Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer
Sponsored by National Cancer Institute (NCI)
About this study
This phase III trial compares the effect of bevacizumab and osimertinib combination vs. osimertinib alone for the treatment of non-small cell lung cancer that has spread outside of the lungs (stage IIIB-IV) and has a change (mutation) in a gene called EGFR. The EGFR protein is involved in cell signaling pathways that control cell division and survival. Sometimes, mutations in the EGFR gene cause EGFR proteins to be made in higher than normal amounts on some types of cancer cells. This causes cancer cells to divide more rapidly. Osimertinib may stop the growth of tumor cells by blocking EGFR that is needed for cell growth in this type of cancer. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving osimertinib with bevacizumab may control cancer for longer and help patients live longer as compared to osimertinib alone.
PRIMARY OBJECTIVE: I. To evaluate progression-free survival (PFS) of osimertinib (AZD9291) and bevacizumab versus osimertinib (AZD9291) alone as first-line treatment for patients with metastatic EGFR-mutant lung cancers. SECONDARY OBJECTIVES: I. To evaluate overall survival (OS). II. To evaluate best objective response rate and duration of objective response. III. To evaluate time to central nervous system (CNS) progression and CNS PFS. IV. To evaluate toxicity of the combination regimen. CORRELATIVE OBJECTIVES: I. To characterize mechanisms of resistance to osimertinib (AZD9291) and osimertinib (AZD9291) with bevacizumab first-line therapy through post-progression circulating tumor-derived deoxyribonucleic acid (ctDNA). II. To assess for ctDNA clearance on study treatment and assoc…
Where this study is enrolling (325)
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Katmai Oncology Group
Anchorage, Alaska
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Alaska Oncology and Hematology LLC
Anchorage, Alaska
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Fairbanks Memorial Hospital
Fairbanks, Alaska
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Cancer Center at Saint Joseph's
Phoenix, Arizona
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NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas
Show all 325 locations
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Kaiser Permanente-Fremont
Fremont, California
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Stanford Cancer Institute Palo Alto
Palo Alto, California
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Kaiser Permanente-Fresno
Fresno, California
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Kaiser Permanente-Modesto
Modesto, California
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Kaiser Permanente-Oakland
Oakland, California
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Kaiser Permanente-Richmond
Richmond, California
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Kaiser Permanente-Roseville
Roseville, California
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San Francisco, California
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Kaiser Permanente-Santa Rosa
Santa Rosa, California
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Kaiser Permanente-Santa Teresa-San Jose
San Jose, California
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Kaiser Permanente-South Sacramento
Sacramento, California
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Kaiser Permanente-South San Francisco
South San Francisco, California
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Kaiser Permanente-Stockton
Stockton, California
- Call 510-248-1600
Washington Health
Fremont, California
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Kaiser Permanente-Vallejo
Vallejo, California
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Kaiser San Rafael-Gallinas
San Rafael, California
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Kaiser Permanente-Walnut Creek
Walnut Creek, California
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Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California
- Call 916-734-3089
University of California Davis Comprehensive Cancer Center
Sacramento, California
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Kaiser Permanente Medical Center-Vacaville
Vacaville, California
- Call 877-642-4691
Kaiser Permanente Dublin
Dublin, California
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- Call 833-574-2273
Kaiser Permanente Fresno Orchard Plaza
Fresno, California
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Kaiser Permanente Downtown Commons
Sacramento, California
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Kaiser Permanente- Modesto MOB II
Modesto, California
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San Leandro, California
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Kaiser Permanente-Deer Valley Medical Center
Antioch, California
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Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado
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Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado
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Rocky Mountain Cancer Centers - Swedish
Englewood, Colorado
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Lafayette, Colorado
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Lone Tree, Colorado
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Kaiser Permanente-Franklin
Denver, Colorado
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Hartford Hospital
Hartford, Connecticut
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Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut
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Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut
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Yale University
New Haven, Connecticut
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Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut
- Call 866-662-5678
Midstate Medical Center
Meriden, Connecticut
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- Call 860-224-5660
The Hospital of Central Connecticut
New Britain, Connecticut
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Stamford Hospital/Bennett Cancer Center
Stamford, Connecticut
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Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut
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Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut
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Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut
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Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut
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Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut
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Guilford, Connecticut
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Waterford, Connecticut
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Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut
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Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut
- Call 202-741-2210
George Washington University Medical Center
Washington D.C., District of Columbia
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Holy Cross Hospital
Fort Lauderdale, Florida
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Emory University Hospital Midtown
Atlanta, Georgia
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Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia
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Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia
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Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii
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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
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Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho
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Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho
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Caldwell, Idaho
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Nampa, Idaho
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Saint Luke's Cancer Institute - Boise
Boise, Idaho
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Fruitland, Idaho
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Meridian, Idaho
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Twin Falls, Idaho
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Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois
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Geneva, Illinois
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Washington, Illinois
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Bloomington, Illinois
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Canton, Illinois
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Carthage, Illinois
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Illinois CancerCare-Dixon
Dixon, Illinois
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Eureka, Illinois
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Galesburg, Illinois
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Kewanee, Illinois
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Macomb, Illinois
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Ottawa, Illinois
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Pekin, Illinois
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Peoria, Illinois
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Peru, Illinois
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Princeton, Illinois
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Ingalls Memorial Hospital
Harvey, Illinois
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SSM Health Good Samaritan
Mount Vernon, Illinois
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Springfield Memorial Hospital
Springfield, Illinois
- Call 800-444-7541
Springfield Clinic
Springfield, Illinois
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- Call 217-545-7929
Southern Illinois University School of Medicine
Springfield, Illinois
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Cancer Care Center of O'Fallon
O'Fallon, Illinois
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Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois
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Rush-Copley Medical Center
Aurora, Illinois
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Carle at The Riverfront
Danville, Illinois
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Carle Cancer Center
Urbana, Illinois
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Carle Physician Group-Effingham
Effingham, Illinois
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Crossroads Cancer Center
Effingham, Illinois
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Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois
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Centralia Oncology Clinic
Centralia, Illinois
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Northwestern University
Chicago, Illinois
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Northwestern Medicine Orland Park
Orland Park, Illinois
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Northwestern Medicine Oak Brook
Oak Brook, Illinois
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Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois
- Call 312-695-1102
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois
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- Call 312-355-3046
University of Illinois
Chicago, Illinois
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Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois
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DeKalb, Illinois
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Saint Mary Medical Center
Hobart, Indiana
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Saint Catherine Hospital
Indianapolis, Indiana
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The Community Hospital
Munster, Indiana
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Women's Diagnostic Center - Munster
Munster, Indiana
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Northwest Oncology LLC
Dyer, Indiana
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Northwest Cancer Center - Valparaiso
Valparaiso, Indiana
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Northwest Cancer Center - Hobart
Hobart, Indiana
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Northwest Cancer Center - Crown Point
Crown Point, Indiana
- Call 515-282-2200
Broadlawns Medical Center
Des Moines, Iowa
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Saint Anthony Regional Hospital
Carroll, Iowa
- Call 515-956-4132
Mary Greeley Medical Center
Ames, Iowa
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McFarland Clinic - Ames
Ames, Iowa
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McFarland Clinic - Marshalltown
Marshalltown, Iowa
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McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa
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UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge, Iowa
- Call 515-241-3305
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa
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UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa
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UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa
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UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa
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UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa
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Iowa Methodist Medical Center
Des Moines, Iowa
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Cancer Center of Kansas - Wichita
Wichita, Kansas
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Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas
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Ascension Via Christi Hospitals Wichita
Wichita, Kansas
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UMass Memorial Medical Center - University Campus
Worcester, Massachusetts
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Genesys Hurley Cancer Institute
Flint, Michigan
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Hematology Oncology Consultants-Clarkston
Clarkston, Michigan
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Henry Ford Health Saint John Hospital
Detroit, Michigan
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Henry Ford Health Warren Hospital
Warren, Michigan
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Henry Ford River District Hospital
East China Township, Michigan
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Henry Ford Saint John Hospital - Academic
Grosse Pointe Woods, Michigan
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Henry Ford Saint John Hospital - Macomb Medical
Macomb, Michigan
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Henry Ford Saint John Hospital - Van Elslander
Grosse Pointe Woods, Michigan
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Henry Ford Warren Hospital - GLCMS
Warren, Michigan
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Hurley Medical Center
Flint, Michigan
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Huron Gastroenterology PC
Ypsilanti, Michigan
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Corewell Health William Beaumont University Hospital
Royal Oak, Michigan
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Corewell Health Dearborn Hospital
Dearborn, Michigan
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Corewell Health Beaumont Troy Hospital
Troy, Michigan
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Michigan Healthcare Professionals Pontiac
Pontiac, Michigan
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MyMichigan Medical Center Saginaw
Saginaw, Michigan
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MyMichigan Medical Center Tawas
Tawas City, Michigan
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Newland Medical Associates-Pontiac
Pontiac, Michigan
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Chelsea Hospital
Chelsea, 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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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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Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan
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Trinity Health Medical Center - Brighton
Brighton, Michigan
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Canton, Michigan
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Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan
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Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan
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Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan
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University of Michigan Health - Sparrow Lansing
Lansing, Michigan
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Minnesota Oncology - Burnsville
Burnsville, Minnesota
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Regions Hospital
Saint Paul, Minnesota
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Minnesota Oncology - Edina
Edina, Minnesota
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Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota
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Mercy Hospital
Coon Rapids, Minnesota
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Fairview Southdale Hospital
Edina, Minnesota
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Abbott-Northwestern Hospital
Minneapolis, Minnesota
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Ridgeview Medical Center
Waconia, Minnesota
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Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota
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Saint Francis Regional Medical Center
Shakopee, Minnesota
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Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota
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Saint John's Hospital - Healtheast
Maplewood, Minnesota
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United Hospital
Saint Paul, Minnesota
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Hennepin County Medical Center
Minneapolis, Minnesota
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Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi
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Baptist Memorial Hospital and Cancer Center-Union County
New Albany, 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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Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi
- Call 314-996-5569
Parkland Health Center - Farmington
Farmington, Missouri
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Mercy Hospital South
St Louis, Missouri
- Call 314-251-7066
Mercy Hospital Saint Louis
St Louis, 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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Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri
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Saint Luke's Hospital
Chesterfield, Missouri
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Saint Francis Medical Center
Cape Girardeau, Missouri
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Community Medical Center
Missoula, Montana
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Bozeman, 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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Benefis Sletten Cancer Institute
Great Falls, Montana
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Community Hospital of Anaconda
Anaconda, Montana
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Cancer Partners of Nebraska
Lincoln, Nebraska
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The Valley Hospital - Luckow Pavilion
Paramus, New Jersey
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Monmouth Medical Center Southern Campus
Lakewood, New Jersey
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Monmouth Medical Center
Long Branch, New Jersey
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Valley Health System Ridgewood Campus
Ridgewood, New Jersey
- Call 973-322-5200
Cooperman Barnabas Medical Center
Livingston, New Jersey
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Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey
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Englewood Hospital and Medical Center
Englewood, New Jersey
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Jersey City Medical Center
Jersey City, New Jersey
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Memorial Sloan Kettering Bergen
Montvale, New Jersey
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Memorial Sloan Kettering Monmouth
Middletown, New Jersey
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Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey
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University of New Mexico Cancer Center
Albuquerque, New Mexico
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State University of New York Upstate Medical University
Syracuse, New York
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Roswell Park Cancer Institute
Buffalo, New York
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The Cancer Institute at Saint Francis Hospital
East Hills, New York
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Montefiore Medical Center - Moses Campus
The Bronx, New York
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Dickstein Cancer Treatment Center
White Plains, New York
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Memorial Sloan Kettering Westchester
Harrison, New York
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Memorial Sloan Kettering Nassau
Uniondale, New York
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Memorial Sloan Kettering Commack
Commack, New York
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Memorial Sloan Kettering Cancer Center
New York, New York
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Upstate Cancer Center at Verona
Verona, New York
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Upstate Cancer Center at Oswego
Oswego, New York
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Montefiore Medical Center-Einstein Campus
The Bronx, New York
- Call 518-926-6700
Glens Falls Hospital
Glens Falls, New York
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- Call 516-326-7514
Good Samaritan University Hospital
West Islip, New York
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Mount Sinai Chelsea
New York, New York
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Mount Sinai Hospital
New York, New York
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Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina
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Novant Health Presbyterian Medical Center
Charlotte, North Carolina
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Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina
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Novant Health Cancer Institute - Mount Airy
Mount Airy, North Carolina
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Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina
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Novant Health Forsyth Medical Center
Winston-Salem, North Carolina
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Novant Health Cancer Institute - Huntersville
Huntersville, North Carolina
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Kernersville, North Carolina
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Novant Health Cancer Institute - Matthews
Matthews, North Carolina
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Novant Health Cancer Institute - Mooresville
Mooresville, North Carolina
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Genesis Healthcare System Cancer Care Center
Zanesville, Ohio
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Premier Blood and Cancer Center
Dayton, Ohio
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Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio
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Knox Community Hospital
Mount Vernon, Ohio
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Miami Valley Hospital North
Dayton, Ohio
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Case Western Reserve University
Cleveland, Ohio
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OhioHealth Marion General Hospital
Marion, Ohio
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Dayton Physicians LLC-Atrium
Franklin, Ohio
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Delaware Health Center-Grady Cancer Center
Delaware, Ohio
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Miami Valley Cancer Care and Infusion
Greenville, Ohio
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Doctors Hospital
Columbus, Ohio
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Chillicothe, Ohio
- I'm interested
Licking Memorial Hospital
Newark, Ohio
- I'm interested
Marietta Memorial Hospital
Marietta, Ohio
- I'm interested
Southern Ohio Medical Center
Portsmouth, Ohio
- I'm interested
Springfield Regional Cancer Center
Springfield, Ohio
- I'm interested
Cleveland Clinic Foundation
Cleveland, Ohio
- I'm interested
Strecker Cancer Center-Belpre
Belpre, Ohio
- I'm interested
Memorial Hospital
Marysville, Ohio
- I'm interested
The Mark H Zangmeister Center
Columbus, Ohio
- I'm interested
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio
- I'm interested
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio
- I'm interested
Grant Medical Center
Columbus, Ohio
- I'm interested
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio
- I'm interested
UH Seidman Cancer Center at Southwest General Hospital
Middleburg Heights, Ohio
- Call 800-641-2422
UH Seidman Cancer Center at UH Avon Health Center
Avon, Ohio
This research site can be reached directly by phone. Call to ask about this study.
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- I'm interested
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio
- I'm interested
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio
- I'm interested
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio
- I'm interested
Miami Valley Hospital
Dayton, Ohio
- I'm interested
Miami Valley Hospital South
Centerville, Ohio
- Call 405-773-6613
Integris Cancer Institute of Oklahoma
Oklahoma City, Oklahoma
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- I'm interested
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma
- I'm interested
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon
- I'm interested
Saint Charles Health System
Bend, Oregon
- I'm interested
Providence Portland Medical Center
Portland, Oregon
- I'm interested
Providence Saint Vincent Medical Center
Portland, Oregon
- Call 877-441-7957
WellSpan Health-York Cancer Center
York, Pennsylvania
This research site can be reached directly by phone. Call to ask about this study.
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- Call 877-441-7957
WellSpan Health-York Hospital
York, Pennsylvania
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- I'm interested
Paoli Memorial Hospital
Paoli, Pennsylvania
- Call 800-836-0388
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania
This research site can be reached directly by phone. Call to ask about this study.
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- Call 717-721-4840
Ephrata Cancer Center
Ephrata, Pennsylvania
This research site can be reached directly by phone. Call to ask about this study.
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- Call 717-632-1559
WellSpan Medical Oncology and Hematology
Hanover, Pennsylvania
This research site can be reached directly by phone. Call to ask about this study.
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- I'm interested
Lankenau Medical Center
Wynnewood, Pennsylvania
- Call 877-441-7957
Adams Cancer Center
Gettysburg, Pennsylvania
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- I'm interested
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania
- I'm interested
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania
- I'm interested
Riddle Memorial Hospital
Media, Pennsylvania
- Call 717-217-6020
WellSpan Medical Oncology and Hematology
Chambersburg, Pennsylvania
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- I'm interested
Sechler Family Cancer Center
Lebanon, Pennsylvania
- I'm interested
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania
- I'm interested
Fox Chase Cancer Center
Philadelphia, Pennsylvania
- I'm interested
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota
- I'm interested
Sanford USD Medical Center - Sioux Falls
Sioux Falls, 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
Methodist Willowbrook Hospital
Houston, Texas
- I'm interested
Parkland Memorial Hospital
Dallas, Texas
- I'm interested
Houston Methodist Saint John Hospital
Nassau Bay, Texas
- I'm interested
Houston Methodist San Jacinto Hospital
Baytown, Texas
- Call 281.274.7000
Houston Methodist Sugar Land Hospital
Sugar Land, Texas
This research site can be reached directly by phone. Call to ask about this study.
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- Call 713.790.3311
Houston Methodist Hospital
Houston, Texas
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- I'm interested
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas
- Call 832.522.6070
Houston Methodist West Hospital
Houston, Texas
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- I'm interested
Houston Methodist The Woodlands Hospital
The Woodlands, Texas
- I'm interested
Houston Methodist Cypress Hospital
Cypress, Texas
- I'm interested
University of Virginia Cancer Center
Charlottesville, Virginia
- I'm interested
Kadlec Clinic Hematology and Oncology
Kennewick, Washington
- Call 304-388-9944
West Virginia University Charleston Division
Charleston, West Virginia
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- I'm interested
Marshfield Medical Center - Weston
Weston, Wisconsin
- I'm interested
ThedaCare Cancer Care - Oshkosh
Oshkosh, Wisconsin
- I'm interested
Marshfield Medical Center-Rice Lake
Rice Lake, 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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- Call 262-928-7632
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin
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- I'm interested
Gundersen Lutheran Medical Center
La Crosse, Wisconsin
- I'm interested
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin
- I'm interested
ThedaCare Cancer Care - New London
New London, Wisconsin
- I'm interested
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin
- I'm interested
ThedaCare Cancer Care - Berlin
Berlin, Wisconsin
- I'm interested
ThedaCare Cancer Care - Shawano
Shawano, Wisconsin
- I'm interested
Mercyhealth Hospital and Cancer Center - Janesville
Janesville, Wisconsin
- I'm interested
ThedaCare Regional Medical Center - Neenah
Neenah, Wisconsin
- I'm interested
ThedaCare Regional Cancer Center
Appleton, Wisconsin
- I'm interested
ThedaCare Cancer Care - Waupaca
Waupaca, Wisconsin
- I'm interested
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin
- I'm interested
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin
- Call 414-805-3666
Medical College of Wisconsin
Milwaukee, Wisconsin
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- I'm interested
ProHealth D N Greenwald Center
Mukwonago, Wisconsin
- I'm interested
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin
Who can participate
Inclusion criteria
- ✓Patient must have a pathologically-confirmed diagnosis of non-squamous, non-small cell lung cancer (NSCLC)
- ✓Patient must have advanced disease, defined as - either stage IV disease, stage IIIB disease not amenable to definitive multi-modality therapy, or recurrent disease after a prior diagnosis of stage I-III disease. All staging is via the American Joint Committee on Cancer (AJCC)/International Association for the Study of Lung Cancer (IASLC) 8th edition staging criteria
- ✓Patient must have somatic activating sensitizing mutation in EGFR (e.g. but not limited to Exon 19 deletion, L858R, E709X, G719X, exon 19 insertions, L861Q, S768I). Patients with non-sensitizing mutations in EGFR (EGFR exon 20 insertions) are not eligible. Test results originating from a Clinical Laboratory Improvement Act (CLIA)-certified or similarly accredited laboratory are acceptable; no specific assay is mandated. Plasma, cytology, or tumor tissue can be utilized for mutation testing
- ✓Patient must not have received any prior treatment with an anti-VEGF agent
- ✓NOTE: Prior treatment with an EGFR TKI is not allowed, however if a candidate for this study has already started osimertinib within 21 days prior to randomization, the exact osimertinib start date is known, and the patient had the required study baseline imaging completed prior to the osimertinib start date, the patient will be eligible
- ✓Patients that have received prior radiation therapy are eligible. Radiation (limited field stereotactic radiation or conventional radiation) must have been completed at least one week prior to study drug initiation and more extensive field radiation (i.e., whole-brain radiotherapy \[WBRT\]) must have been completed at least two weeks prior to drug initiation
- ✓Patient must not have any risk factors for anti-VEGF administration, specifically, hemoptysis, active cardiovascular disease, uncontrolled hypertension, significant proteinuria (screening urinalysis \> 300 mg/dl) and tumor invading major blood vessels
- ✓Patient must have measurable disease. Baseline measurements of sites of disease must be obtained within 4 weeks prior to study randomization. If a potential target lesion is previously irradiated without subsequent growth and/or is radiated after the imaging from which baseline measurements are obtained, they cannot be included as target lesions, and additional target lesions are required to meet criteria for measurable disease
- ✓Patient must not have had any prior systemic treatment for metastatic disease
- ✓Patient must be ≥ 18 years of age
- ✓Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- ✓Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used
- ✓All females of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy
- ✓A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
- ✓Patient of childbearing potential and sexually active males must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for 2 weeks prior to the start of treatment, while on study treatment, and for
- ✓6 weeks after the last dose of protocol treatment for female patients on the osimertinib (AZD9291) alone arm
- ✓4 months after the last dose of protocol treatment for male patients on osimertinib (AZD9291) alone arm
- ✓6 months after the last dose of protocol treatment for all patients on osimertinib (AZD9291) plus bevacizumab combination arm
- ✓NOTE: Female patients should also not breastfeed while on treatment and for 6 months after the last dose bevacizumab
- ✓Leukocytes \>= 3,000/mcL (obtained =\< 14 days prior to randomization)
- ✓Absolute neutrophil count \>= 1,500/mcL (obtained =\< 14 days prior to randomization)
- ✓Platelets \>= 100,000/mcL (obtained =\< 14 days prior to randomization)
- ✓Hemoglobin \>= 9 g/dL (obtained =\< 14 days prior to randomization)
- ✓Total bilirubin and creatinine =\< 1.5 x institutional upper limit of normal (ULN) (obtained =\< 14 days prior to randomization)
- ✓Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional ULN (obtained =\< 14 days prior to randomization)
- ✓Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- ✓For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- ✓Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- ✓Patients with treated brain metastases are eligible if neurologically stable without glucocorticoid therapy after the stated washout period from radiation therapy (RT) or surgery provided the metastatic lesions are non-hemorrhagic
- ✓Patients with untreated brain metastases or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required provided the metastatic lesions are non-hemorrhagic and are neurologically stable without glucocorticoid therapy
- ✓Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- ✓Patients with known history or current symptoms of cardiac disease, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
- ✓Patient must have the ability to understand and the willingness to sign a written informed consent document and comply with study requirements
- ✓Patient must not have had treatment with any investigational drug within five half-lives or 3 months (whichever is greater), prior to study initiation
- ✓Patient must not be currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of CYP3A4. For any patient currently receiving such inducers of CYP3A4, they must discontinue use prior to first dose of study treatment. All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYP3A4
- ✓Patient must not have any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of randomization, with the exception of alopecia and grade 2 prior platinum-therapy-related neuropathy
- ✓Patient must not have any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it challenging for the patient to participate in the study. Screening for chronic conditions is not required
- ✓Patient must not have refractory nausea and vomiting, chronic gastrointestinal diseases, the inability to swallow the osimertinib tablets or previous significant bowel resection that would preclude adequate absorption of osimertinib
- ✓Patient must not have a medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease
- ✓Patient must not have a history of hypersensitivity to active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib
- ✓Patient must not have mean resting corrected QT interval (QTc) \> 470 msec obtained from 3 electrocardiograms (ECGs), using the screening clinic ECG machine derived QTc value (using Bazett's correction)
- ✓Patient must not have any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block, third degree heart block and second-degree heart block
- ✓Patient must not have any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, electrolyte abnormalities (including: potassium \< lower limit of normal \[LLN\]; magnesium \< LLN; calcium \< LLN), congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval and cause torsades de pointes
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.