Erlotinib cloridrato e cabozantinib-s-malato da soli o in combinazione come terapia di seconda o terza linea nel trattamento di pazienti con carcinoma polmonare non a piccole cellule in stadio IV
10 novembre 2026 aggiornato da: National Cancer Institute (NCI)
Uno studio randomizzato di fase II su Erlotinib, Cabozantinib o Erlotinib più Cabozantinib come terapia di 2a o 3a linea in pazienti con NSCLC wild-type di EGFR
This randomized phase II trial studies how well giving erlotinib hydrochloride and cabozantinib-s-malate alone or in combination works as second or third line therapy in treating patient with stage IV non-small cell lung cancer. Erlotinib hydrochloride and cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving erlotinib hydrochloride together with cabozantinib-s-malate is more effective than erlotinib hydrochloride or cabozantinib-s-malate alone in treating non-small cell lung cancer.
Panoramica dello studio
Stato
Attivo, non reclutante
Condizioni
Intervento / Trattamento
Descrizione dettagliata
PRIMARY OBJECTIVES:
I. To compare the progression-free survival (PFS) associated with patients treated with erlotinib (erlotinib hydrochloride) versus (vs) erlotinib plus cabozantinib (cabozantinib-s-malate).
II. To compare the PFS associated with patients treated with erlotinib vs cabozantinib.
SECONDARY OBJECTIVES:
I. To evaluate overall survival in the three treatment arms. II. To evaluate best objective response rate in the three treatment arms. III. To define the toxicity associated with each regimen. IV. To conduct correlative science studies that will help to select predictive biomarkers of response to therapy, including mesenchymal-epidermal transition (MET) expression and potentially other tissue biomarkers, plasma biomarkers, and bone scans.
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
ARM A (erlotinib): Patients receive erlotinib orally (PO) daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM B (cabozantinib): Patients receive cabozantinib PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM C (erlotinib+cabozantinib): Patients receive erlotinib as patients in Arm A and cabozantinib as patients in Arm B. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM Z: Patients achieving disease progression in Arm A or Arm B may receive erlotinib and cabozantinib as patients in Arm C. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
125
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Arizona
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Scottsdale, Arizona, Stati Uniti, 85259
- Mayo Clinic in Arizona
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California
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Modesto, California, Stati Uniti, 95355
- Memorial Medical Center
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Monterey, California, Stati Uniti, 93940
- Community Hospital of Monterey Peninsula
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Palo Alto, California, Stati Uniti, 94304
- VA Palo Alto Health Care System
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Palo Alto, California, Stati Uniti, 94304
- Stanford Cancer Institute Palo Alto
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Rancho Mirage, California, Stati Uniti, 92270
- Eisenhower Medical Center
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Colorado
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Aurora, Colorado, Stati Uniti, 80012
- The Medical Center of Aurora
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Boulder, Colorado, Stati Uniti, 80303
- Boulder Community Foothills Hospital
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Boulder, Colorado, Stati Uniti, 80304
- Rocky Mountain Cancer Centers-Boulder
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Colorado Springs, Colorado, Stati Uniti, 80907
- Penrose-Saint Francis Healthcare
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Colorado Springs, Colorado, Stati Uniti, 80907
- Rocky Mountain Cancer Centers-Penrose
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Denver, Colorado, Stati Uniti, 80218
- Presbyterian - Saint Lukes Medical Center - Health One
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Denver, Colorado, Stati Uniti, 80220
- Rose Medical Center
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Denver, Colorado, Stati Uniti, 80218
- Rocky Mountain Cancer Centers-Midtown
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Denver, Colorado, Stati Uniti, 80220
- Rocky Mountain Cancer Centers-Rose
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Denver, Colorado, Stati Uniti, 80218
- Colorado Blood Cancer Institute
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Denver, Colorado, Stati Uniti, 80222
- Western States Cancer Research NCORP
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Denver, Colorado, Stati Uniti, 80218
- Saint Joseph Hospital - Cancer Centers of Colorado
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Denver, Colorado, Stati Uniti, 80210
- AdventHealth Porter
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Durango, Colorado, Stati Uniti, 81301
- Mercy Medical Center
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Englewood, Colorado, Stati Uniti, 80113
- Mountain Blue Cancer Care Center - Swedish
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Englewood, Colorado, Stati Uniti, 80113
- Swedish Medical Center
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Golden, Colorado, Stati Uniti, 80401
- Mountain Blue Cancer Care Center
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Greeley, Colorado, Stati Uniti, 80631
- Banner North Colorado Medical Center
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Greenwood Village, Colorado, Stati Uniti, 80111
- Rocky Mountain Cancer Centers-Greenwood Village
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Lakewood, Colorado, Stati Uniti, 80228
- Rocky Mountain Cancer Centers-Lakewood
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Lakewood, Colorado, Stati Uniti, 80228
- CommonSpirit Saint Anthony Hospital Cancer Center
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Littleton, Colorado, Stati Uniti, 80122
- AdventHealth Littleton
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Lone Tree, Colorado, Stati Uniti, 80124
- Sky Ridge Medical Center
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Lone Tree, Colorado, Stati Uniti, 80124
- Rocky Mountain Cancer Centers-Sky Ridge
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Longmont, Colorado, Stati Uniti, 80501
- Longmont United Hospital
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Longmont, Colorado, Stati Uniti, 80501
- Rocky Mountain Cancer Centers-Longmont
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Loveland, Colorado, Stati Uniti, 80539
- Banner North Colorado Medical Center - Loveland Campus
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Parker, Colorado, Stati Uniti, 80138
- Rocky Mountain Cancer Centers-Parker
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Parker, Colorado, Stati Uniti, 80138
- AdventHealth Parker
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Pueblo, Colorado, Stati Uniti, 81004
- Saint Mary Corwin Medical Center
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Pueblo, Colorado, Stati Uniti, 81008
- Rocky Mountain Cancer Centers - Pueblo
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Wheat Ridge, Colorado, Stati Uniti, 80401
- Intermountain Health Lutheran Hospital
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Connecticut
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Hartford, Connecticut, Stati Uniti, 06105
- Smilow Cancer Hospital Care Center at Saint Francis
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New Britain, Connecticut, Stati Uniti, 06050
- The Hospital of Central Connecticut
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Delaware
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Lewes, Delaware, Stati Uniti, 19958
- Beebe Medical Center
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Newark, Delaware, Stati Uniti, 19713
- Helen F Graham Cancer Center
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Newark, Delaware, Stati Uniti, 19713
- Delaware Clinical and Laboratory Physicians PA
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Newark, Delaware, Stati Uniti, 19713
- Medical Oncology Hematology Consultants PA
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Newark, Delaware, Stati Uniti, 19718
- Christiana Care Health System-Christiana Hospital
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Rehoboth Beach, Delaware, Stati Uniti, 19971
- Beebe Health Campus
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Seaford, Delaware, Stati Uniti, 19973
- TidalHealth Nanticoke / Allen Cancer Center
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Wilmington, Delaware, Stati Uniti, 19801
- Christiana Care Health System-Wilmington Hospital
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Florida
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Miami, Florida, Stati Uniti, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
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Georgia
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Atlanta, Georgia, Stati Uniti, 30322
- Emory University Hospital/Winship Cancer Institute
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Atlanta, Georgia, Stati Uniti, 30342
- Emory Saint Joseph's Hospital
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Decatur, Georgia, Stati Uniti, 30033
- Atlanta VA Medical Center
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Macon, Georgia, Stati Uniti, 31201
- Atrium Health Navicent
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Savannah, Georgia, Stati Uniti, 31405
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
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Idaho
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Boise, Idaho, Stati Uniti, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Illinois
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Aurora, Illinois, Stati Uniti, 60504
- Rush-Copley Medical Center
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Bloomington, Illinois, Stati Uniti, 61704
- Illinois CancerCare-Bloomington
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Bloomington, Illinois, Stati Uniti, 61701
- OSF Saint Joseph Medical Center
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Canton, Illinois, Stati Uniti, 61520
- Illinois CancerCare-Canton
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Carthage, Illinois, Stati Uniti, 62321
- Illinois CancerCare-Carthage
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Centralia, Illinois, Stati Uniti, 62801
- Centralia Oncology Clinic
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Chicago, Illinois, Stati Uniti, 60611
- Northwestern University
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Danville, Illinois, Stati Uniti, 61832
- Carle at The Riverfront
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Decatur, Illinois, Stati Uniti, 62526
- Decatur Memorial Hospital
-
Decatur, Illinois, Stati Uniti, 62526
- Cancer Care Specialists of Illinois - Decatur
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Decatur, Illinois, Stati Uniti, 62526
- Heartland Cancer Research NCORP
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Effingham, Illinois, Stati Uniti, 62401
- Crossroads Cancer Center
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Effingham, Illinois, Stati Uniti, 62401
- Carle Physician Group-Effingham
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Eureka, Illinois, Stati Uniti, 61530
- Illinois CancerCare-Eureka
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Evanston, Illinois, Stati Uniti, 60201
- NorthShore University HealthSystem-Evanston Hospital
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Galesburg, Illinois, Stati Uniti, 61401
- Illinois CancerCare-Galesburg
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Glenview, Illinois, Stati Uniti, 60026
- NorthShore University HealthSystem-Glenbrook Hospital
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Harvey, Illinois, Stati Uniti, 60426
- Ingalls Memorial Hospital
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Highland Park, Illinois, Stati Uniti, 60035
- NorthShore University HealthSystem-Highland Park Hospital
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Highland Park, Illinois, Stati Uniti, 60035
- Hematology Oncology Associates of Illinois-Highland Park
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Kankakee, Illinois, Stati Uniti, 60901
- Presence Saint Mary's Hospital
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Kewanee, Illinois, Stati Uniti, 61443
- Illinois CancerCare-Kewanee Clinic
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Libertyville, Illinois, Stati Uniti, 60048
- AMG Libertyville - Oncology
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Macomb, Illinois, Stati Uniti, 61455
- Illinois CancerCare-Macomb
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Mattoon, Illinois, Stati Uniti, 61938
- Carle Physician Group-Mattoon/Charleston
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Moline, Illinois, Stati Uniti, 61265
- Garneau, Stewart C MD (UIA Investigator)
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Moline, Illinois, Stati Uniti, 61265
- Porubcin, Michael MD (UIA Investigator)
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Moline, Illinois, Stati Uniti, 61265
- Spector, David MD (UIA Investigator)
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Moline, Illinois, Stati Uniti, 61265
- Trinity Medical Center
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Monmouth, Illinois, Stati Uniti, 61462
- Illinois CancerCare-Monmouth
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Niles, Illinois, Stati Uniti, 60714
- Illinois Cancer Specialists-Niles
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Normal, Illinois, Stati Uniti, 61761
- Carle Cancer Institute Normal
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Ottawa, Illinois, Stati Uniti, 61350
- Illinois CancerCare-Ottawa Clinic
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Ottawa, Illinois, Stati Uniti, 61350
- Ottawa Regional Hospital and Healthcare Center
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Pekin, Illinois, Stati Uniti, 61554
- Illinois CancerCare-Pekin
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Pekin, Illinois, Stati Uniti, 61554
- OSF Saint Francis Radiation Oncology at Pekin
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Peoria, Illinois, Stati Uniti, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Stati Uniti, 61637
- OSF Saint Francis Medical Center
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Peoria, Illinois, Stati Uniti, 61615
- Illinois CancerCare-Peoria
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Peoria, Illinois, Stati Uniti, 61614
- Proctor Hospital
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Peru, Illinois, Stati Uniti, 61354
- Illinois CancerCare-Peru
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Peru, Illinois, Stati Uniti, 61354
- Illinois Valley Hospital
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Princeton, Illinois, Stati Uniti, 61356
- Illinois CancerCare-Princeton
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Rockford, Illinois, Stati Uniti, 61104
- Swedish American Hospital
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Rockford, Illinois, Stati Uniti, 61114
- UW Health Carbone Cancer Center Rockford
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Skokie, Illinois, Stati Uniti, 60076
- Hematology Oncology Associates of Illinois - Skokie
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Springfield, Illinois, Stati Uniti, 62781
- Springfield Memorial Hospital
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Urbana, Illinois, Stati Uniti, 61801
- Carle Cancer Center
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Urbana, Illinois, Stati Uniti, 61801
- The Carle Foundation Hospital
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Yorkville, Illinois, Stati Uniti, 60560
- Rush-Copley Healthcare Center
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Indiana
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Bloomington, Indiana, Stati Uniti, 47408
- IU Health Bloomington
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Elkhart, Indiana, Stati Uniti, 46515
- Elkhart General Hospital
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Elkhart, Indiana, Stati Uniti, 46514
- Michiana Hematology Oncology PC-Elkhart
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Elkhart, Indiana, Stati Uniti, 46514-2098
- Elkhart Clinic
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Indianapolis, Indiana, Stati Uniti, 46202
- Indiana University/Melvin and Bren Simon Cancer Center
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Indianapolis, Indiana, Stati Uniti, 46219
- IU Health Central Indiana Cancer Centers-East
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Kokomo, Indiana, Stati Uniti, 46904
- Community Howard Regional Health
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La Porte, Indiana, Stati Uniti, 46350
- IU Health La Porte Hospital
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Michigan City, Indiana, Stati Uniti, 46360
- Franciscan Saint Anthony Health-Michigan City
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Michigan City, Indiana, Stati Uniti, 46360
- Woodland Cancer Care Center
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Mishawaka, Indiana, Stati Uniti, 46545
- Michiana Hematology Oncology PC-Mishawaka
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Mishawaka, Indiana, Stati Uniti, 46545
- Saint Joseph Regional Medical Center-Mishawaka
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Muncie, Indiana, Stati Uniti, 47303
- IU Health Ball Memorial Hospital
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Plymouth, Indiana, Stati Uniti, 46563
- Michiana Hematology Oncology PC-Plymouth
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South Bend, Indiana, Stati Uniti, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, Stati Uniti, 46628
- Northern Indiana Cancer Research Consortium
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South Bend, Indiana, Stati Uniti, 46617
- South Bend Clinic
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Westville, Indiana, Stati Uniti, 46391
- Michiana Hematology Oncology PC-Westville
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Iowa
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Ames, Iowa, Stati Uniti, 50010
- Mary Greeley Medical Center
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Ames, Iowa, Stati Uniti, 50010
- McFarland Clinic - Ames
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Bettendorf, Iowa, Stati Uniti, 52722
- Constantinou, Costas L MD (UIA Investigator)
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Boone, Iowa, Stati Uniti, 50036
- McFarland Clinic - Boone
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Cedar Rapids, Iowa, Stati Uniti, 52403
- Mercy Hospital
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Cedar Rapids, Iowa, Stati Uniti, 52403
- Oncology Associates at Mercy Medical Center
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Clive, Iowa, Stati Uniti, 50325
- Mercy Cancer Center-West Lakes
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Clive, Iowa, Stati Uniti, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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Des Moines, Iowa, Stati Uniti, 50309
- Iowa Methodist Medical Center
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Des Moines, Iowa, Stati Uniti, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, Stati Uniti, 50316
- Iowa Lutheran Hospital
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Des Moines, Iowa, Stati Uniti, 50309
- Iowa-Wide Oncology Research Coalition NCORP
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Des Moines, Iowa, Stati Uniti, 50309
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
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Des Moines, Iowa, Stati Uniti, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
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Jefferson, Iowa, Stati Uniti, 50129
- McFarland Clinic - Jefferson
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Marshalltown, Iowa, Stati Uniti, 50158
- McFarland Clinic - Marshalltown
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Mason City, Iowa, Stati Uniti, 50401
- Mercy Medical Center - North Iowa
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Sioux City, Iowa, Stati Uniti, 51101
- Siouxland Regional Cancer Center
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Sioux City, Iowa, Stati Uniti, 51102
- Mercy Medical Center-Sioux City
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Sioux City, Iowa, Stati Uniti, 51104
- Saint Luke's Regional Medical Center
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West Des Moines, Iowa, Stati Uniti, 50266
- Mercy Medical Center-West Lakes
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Kansas
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Chanute, Kansas, Stati Uniti, 66720
- Cancer Center of Kansas - Chanute
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Dodge City, Kansas, Stati Uniti, 67801
- Cancer Center of Kansas - Dodge City
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El Dorado, Kansas, Stati Uniti, 67042
- Cancer Center of Kansas - El Dorado
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Fort Scott, Kansas, Stati Uniti, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, Stati Uniti, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, Stati Uniti, 67068
- Cancer Center of Kansas-Kingman
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Lawrence, Kansas, Stati Uniti, 66044
- Lawrence Memorial Hospital
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Liberal, Kansas, Stati Uniti, 67905
- Cancer Center of Kansas-Liberal
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Manhattan, Kansas, Stati Uniti, 66502
- Cancer Center of Kansas-Manhattan
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McPherson, Kansas, Stati Uniti, 67460
- Cancer Center of Kansas - McPherson
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Newton, Kansas, Stati Uniti, 67114
- Cancer Center of Kansas - Newton
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Parsons, Kansas, Stati Uniti, 67357
- Cancer Center of Kansas - Parsons
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Pratt, Kansas, Stati Uniti, 67124
- Cancer Center of Kansas - Pratt
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Salina, Kansas, Stati Uniti, 67401
- Cancer Center of Kansas - Salina
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Wellington, Kansas, Stati Uniti, 67152
- Cancer Center of Kansas - Wellington
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Wichita, Kansas, Stati Uniti, 67214
- Ascension Via Christi Hospitals Wichita
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Wichita, Kansas, Stati Uniti, 67208
- Cancer Center of Kansas-Wichita Medical Arts Tower
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Wichita, Kansas, Stati Uniti, 67214
- Cancer Center of Kansas - Wichita
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Wichita, Kansas, Stati Uniti, 67208
- Associates In Womens Health
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Wichita, Kansas, Stati Uniti, 67214
- Wichita NCI Community Oncology Research Program
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Winfield, Kansas, Stati Uniti, 67156
- Cancer Center of Kansas - Winfield
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Louisiana
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Baton Rouge, Louisiana, Stati Uniti, 70809
- Ochsner Health Center-Summa
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New Orleans, Louisiana, Stati Uniti, 70121
- Ochsner Medical Center Jefferson
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New Orleans, Louisiana, Stati Uniti, 70115
- Ochsner Baptist Medical Center
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Maine
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York Village, Maine, Stati Uniti, 03909
- York Hospital
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Maryland
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Baltimore, Maryland, Stati Uniti, 21204
- Greater Baltimore Medical Center
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Elkton, Maryland, Stati Uniti, 21921
- Christiana Care - Union Hospital
-
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Michigan
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Adrian, Michigan, Stati Uniti, 49221
- Bixby Medical Center
-
Adrian, Michigan, Stati Uniti, 49221
- Hickman Cancer Center
-
Ann Arbor, Michigan, Stati Uniti, 48106
- Michigan Cancer Research Consortium NCORP
-
Ann Arbor, Michigan, Stati Uniti, 48106
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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Dearborn, Michigan, Stati Uniti, 48124
- Corewell Health Dearborn Hospital
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Detroit, Michigan, Stati Uniti, 48236
- Henry Ford Health Saint John Hospital
-
Escanaba, Michigan, Stati Uniti, 49829
- OSF Saint Francis Hospital and Medical Group
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Flint, Michigan, Stati Uniti, 48503
- Hurley Medical Center
-
Flint, Michigan, Stati Uniti, 48503
- Genesys Hurley Cancer Institute
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Jackson, Michigan, Stati Uniti, 49201
- Allegiance Health
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Kalamazoo, Michigan, Stati Uniti, 49007
- West Michigan Cancer Center
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Kalamazoo, Michigan, Stati Uniti, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, Stati Uniti, 49048
- Beacon Kalamazoo
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Lansing, Michigan, Stati Uniti, 48912
- University of Michigan Health - Sparrow Lansing
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Livonia, Michigan, Stati Uniti, 48154
- Trinity Health Saint Mary Mercy Livonia Hospital
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Monroe, Michigan, Stati Uniti, 48162
- Mercy Memorial Hospital
-
Monroe, Michigan, Stati Uniti, 48162
- Toledo Clinic Cancer Centers-Monroe
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Pontiac, Michigan, Stati Uniti, 48341
- Trinity Health Saint Joseph Mercy Oakland Hospital
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Port Huron, Michigan, Stati Uniti, 48060
- Lake Huron Medical Center
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Saginaw, Michigan, Stati Uniti, 48601
- MyMichigan Medical Center Saginaw
-
Saint Joseph, Michigan, Stati Uniti, 49085
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
-
Saint Joseph, Michigan, Stati Uniti, 49085
- Corewell Health Lakeland Hospitals - Saint Joseph Hospital
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Warren, Michigan, Stati Uniti, 48093
- Henry Ford Health Warren Hospital
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Minnesota
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Bemidji, Minnesota, Stati Uniti, 56601
- Sanford Joe Lueken Cancer Center
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Burnsville, Minnesota, Stati Uniti, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Stati Uniti, 55433
- Mercy Hospital
-
Edina, Minnesota, Stati Uniti, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, Stati Uniti, 55432
- Unity Hospital
-
Hutchinson, Minnesota, Stati Uniti, 55350
- Hutchinson Area Health Care
-
Maplewood, Minnesota, Stati Uniti, 55109
- Saint John's Hospital - Healtheast
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Maplewood, Minnesota, Stati Uniti, 55109
- Minnesota Oncology Hematology PA-Maplewood
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Minneapolis, Minnesota, Stati Uniti, 55415
- Hennepin County Medical Center
-
Minneapolis, Minnesota, Stati Uniti, 55407
- Abbott-Northwestern Hospital
-
New Ulm, Minnesota, Stati Uniti, 56073
- New Ulm Medical Center
-
Robbinsdale, Minnesota, Stati Uniti, 55422
- North Memorial Medical Health Center
-
Saint Louis Park, Minnesota, Stati Uniti, 55416
- Park Nicollet Clinic - Saint Louis Park
-
Saint Louis Park, Minnesota, Stati Uniti, 55416
- Metro Minnesota Community Oncology Research Consortium
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Saint Paul, Minnesota, Stati Uniti, 55101
- Regions Hospital
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Saint Paul, Minnesota, Stati Uniti, 55102
- United Hospital
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Shakopee, Minnesota, Stati Uniti, 55379
- Saint Francis Regional Medical Center
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Stillwater, Minnesota, Stati Uniti, 55082
- Lakeview Hospital
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Waconia, Minnesota, Stati Uniti, 55387
- Ridgeview Medical Center
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Willmar, Minnesota, Stati Uniti, 56201
- Rice Memorial Hospital
-
Woodbury, Minnesota, Stati Uniti, 55125
- Minnesota Oncology Hematology PA-Woodbury
-
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Missouri
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Cape Girardeau, Missouri, Stati Uniti, 63703
- Saint Francis Medical Center
-
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Nebraska
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Lincoln, Nebraska, Stati Uniti, 68510
- Nebraska Cancer Research Center
-
Omaha, Nebraska, Stati Uniti, 68124
- Alegent Health Bergan Mercy Medical Center
-
Omaha, Nebraska, Stati Uniti, 68122
- Alegent Health Immanuel Medical Center
-
Omaha, Nebraska, Stati Uniti, 68130
- Alegent Health Lakeside Hospital
-
Omaha, Nebraska, Stati Uniti, 68106
- Missouri Valley Cancer Consortium
-
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Nevada
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Henderson, Nevada, Stati Uniti, 89052
- Comprehensive Cancer Centers of Nevada - Henderson
-
Henderson, Nevada, Stati Uniti, 89052
- Cancer and Blood Specialists-Henderson
-
Henderson, Nevada, Stati Uniti, 89052
- Las Vegas Cancer Center-Henderson
-
Henderson, Nevada, Stati Uniti, 89074
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
-
Henderson, Nevada, Stati Uniti, 89074
- Oncology Las Vegas - Henderson
-
Las Vegas, Nevada, Stati Uniti, 89106
- Radiation Oncology Centers of Nevada Central
-
Las Vegas, Nevada, Stati Uniti, 89119
- Radiation Oncology Centers of Nevada Southeast
-
Las Vegas, Nevada, Stati Uniti, 89128
- Comprehensive Cancer Centers of Nevada - Northwest
-
Las Vegas, Nevada, Stati Uniti, 89144
- Comprehensive Cancer Centers of Nevada-Summerlin
-
Las Vegas, Nevada, Stati Uniti, 89148
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Stati Uniti, 89169
- Comprehensive Cancer Centers of Nevada - Central Valley
-
Las Vegas, Nevada, Stati Uniti, 89102
- University Medical Center of Southern Nevada
-
Las Vegas, Nevada, Stati Uniti, 89106
- Cancer and Blood Specialists-Shadow
-
Las Vegas, Nevada, Stati Uniti, 89109
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
-
Las Vegas, Nevada, Stati Uniti, 89113
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
-
Las Vegas, Nevada, Stati Uniti, 89121
- Cancer Therapy and Integrative Medicine
-
Las Vegas, Nevada, Stati Uniti, 89128
- Cancer and Blood Specialists-Tenaya
-
Las Vegas, Nevada, Stati Uniti, 89128
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
-
Las Vegas, Nevada, Stati Uniti, 89148-2405
- Las Vegas Cancer Center-Medical Center
-
Las Vegas, Nevada, Stati Uniti, 89149
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
-
Las Vegas, Nevada, Stati Uniti, 89120
- Nevada Cancer Research Foundation NCORP
-
Las Vegas, Nevada, Stati Uniti, 89128
- Oncology Las Vegas - Tenaya
-
Las Vegas, Nevada, Stati Uniti, 89183
- OptumCare Cancer Care at Fort Apache
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New Jersey
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Camden, New Jersey, Stati Uniti, 08103
- Cooper Hospital University Medical Center
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East Orange, New Jersey, Stati Uniti, 07018-1095
- Veterans Adminstration New Jersey Health Care System
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Hackensack, New Jersey, Stati Uniti, 07601
- Hackensack University Medical Center
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Long Branch, New Jersey, Stati Uniti, 07740
- Monmouth Medical Center
-
Morristown, New Jersey, Stati Uniti, 07960
- Morristown Medical Center
-
Mount Holly, New Jersey, Stati Uniti, 08060
- Virtua Memorial
-
Newark, New Jersey, Stati Uniti, 07101
- Rutgers New Jersey Medical School
-
Summit, New Jersey, Stati Uniti, 07902
- Overlook Hospital
-
Vineland, New Jersey, Stati Uniti, 08360
- Inspira Medical Center Vineland
-
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New Mexico
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Albuquerque, New Mexico, Stati Uniti, 87106
- University of New Mexico Cancer Center
-
Las Cruces, New Mexico, Stati Uniti, 88011
- Memorial Medical Center-Las Cruces
-
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New York
-
Stony Brook, New York, Stati Uniti, 11794
- Stony Brook University Medical Center
-
The Bronx, New York, Stati Uniti, 10467
- Montefiore Medical Center - Moses Campus
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The Bronx, New York, Stati Uniti, 10461
- Montefiore Medical Center-Weiler Hospital
-
White Plains, New York, Stati Uniti, 10601
- Dickstein Cancer Treatment Center
-
-
North Dakota
-
Fargo, North Dakota, Stati Uniti, 58122
- Sanford Roger Maris Cancer Center
-
Fargo, North Dakota, Stati Uniti, 58122
- Sanford Broadway Medical Center
-
-
Ohio
-
Akron, Ohio, Stati Uniti, 44304
- Summa Health System - Akron Campus
-
Belpre, Ohio, Stati Uniti, 45714
- Strecker Cancer Center-Belpre
-
Bowling Green, Ohio, Stati Uniti, 43402
- Toledo Clinic Cancer Centers-Bowling Green
-
Canton, Ohio, Stati Uniti, 44708
- Cleveland Clinic Mercy Hospital
-
Chillicothe, Ohio, Stati Uniti, 45601
- Adena Regional Medical Center
-
Cleveland, Ohio, Stati Uniti, 44106
- Case Western Reserve University
-
Cleveland, Ohio, Stati Uniti, 44109
- MetroHealth Medical Center
-
Columbus, Ohio, Stati Uniti, 43214
- Riverside Methodist Hospital
-
Columbus, Ohio, Stati Uniti, 43219
- The Mark H Zangmeister Center
-
Columbus, Ohio, Stati Uniti, 43214
- Columbus Oncology and Hematology Associates Inc
-
Columbus, Ohio, Stati Uniti, 43228
- Doctors Hospital
-
Columbus, Ohio, Stati Uniti, 43215
- Grant Medical Center
-
Columbus, Ohio, Stati Uniti, 43222
- Mount Carmel Health Center West
-
Columbus, Ohio, Stati Uniti, 43215
- Columbus NCI Community Oncology Research Program
-
Delaware, Ohio, Stati Uniti, 43015
- Delaware Health Center-Grady Cancer Center
-
Delaware, Ohio, Stati Uniti, 43015
- Delaware Radiation Oncology
-
Delaware, Ohio, Stati Uniti, 43015
- Grady Memorial Hospital
-
Lancaster, Ohio, Stati Uniti, 43130
- Fairfield Medical Center
-
Lima, Ohio, Stati Uniti, 45801
- Saint Rita's Medical Center
-
Lima, Ohio, Stati Uniti, 45804
- Lima Memorial Hospital
-
Marietta, Ohio, Stati Uniti, 45750
- Marietta Memorial Hospital
-
Maumee, Ohio, Stati Uniti, 43537
- Toledo Clinic Cancer Centers-Maumee
-
Mount Vernon, Ohio, Stati Uniti, 43050
- Knox Community Hospital
-
Newark, Ohio, Stati Uniti, 43055
- Licking Memorial Hospital
-
Newark, Ohio, Stati Uniti, 43055
- Newark Radiation Oncology
-
Oregon, Ohio, Stati Uniti, 43616
- Saint Charles Hospital
-
Oregon, Ohio, Stati Uniti, 43616
- Toledo Clinic Cancer Centers-Oregon
-
Portsmouth, Ohio, Stati Uniti, 45662
- Southern Ohio Medical Center
-
Springfield, Ohio, Stati Uniti, 45504
- Springfield Regional Medical Center
-
Sylvania, Ohio, Stati Uniti, 43560
- ProMedica Flower Hospital
-
Tiffin, Ohio, Stati Uniti, 44883
- Mercy Hospital of Tiffin
-
Toledo, Ohio, Stati Uniti, 43606
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
-
Toledo, Ohio, Stati Uniti, 43623
- Mercy Health - Saint Anne Hospital
-
Toledo, Ohio, Stati Uniti, 43623
- Toledo Clinic Cancer Centers-Toledo
-
Toledo, Ohio, Stati Uniti, 43614
- University of Toledo
-
Toledo, Ohio, Stati Uniti, 43617
- Toledo Community Hospital Oncology Program CCOP
-
Toledo, Ohio, Stati Uniti, 43608
- Mercy Health - Saint Vincent Hospital
-
Wauseon, Ohio, Stati Uniti, 43567
- Fulton County Health Center
-
Westerville, Ohio, Stati Uniti, 43081
- Saint Ann's Hospital
-
Zanesville, Ohio, Stati Uniti, 43701
- Genesis Healthcare System Cancer Care Center
-
-
Pennsylvania
-
Bryn Mawr, Pennsylvania, Stati Uniti, 19010
- Bryn Mawr Hospital
-
Danville, Pennsylvania, Stati Uniti, 17822
- Geisinger Medical Center
-
Doylestown, Pennsylvania, Stati Uniti, 18901
- Doylestown Hospital
-
Erie, Pennsylvania, Stati Uniti, 16505
- UPMC Hillman Cancer Center Erie
-
Hazleton, Pennsylvania, Stati Uniti, 18201
- Geisinger Medical Center-Cancer Center Hazleton
-
Hershey, Pennsylvania, Stati Uniti, 17033-0850
- Penn State Milton S Hershey Medical Center
-
Lancaster, Pennsylvania, Stati Uniti, 17602
- Lancaster General Hospital
-
Lewisburg, Pennsylvania, Stati Uniti, 17837
- Geisinger Medical Oncology-Lewisburg
-
Paoli, Pennsylvania, Stati Uniti, 19301
- Paoli Memorial Hospital
-
Philadelphia, Pennsylvania, Stati Uniti, 19107
- Thomas Jefferson University Hospital
-
Philadelphia, Pennsylvania, Stati Uniti, 19141
- Einstein Medical Center Philadelphia
-
Pottsville, Pennsylvania, Stati Uniti, 17901
- Geisinger Cancer Services-Pottsville
-
Sayre, Pennsylvania, Stati Uniti, 18840
- Guthrie Medical Group PC-Robert Packer Hospital
-
State College, Pennsylvania, Stati Uniti, 16801
- Geisinger Medical Group
-
Wilkes-Barre, Pennsylvania, Stati Uniti, 18711
- Geisinger Wyoming Valley/Henry Cancer Center
-
Wynnewood, Pennsylvania, Stati Uniti, 19096
- Lankenau Medical Center
-
Wynnewood, Pennsylvania, Stati Uniti, 19096
- Main Line Health NCORP
-
York, Pennsylvania, Stati Uniti, 17403
- WellSpan Health-York Hospital
-
-
South Dakota
-
Sioux Falls, South Dakota, Stati Uniti, 57117-5134
- Sanford USD Medical Center - Sioux Falls
-
Sioux Falls, South Dakota, Stati Uniti, 57104
- Sanford Cancer Center Oncology Clinic
-
-
Texas
-
Austin, Texas, Stati Uniti, 78701
- Dell Seton Medical Center at The University of Texas
-
San Antonio, Texas, Stati Uniti, 78229
- University of Texas Health Science Center at San Antonio
-
Tyler, Texas, Stati Uniti, 75708
- University of Texas Health Science Center at Tyler
-
-
Virginia
-
Fredericksburg, Virginia, Stati Uniti, 22401
- Fredericksburg Oncology Inc
-
-
West Virginia
-
Charleston, West Virginia, Stati Uniti, 25304
- Vandalia Health/CAMC Institute for Academic Medicine
-
Morgantown, West Virginia, Stati Uniti, 26506
- West Virginia University Healthcare
-
Wheeling, West Virginia, Stati Uniti, 26003
- Wheeling Hospital/Schiffler Cancer Center
-
-
Wisconsin
-
Chippewa Falls, Wisconsin, Stati Uniti, 54729
- Marshfield Clinic-Chippewa Center
-
Eau Claire, Wisconsin, Stati Uniti, 54701
- HSHS Sacred Heart Hospital
-
Eau Claire, Wisconsin, Stati Uniti, 54701
- Marshfield Clinic Cancer Center at Sacred Heart
-
Green Bay, Wisconsin, Stati Uniti, 54301
- Saint Vincent Hospital Cancer Center Green Bay
-
Green Bay, Wisconsin, Stati Uniti, 54303
- Saint Vincent Hospital Cancer Center at Saint Mary's
-
Green Bay, Wisconsin, Stati Uniti, 54301-3526
- Green Bay Oncology at Saint Vincent Hospital
-
Johnson Creek, Wisconsin, Stati Uniti, 53038
- University of Wisconsin Carbone Cancer Center - Johnson Creek
-
Madison, Wisconsin, Stati Uniti, 53792
- University of Wisconsin Carbone Cancer Center - University Hospital
-
Madison, Wisconsin, Stati Uniti, 53715
- SSM Health Dean Medical Group - South Madison Campus
-
Manitowoc, Wisconsin, Stati Uniti, 54221
- Holy Family Memorial Hospital
-
Marinette, Wisconsin, Stati Uniti, 54143
- Bay Area Medical Center
-
Marshfield, Wisconsin, Stati Uniti, 54449
- Marshfield Medical Center-Marshfield
-
Marshfield, Wisconsin, Stati Uniti, 54449
- Marshfield Medical Center
-
Milwaukee, Wisconsin, Stati Uniti, 53226
- Medical College of Wisconsin
-
Minocqua, Wisconsin, Stati Uniti, 54548
- Marshfield Medical Center - Minocqua
-
New Richmond, Wisconsin, Stati Uniti, 54017
- Cancer Center of Western Wisconsin
-
Oconomowoc, Wisconsin, Stati Uniti, 53066
- ProHealth Oconomowoc Memorial Hospital
-
Oconto Falls, Wisconsin, Stati Uniti, 54154
- Saint Vincent Hospital Cancer Center at Oconto Falls
-
Rhinelander, Wisconsin, Stati Uniti, 54501
- Saint Mary's Hospital
-
Rhinelander, Wisconsin, Stati Uniti, 54501
- Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
-
Rice Lake, Wisconsin, Stati Uniti, 54868
- Marshfield Medical Center-Rice Lake
-
Sheboygan, Wisconsin, Stati Uniti, 53081
- HSHS Saint Nicholas Hospital
-
Stevens Point, Wisconsin, Stati Uniti, 54481
- Aspirus Cancer Care - Stevens Point
-
Waukesha, Wisconsin, Stati Uniti, 53188
- ProHealth Waukesha Memorial Hospital
-
Wausau, Wisconsin, Stati Uniti, 54401
- Marshfield Clinic-Wausau Center
-
Weston, Wisconsin, Stati Uniti, 54476
- Marshfield Medical Center - Weston
-
Wisconsin Rapids, Wisconsin, Stati Uniti, 54494
- Aspirus Cancer Care - Wisconsin Rapids
-
Wisconsin Rapids, Wisconsin, Stati Uniti, 54494
- Marshfield Clinic - Wisconsin Rapids Center
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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
Altri nomi:
|
|
Sperimentale: 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
Altri nomi:
|
|
Sperimentale: 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
Altri nomi:
Given PO
Altri nomi:
|
|
Sperimentale: 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
Altri nomi:
Given PO
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Progression-free Survival (PFS)
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Proporzione di pazienti con tossicità di grado peggiore di grado 3 o superiore
Lasso di tempo: Valutato ogni 4 settimane durante il trattamento e per 30 giorni dopo la fine del trattamento
|
Valutato ogni 4 settimane durante il trattamento e per 30 giorni dopo la fine del trattamento
|
|
|
Overall Survival (OS)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Joel W Neal, ECOG-ACRIN Cancer Research Group
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
13 febbraio 2013
Completamento primario (Effettivo)
14 agosto 2015
Completamento dello studio (Stimato)
31 marzo 2027
Date di iscrizione allo studio
Primo inviato
15 ottobre 2012
Primo inviato che soddisfa i criteri di controllo qualità
15 ottobre 2012
Primo Inserito (Stimato)
17 ottobre 2012
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
13 novembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
10 novembre 2026
Ultimo verificato
1 settembre 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Neoplasie per sede
- Neoplasie
- Malattie delle vie respiratorie
- Malattie polmonari
- Neoplasie delle vie respiratorie
- Neoplasie toraciche
- Neoplasie polmonari
- Carcinoma, broncogeno
- Neoplasie bronchiali
- Carcinoma, polmone non a piccole cellule
- Composti eterociclici
- Composti eterociclici, 2 anelli
- Composti eterociclici, anello fuso
- Chinazoline
- Erlotinib cloridrato
- Cabozantinib
Altri numeri di identificazione dello studio
- NCI-2012-01938
- U10CA180820 (Sovvenzione/contratto NIH degli Stati Uniti)
- U10CA021115 (Sovvenzione/contratto NIH degli Stati Uniti)
- NCI-2012-01938 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
- ECOG-E1512
- CDR0000741879
- E1512 (Altro identificatore: CTEP)
- E1512 (Altro identificatore: ECOG-ACRIN Cancer Research Group)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .