Adding the Immunotherapy Drug Cemiplimab to Usual Treatment for People With Advanced Non-Small Cell Lung Cancer Who Had Previous Treatment With Platinum Chemotherapy and Immunotherapy (An Expanded Lung-MAP Treatment Trial)
Sponsored by SWOG Cancer Research Network
About this study
This phase II/III Expanded Lung-MAP treatment trial compares the effect of adding cemiplimab to docetaxel and ramucirumab versus docetaxel and ramucirumab alone in treating patients with non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Cemiplimab is a monoclonal antibody that stimulates the immune system by blocking the PD-1 pathway. Tumors use the PD-1 pathway to escape attacks from the immune system. By blocking the PD-1 pathway, cemiplimab may help the immune system recognize and attack tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Adding cemiplimab to usual treatment, docetaxel and ramucirumab, may kill more tumor cells compared to docetaxel and ramucirumab alone in treating patients with stage IV or recurrent non-small cell lung cancer.
PRIMARY OBJECTIVE: I. To compare overall survival (OS) between participants randomized to docetaxel and ramucirumab with or without cemiplimab (REGN2810) who have acquired resistance to platinum-based chemotherapy and immunotherapy for stage IV or recurrent non-small cell lung cancer (NSCLC). SECONDARY OBJECTIVES: I. To compare investigator-assessed progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 between the arms. II. To compare investigator-assessed response rates (confirmed or unconfirmed, complete response \[CR\] or partial response \[PR\]) per RECIST 1.1 between the arms among participants with measurable disease. III. To compare the investigator-assessed disease control rate (confirmed or unconfirmed, complete response \[CR\], or part…
Where this study is enrolling (381)
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Mobile Infirmary Medical Center
Mobile, Alabama
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Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis
Daphne, Alabama
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Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland
Saraland, Alabama
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Thomas Hospital
Fairhope, Alabama
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Katmai Oncology Group
Anchorage, Alaska
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Banner University Medical Center - Tucson
Tucson, Arizona
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University of Arizona Cancer Center-North Campus
Tucson, Arizona
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NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas
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City of Hope Comprehensive Cancer Center
Duarte, California
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City of Hope Antelope Valley
Lancaster, California
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City of Hope at Irvine Lennar
Irvine, California
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Kaiser Permanente-Riverside
Riverside, California
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Ontario, California
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Oakland, California
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Irvine, California
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Veterans Affairs Medical Center - San Francisco
San Francisco, California
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Fresno, California
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Fontana, California
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Bellflower, California
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Baldwin Park, California
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Anaheim, California
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Los Angeles, California
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Harbor City, California
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San Leandro, California
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Kaiser Permanente - Panorama City
Panorama City, California
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University of California Davis Comprehensive Cancer Center
Sacramento, California
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UC San Diego Moores Cancer Center
La Jolla, California
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Tower Cancer Research Foundation
Beverly Hills, California
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Torrance Memorial Physician Network - Cancer Care
Torrance, California
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Santa Clara, California
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Los Angeles, California
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Kaiser Permanente Fresno Orchard Plaza
Fresno, California
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Sacramento, California
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Walnut Creek, California
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San Rafael, California
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Vallejo, California
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South San Francisco, California
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Kaiser Permanente-Woodland Hills
Woodland Hills, California
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Loma Linda University Medical Center
Loma Linda, California
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Kaiser Permanente-Santa Teresa-San Jose
San Jose, California
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San Marcos, California
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San Francisco, California
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Roseville, California
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Mather Veteran Affairs Medical Center
Mather, California
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Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California
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Fremont - Rideout Cancer Center
Marysville, California
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Mills Health Center
San Mateo, California
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San Diego, California
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Enloe Medical Center
Chico, California
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Eisenhower Medical Center
Rancho Mirage, California
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Upland, California
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City of Hope South Bay
Torrance, California
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Cedars-Sinai Cancer - Tarzana
Tarzana, California
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Cedars-Sinai Medical Center
Los Angeles, California
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Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut
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Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut
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Torrington, Connecticut
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Derby, Connecticut
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Trumbull, Connecticut
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Fairfield, Connecticut
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Guilford, Connecticut
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Hartford, Connecticut
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Stamford, Connecticut
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Greenwich, Connecticut
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Glastonbury, Connecticut
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North Haven, Connecticut
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New Haven, Connecticut
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Medical Oncology Hematology Consultants PA
Newark, Delaware
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Rehoboth Beach, Delaware
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Newark, Delaware
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Millville, Delaware
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Washington D.C., District of Columbia
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Gainesville, Florida
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Tampa, Florida
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Gainesville, Georgia
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Atlanta, Georgia
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Atlanta, Georgia
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Savannah, Georgia
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Duluth, Georgia
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Atlanta, Georgia
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Decatur, Georgia
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Johns Creek, Georgia
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Atlanta, Georgia
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Lawrenceville, Georgia
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Atlanta, Georgia
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Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho
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Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho
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Meridian, Idaho
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Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho
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Nampa, Idaho
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Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho
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Sandpoint, Idaho
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Caldwell, Idaho
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Idaho Urologic Institute-Meridian
Meridian, Idaho
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Boise, Idaho
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Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho
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Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois
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Condell Memorial Hospital
Libertyville, Illinois
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Crossroads Cancer Center
Effingham, Illinois
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Carle Cancer Institute Normal
Normal, Illinois
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Decatur Memorial Hospital
Decatur, Illinois
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Northwestern University
Chicago, Illinois
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Orland Park, Illinois
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Oak Brook, Illinois
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Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois
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Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois
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Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois
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Warrenville, Illinois
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Carle Cancer Center
Urbana, Illinois
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Normal, Illinois
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DeKalb, Illinois
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Geneva, Illinois
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Danville, Illinois
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Memorial Hospital East
Shiloh, Illinois
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Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois
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Cancer Care Center of O'Fallon
O'Fallon, Illinois
- Call 708-226-4357
Loyola University Medical Center
Maywood, Illinois
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Illinois CancerCare-Macomb
Macomb, Illinois
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Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois
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Illinois CancerCare-Pekin
Pekin, Illinois
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Illinois CancerCare-Peoria
Peoria, Illinois
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Illinois CancerCare-Peru
Peru, Illinois
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Illinois CancerCare-Princeton
Princeton, Illinois
- Call 217-545-7929
Southern Illinois University School of Medicine
Springfield, Illinois
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Springfield Clinic
Springfield, Illinois
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Advocate Good Samaritan Hospital
Downers Grove, Illinois
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Springfield Memorial Hospital
Springfield, Illinois
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Advocate Christ Medical Center
Oak Lawn, Illinois
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AMG Libertyville - Oncology
Libertyville, Illinois
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AMG Crystal Lake - Oncology
Crystal Lake, Illinois
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Advocate South Suburban Hospital
Hazel Crest, Illinois
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Advocate Sherman Hospital
Elgin, Illinois
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Advocate Outpatient Center - Oak Lawn
Oak Lawn, Illinois
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Advocate Outpatient Center - Aurora
Aurora, Illinois
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Advocate Lutheran General Hospital
Park Ridge, Illinois
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Advocate Illinois Masonic Medical Center
Chicago, Illinois
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Advocate High Tech Medical Park
Palos Heights, Illinois
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Advocate Good Shepherd Hospital
Barrington, Illinois
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Carle Physician Group-Effingham
Effingham, Illinois
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HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois
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Illinois CancerCare - Washington
Washington, Illinois
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Illinois CancerCare-Bloomington
Bloomington, Illinois
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Illinois CancerCare-Canton
Canton, Illinois
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Illinois CancerCare-Carthage
Carthage, Illinois
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Illinois CancerCare-Dixon
Dixon, Illinois
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Illinois CancerCare-Eureka
Eureka, Illinois
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Illinois CancerCare-Galesburg
Galesburg, Illinois
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Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois
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Richard L. Roudebush Veterans Affairs Medical Center
Indianapolis, Indiana
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Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana
- Call 785-623-5774
HaysMed
Hays, Kansas
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The University of Kansas Cancer Center - Olathe
Olathe, Kansas
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University of Kansas Cancer Center-Overland Park
Overland Park, Kansas
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University of Kansas Cancer Center
Kansas City, Kansas
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University of Kansas Clinical Research Center
Fairway, Kansas
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University of Kansas Health System Saint Francis Campus
Topeka, Kansas
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University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas
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University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas
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Salina Regional Health Center
Salina, Kansas
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Lawrence Memorial Hospital
Lawrence, Kansas
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Veteran Administration Eastern Kansas Healthcare
Leavenworth, Kansas
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University of Kentucky/Markey Cancer Center
Lexington, Kentucky
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Penobscot Bay Medical Center
Rockport, Maine
- Call 207-459-1600
MaineHealth Cancer Care Center of York County
Sanford, Maine
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Harold Alfond Center for Cancer Care
Augusta, Maine
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MaineHealth Cancer Care and IV Therapy - Brunswick
Brunswick, Maine
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MaineHealth LincolnHealth Hospital
Damariscotta, Maine
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MaineHealth Waldo Hospital
Belfast, Maine
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Lafayette Family Cancer Center-EMMC
Brewer, Maine
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MaineHealth Cancer Care and IV Therapy - South Portland
South Portland, Maine
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Kaiser Permanente Lutherville - Timonium Medical Center
Lutherville, Maryland
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Kaiser Permanente - Largo Medical Center
Largo, Maryland
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Kaiser Permanente-Gaithersburg Medical Center
Gaithersburg, Maryland
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Kaiser Permanente-Woodlawn Medical Center
Baltimore, Maryland
- Call 410-368-2910
Saint Agnes Hospital
Baltimore, Maryland
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UPMC Western Maryland
Cumberland, Maryland
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Baystate Medical Center
Springfield, Massachusetts
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UMass Memorial Medical Center - University Campus
Worcester, Massachusetts
- Call 978-922-3000
Beverly Hospital
Beverly, Massachusetts
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Lahey Medical Center-Peabody
Peabody, Massachusetts
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Lahey Hospital and Medical Center
Burlington, Massachusetts
- Call 978-283-4000
Addison Gilbert Hospital
Gloucester, Massachusetts
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Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan
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Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan
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OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan
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Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan
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Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan
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Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan
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Genesys Hurley Cancer Institute
Flint, Michigan
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University of Michigan Health - Sparrow Lansing
Lansing, Michigan
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Cancer Hematology Centers - Flint
Flint, Michigan
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Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan
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Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota
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North Memorial Medical Health Center
Robbinsdale, Minnesota
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Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota
- Call 605-312-3320
Sanford Cancer Center Worthington
Worthington, Minnesota
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Abbott-Northwestern Hospital
Minneapolis, Minnesota
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Sanford Joe Lueken Cancer Center
Bemidji, Minnesota
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Essentia Health Sandstone
Sandstone, Minnesota
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Fairview Southdale Hospital
Edina, Minnesota
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Mercy Hospital
Coon Rapids, Minnesota
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Essentia Health Cancer Center
Duluth, Minnesota
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Essentia Health - Deer River Clinic
Deer River, Minnesota
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Essentia Health Virginia Clinic
Virginia, Minnesota
- Call 218-786-3308
Essentia Health Hibbing Clinic
Hibbing, Minnesota
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Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota
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United Hospital
Saint Paul, Minnesota
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Regions Hospital
Saint Paul, Minnesota
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Gulfport Memorial Hospital
Gulfport, Mississippi
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Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi
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Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi
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Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi
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Baptist Cancer Center-Grenada
Grenada, Mississippi
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Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi
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Saint Francis Medical Center
Cape Girardeau, Missouri
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BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri
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Siteman Cancer Center-South County
St Louis, Missouri
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Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri
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Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri
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Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri
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Siteman Cancer Center at Christian Hospital
St Louis, Missouri
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University of Kansas Cancer Center - North
Kansas City, Missouri
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University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri
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University of Kansas Cancer Center - Briarcliff
Kansas City, Missouri
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Mercy Hospital South
St Louis, Missouri
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Lake Regional Hospital
Osage Beach, Missouri
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Kansas City Veterans Affairs Medical Center
Kansas City, Missouri
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Missouri Baptist Medical Center
St Louis, Missouri
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Missouri Baptist Sullivan Hospital
Sullivan, Missouri
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University Health Truman Medical Center
Kansas City, Missouri
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Washington University School of Medicine
St Louis, Missouri
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Parkland Health Center - Farmington
Farmington, Missouri
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Benefis Sletten Cancer Institute
Great Falls, Montana
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Community Medical Center
Missoula, Montana
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Community Hospital of Anaconda
Anaconda, Montana
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Logan Health Medical Center
Kalispell, Montana
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Billings Clinic Cancer Center
Billings, Montana
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Bozeman Health Deaconess Hospital
Bozeman, Montana
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New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire
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Solinsky Center for Cancer Care
Manchester, New Hampshire
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Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire
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Virtua Voorhees
Voorhees Township, New Jersey
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Virtua Samson Cancer Center
Moorestown, New Jersey
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University of New Mexico Cancer Center
Albuquerque, New Mexico
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James J Peters VA Medical Center
The Bronx, New York
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Wilmot Cancer Institute at Webster
Webster, New York
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Montefiore Medical Center-Einstein Campus
The Bronx, New York
- Call 585-275-5830
University of Rochester
Rochester, New York
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FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina
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Durham VA Medical Center
Durham, North Carolina
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Sanford Bismarck Medical Center
Bismarck, North Dakota
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Sanford Broadway Medical Center
Fargo, North Dakota
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Sanford Roger Maris Cancer Center
Fargo, North Dakota
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Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota
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Delaware Health Center-Grady Cancer Center
Delaware, Ohio
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Grant Medical Center
Columbus, Ohio
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Grady Memorial Hospital
Delaware, Ohio
- Call 937-569-7515
Miami Valley Cancer Care and Infusion
Greenville, Ohio
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- I'm interested
Miami Valley Hospital North
Dayton, Ohio
- I'm interested
Miami Valley Hospital South
Centerville, Ohio
- I'm interested
Miami Valley Hospital
Dayton, Ohio
- I'm interested
Dublin Methodist Hospital
Dublin, Ohio
- I'm interested
Doctors Hospital
Columbus, Ohio
- I'm interested
OhioHealth Mansfield Hospital
Mansfield, Ohio
- I'm interested
OhioHealth Marion General Hospital
Marion, Ohio
- I'm interested
OhioHealth O'Bleness Hospital
Athens, Ohio
- I'm interested
OhioHealth Pickerington Methodist Hospital
Pickerington, Ohio
- I'm interested
OhioHealth Westerville Medical Campus/Westerville Cancer Center
Westerville, Ohio
- Call 937-276-8320
Premier Blood and Cancer Center
Dayton, Ohio
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- I'm interested
ProMedica Flower Hospital
Sylvania, Ohio
- I'm interested
Riverside Methodist Hospital
Columbus, Ohio
- I'm interested
Columbus Oncology and Hematology Associates
Dublin, Ohio
- I'm interested
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio
- I'm interested
Aultman Health Foundation
Canton, Ohio
- I'm interested
Upper Valley Medical Center
Troy, Ohio
- I'm interested
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio
- I'm interested
Integris Southwest Medical Center
Oklahoma City, Oklahoma
- I'm interested
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma
- Call 877-231-4440
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma
This research site can be reached directly by phone. Call to ask about this study.
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- Call 405-752-3402
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma
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- I'm interested
Providence Willamette Falls Medical Center
Oregon City, Oregon
- I'm interested
Providence Portland Medical Center
Portland, Oregon
- I'm interested
Oregon Health and Science University
Portland, Oregon
- I'm interested
Providence Newberg Medical Center
Newberg, Oregon
- Call 503-561-2618
Salem Hospital
Salem, Oregon
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- I'm interested
Providence Saint Vincent Medical Center
Portland, Oregon
- I'm interested
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon
- I'm interested
Saint Alphonsus Cancer Care Center-Baker City
Baker City, Oregon
- Call 412-647-8073
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania
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- I'm interested
UPMC Cancer Center at UPMC Horizon
Farrell, Pennsylvania
- Call 717-217-6020
WellSpan Medical Oncology and Hematology
Chambersburg, Pennsylvania
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- Call 717-741-9229
Cancer Care Associates of York
York, Pennsylvania
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- I'm interested
Arnold Palmer Cancer Center Medical Oncology Norwin
N. Huntingdon, Pennsylvania
- I'm interested
UPMC Hillman Cancer Center in Coraopolis
Moon Township, Pennsylvania
- I'm interested
Fox Chase Cancer Center
Philadelphia, Pennsylvania
- I'm interested
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania
- I'm interested
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania
- I'm interested
UPMC Hillman Cancer Center at Butler Health System
Butler, Pennsylvania
- I'm interested
UPMC Cancer Center-Washington
Washington, Pennsylvania
- I'm interested
UPMC Cancer Center-Uniontown
Uniontown, Pennsylvania
- Call 724-838-1900
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania
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- Call 724-230-3030
UPMC Cancer Center-Natrona Heights
Natrona Heights, Pennsylvania
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- Call 814-676-7900
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania
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- Call 412-647-8073
UPMC Cancer Center at UPMC McKeesport
McKeesport, Pennsylvania
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- I'm interested
Sechler Family Cancer Center
Lebanon, Pennsylvania
- I'm interested
IRMC Cancer Center
Indiana, Pennsylvania
- I'm interested
Temple University Hospital
Philadelphia, Pennsylvania
- Call 412-784-4900
UPMC-Saint Margaret
Pittsburgh, Pennsylvania
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- Call 412-502-3920
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania
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- Call 412-367-6454
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania
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- Call 814-534-4724
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania
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- I'm interested
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania
- Call 877-441-7957
Adams Cancer Center
Gettysburg, Pennsylvania
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- Call 800-598-4282
UPMC Susquehanna
Williamsport, Pennsylvania
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- I'm interested
Divine Providence Hospital
Williamsport, Pennsylvania
- I'm interested
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania
- I'm interested
UPMC Hillman Cancer Center - Passavant - Cranberry
Cranberry Township, Pennsylvania
- I'm interested
UPMC Hillman Cancer Center - Part of Frick Hospital
Mount Pleasant, Pennsylvania
- I'm interested
UPMC Hillman Cancer Center - New Castle
New Castle, Pennsylvania
- Call 717-721-4840
Ephrata Cancer Center
Ephrata, Pennsylvania
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- I'm interested
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania
- I'm interested
SMC Center for Hematology Oncology Union
Union, South Carolina
- I'm interested
Gibbs Cancer Center-Pelham
Greer, South Carolina
- I'm interested
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina
- I'm interested
South Carolina Cancer Specialists PC
Hilton Head Island, South Carolina
- I'm interested
Spartanburg Medical Center
Spartanburg, South Carolina
- I'm interested
Saint Joseph's/Candler - Bluffton Campus
Bluffton, South Carolina
- I'm interested
AnMed Health Cancer Center
Anderson, South Carolina
- I'm interested
Medical University of South Carolina
Charleston, South Carolina
- I'm interested
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota
- I'm interested
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota
- I'm interested
Rapid City Regional Hospital
Rapid City, South Dakota
- I'm interested
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee
- I'm interested
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee
- I'm interested
The Don and Sybil Harrington Cancer Center
Amarillo, Texas
- I'm interested
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah
- I'm interested
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont
- Call 866-687-8387
White River Junction Veteran Administration Medical Center
White River Junction, Vermont
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- I'm interested
VCU Massey Cancer Center at Stony Point
Richmond, Virginia
- I'm interested
Centra Alan B Pearson Regional Cancer Center
Lynchburg, Virginia
- I'm interested
University of Virginia Cancer Center
Charlottesville, Virginia
- I'm interested
Virginia Cancer Institute
Richmond, Virginia
- I'm interested
Kaiser Permanente Tysons Corner Medical Center
McLean, Virginia
- I'm interested
Kaiser Permanente-Caton Hill Medical Center
Woodbridge, Virginia
- I'm interested
VCU Community Memorial Health Center
South Hill, Virginia
- I'm interested
VCU Massey Comprehensive Cancer Center
Richmond, Virginia
- Call 304-243-6442
Wheeling Hospital/Schiffler Cancer Center
Wheeling, West Virginia
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- I'm interested
Edwards Comprehensive Cancer Center
Huntington, West Virginia
- I'm interested
WVUH-Berkely Medical Center
Martinsburg, West Virginia
- I'm interested
United Hospital Center
Bridgeport, West Virginia
- I'm interested
Camden Clark Medical Center
Parkersburg, West Virginia
- I'm interested
West Virginia University Healthcare
Morgantown, West Virginia
- I'm interested
Aurora West Allis Medical Center
West Allis, Wisconsin
- I'm interested
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin
- I'm interested
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin
- I'm interested
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin
- I'm interested
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin
- I'm interested
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin
- I'm interested
Gundersen Lutheran Medical Center
La Crosse, Wisconsin
- I'm interested
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin
- I'm interested
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin
- I'm interested
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin
- I'm interested
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin
- I'm interested
Sheboygan Physicians Group
Sheboygan, Wisconsin
- I'm interested
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin
- I'm interested
Marshfield Medical Center - Weston
Weston, Wisconsin
- I'm interested
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin
- I'm interested
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin
- I'm interested
Aurora BayCare Medical Center
Green Bay, Wisconsin
- I'm interested
Aurora Cancer Care-Grafton
Grafton, Wisconsin
- I'm interested
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin
- I'm interested
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin
- I'm interested
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin
- I'm interested
Aurora Cancer Care-Racine
Racine, Wisconsin
- I'm interested
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin
- I'm interested
Duluth Clinic Ashland
Ashland, Wisconsin
- I'm interested
Aurora Health Care Germantown Health Center
Germantown, Wisconsin
- I'm interested
Aurora Medical Center in Summit
Summit, Wisconsin
- I'm interested
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin
- I'm interested
Aurora Saint Luke's South Shore
Cudahy, Wisconsin
- I'm interested
Aurora Sinai Medical Center
Milwaukee, Wisconsin
Who can participate
Inclusion criteria
- ✓Participants must have been assigned to S1800E by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1800E is determined by the LUNGMAP protocol
- ✓Participants must have measurable or non-measurable disease documented by CT or MRI. The CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality. Measurable disease must be assessed within 28 days prior to randomization. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non-measurable disease must be assessed within 42 days prior to randomization. All disease must be assessed and documented on the Baseline Tumor Assessment Form. Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to registration
- ✓Participants must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to randomization
- ✓Participants must have received exactly one anti-PD-1 or anti-PD-L1 therapy for advanced disease (stage IV or recurrent disease, or stage I-III disease in certain circumstances outlined below). Anti-PD-1 or anti-PD-L1 therapy may have been given alone or in combination with other therapy. For participants who received neoadjuvant, adjuvant, and/or consolidation anti-PD-1 or anti-PD-L1 therapy for stage I-III disease:
- ✓If they experienced disease progression within (≤) 365 days from initiation (cycle 1 day 1) or anti-PD-1 or anti-PD-L1 therapy, this counts as the single allowed anti-PD-1 or anti-PD-L1 therapy for advanced disease
- ✓If they experienced disease progression more than (\>) 365 days from initiation (cycle 1 day 1) or anti-PD-1 or anti-PD-L1 therapy, this is not considered anti-PD-1 or anti-PD-L1 therapy for advance disease. These participants must have received anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease
- ✓Participants must have experienced disease progression (in the opinion of the treating investigator) more than (\>) 84 days following initiation (cycle 1 day 1) of their most recent anti-PD-1 or anti-PD-L1 therapy
- ✓Participants who received anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease must have had a best response of stable disease, partial response or complete response (in the opinion of the treating investigator) on the anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease
- ✓Participants must have received platinum-based chemotherapy and experienced disease progression (in the opinion of the treating investigator) during or after this regimen
- ✓Participants with a known sensitizing molecular alteration for which a Food and Drug Administration (FDA)-approved targeted therapy for NSCLC exists (e.g., EGFR, ALK, ROS1, BRAF, RET, NTRK, KRAS, HER2, and MET sensitizing mutations), must have previously received at least one of the approved therapy(s). Prior targeted therapy for participants with targetable alterations is allowed if all other eligibility criteria are also met
- ✓Participants must have recovered (≤ grade 1) from any side effects from the most recent anti-cancer treatment prior to randomization
- ✓Participants must not have received prior therapy with docetaxel for this disease
- ✓Participants must not have received any palliative radiation therapy within 14 days (or palliative bone radiation therapy within 7 days) prior to randomization
- ✓Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, or biologic therapy for cancer treatment while receiving treatment on this study
- ✓Participants must not have undergone major surgery within 28 days prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization. Participants must not have postoperative bleeding complications or wound complications from a surgical procedure performed within 2 months prior to randomization. The participant must not have elective or planned major surgery to be performed during the course of this study
- ✓Absolute neutrophil count ≥ 1.5 x 10\^3/uL (within 28 days prior to randomization)
- ✓Hemoglobin ≥ 9.0 g/dL (within 28 days prior to randomization)
- ✓Platelets ≥ 100 x 10\^3/uL (within 28 days prior to randomization)
- ✓Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to randomization) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN
- ✓Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN (within 28 days prior to randomization). Participants with history of liver metastasis must have AST and ALT ≤ 5 x ULN
- ✓Participants must have a creatinine ≤ the institutional (I)ULN or calculated creatinine clearance ≥ 50 mL/min using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 28 days prior to randomization
- ✓Participants must have a urinary protein test performed within 28 days prior to randomization
- ✓Participants' most recent Zubrod/Eastern Cooperative Oncology Group (ECOG) performance status must be 0-1 and be documented within 28 days prior to randomization
- ✓Participants must have a completed medical history and physical exam within 28 days prior to randomization
- ✓Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to randomization, if indicated by the treating investigator
- ✓Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to randomization, if indicated by the treating investigator
- ✓Participants with known human immunodeficiency virus (HIV) infection are eligible, provided they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 6 months prior to randomization
- ✓Participants must not have a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen
- ✓Participants must not have an active autoimmune disease that has required systemic treatment within 730 days prior to randomization (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
- ✓Participants must not have any history of primary immunodeficiency
- ✓Participants must be able to safely receive study therapy and must not have experienced the following:
- ✓Any grade 3 or worse immune-mediated adverse event. Exception: asymptomatic nonbullous/nonexfoliative rash
- ✓Any unresolved grade 2 immune-mediated adverse event
- ✓Any toxicity that led to permanent discontinuation of prior anti-PD-1/PD-L1 immunotherapy
- ✓Exception to the above: Toxicities of any grade that requires replacement therapy and has stabilized on therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are allowed
- ✓Participants must not have any history of organ transplant that requires use of immunosuppressives
- ✓Participants must not have received a live or live attenuated vaccine within 28 days prior to randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever rabies, Bacillus Calmette-Guerin (BCG) and typhoid vaccine. Seasonal influenza vaccines and COVID-19 vaccines are allowed, however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated and are not allowed
- ✓Participants must not have clinical signs or symptoms of active tuberculosis infection
- ✓Participants must not have a history of (non-infectious) pneumonitis that required steroids or current pneumonitis/interstitial lung disease
- ✓Participants must not have had a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization
- ✓Participants must not have a history of gastrointestinal perforation or fistula within 6 months prior to randomization
- ✓Participants must not have grade 3-4 gastrointestinal bleeding (defined by National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v\]5) within 3 months prior to randomization. No history of gastrointestinal (GI) bleed within 3 months prior to randomization
- ✓Participants must not have any grade III/IV cardiac disease as defined by the New York Heart Association criteria (i.e., participants with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months prior to randomization, or serious uncontrolled cardiac arrhythmia
- ✓Participants must not have experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to randomization
- ✓Participants must not have gross hemoptysis within two months prior to randomization (defined as bright red blood or ≥ 1/2 teaspoon) or with radiographic evidence of intratumor cavitation or has radiologically documented evidence of major blood vessel invasion or encasement by cancer
- ✓Participants must not have been diagnosed with venous thrombosis within 3 months prior to randomization. Participants with venous thrombosis diagnosed more than 3 months prior to randomization must be on stable doses of anticoagulants
- ✓Participants must not have cirrhosis at a level of Child-Pugh B (or worse) AND a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis, OR any degree of cirrhosis
- ✓Participants must not be pregnant or breastfeeding (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
- ✓Participants must agree to have blood specimens submitted for circulating tumor DNA (ctDNA)
- ✓Participants must be offered participation in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG specimen tracking system
- ✓NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
- ✓Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. NOTE: Participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.