Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial
Sponsored by National Cancer Institute (NCI)
About this study
This phase III trial compares durvalumab to the usual approach (patient observation) after surgery for the treatment of patients with early-stage non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The usual approach for patients who are not in a study is to closely watch a patient's condition after surgery and to have regular visits with their doctor to watch for signs of the cancer coming back. Usually, patients do not receive further treatment unless the cancer returns. This study will help determine whether this different approach with durvalumab is better, the same, or worse than the usual approach of observation. Giving durvalumab may help patients live longer and prevent early-stage non-small cell lung cancer from coming back as compared to the usual approach.
PRIMARY OBJECTIVE: I. To compare disease free survival (DFS) in stage II-IIIB non-small cell lung cancer participants who achieved a pathologic complete response (pCR) following standard of care neoadjuvant chemo-immunotherapy and are randomized to adjuvant durvalumab (MEDI4736) versus surveillance. SECONDARY OBJECTIVES: I. To compare the overall survival (OS) between the arms. II. To evaluate the frequency and severity of toxicities of adjuvant durvalumab (MEDI4736). III. To compare the event free survival (EFS) between the arms. TRANSLATIONAL MEDICINE OBJECTIVE: I. To bank specimens and images for additional future translational medicine studies. QUALITY OF LIFE (QOL) PRIMARY OBJECTIVE: I. To compare patient-reported quality of life (QOL) status between treatment arms at 6 months…
Where this study is enrolling (272)
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NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas
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Kaiser San Rafael-Gallinas
San Rafael, California
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UC San Diego Moores Cancer Center
La Jolla, California
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Kaiser Permanente-Santa Teresa-San Jose
San Jose, California
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Kaiser Permanente-San Francisco
San Francisco, California
Show all 272 locations
- Call 833-574-2273
Kaiser Permanente Fresno Orchard Plaza
Fresno, California
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Kaiser Permanente-Fremont
Fremont, California
- Call 877-642-4691
Kaiser Permanente Dublin
Dublin, California
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Kaiser Permanente-South San Francisco
South San Francisco, California
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Torrance Memorial Physician Network - Cancer Care
Torrance, California
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Kaiser Permanente-Vallejo
Vallejo, California
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Kaiser Permanente Downtown Commons
Sacramento, California
- Call 916-734-3089
University of California Davis Comprehensive Cancer Center
Sacramento, California
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Kaiser Permanente-Oakland
Oakland, California
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Tower Cancer Research Foundation
Beverly Hills, California
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Kaiser Permanente-Roseville
Roseville, California
- Call 877-642-4691
Kaiser Permanente- Modesto MOB II
Modesto, California
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Cedars-Sinai Medical Center
Los Angeles, California
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Kaiser Permanente-South Sacramento
Sacramento, California
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Kaiser Permanente San Leandro
San Leandro, California
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Kaiser Permanente-Walnut Creek
Walnut Creek, California
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Kaiser Permanente-Santa Rosa
Santa Rosa, California
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Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California
- Call 800-741-8387
Veterans Affairs Loma Linda Healthcare System
Loma Linda, California
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Kaiser Permanente-Rock Creek
Lafayette, Colorado
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Kaiser Permanente-Lone Tree
Lone Tree, Colorado
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Kaiser Permanente-Franklin
Denver, Colorado
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Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado
- Call 866-662-5678
Midstate Medical Center
Meriden, Connecticut
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- Call 860-972-4700
Hartford HealthCare - Avon
Avon, Connecticut
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- Call 860-545-5363
Hartford Hospital
Hartford, Connecticut
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- Call 860-972-4700
Hartford HealthCare - Manchester
Manchester, Connecticut
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- Call 860-224-5660
The Hospital of Central Connecticut
New Britain, Connecticut
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Beebe South Coastal Health Campus
Millville, Delaware
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Beebe Health Campus
Rehoboth Beach, Delaware
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Helen F Graham Cancer Center
Newark, Delaware
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Medical Oncology Hematology Consultants PA
Newark, Delaware
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Moffitt Cancer Center - McKinley Campus
Tampa, Florida
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Moffitt Cancer Center
Tampa, Florida
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Winter Haven Hospital
Winter Haven, Florida
- Call 786-596-2000
Miami Cancer Institute
Miami, Florida
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Saint Anthony's Hospital Cancer Care Center
St. Petersburg, Florida
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South Florida Baptist Hospital
Plant City, Florida
- Call 855-314-8646
Morton Plant Hospital
Clearwater, Florida
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Moffitt Cancer Center-International Plaza
Tampa, Florida
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Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida
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Emory Decatur Hospital
Decatur, Georgia
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Emory University Hospital Midtown
Atlanta, Georgia
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Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia
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Emory Saint Joseph's Hospital
Atlanta, Georgia
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Emory Johns Creek Hospital
Johns Creek, Georgia
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Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii
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Hawaii Cancer Care - Westridge
‘Aiea, Hawaii
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The Queen's Medical Center - West Oahu
‘Ewa Beach, Hawaii
- Call 808-531-8521
Queen's Cancer Center - Kuakini
Honolulu, Hawaii
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- Call 808-545-8548
Queen's Medical Center
Honolulu, Hawaii
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- Call 808-532-0315
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii
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Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii
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Saint Luke's Cancer Institute - Meridian
Meridian, Idaho
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Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho
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Saint Luke's Cancer Institute - Boise
Boise, Idaho
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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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Saint Luke's Cancer Institute - Nampa
Nampa, Idaho
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Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho
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Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho
- Call 312-695-1102
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois
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- Call 815-334-5566
Northwestern Medicine Huntley Hospital
Huntley, Illinois
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Northwestern Medicine Oak Brook
Oak Brook, Illinois
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Northwestern Medicine Orland Park
Orland Park, Illinois
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Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois
- Call 708-226-4357
Loyola University Medical Center
Maywood, Illinois
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Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois
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Northwestern University
Chicago, Illinois
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Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois
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Northwestern Medicine Cancer Center Delnor
Geneva, Illinois
- Call 312-695-1102
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois
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Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana
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IU Health North Hospital
Carmel, Indiana
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IU Health West Hospital
Avon, Indiana
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Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana
- Call 515-282-2200
Broadlawns Medical Center
Des Moines, Iowa
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- Call 515-241-3305
Mercy Medical Center - Des Moines
Des Moines, Iowa
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- Call 515-956-4132
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa
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UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge, Iowa
- Call 515-956-4132
McFarland Clinic - Marshalltown
Marshalltown, Iowa
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- Call 515-241-3305
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa
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- Call 515-241-3305
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa
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Saint Anthony Regional Hospital
Carroll, Iowa
- Call 515-241-3305
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa
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McFarland Clinic - Ames
Ames, Iowa
- Call 515-241-3305
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa
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- Call 515-956-4132
Mary Greeley Medical Center
Ames, Iowa
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- Call 515-241-6727
Iowa Methodist Medical Center
Des Moines, Iowa
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- Call 515-241-3305
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa
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- Call 785-623-5774
HaysMed
Hays, Kansas
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- Call 785-295-8000
University of Kansas Health System Saint Francis Campus
Topeka, Kansas
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Salina Regional Health Center
Salina, Kansas
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The University of Kansas Cancer Center - Olathe
Olathe, Kansas
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Lawrence Memorial Hospital
Lawrence, Kansas
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University Medical Center New Orleans
New Orleans, Louisiana
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MaineHealth Cancer Care and IV Therapy - South Portland
South Portland, Maine
- Call 207-626-4855
Harold Alfond Center for Cancer Care
Augusta, Maine
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MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine
- Call 240-964-1400
UPMC Western Maryland
Cumberland, Maryland
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UM Upper Chesapeake Hematology and Oncology - Aberdeen
Aberdeen, Maryland
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Lahey Clinic
Burlington, Massachusetts
- Call 978-922-3000
Beverly Hospital
Beverly, Massachusetts
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UMass Memorial Medical Center - University Campus
Worcester, Massachusetts
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Lahey Clinic Peabody
Peabody, Massachusetts
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Baystate Medical Center
Springfield, Massachusetts
- Call 978-283-4000
Addison Gilbert Hospital
Gloucester, Massachusetts
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Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan
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University of Michigan Rogel Cancer Center
Ann Arbor, Michigan
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Bronson Battle Creek
Battle Creek, Michigan
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Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan
- I'm interested
Henry Ford Hospital
Detroit, Michigan
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Henry Ford Saint John Hospital - Van Elslander
Grosse Pointe Woods, Michigan
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Bronson Methodist Hospital
Kalamazoo, Michigan
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West Michigan Cancer Center
Kalamazoo, Michigan
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University of Michigan Health - Sparrow Lansing
Lansing, Michigan
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Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan
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Henry Ford Saint John Hospital - Macomb Medical
Macomb, Michigan
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Henry Ford Warren Hospital - Breast Macomb
Macomb, Michigan
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Trinity Health Muskegon Hospital
Muskegon, Michigan
- Call 616-391-1230
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan
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Henry Ford Health Providence Novi Hospital
Novi, Michigan
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Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan
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Henry Ford Health Providence Southfield Hospital
Southfield, Michigan
- I'm interested
Munson Medical Center
Traverse City, Michigan
- Call 248-551-7695
Corewell Health Beaumont Troy Hospital
Troy, Michigan
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Henry Ford Madison Heights Hospital - Breast
Warren, Michigan
- Call 800-865-1125
University of Michigan - Brighton Center for Specialty Care
Brighton, Michigan
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Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan
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Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan
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Henry Ford Health Saint John Hospital
Detroit, Michigan
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Henry Ford River District Hospital
East China Township, Michigan
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OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan
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Cancer Hematology Centers - Flint
Flint, Michigan
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Genesys Hurley Cancer Institute
Flint, Michigan
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Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan
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Henry Ford Saint John Hospital - Breast
Grosse Pointe Woods, Michigan
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Corewell Health Reed City Hospital
Reed City, Michigan
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Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan
- Call 248-551-7695
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan
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Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan
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Henry Ford Health Warren Hospital
Warren, Michigan
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Henry Ford Warren Hospital - GLCMS
Warren, Michigan
- I'm interested
University of Michigan Health - West
Wyoming, Michigan
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Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan
- I'm interested
Henry Ford Saint John Hospital - Academic
Grosse Pointe Woods, Michigan
- I'm interested
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan
- I'm interested
Mercy Hospital
Coon Rapids, Minnesota
- I'm interested
Essentia Health - Deer River Clinic
Deer River, Minnesota
- I'm interested
Essentia Health Cancer Center
Duluth, Minnesota
- I'm interested
Fairview Southdale Hospital
Edina, Minnesota
- I'm interested
Minnesota Oncology - Edina
Edina, Minnesota
- Call 218-786-3308
Essentia Health Hibbing Clinic
Hibbing, Minnesota
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Abbott-Northwestern Hospital
Minneapolis, Minnesota
- Call 612-467-2800
Minneapolis VA Medical Center
Minneapolis, Minnesota
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Essentia Health Virginia Clinic
Virginia, Minnesota
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Essentia Health Sandstone
Sandstone, Minnesota
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United Hospital
Saint Paul, Minnesota
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Regions Hospital
Saint Paul, Minnesota
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Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota
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Sanford Joe Lueken Cancer Center
Bemidji, Minnesota
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Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota
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Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi
- I'm interested
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi
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Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi
- I'm interested
Baptist Cancer Center-Grenada
Grenada, Mississippi
- Call 601-815-6700
University of Mississippi Medical Center
Jackson, Mississippi
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Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi
- Call 888-446-3729
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri
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- Call 314-251-7066
Mercy Hospital Saint Louis
St Louis, Missouri
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Mercy Hospital South
St Louis, Missouri
- Call 816-404-4375
University Health Truman Medical Center
Kansas City, Missouri
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- Call 800-648-6274
Saint Vincent Frontier Cancer Center
Billings, Montana
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Billings Clinic Cancer Center
Billings, Montana
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Community Hospital of Anaconda
Anaconda, Montana
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Bozeman Health Deaconess Hospital
Bozeman, Montana
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Community Medical Center
Missoula, Montana
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Logan Health Medical Center
Kalispell, Montana
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Benefis Sletten Cancer Institute
Great Falls, Montana
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University of New Mexico Cancer Center
Albuquerque, New Mexico
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Roswell Park Cancer Institute
Buffalo, New York
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Montefiore Medical Center-Einstein Campus
The Bronx, New York
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James J Peters VA Medical Center
The Bronx, New York
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Montefiore Medical Center - Moses Campus
The Bronx, New York
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Montefiore Medical Center-Weiler Hospital
The Bronx, New York
- Call 888-275-3853
Duke University Medical Center
Durham, North Carolina
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Duke Cancer Center Cary
Cary, North Carolina
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Durham VA Medical Center
Durham, North Carolina
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FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina
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Duke Cancer Center Raleigh
Raleigh, North Carolina
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Sanford Bismarck Medical Center
Bismarck, North Dakota
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Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota
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Sanford Roger Maris Cancer Center
Fargo, North Dakota
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Sanford Broadway Medical Center
Fargo, North Dakota
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Miami Valley Hospital South
Centerville, Ohio
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Aultman Health Foundation
Canton, Ohio
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio
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Miami Valley Hospital
Dayton, Ohio
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Miami Valley Hospital North
Dayton, Ohio
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Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio
- Call 937-569-7515
Miami Valley Cancer Care and Infusion
Greenville, Ohio
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University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma
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Oregon Health and Science University
Portland, Oregon
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Providence Portland Medical Center
Portland, Oregon
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Providence Saint Vincent Medical Center
Portland, Oregon
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Riddle Memorial Hospital
Media, Pennsylvania
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UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania
- Call 610-988-9323
Reading Hospital
West Reading, Pennsylvania
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Lankenau Medical Center
Wynnewood, Pennsylvania
- Call 724-838-1900
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania
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- Call 412-647-8073
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania
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Jefferson Torresdale Hospital
Philadelphia, Pennsylvania
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Thomas Jefferson University Hospital
Philadelphia, Pennsylvania
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Paoli Memorial Hospital
Paoli, Pennsylvania
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UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania
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Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania
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Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania
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Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania
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Bryn Mawr Hospital
Bryn Mawr, Pennsylvania
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Pocono Medical Center
East Stroudsburg, Pennsylvania
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UPMC Hillman Cancer Center Erie
Erie, Pennsylvania
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UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania
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Prisma Health Cancer Institute - Seneca
Seneca, South Carolina
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Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina
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Prisma Health Cancer Institute - Easley
Easley, South Carolina
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SMC Center for Hematology Oncology Union
Union, South Carolina
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Spartanburg Medical Center
Spartanburg, South Carolina
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Gibbs Cancer Center-Pelham
Greer, South Carolina
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Prisma Health Cancer Institute - Greer
Greer, South Carolina
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Prisma Health Cancer Institute - Eastside
Greenville, South Carolina
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Prisma Health Cancer Institute - Faris
Greenville, South Carolina
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Prisma Health Cancer Institute - Butternut
Greenville, South Carolina
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Tidelands Georgetown Memorial Hospital
Georgetown, South Carolina
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Gibbs Cancer Center-Gaffney
Gaffney, South Carolina
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Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota
- I'm interested
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota
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Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee
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Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee
- I'm interested
Hematology Oncology Associates of Fredericksburg Inc
Fredericksburg, Virginia
- I'm interested
Centra Alan B Pearson Regional Cancer Center
Lynchburg, Virginia
- I'm interested
VCU Community Memorial Health Center
South Hill, Virginia
- I'm interested
Virginia Cancer Institute
Richmond, Virginia
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Swedish Medical Center-First Hill
Seattle, Washington
- I'm interested
Swedish Cancer Institute-Edmonds
Edmonds, Washington
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Swedish Cancer Institute-Issaquah
Issaquah, Washington
- I'm interested
Edwards Comprehensive Cancer Center
Huntington, West Virginia
- I'm interested
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin
- I'm interested
Gundersen Lutheran Medical Center
La Crosse, Wisconsin
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Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin
- I'm interested
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin
- I'm interested
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin
- I'm interested
Duluth Clinic Ashland
Ashland, Wisconsin
- I'm interested
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin
- I'm interested
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin
- I'm interested
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin
- I'm interested
Sheboygan Physicians Group
Sheboygan, Wisconsin
- I'm interested
Aspirus Medford Hospital
Medford, Wisconsin
- Call 715-422-7718
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin
This research site can be reached directly by phone. Call to ask about this study.
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- I'm interested
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin
- I'm interested
Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
Rhinelander, Wisconsin
- I'm interested
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin
- I'm interested
Aspirus Cancer Care-Antigo-Volm Cancer Center
Antigo, Wisconsin
- I'm interested
ProHealth D N Greenwald Center
Mukwonago, Wisconsin
- Call 262-928-7878
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin
This research site can be reached directly by phone. Call to ask about this study.
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- I'm interested
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin
- I'm interested
Marshfield Medical Center - Weston
Weston, Wisconsin
- Call 877-405-6866
Aspirus Cancer Care-Wausau
Wausau, Wisconsin
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Who can participate
Inclusion criteria
- ✓Participants must have histologically or cytological confirmed diagnosis of clinical stage II-IIIB (excluding clinical N3 disease) non-small cell lung cancer (NSCLC)
- ✓Participants must have had a complete (R0) resection of NSCLC (with appropriate lymph node sampling as defined by the National Comprehensive Cancer Network \[NCCN\] guidelines) within 84 days (12 weeks) prior to randomization. Acceptable types of surgical resection are: lobectomy, sleeve resection, bi-lobectomy, or pneumonectomy. Wedge resection is not allowed.
- ✓Note the NCCN guidelines: N1 and N2 node resection and mapping is a routine component of lung cancer resections. It is recommended at a minimum one N1 and three N2 stations is sampled or complete lymph node dissection. Formal ipsilateral mediastinal lymph node dissection is indicated for participants undergoing resection for N2 disease
- ✓Participants must have a pathologic complete response (pCR) (no viable tumor in the resected specimen or lymph nodes), as determined by local pathology review
- ✓Participants must have a PD-L1 status result (e.g. \[\< 1% versus \>= 1% or unknown\])
- ✓Participants must not have known EGFR mutations, or ALK gene fusion
- ✓Participants must have received at least two cycles of neoadjuvant platinum-based chemotherapy and anti-PD-1 or anti-PD-L1 therapy. The neoadjuvant treatment must be Food and Drug Administration (FDA) approved and standard of care as listed in NCCN guidelines
- ✓Participants must not be planning to receive any concurrent non-protocol directed chemotherapy, immunotherapy, biologic or hormonal therapy for NSCLC treatment while receiving treatment on this study
- ✓Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 28 days prior to randomization
- ✓Participants must not have medical contraindications or severe adverse events to receiving anti-PD-1 or anti-PD-L1 therapy
- ✓Participants must not have received post-operative radiation therapy (PORT) for NSCLC
- ✓Participants must not have any unresolved toxicity National Cancer Institute (NCI) CTCAE grade ≥ 2 from previous anticancer therapy with the exception of alopecia, and vitiligo. Note, participants with grade ≥2 neuropathy may be included at the discretion of the treating investigator. Note, participants with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included at the discretion of the treating investigator
- ✓Participant must be ≥ 18 years old at time of study entry
- ✓Participants must have body weight \> 30 kg
- ✓Participant must have Zubrod performance status of 0-2
- ✓Participant must have a complete medical history and physical exam within 28 days prior to randomization
- ✓Hemoglobin \> 9.0 g/dL (within 28 days prior to randomization)
- ✓Absolute neutrophil count ≥ 1.5 x 10\^3/uL (within 28 days prior to randomization)
- ✓Platelets ≥ 100 x 10\^3/uL (within 28 days prior to randomization)
- ✓Total bilirubin ≤ 1 x institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN (within 28 days prior to randomization)
- ✓Aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 3 × institutional ULN (within 28 days prior to randomization)
- ✓Participants must have a calculated creatinine clearance ≥ 40 mL/min using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 28 days prior to randomization. For creatinine clearance formula see the tools on the Clinical Research Associate (CRA) Workbench https://txwb.crab.org/TXWB/Tools.aspx
- ✓Participants must have fully recovered from the effects of prior surgery in the opinion of the treating investigator
- ✓Participants with a known history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to randomization
- ✓Participants with a known history 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
- ✓Participants with a known 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
- ✓Participants must not have had an organ transplant
- ✓Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen
- ✓Participant must not have medical contraindications to receiving immunotherapy, including history of non-infectious pneumonitis that required steroids or active autoimmune disease that has required systemic treatment with disease modifying agents, corticosteroids or immunosuppressive drugs in the past two years. Replacement therapy (e.g. thyroxine for pre-existing hypothyroidism, insulin for type I diabetes mellitus, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Intra-articular steroid injections are allowed
- ✓Participants must not be pregnant or nursing (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 during protocol therapy and for 6 months following completion of protocol therapy 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 should not breastfeed during protocol therapy and for 6 months following completion of protocol therapy
- ✓Participants must not have received a live or live attenuated vaccine within 28 days prior 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 coronavirus disease 19 (COVID-19) vaccines are allowed, however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated, and are not allowed
- ✓Participants must be offered the opportunity to participate in specimen banking
- ✓Participants who can complete FACT-L, FACT-BRM, and PRO-CTCAE questionnaires forms in English, or Spanish must agree to participate in the patient-reported outcome study
- ✓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
- ✓For 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.