
Hutchinson, Minnesota, Förenta staterna, 55350
- Hutchinson Area Health Care
-
Maplewood, Minnesota, Förenta staterna, 55109
- Saint John's Hospital - Healtheast
-
Maplewood, Minnesota, Förenta staterna, 55109
- Minnesota Oncology Hematology PA-Maplewood
-
Minneapolis, Minnesota, Förenta staterna, 55415
- Hennepin County Medical Center
-
Minneapolis, Minnesota, Förenta staterna, 55407
- Abbott-Northwestern Hospital
-
New Ulm, Minnesota, Förenta staterna, 56073
- New Ulm Medical Center
-
Robbinsdale, Minnesota, Förenta staterna, 55422
- North Memorial Medical Health Center
-
Saint Louis Park, Minnesota, Förenta staterna, 55416
- Park Nicollet Clinic - Saint Louis Park
-
Saint Louis Park, Minnesota, Förenta staterna, 55416
- Metro Minnesota Community Oncology Research Consortium
-
Saint Paul, Minnesota, Förenta staterna, 55101
- Regions Hospital
-
Saint Paul, Minnesota, Förenta staterna, 55102
- United Hospital
-
Shakopee, Minnesota, Förenta staterna, 55379
- Saint Francis Regional Medical Center
-
Stillwater, Minnesota, Förenta staterna, 55082
- Lakeview Hospital
-
Waconia, Minnesota, Förenta staterna, 55387
- Ridgeview Medical Center
-
Willmar, Minnesota, Förenta staterna, 56201
- Rice Memorial Hospital
-
Woodbury, Minnesota, Förenta staterna, 55125
- Minnesota Oncology Hematology PA-Woodbury
-
-
Missouri
-
Cape Girardeau, Missouri, Förenta staterna, 63703
- Saint Francis Medical Center
-
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Nebraska
-
Lincoln, Nebraska, Förenta staterna, 68510
- Nebraska Cancer Research Center
-
Omaha, Nebraska, Förenta staterna, 68124
- Alegent Health Bergan Mercy Medical Center
-
Omaha, Nebraska, Förenta staterna, 68122
- Alegent Health Immanuel Medical Center
-
Omaha, Nebraska, Förenta staterna, 68130
- Alegent Health Lakeside Hospital
-
Omaha, Nebraska, Förenta staterna, 68106
- Missouri Valley Cancer Consortium
-
-
Nevada
-
Henderson, Nevada, Förenta staterna, 89052
- Comprehensive Cancer Centers of Nevada - Henderson
-
Henderson, Nevada, Förenta staterna, 89052
- Cancer and Blood Specialists-Henderson
-
Henderson, Nevada, Förenta staterna, 89052
- Las Vegas Cancer Center-Henderson
-
Henderson, Nevada, Förenta staterna, 89074
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
-
Henderson, Nevada, Förenta staterna, 89074
- Oncology Las Vegas - Henderson
-
Las Vegas, Nevada, Förenta staterna, 89106
- Radiation Oncology Centers of Nevada Central
-
Las Vegas, Nevada, Förenta staterna, 89119
- Radiation Oncology Centers of Nevada Southeast
-
Las Vegas, Nevada, Förenta staterna, 89128
- Comprehensive Cancer Centers of Nevada - Northwest
-
Las Vegas, Nevada, Förenta staterna, 89144
- Comprehensive Cancer Centers of Nevada-Summerlin
-
Las Vegas, Nevada, Förenta staterna, 89148
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Förenta staterna, 89169
- Comprehensive Cancer Centers of Nevada - Central Valley
-
Las Vegas, Nevada, Förenta staterna, 89102
- University Medical Center of Southern Nevada
-
Las Vegas, Nevada, Förenta staterna, 89106
- Cancer and Blood Specialists-Shadow
-
Las Vegas, Nevada, Förenta staterna, 89109
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
-
Las Vegas, Nevada, Förenta staterna, 89113
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
-
Las Vegas, Nevada, Förenta staterna, 89121
- Cancer Therapy and Integrative Medicine
-
Las Vegas, Nevada, Förenta staterna, 89128
- Cancer and Blood Specialists-Tenaya
-
Las Vegas, Nevada, Förenta staterna, 89128
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
-
Las Vegas, Nevada, Förenta staterna, 89148-2405
- Las Vegas Cancer Center-Medical Center
-
Las Vegas, Nevada, Förenta staterna, 89149
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
-
Las Vegas, Nevada, Förenta staterna, 89120
- Nevada Cancer Research Foundation NCORP
-
Las Vegas, Nevada, Förenta staterna, 89128
- Oncology Las Vegas - Tenaya
-
Las Vegas, Nevada, Förenta staterna, 89183
- OptumCare Cancer Care at Fort Apache
-
-
New Jersey
-
Camden, New Jersey, Förenta staterna, 08103
- Cooper Hospital University Medical Center
-
East Orange, New Jersey, Förenta staterna, 07018-1095
- Veterans Adminstration New Jersey Health Care System
-
Hackensack, New Jersey, Förenta staterna, 07601
- Hackensack University Medical Center
-
Long Branch, New Jersey, Förenta staterna, 07740
- Monmouth Medical Center
-
Morristown, New Jersey, Förenta staterna, 07960
- Morristown Medical Center
-
Mount Holly, New Jersey, Förenta staterna, 08060
- Virtua Memorial
-
Newark, New Jersey, Förenta staterna, 07101
- Rutgers New Jersey Medical School
-
Summit, New Jersey, Förenta staterna, 07902
- Overlook Hospital
-
Vineland, New Jersey, Förenta staterna, 08360
- Inspira Medical Center Vineland
-
-
New Mexico
-
Albuquerque, New Mexico, Förenta staterna, 87106
- University of New Mexico Cancer Center
-
Las Cruces, New Mexico, Förenta staterna, 88011
- Memorial Medical Center-Las Cruces
-
-
New York
-
Stony Brook, New York, Förenta staterna, 11794
- Stony Brook University Medical Center
-
The Bronx, New York, Förenta staterna, 10467
- Montefiore Medical Center - Moses Campus
-
The Bronx, New York, Förenta staterna, 10461
- Montefiore Medical Center-Weiler Hospital
-
White Plains, New York, Förenta staterna, 10601
- Dickstein Cancer Treatment Center
-
-
North Dakota
-
Fargo, North Dakota, Förenta staterna, 58122
- Sanford Roger Maris Cancer Center
-
Fargo, North Dakota, Förenta staterna, 58122
- Sanford Broadway Medical Center
-
-
Ohio
-
Akron, Ohio, Förenta staterna, 44304
- Summa Health System - Akron Campus
-
Belpre, Ohio, Förenta staterna, 45714
- Strecker Cancer Center-Belpre
-
Bowling Green, Ohio, Förenta staterna, 43402
- Toledo Clinic Cancer Centers-Bowling Green
-
Canton, Ohio, Förenta staterna, 44708
- Cleveland Clinic Mercy Hospital
-
Chillicothe, Ohio, Förenta staterna, 45601
- Adena Regional Medical Center
-
Cleveland, Ohio, Förenta staterna, 44106
- Case Western Reserve University
-
Cleveland, Ohio, Förenta staterna, 44109
- MetroHealth Medical Center
-
Columbus, Ohio, Förenta staterna, 43214
- Riverside Methodist Hospital
-
Columbus, Ohio, Förenta staterna, 43219
- The Mark H Zangmeister Center
-
Columbus, Ohio, Förenta staterna, 43214
- Columbus Oncology and Hematology Associates Inc
-
Columbus, Ohio, Förenta staterna, 43228
- Doctors Hospital
-
Columbus, Ohio, Förenta staterna, 43215
- Grant Medical Center
-
Columbus, Ohio, Förenta staterna, 43222
- Mount Carmel Health Center West
-
Columbus, Ohio, Förenta staterna, 43215
- Columbus NCI Community Oncology Research Program
-
Delaware, Ohio, Förenta staterna, 43015
- Delaware Health Center-Grady Cancer Center
-
Delaware, Ohio, Förenta staterna, 43015
- Delaware Radiation Oncology
-
Delaware, Ohio, Förenta staterna, 43015
- Grady Memorial Hospital
-
Lancaster, Ohio, Förenta staterna, 43130
- Fairfield Medical Center
-
Lima, Ohio, Förenta staterna, 45801
- Saint Rita's Medical Center
-
Lima, Ohio, Förenta staterna, 45804
- Lima Memorial Hospital
-
Marietta, Ohio, Förenta staterna, 45750
- Marietta Memorial Hospital
-
Maumee, Ohio, Förenta staterna, 43537
- Toledo Clinic Cancer Centers-Maumee
-
Mount Vernon, Ohio, Förenta staterna, 43050
- Knox Community Hospital
-
Newark, Ohio, Förenta staterna, 43055
- Licking Memorial Hospital
-
Newark, Ohio, Förenta staterna, 43055
- Newark Radiation Oncology
-
Oregon, Ohio, Förenta staterna, 43616
- Saint Charles Hospital
-
Oregon, Ohio, Förenta staterna, 43616
- Toledo Clinic Cancer Centers-Oregon
-
Portsmouth, Ohio, Förenta staterna, 45662
- Southern Ohio Medical Center
-
Springfield, Ohio, Förenta staterna, 45504
- Springfield Regional Medical Center
-
Sylvania, Ohio, Förenta staterna, 43560
- ProMedica Flower Hospital
-
Tiffin, Ohio, Förenta staterna, 44883
- Mercy Hospital of Tiffin
-
Toledo, Ohio, Förenta staterna, 43606
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
-
Toledo, Ohio, Förenta staterna, 43623
- Mercy Health - Saint Anne Hospital
-
Toledo, Ohio, Förenta staterna, 43623
- Toledo Clinic Cancer Centers-Toledo
-
Toledo, Ohio, Förenta staterna, 43614
- University of Toledo
-
Toledo, Ohio, Förenta staterna, 43617
- Toledo Community Hospital Oncology Program CCOP
-
Toledo, Ohio, Förenta staterna, 43608
- Mercy Health - Saint Vincent Hospital
-
Wauseon, Ohio, Förenta staterna, 43567
- Fulton County Health Center
-
Westerville, Ohio, Förenta staterna, 43081
- Saint Ann's Hospital
-
Zanesville, Ohio, Förenta staterna, 43701
- Genesis Healthcare System Cancer Care Center
-
-
Pennsylvania
-
Bryn Mawr, Pennsylvania, Förenta staterna, 19010
- Bryn Mawr Hospital
-
Danville, Pennsylvania, Förenta staterna, 17822
- Geisinger Medical Center
-
Doylestown, Pennsylvania, Förenta staterna, 18901
- Doylestown Hospital
-
Erie, Pennsylvania, Förenta staterna, 16505
- UPMC Hillman Cancer Center Erie
-
Hazleton, Pennsylvania, Förenta staterna, 18201
- Geisinger Medical Center-Cancer Center Hazleton
-
Hershey, Pennsylvania, Förenta staterna, 17033-0850
- Penn State Milton S Hershey Medical Center
-
Lancaster, Pennsylvania, Förenta staterna, 17602
- Lancaster General Hospital
-
Lewisburg, Pennsylvania, Förenta staterna, 17837
- Geisinger Medical Oncology-Lewisburg
-
Paoli, Pennsylvania, Förenta staterna, 19301
- Paoli Memorial Hospital
-
Philadelphia, Pennsylvania, Förenta staterna, 19107
- Thomas Jefferson University Hospital
-
Philadelphia, Pennsylvania, Förenta staterna, 19141
- Einstein Medical Center Philadelphia
-
Pottsville, Pennsylvania, Förenta staterna, 17901
- Geisinger Cancer Services-Pottsville
-
Sayre, Pennsylvania, Förenta staterna, 18840
- Guthrie Medical Group PC-Robert Packer Hospital
-
State College, Pennsylvania, Förenta staterna, 16801
- Geisinger Medical Group
-
Wilkes-Barre, Pennsylvania, Förenta staterna, 18711
- Geisinger Wyoming Valley/Henry Cancer Center
-
Wynnewood, Pennsylvania, Förenta staterna, 19096
- Lankenau Medical Center
-
Wynnewood, Pennsylvania, Förenta staterna, 19096
- Main Line Health NCORP
-
York, Pennsylvania, Förenta staterna, 17403
- WellSpan Health-York Hospital
-
-
South Dakota
-
Sioux Falls, South Dakota, Förenta staterna, 57117-5134
- Sanford USD Medical Center - Sioux Falls
-
Sioux Falls, South Dakota, Förenta staterna, 57104
- Sanford Cancer Center Oncology Clinic
-
-
Texas
-
Austin, Texas, Förenta staterna, 78701
- Dell Seton Medical Center at The University of Texas
-
San Antonio, Texas, Förenta staterna, 78229
- University of Texas Health Science Center at San Antonio
-
Tyler, Texas, Förenta staterna, 75708
- University of Texas Health Science Center at Tyler
-
-
Virginia
-
Fredericksburg, Virginia, Förenta staterna, 22401
- Fredericksburg Oncology Inc
-
-
West Virginia
-
Charleston, West Virginia, Förenta staterna, 25304
- Vandalia Health/CAMC Institute for Academic Medicine
-
Morgantown, West Virginia, Förenta staterna, 26506
- West Virginia University Healthcare
-
Wheeling, West Virginia, Förenta staterna, 26003
- Wheeling Hospital/Schiffler Cancer Center
-
-
Wisconsin
-
Chippewa Falls, Wisconsin, Förenta staterna, 54729
- Marshfield Clinic-Chippewa Center
-
Eau Claire, Wisconsin, Förenta staterna, 54701
- HSHS Sacred Heart Hospital
-
Eau Claire, Wisconsin, Förenta staterna, 54701
- Marshfield Clinic Cancer Center at Sacred Heart
-
Green Bay, Wisconsin, Förenta staterna, 54301
- Saint Vincent Hospital Cancer Center Green Bay
-
Green Bay, Wisconsin, Förenta staterna, 54303
- Saint Vincent Hospital Cancer Center at Saint Mary's
-
Green Bay, Wisconsin, Förenta staterna, 54301-3526
- Green Bay Oncology at Saint Vincent Hospital
-
Johnson Creek, Wisconsin, Förenta staterna, 53038
- University of Wisconsin Carbone Cancer Center - Johnson Creek
-
Madison, Wisconsin, Förenta staterna, 53792
- University of Wisconsin Carbone Cancer Center - University Hospital
-
Madison, Wisconsin, Förenta staterna, 53715
- SSM Health Dean Medical Group - South Madison Campus
-
Manitowoc, Wisconsin, Förenta staterna, 54221
- Holy Family Memorial Hospital
-
Marinette, Wisconsin, Förenta staterna, 54143
- Bay Area Medical Center
-
Marshfield, Wisconsin, Förenta staterna, 54449
- Marshfield Medical Center-Marshfield
-
Marshfield, Wisconsin, Förenta staterna, 54449
- Marshfield Medical Center
-
Milwaukee, Wisconsin, Förenta staterna, 53226
- Medical College of Wisconsin
-
Minocqua, Wisconsin, Förenta staterna, 54548
- Marshfield Medical Center - Minocqua
-
New Richmond, Wisconsin, Förenta staterna, 54017
- Cancer Center of Western Wisconsin
-
Oconomowoc, Wisconsin, Förenta staterna, 53066
- ProHealth Oconomowoc Memorial Hospital
-
Oconto Falls, Wisconsin, Förenta staterna, 54154
- Saint Vincent Hospital Cancer Center at Oconto Falls
-
Rhinelander, Wisconsin, Förenta staterna, 54501
- Saint Mary's Hospital
-
Rhinelander, Wisconsin, Förenta staterna, 54501
- Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
-
Rice Lake, Wisconsin, Förenta staterna, 54868
- Marshfield Medical Center-Rice Lake
-
Sheboygan, Wisconsin, Förenta staterna, 53081
- HSHS Saint Nicholas Hospital
-
Stevens Point, Wisconsin, Förenta staterna, 54481
- Aspirus Cancer Care - Stevens Point
-
Waukesha, Wisconsin, Förenta staterna, 53188
- ProHealth Waukesha Memorial Hospital
-
Wausau, Wisconsin, Förenta staterna, 54401
- Marshfield Clinic-Wausau Center
-
Weston, Wisconsin, Förenta staterna, 54476
- Marshfield Medical Center - Weston
-
Wisconsin Rapids, Wisconsin, Förenta staterna, 54494
- Aspirus Cancer Care - Wisconsin Rapids
-
Wisconsin Rapids, Wisconsin, Förenta staterna, 54494
- Marshfield Clinic - Wisconsin Rapids Center
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Criteria:
-
Tumor with a sensitizing mutation in epidermal growth factor receptor (EGFR), defined as follows:
- EGFR mutation testing of tumor has been performed and did not demonstrate an EGFR tyrosine kinase inhibitor sensitizing mutation; at minimum, testing for EGFR exon 19 deletion and exon 21 L858R mutations must have been included; OR
- EGFR mutation testing has been attempted and is inconclusive (for example, due to lack of sufficient deoxyribonucleic acid [DNA] yield); OR
- EGFR mutation status is unknown but tumor is positive for at least one alternative driver mutation, i.e: Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation, v-raf murine sarcoma viral oncogene homolog B (BRAF) mutation, human epidermal growth factor receptor 2 (HER2) mutation, ret proto-oncogene (RET) rearrangement/fusion, or one not listed following approval by the study chair prior to registration
Inclusion Criteria:
- INCLUSION CRITERIA STEP 1:
- Cytologically or histologically confirmed non-small cell lung carcinoma (NSCLC)
- Predominant non-squamous histology (patients with NSCLC not otherwise specified [NOS] are eligible); mixed tumors will be categorized by the predominant cell type; if small cell elements are present the patient is ineligible
- Stage IV disease (includes M1a, M1b, or recurrent disease), according to the 7th edition of the lung cancer TNM classification system
- Patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 criteria; baseline measurements and evaluation of all sites of disease must be obtained within 4 weeks prior to registration
- Prior to registration, the investigator/site must confirm that sufficient pathology material representative of patient's cancer is available for submission for MET immunohistochemical (IHC) testing
- Patients must have received one or two lines of prior chemotherapy (first line platinum-doublet based chemotherapy plus switch maintenance chemotherapy counts as one line of therapy); prior adjuvant chemotherapy for early stage disease does not count as one line of therapy if 12 months or greater elapsed between completion of adjuvant therapy and initiation of first-line systemic therapy; if less than 12 months elapsed, adjuvant chemotherapy counts as one line of therapy
- Any prior chemotherapy (based on administration schedule) must have been completed in greater than or equal to the time frames specified in the protocol
- Patients must have discontinued treatment with any other type of investigational agent >= 4 weeks prior to registration
- Patients must have recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
- Patients with no known brain metastasis at baseline must have baseline brain imaging within 12 weeks prior to study registration not demonstrating brain metastases; patients with brain metastases at baseline must have baseline brain imagining within 4 weeks prior to study registration and meet all of the specific criteria for brain mets listed in the protocol
- Radiation related toxicities must have resolved to =< grade 1 prior to registration
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-2
- Patients must have an anticipated life expectancy greater than 3 months
- Acceptable bone marrow, renal and hepatic function within 2 weeks prior to registration as defined in the protocol
- Patients must have corrected QT interval calculated by the Fridericia formula (QTcF) =< 500 ms within 28 days before registration
- Patients must be able to swallow tablets
- INCLUSION CRITERIA STEP 2:
- Patients must have met all eligibility requirements for Step 1 at time of registration to Step 1 to be eligible for Step 2
- Patients must have radiographic progressive disease per RECIST v1.1 criteria after >= 2 courses of therapy on Arm A or Arm B
- Patients must be registered to Step 2 within 4 weeks of the last dose of treatment administration from Step 1
- Patients must have an ECOG performance status between 0-2
- Patients must have recovered to baseline (pre-Step 1) or CTCAE version 4.0 <= grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant AEs
Exclusion Criteria:
-
EXCLUSION CRITERIA STEP 1:
-
Patients without sufficient pathology material representative of the patient's cancer (tumor block or 10 unstained slides)
-
Prior erlotinib, other EGFR tyrosine kinase inhibitor therapy, vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor therapy, Met tyrosine kinase inhibitor therapy, or Met monoclonal antibody (MetMAb); prior antibody therapy such as bevacizumab or cetuximab is allowed with a washout period depending on dosing interval and investigational nature
-
Prior radiation therapy to the thoracic cavity, abdomen, or pelvis within 3 months prior to registration, to bone or brain metastasis within 14 days prior to registration, or to any other site within 28 days prior to registration
-
History of the following: Clinically-significant gastrointestinal (GI) bleeding within 6 months prior to registration; Hemoptysis of >= 0.5 teaspoon (2.5 mL) of red blood within 3 months prior to registration; Any other signs indicative of pulmonary hemorrhage within 3 months prior to registration
-
Radiographic or other evidence of the following within 28 days prior to registration: • Tumor invading the GI tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor; Cavitating pulmonary lesion(s); Tumor in contact with, invading or encasing any major blood vessels
-
Psychiatric illness/social situations that would limit compliance with study requirements
-
History of major thrombotic events (deep vein thrombosis [DVT] or pulmonary embolism [PE]) within 6 months prior to registration
-
Concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, low molecular weight heparin (LMWH), thrombin or Factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel). (low dose aspirin [=< 81 mg/day] and prophylactic LMWH are permitted)
-
Concomitant treatment of strong cytochrome P450 3A4 (CYP3A4) inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. John's wort)
-
Cardiovascular disorders including: Congestive heart failure (CHF): New York Heart Association (NYHA) class III (moderate) or class IV (severe) at the time of screening;
-
Concurrent uncontrolled hypertension; Any history of congenital long QT syndrome; Any of the following within 6 months prior to registration:
- Unstable angina pectoris
- Clinically-significant cardiac arrhythmias
- Stroke (including transient ischemic attack [TIA], or other ischemic event)
- Myocardial infarction
-
GI disorders particularly those associated with a high risk of perforation or fistula formation specified in the protocol
-
Other disorders associated with a high risk of fistula formation including percutaneous endoscopic gastrostomy (PEG) tube placement within 3 months prior to registration
-
Uncontrolled, significant, intercurrent or recent illness
-
Prior malignancy within 2 years prior to registration which required systemic treatment or is currently active
-
Pregnant or breast-feeding
-
Patients with known human immunodeficiency virus (HIV) disease taking antiretroviral therapy
-
Known chronic active hepatitis B
-
EXCLUSION CRITERIA (STEP 2):
-
Intervening anticancer treatment or major surgical procedure(s) between Step 1 and Step 2, except palliative radiation to the bone finishing >= 2 weeks prior to registration to Step 2
-
Central nervous system (CNS) progression; patients with stable CNS disease are allowed
-
Intercurrent illness or disease complication that the investigator believes would limit the ability to safely tolerate the combination of erlotinib and cabozantinib
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
Andra namn:
|
|
Experimentell: 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
Andra namn:
|
|
Experimentell: 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
Andra namn:
Given PO
Andra namn:
|
|
Experimentell: 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
Andra namn:
Given PO
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Progression-free Survival (PFS)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Andel patienter med värsta grad av toxicitet av grad 3 eller högre
Tidsram: Bedöms var 4:e vecka under behandlingen och i 30 dagar efter avslutad behandling
|
Bedöms var 4:e vecka under behandlingen och i 30 dagar efter avslutad behandling
|
|
|
Overall Survival (OS)
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Joel W Neal, ECOG-ACRIN Cancer Research Group
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
13 februari 2013
Primärt slutförande (Faktisk)
14 augusti 2015
Avslutad studie (Beräknad)
31 mars 2027
Studieregistreringsdatum
Först inskickad
15 oktober 2012
Först inskickad som uppfyllde QC-kriterierna
15 oktober 2012
Första postat (Beräknad)
17 oktober 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
13 november 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 november 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter plats
- Neoplasmer
- Luftvägssjukdomar
- Lungsjukdomar
- Neoplasmer i andningsvägarna
- Thoracic neoplasmer
- Lungneoplasmer
- Karcinom, bronkogent
- Bronkiella neoplasmer
- Karcinom, icke-småcellig lunga
- Heterocykliska föreningar
- Heterocykliska föreningar, 2-ring
- Heterocykliska föreningar, smältring
- Kinazoliner
- Erlotinib hydroklorid
- cabozantinib
Andra studie-ID-nummer
- NCI-2012-01938
- U10CA180820 (U.S.S. NIH-anslag/kontrakt)
- U10CA021115 (U.S.S. NIH-anslag/kontrakt)
- NCI-2012-01938 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
- ECOG-E1512
- CDR0000741879
- E1512 (Annan identifierare: CTEP)
- E1512 (Annan identifierare: ECOG-ACRIN Cancer Research Group)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .