- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04533451
Testing the Effects of MK-3475 (Pembrolizumab) With or Without the Usual Chemotherapy Treatment for Patients 70 Years of Age and Older With Advanced Non-small Cell Lung Cancer
Older Non-Small Cell Lung Cancer Patients (>/= 70 Years of Age) Treated With First-Line MK-3475 (Pembrolizumab)+/- Chemotherapy (Oncologist's/Patient's Choice)
Study Overview
Status
Conditions
Detailed Description
The primary and secondary objectives of the study:
PRIMARY OBJECTIVE:
I. To estimate the adverse event profile of MK-3475 (pembrolizumab) in non-small cell lung cancer patients who are age 70 years of age or older and who are treated with MK-3475 (pembrolizumab) +/- chemotherapy in a first-line setting.
SECONDARY OBJECTIVES:
I. To estimate overall survival. II. To describe patient quality of life during the treatment using the Linear Analogue Self-Assessment (LASA) questionnaire.
III. To explore whether Comprehensive Geriatric Assessment (CGA) -derived risk score is able to predict rates of severe adverse events in older cancer patients who receive MK-3475 (pembrolizumab) or MK-3475 (pembrolizumab) + chemotherapy.
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP A: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
GROUP B: Patients receive pembrolizumab IV over 30 minutes, pemetrexed IV over 10 minutes, and carboplatin IV per institutional guidelines on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up annually for up to 5 years after registration.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alaska
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Anchorage, Alaska, United States, 98508
- Anchorage Associates in Radiation Medicine
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Anchorage, Alaska, United States, 99508
- Alaska Breast Care and Surgery LLC
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Anchorage, Alaska, United States, 99508
- Alaska Oncology and Hematology LLC
-
Anchorage, Alaska, United States, 99508
- Alaska Women's Cancer Care
-
Anchorage, Alaska, United States, 99508
- Anchorage Oncology Centre
-
Anchorage, Alaska, United States, 99508
- Katmai Oncology Group
-
Anchorage, Alaska, United States, 99508
- Providence Alaska Medical Center
-
Anchorage, Alaska, United States, 99504
- Anchorage Radiation Therapy Center
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Fairbanks, Alaska, United States, 99701
- Fairbanks Memorial Hospital
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Arizona
-
Kingman, Arizona, United States, 86401
- Kingman Regional Medical Center
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California
-
Arroyo Grande, California, United States, 93420
- PCR Oncology
-
Arroyo Grande, California, United States, 93420
- Mission Hope Medical Oncology - Arroyo Grande
-
La Jolla, California, United States, 92093
- UC San Diego Moores Cancer Center
-
Saint Helena, California, United States, 94574
- Saint Helena Hospital
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San Luis Obispo, California, United States, 93401
- Pacific Central Coast Health Center-San Luis Obispo
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Santa Maria, California, United States, 93444
- Mission Hope Medical Oncology - Santa Maria
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Colorado
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Aurora, Colorado, United States, 80012
- Rocky Mountain Cancer Centers-Aurora
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Aurora, Colorado, United States, 80012
- The Medical Center of Aurora
-
Boulder, Colorado, United States, 80303
- Boulder Community Foothills Hospital
-
Boulder, Colorado, United States, 80304
- Rocky Mountain Cancer Centers-Boulder
-
Centennial, Colorado, United States, 80112
- Rocky Mountain Cancer Centers - Centennial
-
Colorado Springs, Colorado, United States, 80907
- Penrose-Saint Francis Healthcare
-
Denver, Colorado, United States, 80210
- Porter Adventist Hospital
-
Denver, Colorado, United States, 80218
- Presbyterian - Saint Lukes Medical Center - Health One
-
Denver, Colorado, United States, 80218
- SCL Health Saint Joseph Hospital
-
Denver, Colorado, United States, 80220
- Rose Medical Center
-
Denver, Colorado, United States, 80218
- Rocky Mountain Cancer Centers-Midtown
-
Denver, Colorado, United States, 80220
- Rocky Mountain Cancer Centers-Rose
-
Denver, Colorado, United States, 80218
- Colorado Blood Cancer Institute
-
Denver, Colorado, United States, 80209
- The Women's Imaging Center
-
Denver, Colorado, United States, 80206
- National Jewish Health-Main Campus
-
Denver, Colorado, United States, 80220
- Western Surgical Care
-
Englewood, Colorado, United States, 80113
- Mountain Blue Cancer Care Center - Swedish
-
Englewood, Colorado, United States, 80113
- Swedish Medical Center
-
Englewood, Colorado, United States, 80113
- Rocky Mountain Cancer Centers - Swedish
-
Englewood, Colorado, United States, 80113
- The Melanoma and Skin Cancer Institute
-
Golden, Colorado, United States, 80401
- National Jewish Health-Western Hematology Oncology
-
Grand Junction, Colorado, United States, 81501
- Saint Mary's Hospital and Regional Medical Center
-
Greeley, Colorado, United States, 80631
- North Colorado Medical Center
-
Lakewood, Colorado, United States, 80228
- Saint Anthony Hospital
-
Lakewood, Colorado, United States, 80228
- Rocky Mountain Cancer Centers-Lakewood
-
Littleton, Colorado, United States, 80120
- Rocky Mountain Cancer Centers-Littleton
-
Littleton, Colorado, United States, 80122
- Littleton Adventist Hospital
-
Lone Tree, Colorado, United States, 80124
- Sky Ridge Medical Center
-
Lone Tree, Colorado, United States, 80124
- Rocky Mountain Cancer Centers-Sky Ridge
-
Longmont, Colorado, United States, 80501
- Longmont United Hospital
-
Loveland, Colorado, United States, 80539
- McKee Medical Center
-
Parker, Colorado, United States, 80138
- Parker Adventist Hospital
-
Pueblo, Colorado, United States, 81004
- Saint Mary Corwin Medical Center
-
Thornton, Colorado, United States, 80260
- Rocky Mountain Cancer Centers-Thornton
-
Thornton, Colorado, United States, 80260
- National Jewish Health-Northern Hematology Oncology
-
Wheat Ridge, Colorado, United States, 80033
- SCL Health Lutheran Medical Center
-
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Delaware
-
Frankford, Delaware, United States, 19945
- Beebe South Coastal Health Campus
-
Lewes, Delaware, United States, 19958
- Beebe Medical Center
-
Newark, Delaware, United States, 19713
- Helen F Graham Cancer Center
-
Newark, Delaware, United States, 19713
- Delaware Clinical and Laboratory Physicians PA
-
Newark, Delaware, United States, 19713
- Medical Oncology Hematology Consultants PA
-
Newark, Delaware, United States, 19718
- Christiana Care Health System-Christiana Hospital
-
Rehoboth Beach, Delaware, United States, 19971
- Beebe Health Campus
-
Wilmington, Delaware, United States, 19801
- Christiana Care Health System-Wilmington Hospital
-
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Florida
-
Clearwater, Florida, United States, 33756
- Morton Plant Hospital
-
Plant City, Florida, United States, 33563
- South Florida Baptist Hospital
-
Saint Petersburg, Florida, United States, 33705
- Saint Anthony's Hospital Cancer Care Center
-
Tampa, Florida, United States, 33612
- Moffitt Cancer Center
-
Tampa, Florida, United States, 33607
- Moffitt Cancer Center-International Plaza
-
Tampa, Florida, United States, 33607
- Saint Joseph's Hospital/Children's Hospital-Tampa
-
Tampa, Florida, United States, 33612
- Moffitt Cancer Center - McKinley Campus
-
Wesley Chapel, Florida, United States, 33544
- Moffitt Cancer Center at Wesley Chapel
-
Winter Haven, Florida, United States, 33881
- Winter Haven Hospital
-
-
Georgia
-
Savannah, Georgia, United States, 31405
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
-
-
Idaho
-
Boise, Idaho, United States, 83706
- Saint Alphonsus Cancer Care Center-Boise
-
Boise, Idaho, United States, 83712
- Saint Luke's Cancer Institute - Boise
-
Caldwell, Idaho, United States, 83605
- Saint Alphonsus Cancer Care Center-Caldwell
-
Coeur d'Alene, Idaho, United States, 83814
- Kootenai Health - Coeur d'Alene
-
Emmett, Idaho, United States, 83617
- Walter Knox Memorial Hospital
-
Fruitland, Idaho, United States, 83619
- Saint Luke's Cancer Institute - Fruitland
-
Meridian, Idaho, United States, 83642
- Idaho Urologic Institute-Meridian
-
Meridian, Idaho, United States, 83642
- Saint Luke's Cancer Institute - Meridian
-
Nampa, Idaho, United States, 83686
- Saint Luke's Cancer Institute - Nampa
-
Nampa, Idaho, United States, 83687
- Saint Alphonsus Cancer Care Center-Nampa
-
Post Falls, Idaho, United States, 83854
- Kootenai Clinic Cancer Services - Post Falls
-
Sandpoint, Idaho, United States, 83864
- Kootenai Cancer Clinic
-
Twin Falls, Idaho, United States, 83301
- Saint Luke's Cancer Institute - Twin Falls
-
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Illinois
-
Aurora, Illinois, United States, 60504
- Rush - Copley Medical Center
-
Centralia, Illinois, United States, 62801
- Centralia Oncology Clinic
-
Centralia, Illinois, United States, 62801
- Saint Mary's Hospital
-
Chicago, Illinois, United States, 60612
- University of Illinois
-
Chicago, Illinois, United States, 60612
- Jesse Brown Veterans Affairs Medical Center
-
Danville, Illinois, United States, 61832
- Carle at The Riverfront
-
Decatur, Illinois, United States, 62526
- Decatur Memorial Hospital
-
Decatur, Illinois, United States, 62526
- Cancer Care Specialists of Illinois - Decatur
-
Effingham, Illinois, United States, 62401
- Crossroads Cancer Center
-
Effingham, Illinois, United States, 62401
- Carle Physician Group-Effingham
-
Harvey, Illinois, United States, 60426
- Ingalls Memorial Hospital
-
Joliet, Illinois, United States, 60435
- Duly Health and Care Joliet
-
Mount Vernon, Illinois, United States, 62864
- Good Samaritan Regional Health Center
-
O'Fallon, Illinois, United States, 62269
- Cancer Care Center of O'Fallon
-
River Forest, Illinois, United States, 60305
- West Suburban Medical Center
-
Springfield, Illinois, United States, 62781
- Memorial Medical Center
-
Springfield, Illinois, United States, 62702
- Southern Illinois University School of Medicine
-
Springfield, Illinois, United States, 62702
- Springfield Clinic
-
Urbana, Illinois, United States, 61801
- Carle Cancer Center
-
Urbana, Illinois, United States, 61801
- The Carle Foundation Hospital
-
Yorkville, Illinois, United States, 60560
- Rush-Copley Healthcare Center
-
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Indiana
-
Richmond, Indiana, United States, 47374
- Reid Health
-
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Iowa
-
Ames, Iowa, United States, 50010
- Mary Greeley Medical Center
-
Ames, Iowa, United States, 50010
- McFarland Clinic - Ames
-
Boone, Iowa, United States, 50036
- McFarland Clinic - Boone
-
Carroll, Iowa, United States, 51401
- Saint Anthony Regional Hospital
-
Cedar Rapids, Iowa, United States, 52402
- Physicians' Clinic of Iowa PC
-
Clive, Iowa, United States, 50325
- Mercy Cancer Center-West Lakes
-
Clive, Iowa, United States, 50325
- Medical Oncology and Hematology Associates-West Des Moines
-
Council Bluffs, Iowa, United States, 51502
- Jennie Edmundson Memorial Hospital
-
Council Bluffs, Iowa, United States, 51503
- Heartland Oncology and Hematology LLP
-
Creston, Iowa, United States, 50801
- Greater Regional Medical Center
-
Des Moines, Iowa, United States, 50309
- Iowa Methodist Medical Center
-
Des Moines, Iowa, United States, 50314
- Mercy Medical Center - Des Moines
-
Des Moines, Iowa, United States, 50309
- Medical Oncology and Hematology Associates-Des Moines
-
Des Moines, Iowa, United States, 50314
- Broadlawns Medical Center
-
Des Moines, Iowa, United States, 50314
- Mission Cancer and Blood - Laurel
-
Des Moines, Iowa, United States, 50316
- Iowa Lutheran Hospital
-
Fort Dodge, Iowa, United States, 50501
- Trinity Regional Medical Center
-
Fort Dodge, Iowa, United States, 50501
- McFarland Clinic - Trinity Cancer Center
-
Jefferson, Iowa, United States, 50129
- McFarland Clinic - Jefferson
-
Marshalltown, Iowa, United States, 50158
- McFarland Clinic - Marshalltown
-
West Des Moines, Iowa, United States, 50266-7700
- Methodist West Hospital
-
West Des Moines, Iowa, United States, 50266
- Mercy Medical Center-West Lakes
-
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Louisiana
-
Monroe, Louisiana, United States, 71202
- Ochsner LSU Health Monroe Medical Center
-
New Orleans, Louisiana, United States, 70112
- University Medical Center New Orleans
-
New Orleans, Louisiana, United States, 70112
- Louisiana State University Health Science Center
-
Shreveport, Louisiana, United States, 71103
- LSU Health Sciences Center at Shreveport
-
Shreveport, Louisiana, United States, 71101
- Ochsner LSU Health Saint Mary's Medical Center
-
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Maine
-
Augusta, Maine, United States, 04330
- Harold Alfond Center for Cancer Care
-
Biddeford, Maine, United States, 04005
- MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
-
Sanford, Maine, United States, 04073
- MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
-
South Portland, Maine, United States, 04106
- Maine Medical Partners - South Portland
-
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Maryland
-
Baltimore, Maryland, United States, 21215
- Sinai Hospital of Baltimore
-
Baltimore, Maryland, United States, 21229
- Saint Agnes Hospital
-
Bethesda, Maryland, United States, 20889-5600
- Walter Reed National Military Medical Center
-
Randallstown, Maryland, United States, 21133
- Northwest Hospital Center
-
Westminster, Maryland, United States, 21157
- William E Kahlert Regional Cancer Center/Sinai Hospital
-
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Massachusetts
-
Springfield, Massachusetts, United States, 01199
- Baystate Medical Center
-
-
Michigan
-
Adrian, Michigan, United States, 49221
- Hickman Cancer Center
-
Ann Arbor, Michigan, United States, 48106
- Saint Joseph Mercy Hospital
-
Battle Creek, Michigan, United States, 49017
- Bronson Battle Creek
-
Brighton, Michigan, United States, 48114
- Saint Joseph Mercy Brighton
-
Brighton, Michigan, United States, 48114
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
-
Canton, Michigan, United States, 48188
- Saint Joseph Mercy Canton
-
Canton, Michigan, United States, 48188
- Trinity Health IHA Medical Group Hematology Oncology - Canton
-
Chelsea, Michigan, United States, 48118
- Saint Joseph Mercy Chelsea
-
Chelsea, Michigan, United States, 48118
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
-
Clarkston, Michigan, United States, 48346
- Hematology Oncology Consultants-Clarkston
-
Clarkston, Michigan, United States, 48346
- Newland Medical Associates-Clarkston
-
Detroit, Michigan, United States, 48236
- Ascension Saint John Hospital
-
East China Township, Michigan, United States, 48054
- Great Lakes Cancer Management Specialists-Doctors Park
-
Flint, Michigan, United States, 48503
- Hurley Medical Center
-
Flint, Michigan, United States, 48503
- Genesee Cancer and Blood Disease Treatment Center
-
Flint, Michigan, United States, 48503
- Genesee Hematology Oncology PC
-
Flint, Michigan, United States, 48503
- Genesys Hurley Cancer Institute
-
Grand Rapids, Michigan, United States, 49503
- Spectrum Health at Butterworth Campus
-
Grand Rapids, Michigan, United States, 49503
- Trinity Health Grand Rapids Hospital
-
Grosse Pointe Woods, Michigan, United States, 48236
- Academic Hematology Oncology Specialists
-
Grosse Pointe Woods, Michigan, United States, 48236
- Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
-
Grosse Pointe Woods, Michigan, United States, 48236
- Michigan Breast Specialists-Grosse Pointe Woods
-
Kalamazoo, Michigan, United States, 49007
- West Michigan Cancer Center
-
Kalamazoo, Michigan, United States, 49007
- Bronson Methodist Hospital
-
Kalamazoo, Michigan, United States, 49048
- Borgess Medical Center
-
Kalamazoo, Michigan, United States, 49009
- Ascension Borgess Cancer Center
-
Lansing, Michigan, United States, 48912
- Sparrow Hospital
-
Livonia, Michigan, United States, 48154
- Trinity Health Saint Mary Mercy Livonia Hospital
-
Livonia, Michigan, United States, 48154
- Hope Cancer Clinic
-
Macomb, Michigan, United States, 48044
- Great Lakes Cancer Management Specialists-Macomb Medical Campus
-
Macomb, Michigan, United States, 48044
- Michigan Breast Specialists-Macomb Township
-
Monroe, Michigan, United States, 48162
- Toledo Clinic Cancer Centers-Monroe
-
Muskegon, Michigan, United States, 49444
- Trinity Health Muskegon Hospital
-
Norton Shores, Michigan, United States, 49444
- Cancer and Hematology Centers of Western Michigan - Norton Shores
-
Novi, Michigan, United States, 48374
- Ascension Providence Hospitals - Novi
-
Pontiac, Michigan, United States, 48341
- Saint Joseph Mercy Oakland
-
Pontiac, Michigan, United States, 48341
- 21st Century Oncology-Pontiac
-
Pontiac, Michigan, United States, 48341
- Hope Cancer Center
-
Pontiac, Michigan, United States, 48341
- Newland Medical Associates-Pontiac
-
Reed City, Michigan, United States, 49677
- Spectrum Health Reed City Hospital
-
Saginaw, Michigan, United States, 48601
- Ascension Saint Mary's Hospital
-
Saint Joseph, Michigan, United States, 49085
- Lakeland Medical Center Saint Joseph
-
Saint Joseph, Michigan, United States, 49085
- Marie Yeager Cancer Center
-
Southfield, Michigan, United States, 48075
- Ascension Providence Hospitals - Southfield
-
Sterling Heights, Michigan, United States, 48312
- Bhadresh Nayak MD PC-Sterling Heights
-
Warren, Michigan, United States, 48093
- Saint John Macomb-Oakland Hospital
-
Warren, Michigan, United States, 48088
- Advanced Breast Care Center PLLC
-
Warren, Michigan, United States, 48093
- Great Lakes Cancer Management Specialists-Macomb Professional Building
-
Warren, Michigan, United States, 48093
- Macomb Hematology Oncology PC
-
Warren, Michigan, United States, 48093
- Michigan Breast Specialists-Warren
-
Ypsilanti, Michigan, United States, 48197
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
-
Ypsilanti, Michigan, United States, 48106
- Huron Gastroenterology PC
-
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Minnesota
-
Aitkin, Minnesota, United States, 56431
- Riverwood Healthcare Center
-
Baxter, Minnesota, United States, 56425
- Essentia Health - Baxter Clinic
-
Brainerd, Minnesota, United States, 56401
- Essentia Health Saint Joseph's Medical Center
-
Burnsville, Minnesota, United States, 55337
- Fairview Ridges Hospital
-
Burnsville, Minnesota, United States, 55337
- Minnesota Oncology - Burnsville
-
Cambridge, Minnesota, United States, 55008
- Cambridge Medical Center
-
Coon Rapids, Minnesota, United States, 55433
- Mercy Hospital
-
Deer River, Minnesota, United States, 56636
- Essentia Health - Deer River Clinic
-
Detroit Lakes, Minnesota, United States, 56501
- Essentia Health Saint Mary's - Detroit Lakes Clinic
-
Duluth, Minnesota, United States, 55805
- Essentia Health Cancer Center
-
Duluth, Minnesota, United States, 55805
- Essentia Health Saint Mary's Medical Center
-
Duluth, Minnesota, United States, 55805
- Miller-Dwan Hospital
-
Edina, Minnesota, United States, 55435
- Fairview Southdale Hospital
-
Ely, Minnesota, United States, 55731
- Essentia Health - Ely Clinic
-
Fergus Falls, Minnesota, United States, 56537
- Lake Region Healthcare Corporation-Cancer Care
-
Fosston, Minnesota, United States, 56542
- Essentia Health - Fosston
-
Fridley, Minnesota, United States, 55432
- Unity Hospital
-
Hibbing, Minnesota, United States, 55746
- Essentia Health Hibbing Clinic
-
International Falls, Minnesota, United States, 56649
- Essentia Health - International Falls Clinic
-
Maple Grove, Minnesota, United States, 55369
- Fairview Clinics and Surgery Center Maple Grove
-
Maplewood, Minnesota, United States, 55109
- Saint John's Hospital - Healtheast
-
Maplewood, Minnesota, United States, 55109
- Minnesota Oncology Hematology PA-Maplewood
-
Minneapolis, Minnesota, United States, 55415
- Hennepin County Medical Center
-
Minneapolis, Minnesota, United States, 55407
- Abbott-Northwestern Hospital
-
Minneapolis, Minnesota, United States, 55454
- Health Partners Inc
-
Monticello, Minnesota, United States, 55362
- Monticello Cancer Center
-
Moose Lake, Minnesota, United States, 55767
- Essentia Health - Moose Lake Clinic
-
New Ulm, Minnesota, United States, 56073
- New Ulm Medical Center
-
Park Rapids, Minnesota, United States, 56470
- Essentia Health - Park Rapids
-
Princeton, Minnesota, United States, 55371
- Fairview Northland Medical Center
-
Robbinsdale, Minnesota, United States, 55422
- North Memorial Medical Health Center
-
Saint Cloud, Minnesota, United States, 56303
- Coborn Cancer Center at Saint Cloud Hospital
-
Saint Louis Park, Minnesota, United States, 55416
- Park Nicollet Clinic - Saint Louis Park
-
Saint Paul, Minnesota, United States, 55101
- Regions Hospital
-
Saint Paul, Minnesota, United States, 55102
- United Hospital
-
Sandstone, Minnesota, United States, 55072
- Essentia Health Sandstone
-
Shakopee, Minnesota, United States, 55379
- Saint Francis Regional Medical Center
-
Stillwater, Minnesota, United States, 55082
- Lakeview Hospital
-
Virginia, Minnesota, United States, 55792
- Essentia Health Virginia Clinic
-
Waconia, Minnesota, United States, 55387
- Ridgeview Medical Center
-
Willmar, Minnesota, United States, 56201
- Rice Memorial Hospital
-
Woodbury, Minnesota, United States, 55125
- Minnesota Oncology Hematology PA-Woodbury
-
Wyoming, Minnesota, United States, 55092
- Fairview Lakes Medical Center
-
-
Missouri
-
Ballwin, Missouri, United States, 63011
- Saint Louis Cancer and Breast Institute-Ballwin
-
Cape Girardeau, Missouri, United States, 63703
- Saint Francis Medical Center
-
Cape Girardeau, Missouri, United States, 63703
- Southeast Cancer Center
-
Creve Coeur, Missouri, United States, 63141
- Siteman Cancer Center at West County Hospital
-
Farmington, Missouri, United States, 63640
- Parkland Health Center - Farmington
-
Joplin, Missouri, United States, 64804
- Freeman Health System
-
Joplin, Missouri, United States, 64804
- Mercy Hospital Joplin
-
Rolla, Missouri, United States, 65401
- Delbert Day Cancer Institute at PCRMC
-
Rolla, Missouri, United States, 65401
- Mercy Clinic-Rolla-Cancer and Hematology
-
Saint Joseph, Missouri, United States, 64506
- Heartland Regional Medical Center
-
Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
-
Saint Louis, Missouri, United States, 63131
- Missouri Baptist Medical Center
-
Saint Louis, Missouri, United States, 63141
- Mercy Hospital Saint Louis
-
Saint Louis, Missouri, United States, 63128
- Mercy Hospital South
-
Saint Louis, Missouri, United States, 63129
- Siteman Cancer Center-South County
-
Saint Louis, Missouri, United States, 63136
- Siteman Cancer Center at Christian Hospital
-
Saint Louis, Missouri, United States, 63109
- Saint Louis Cancer and Breast Institute-South City
-
Saint Louis, Missouri, United States, 63125
- Veteran's Affairs Medical Center - Saint Louis
-
Saint Peters, Missouri, United States, 63376
- Siteman Cancer Center at Saint Peters Hospital
-
Sainte Genevieve, Missouri, United States, 63670
- Sainte Genevieve County Memorial Hospital
-
Springfield, Missouri, United States, 65807
- CoxHealth South Hospital
-
Springfield, Missouri, United States, 65804
- Mercy Hospital Springfield
-
Sullivan, Missouri, United States, 63080
- Missouri Baptist Sullivan Hospital
-
Sunset Hills, Missouri, United States, 63127
- Missouri Baptist Outpatient Center-Sunset Hills
-
Washington, Missouri, United States, 63090
- Mercy Hospital Washington
-
-
Montana
-
Anaconda, Montana, United States, 59711
- Community Hospital of Anaconda
-
Billings, Montana, United States, 59101
- Billings Clinic Cancer Center
-
Billings, Montana, United States, 59101
- Saint Vincent Healthcare
-
Billings, Montana, United States, 59102
- Saint Vincent Frontier Cancer Center
-
Bozeman, Montana, United States, 59715
- Bozeman Deaconess Hospital
-
Butte, Montana, United States, 59701
- Saint James Community Hospital and Cancer Treatment Center
-
Great Falls, Montana, United States, 59405
- Great Falls Clinic
-
Great Falls, Montana, United States, 59405
- Benefis Healthcare- Sletten Cancer Institute
-
Kalispell, Montana, United States, 59901
- Kalispell Regional Medical Center
-
Missoula, Montana, United States, 59804
- Community Medical Hospital
-
Missoula, Montana, United States, 59802
- Saint Patrick Hospital - Community Hospital
-
-
Nebraska
-
Bellevue, Nebraska, United States, 68123
- Nebraska Medicine-Bellevue
-
Grand Island, Nebraska, United States, 68803
- CHI Health Saint Francis
-
Omaha, Nebraska, United States, 68114
- Nebraska Methodist Hospital
-
Omaha, Nebraska, United States, 68198
- University of Nebraska Medical Center
-
Omaha, Nebraska, United States, 68118
- Nebraska Medicine-Village Pointe
-
Omaha, Nebraska, United States, 68114
- Oncology Associates PC
-
-
Nevada
-
Carson City, Nevada, United States, 89703
- Carson Tahoe Regional Medical Center
-
Henderson, Nevada, United States, 89052
- Comprehensive Cancer Centers of Nevada - Henderson
-
Henderson, Nevada, United States, 89052
- OptumCare Cancer Care at Seven Hills
-
Henderson, Nevada, United States, 89052
- Cancer and Blood Specialists-Henderson
-
Henderson, Nevada, United States, 89052
- Las Vegas Cancer Center-Henderson
-
Henderson, Nevada, United States, 89074
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
-
Henderson, Nevada, United States, 89074
- GenesisCare USA - Henderson
-
Henderson, Nevada, United States, 89052
- Comprehensive Cancer Centers of Nevada-Horizon Ridge
-
Henderson, Nevada, United States, 89074
- Las Vegas Urology - Green Valley
-
Henderson, Nevada, United States, 89074
- Las Vegas Urology - Pebble
-
Henderson, Nevada, United States, 89074
- Urology Specialists of Nevada - Green Valley
-
Las Vegas, Nevada, United States, 89144
- Summerlin Hospital Medical Center
-
Las Vegas, Nevada, United States, 89109
- Sunrise Hospital and Medical Center
-
Las Vegas, Nevada, United States, 89102
- OptumCare Cancer Care at Charleston
-
Las Vegas, Nevada, United States, 89106
- Radiation Oncology Centers of Nevada Central
-
Las Vegas, Nevada, United States, 89109
- GenesisCare USA - Las Vegas
-
Las Vegas, Nevada, United States, 89119
- Radiation Oncology Centers of Nevada Southeast
-
Las Vegas, Nevada, United States, 89128
- Comprehensive Cancer Centers of Nevada - Northwest
-
Las Vegas, Nevada, United States, 89128
- OptumCare Cancer Care at MountainView
-
Las Vegas, Nevada, United States, 89135
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
-
Las Vegas, Nevada, United States, 89144
- Comprehensive Cancer Centers of Nevada - Town Center
-
Las Vegas, Nevada, United States, 89144
- Comprehensive Cancer Centers of Nevada-Summerlin
-
Las Vegas, Nevada, United States, 89148
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, United States, 89148
- OptumCare Cancer Care at Fort Apache
-
Las Vegas, Nevada, United States, 89169
- Comprehensive Cancer Centers of Nevada - Central Valley
-
Las Vegas, Nevada, United States, 89102
- University Medical Center of Southern Nevada
-
Las Vegas, Nevada, United States, 89128
- GenesisCare USA - Vegas Tenaya
-
Las Vegas, Nevada, United States, 89148-2405
- Las Vegas Cancer Center-Medical Center
-
Las Vegas, Nevada, United States, 89148
- GenesisCare USA - Fort Apache
-
Las Vegas, Nevada, United States, 89128
- Ann M Wierman MD LTD
-
Las Vegas, Nevada, United States, 89074
- Las Vegas Urology - Pecos
-
Las Vegas, Nevada, United States, 89102
- Desert West Surgery
-
Las Vegas, Nevada, United States, 89103
- Hope Cancer Care of Nevada
-
Las Vegas, Nevada, United States, 89106
- Urology Specialists of Nevada - Central
-
Las Vegas, Nevada, United States, 89113
- Las Vegas Prostate Cancer Center
-
Las Vegas, Nevada, United States, 89113
- Las Vegas Urology - Sunset
-
Las Vegas, Nevada, United States, 89128
- Las Vegas Urology - Cathedral Rock
-
Las Vegas, Nevada, United States, 89128
- Las Vegas Urology - Smoke Ranch
-
Las Vegas, Nevada, United States, 89128
- Urology Specialists of Nevada - Northwest
-
Las Vegas, Nevada, United States, 89169
- University Cancer Center
-
Las Vegas, Nevada, United States, 89113
- Urology Specialists of Nevada - Southwest
-
Pahrump, Nevada, United States, 89048
- Hope Cancer Care of Nevada-Pahrump
-
Reno, Nevada, United States, 89502
- Renown Regional Medical Center
-
Reno, Nevada, United States, 89503
- Saint Mary's Regional Medical Center
-
Reno, Nevada, United States, 89509
- Radiation Oncology Associates
-
-
New Hampshire
-
Concord, New Hampshire, United States, 03301
- New Hampshire Oncology Hematology PA-Concord
-
Manchester, New Hampshire, United States, 03103
- Solinsky Center for Cancer Care
-
-
New Jersey
-
Mullica Hill, New Jersey, United States, 08062
- Inspira Medical Center Mullica Hill
-
-
New York
-
Auburn, New York, United States, 13021
- Hematology Oncology Associates of Central New York-Auburn
-
Bronx, New York, United States, 10468
- James J Peters VA Medical Center
-
East Syracuse, New York, United States, 13057
- Hematology Oncology Associates of Central New York-East Syracuse
-
Glens Falls, New York, United States, 12801
- Glens Falls Hospital
-
New York, New York, United States, 10032
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
-
New York, New York, United States, 10065
- NYP/Weill Cornell Medical Center
-
Syracuse, New York, United States, 13215
- Hematology Oncology Associates of Central New York-Onondaga Hill
-
Valley Stream, New York, United States, 11580
- South Nassau Cancer Center
-
-
North Carolina
-
Asheville, North Carolina, United States, 28803
- AdventHealth Infusion Center Asheville
-
Clayton, North Carolina, United States, 27520
- Johnston Health Clayton
-
Clinton, North Carolina, United States, 28328
- Southeastern Medical Oncology Center-Clinton
-
Clyde, North Carolina, United States, 28721
- AdventHealth Infusion Center Haywood
-
Durham, North Carolina, United States, 27710
- Duke University Medical Center
-
Goldsboro, North Carolina, United States, 27534
- Southeastern Medical Oncology Center-Goldsboro
-
Henderson, North Carolina, United States, 27536
- Maria Parham Hospital
-
Hendersonville, North Carolina, United States, 28792
- AdventHealth Hendersonville
-
Jacksonville, North Carolina, United States, 28546
- Southeastern Medical Oncology Center-Jacksonville
-
Kenansville, North Carolina, United States, 28349
- Vidant Oncology-Kenansville
-
Kinston, North Carolina, United States, 28501
- Vidant Oncology-Kinston
-
Laurinburg, North Carolina, United States, 28352
- Scotland Memorial Hospital-Laurinburg Cancer Center
-
Lumberton, North Carolina, United States, 28358
- Southeastern Regional Medical Center
-
Richlands, North Carolina, United States, 28574
- Vidant Oncology-Richlands
-
Smithfield, North Carolina, United States, 27577
- Johnston Memorial Hospital
-
Weaverville, North Carolina, United States, 28787
- AdventHealth Infusion Center Weaverville
-
-
North Dakota
-
Fargo, North Dakota, United States, 58103
- Essentia Health Cancer Center-South University Clinic
-
Jamestown, North Dakota, United States, 58401
- Essentia Health - Jamestown Clinic
-
-
Ohio
-
Beavercreek, Ohio, United States, 45431
- Indu and Raj Soin Medical Center
-
Boardman, Ohio, United States, 44512
- Saint Elizabeth Boardman Hospital
-
Centerville, Ohio, United States, 45459
- Miami Valley Hospital South
-
Centerville, Ohio, United States, 45459
- Dayton Physicians LLC-Miami Valley South
-
Chillicothe, Ohio, United States, 45601
- Adena Regional Medical Center
-
Cincinnati, Ohio, United States, 45236
- Oncology Hematology Care Inc-Kenwood
-
Columbus, Ohio, United States, 43214
- Riverside Methodist Hospital
-
Columbus, Ohio, United States, 43210
- Ohio State University Comprehensive Cancer Center
-
Columbus, Ohio, United States, 43219
- The Mark H Zangmeister Center
-
Columbus, Ohio, United States, 43228
- Doctors Hospital
-
Columbus, Ohio, United States, 43213
- Mount Carmel East Hospital
-
Columbus, Ohio, United States, 43215
- Grant Medical Center
-
Columbus, Ohio, United States, 43222
- Mount Carmel Health Center West
-
Dayton, Ohio, United States, 45409
- Miami Valley Hospital
-
Dayton, Ohio, United States, 45415
- Dayton Physician LLC-Miami Valley Hospital North
-
Dayton, Ohio, United States, 45415
- Miami Valley Hospital North
-
Delaware, Ohio, United States, 43015
- Delaware Health Center-Grady Cancer Center
-
Delaware, Ohio, United States, 43015
- Grady Memorial Hospital
-
Findlay, Ohio, United States, 45840
- Blanchard Valley Hospital
-
Findlay, Ohio, United States, 45840
- Armes Family Cancer Center
-
Findlay, Ohio, United States, 45840
- Orion Cancer Care
-
Franklin, Ohio, United States, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
-
Franklin, Ohio, United States, 45005
- Dayton Physicians LLC-Atrium
-
Greenville, Ohio, United States, 45331
- Wayne Hospital
-
Greenville, Ohio, United States, 45331
- Dayton Physicians LLC-Wayne
-
Grove City, Ohio, United States, 43123
- Mount Carmel Grove City Hospital
-
Grove City, Ohio, United States, 43123
- Zangmeister Center Grove City
-
Kettering, Ohio, United States, 45429
- Kettering Medical Center
-
Kettering, Ohio, United States, 45409
- Greater Dayton Cancer Center
-
Lancaster, Ohio, United States, 43130
- Fairfield Medical Center
-
Marietta, Ohio, United States, 45750
- Marietta Memorial Hospital
-
Maumee, Ohio, United States, 43537
- Toledo Clinic Cancer Centers-Maumee
-
Mount Vernon, Ohio, United States, 43050
- Knox Community Hospital
-
New Albany, Ohio, United States, 43054
- Mount Carmel New Albany Surgical Hospital
-
Newark, Ohio, United States, 43055
- Licking Memorial Hospital
-
Portsmouth, Ohio, United States, 45662
- Southern Ohio Medical Center
-
Springfield, Ohio, United States, 45505
- Springfield Regional Medical Center
-
Springfield, Ohio, United States, 45504
- Springfield Regional Cancer Center
-
Toledo, Ohio, United States, 43608
- Saint Vincent Mercy Medical Center
-
Toledo, Ohio, United States, 43623
- Mercy Health - Saint Anne Hospital
-
Toledo, Ohio, United States, 43623
- Toledo Clinic Cancer Centers-Toledo
-
Toledo, Ohio, United States, 43614
- University of Toledo
-
Troy, Ohio, United States, 45373
- Upper Valley Medical Center
-
Troy, Ohio, United States, 45373
- Dayton Physicians LLC - Troy
-
Warren, Ohio, United States, 44484
- Saint Joseph Warren Hospital
-
Westerville, Ohio, United States, 43081
- Saint Ann's Hospital
-
Wright-Patterson Air Force Base, Ohio, United States, 45433
- Wright-Patterson Medical Center
-
Youngstown, Ohio, United States, 44501
- Saint Elizabeth Youngstown Hospital
-
Zanesville, Ohio, United States, 43701
- Genesis Healthcare System Cancer Care Center
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73120
- Mercy Hospital Oklahoma City
-
-
Oregon
-
Baker City, Oregon, United States, 97814
- Saint Alphonsus Medical Center-Baker City
-
Corvallis, Oregon, United States, 97330
- Good Samaritan Hospital
-
Ontario, Oregon, United States, 97914
- Saint Alphonsus Medical Center-Ontario
-
-
Pennsylvania
-
Bryn Mawr, Pennsylvania, United States, 19010
- Bryn Mawr Hospital
-
Chadds Ford, Pennsylvania, United States, 19317
- Christiana Care Health System-Concord Health Center
-
Chambersburg, Pennsylvania, United States, 17201
- Chambersburg Hospital
-
Chambersburg, Pennsylvania, United States, 17201
- WellSpan Medical Oncology and Hematology
-
Collegeville, Pennsylvania, United States, 19426
- Main Line Health Center-Collegeville
-
Ephrata, Pennsylvania, United States, 17522
- Ephrata Cancer Center
-
Ephrata, Pennsylvania, United States, 17522
- Ephrata Community Hospital
-
Exton, Pennsylvania, United States, 19341
- Main Line Health Center-Exton
-
Gettysburg, Pennsylvania, United States, 17325
- Adams Cancer Center
-
Hanover, Pennsylvania, United States, 17331
- Cherry Tree Cancer Center
-
Lebanon, Pennsylvania, United States, 17042
- Sechler Family Cancer Center
-
Media, Pennsylvania, United States, 19063
- Riddle Memorial Hospital
-
Paoli, Pennsylvania, United States, 19301
- Paoli Memorial Hospital
-
Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University Hospital
-
Philadelphia, Pennsylvania, United States, 19114
- Jefferson Torresdale Hospital
-
Sayre, Pennsylvania, United States, 18840
- Guthrie Medical Group PC-Robert Packer Hospital
-
Willow Grove, Pennsylvania, United States, 19090
- Asplundh Cancer Pavilion
-
Wynnewood, Pennsylvania, United States, 19096
- Lankenau Medical Center
-
York, Pennsylvania, United States, 17403
- WellSpan Health-York Cancer Center
-
York, Pennsylvania, United States, 17403
- WellSpan Health-York Hospital
-
York, Pennsylvania, United States, 17403
- Cancer Care Associates of York
-
-
Rhode Island
-
Warwick, Rhode Island, United States, 02886
- Kent Hospital
-
-
South Carolina
-
Bluffton, South Carolina, United States, 29910
- Saint Joseph's/Candler - Bluffton Campus
-
Boiling Springs, South Carolina, United States, 29316
- Prisma Health Cancer Institute - Spartanburg
-
Easley, South Carolina, United States, 29640
- Prisma Health Cancer Institute - Easley
-
Georgetown, South Carolina, United States, 29440
- Tidelands Georgetown Memorial Hospital
-
Greenville, South Carolina, United States, 29605
- Prisma Health Cancer Institute - Faris
-
Greenville, South Carolina, United States, 29615
- Prisma Health Cancer Institute - Eastside
-
Greenville, South Carolina, United States, 29605
- Prisma Health Cancer Institute - Butternut
-
Greer, South Carolina, United States, 29650
- Prisma Health Cancer Institute - Greer
-
Hilton Head Island, South Carolina, United States, 29926-3827
- South Carolina Cancer Specialists PC
-
Seneca, South Carolina, United States, 29672
- Prisma Health Cancer Institute - Seneca
-
-
Texas
-
Bryan, Texas, United States, 77802
- Saint Joseph Regional Cancer Center
-
Dallas, Texas, United States, 75216
- Dallas VA Medical Center
-
-
Virginia
-
Chesapeake, Virginia, United States, 23320
- Cancer Specialists of Tidewater Limited
-
Gloucester, Virginia, United States, 23061
- Peninsula Cancer Institute-Gloucester
-
Lynchburg, Virginia, United States, 24501
- Centra Lynchburg Hematology-Oncology Clinic Inc
-
Mechanicsville, Virginia, United States, 23116
- Bon Secours Memorial Regional Medical Center
-
Midlothian, Virginia, United States, 23114
- Bon Secours Saint Francis Medical Center
-
Midlothian, Virginia, United States, 23113
- Bon Secours Westchester Emergency Center
-
Newport News, Virginia, United States, 23601
- Peninsula Cancer Institute-Newport News
-
Norfolk, Virginia, United States, 23505
- Bon Secours DePaul Medical Center
-
Onancock, Virginia, United States, 23417
- Riverside Shore Cancer Center
-
Portsmouth, Virginia, United States, 23707
- Bon Secours Maryview Medical Center
-
Richmond, Virginia, United States, 23298
- Virginia Commonwealth University/Massey Cancer Center
-
Richmond, Virginia, United States, 23229
- Virginia Cancer Institute
-
Richmond, Virginia, United States, 23226
- Bon Secours Saint Mary's Hospital
-
Richmond, Virginia, United States, 23230
- Bon Secours Cancer Institute at Reynolds Crossing
-
South Hill, Virginia, United States, 23970
- VCU Community Memorial Health Center
-
Suffolk, Virginia, United States, 23435
- Cancer Specialists of Tidewater-Suffolk
-
Suffolk, Virginia, United States, 23435
- Bon Secours Health Center at Harbour View
-
Virginia Beach, Virginia, United States, 23454
- Peninsula Cancer Institute-Cancer Specialists of Tidewater
-
Williamsburg, Virginia, United States, 23185
- Peninsula Cancer Institute-Williamsburg
-
-
Washington
-
Bellevue, Washington, United States, 98004
- Overlake Medical Center
-
Edmonds, Washington, United States, 98026
- Swedish Cancer Institute-Edmonds
-
Issaquah, Washington, United States, 98029
- Swedish Cancer Institute-Issaquah
-
Kennewick, Washington, United States, 99336
- Kadlec Clinic Hematology and Oncology
-
Port Townsend, Washington, United States, 98368
- Jefferson Healthcare
-
Renton, Washington, United States, 98055
- Valley Medical Center
-
Seattle, Washington, United States, 98107
- Swedish Medical Center-Ballard Campus
-
Seattle, Washington, United States, 98122
- Swedish Medical Center-First Hill
-
Seattle, Washington, United States, 98122-5711
- Swedish Medical Center-Cherry Hill
-
Walla Walla, Washington, United States, 99362
- Providence Saint Mary Regional Cancer Center
-
Yakima, Washington, United States, 98902
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
-
-
West Virginia
-
Bridgeport, West Virginia, United States, 26330
- United Hospital Center
-
Martinsburg, West Virginia, United States, 25401
- WVUH-Berkely Medical Center
-
Morgantown, West Virginia, United States, 26506
- West Virginia University Healthcare
-
Parkersburg, West Virginia, United States, 26101
- Camden Clark Medical Center
-
Wheeling, West Virginia, United States, 26003
- Wheeling Hospital/Schiffler Cancer Center
-
-
Wisconsin
-
Ashland, Wisconsin, United States, 54806
- Duluth Clinic Ashland
-
Ashland, Wisconsin, United States, 54806
- Northwest Wisconsin Cancer Center
-
Chippewa Falls, Wisconsin, United States, 54729
- Marshfield Clinic-Chippewa Center
-
Eau Claire, Wisconsin, United States, 54701
- Marshfield Medical Center-EC Cancer Center
-
Eau Claire, Wisconsin, United States, 54701
- Mayo Clinic Health System-Eau Claire Clinic
-
Hayward, Wisconsin, United States, 54843
- Essentia Health-Hayward Clinic
-
La Crosse, Wisconsin, United States, 54601
- Gundersen Lutheran Medical Center
-
La Crosse, Wisconsin, United States, 54601
- Mayo Clinic Health System-Franciscan Healthcare
-
Ladysmith, Wisconsin, United States, 54848
- Marshfield Clinic - Ladysmith Center
-
Marshfield, Wisconsin, United States, 54449
- Marshfield Medical Center-Marshfield
-
Menomonee Falls, Wisconsin, United States, 53051
- Froedtert Menomonee Falls Hospital
-
Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
-
Minocqua, Wisconsin, United States, 54548
- Marshfield Clinic-Minocqua Center
-
Mukwonago, Wisconsin, United States, 53149
- ProHealth D N Greenwald Center
-
New Richmond, Wisconsin, United States, 54017
- Cancer Center of Western Wisconsin
-
Oak Creek, Wisconsin, United States, 53154
- Drexel Town Square Health Center
-
Oconomowoc, Wisconsin, United States, 53066
- ProHealth Oconomowoc Memorial Hospital
-
Rice Lake, Wisconsin, United States, 54868
- Marshfield Medical Center-Rice Lake
-
Spooner, Wisconsin, United States, 54801
- Essentia Health-Spooner Clinic
-
Stevens Point, Wisconsin, United States, 54482
- Marshfield Medical Center-River Region at Stevens Point
-
Superior, Wisconsin, United States, 54880
- Essentia Health Saint Mary's Hospital - Superior
-
Waukesha, Wisconsin, United States, 53188
- UW Cancer Center at ProHealth Care
-
Waukesha, Wisconsin, United States, 53188
- ProHealth Waukesha Memorial Hospital
-
Wausau, Wisconsin, United States, 54401
- Marshfield Clinic-Wausau Center
-
West Bend, Wisconsin, United States, 53095
- Froedtert West Bend Hospital/Kraemer Cancer Center
-
Weston, Wisconsin, United States, 54476
- Marshfield Medical Center - Weston
-
Wisconsin Rapids, Wisconsin, United States, 54494
- Marshfield Clinic - Wisconsin Rapids Center
-
-
Wyoming
-
Cheyenne, Wyoming, United States, 82001
- Cheyenne Regional Medical Center-West
-
Cody, Wyoming, United States, 82414
- Billings Clinic-Cody
-
Sheridan, Wyoming, United States, 82801
- Welch Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Documentation of Disease: Histologic or cytologic diagnosis of non-small cell lung cancer (adenocarcinoma). Stage IV or recurrent metastatic non-small cell lung cancer. No planned initiation of definitive (potentially curative) concurrent chemo-radiation
Planning to begin MK-3475 (pembrolizumab) treatment within 14 days of registration, with or without combination chemotherapy. Treating physician considers pembrolizumab as appropriate and plans to proceed with one of the following treatment schedules:
- MK-3475 (pembrolizumab) 200 mg IV flat dose every 21 days or 400 mg IV every 42 days.
- MK-3475 (pembrolizumab) 200 mg IV or 400 mg IV + carboplatin area under the curve (AUC) = 5 + pemetrexed 500 mg/m^2 (20% chemotherapy dose reduction is permitted per the discretion of the treating physician)
- Patients will be ineligible if they have an autoimmune disorder, are post-organ transplantation, or are receiving ongoing immunosuppression treatment
- Prior adjuvant therapy is allowed and must have been completed at least 6 months prior to registration
- No planned radiation or other cancer treatment in the 3 months following registration
- No untreated brain metastases. Patients must be off corticosteroids and asymptomatic at registration
- Absolute neutrophil count (ANC) >= 1500/mm^3 (1.5 x 10^9/L)
- Platelet count: >= 100,000/mm^3 (100 x 10^9/L)
Creatinine >= 30 mL/min* for patients enrolled to pembrolizumab alone and > 45 mL/min for patients enrolled to chemotherapy + pembrolizumab
* Calculated using the Cockcroft-Gault formula
- Total serum bilirubin =< 1.5 upper limit of normal (ULN) (< 3 ULN if Gilbert's disease)
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =< 3 x ULN (=< 5.0 x ULN if liver metastases present)
- Alkaline phosphatase =< 2.5 x ULN (=< 5 x ULN if bone or liver metastases present) Language: Patients must be able to speak and comprehend English in order to complete the mandatory patient-completed measures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A (pembrolizumab)
Patients receive pembrolizumab IV over 30 minutes on day 1.
Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Ancillary studies
Ancillary studies
Given IV
Ancillary studies
|
|
Experimental: Group B (pembrolizumab, pemetrexed, carboplatin)
Patients receive pembrolizumab IV over 30 minutes, pemetrexed IV over 10 minutes, and carboplatin IV per institutional guidelines on day 1.
Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Given IV
Ancillary studies
Ancillary studies
Given IV
Given IV
Ancillary studies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Grade 3 or Worse Adverse Events Post Registration
Time Frame: Up to 7 days of last day of treatment, up to 6 months
|
Assessed by National Cancer Institute Common Terminology Criteria in Adverse Events version 5.0.
The proportion of patients experience grade 3 or worse adverse events (AEs) will be summarized by frequency and percentage along with a 95% confidence interval (CI) separately by type of therapy (monotherapy or combination therapy) as well as combining the two cohorts.
All other individual AEs will be analyzed in an exploratory and hypothesis generating manner; including and not limited to multi-variate logistic regression models considering the baseline demographics and the presence/absence of the AE.
|
Up to 7 days of last day of treatment, up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Survival (OS)
Time Frame: From study registration to death or the last follow-up whichever occurs first, assessed up to 3 years
|
Will be summarized using the Kaplan-Meier estimator, separately by monotherapy or combination therapy as well as by the combined cohort.
|
From study registration to death or the last follow-up whichever occurs first, assessed up to 3 years
|
|
Quality of Life (QOL): Linear Analogue Self-Assessment [LASA] Questionnaire
Time Frame: Up to 9 weeks
|
The overall quality of life score (the first question of the Linear Analogue Self-Assessment [LASA] questionnaire) at each time point as well as change from baseline will be summarized by mean (standard deviation), median (range) along with a longitudinal plot.
The median quality of life (QOL) change from baseline along with a 95% confidence interval (CI) will be estimated using the Hodges-Lehmann method.
The overall quality of life score will be measured on a scale from 0-10, with higher being better.
|
Up to 9 weeks
|
|
Comprehensive Geriatric Assessment Risk Score
Time Frame: At baseline. Per the protocol section 13.5,Comprehensive geriatric assessment would be examined combined by arm.
|
The geriatric risk score, measured as low, medium, or high, will be summarized in a 3X2 frequency table with adverse events.
|
At baseline. Per the protocol section 13.5,Comprehensive geriatric assessment would be examined combined by arm.
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Aminah Jatoi, MD, Mayo Clinic
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Site
- Neoplasms
- Disease Attributes
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Lung Diseases
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Adenocarcinoma of Lung
- Recurrence
- Carcinoma
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Adenocarcinoma
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Antineoplastic Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Folic Acid Antagonists
- Nucleic Acid Synthesis Inhibitors
- Pemetrexed
- Carboplatin
- Pembrolizumab
Other Study ID Numbers
- A171901
- UG1CA189823 (U.S. NIH Grant/Contract)
- NCI-2020-00544 (Registry Identifier: NCI Clinical Trial Reporting Program)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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GFPC InvestigationRecruitingMetastatic Lung Cancer | Metastatic NSCLC | Metastatic Small Cell Lung CancerFrance
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National Cancer Institute (NCI)Active, not recruitingMetastatic Lung Non-Small Cell Carcinoma | Stage IV Lung Cancer AJCC v8 | Advanced Lung Non-Small Cell CarcinomaUnited States
Clinical Trials on Carboplatin
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Eisai Inc.CompletedCancerUnited States, Austria, India
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NHS Greater Glasgow and ClydeCompletedOvarian Cancer | Fallopian Tube Cancer | Primary Peritoneal Cavity CancerUnited Kingdom, Australia, New Zealand
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Duke UniversityCompletedBrain and Central Nervous System TumorsUnited States, Canada
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Samyang Biopharmaceuticals CorporationCompleted
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Shanghai Pulmonary Hospital, Shanghai, ChinaNot yet recruiting
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Zhejiang Cancer HospitalRecruiting
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Tang-Du HospitalRecruitingHead & Neck CancerChina
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Shuangyue LiuNot yet recruiting
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H. Lee Moffitt Cancer Center and Research InstituteNational Cancer Institute (NCI)CompletedUnspecified Adult Solid Tumor, Protocol SpecificUnited States
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Eli Lilly and CompanyCompletedLung NeoplasmsUnited States