Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has a MET Exon 14 Skipping Gene Change (An Expanded Lung-MAP Treatment Trial)
Sponsored by SWOG Cancer Research Network
About this study
This phase II Expanded Lung-MAP treatment trial tests tepotinib with or without ramucirumab for the treatment of patients with advanced non-small cell lung cancer that has spread from where it first started (primary site) to other places in the body (stage IV) or that has come back after a period of improvement (recurrent). Tepotinib is used in patients whose cancer has a mutated (changed) form of a gene called MET. It is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal MET protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving tepotinib with ramucirumab may lower the chance of the cancer from growing or spreading in patients with stage IV or recurrent non-small cell lung cancer.
PRIMARY OBJECTIVE: I. To compare the response rate (confirmed or unconfirmed, complete or partial) between participants with MET exon 14 skipping positive non-small cell lung cancer (NSCLC) randomized to tepotinib with or without ramucirumab. SECONDARY OBJECTIVES: I. To compare the frequency of all-grade treatment- related peripheral edema as defined by Common Terminology Criteria for Adverse Events (CTCAE) between the arms. II. To evaluate the frequency and severity of toxicities within each arm. III. To compare progression-free survival between the arms. IV. To compare overall survival between the arms. V. To estimate the duration of response (DoR) among responders within each arm. TRANSLATIONAL MEDICINE OBJECTIVE: I. To establish a tissue/blood repository for participants with MET…
Where this study is enrolling (241)
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Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis
Daphne, Alabama
- Call 251-435-4584
Thomas Hospital
Fairhope, Alabama
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Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland
Saraland, Alabama
- Call 251-435-3942
Mobile Infirmary Medical Center
Mobile, Alabama
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NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas
Show all 241 locations
- Call 501-686-8274
University of Arkansas for Medical Sciences
Little Rock, Arkansas
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Sutter Pacific Medical Foundation
Santa Rosa, California
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Kaiser Permanente-San Francisco
San Francisco, California
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Cedars-Sinai Medical Center
Los Angeles, California
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Memorial Medical Center
Modesto, California
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Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California
- Call 760-834-3798
Eisenhower Medical Center
Rancho Mirage, California
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Sutter Roseville Medical Center
Roseville, California
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Sutter Medical Center Sacramento
Sacramento, California
- Call 916-734-3089
University of California Davis Comprehensive Cancer Center
Sacramento, California
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California Pacific Medical Center-Pacific Campus
San Francisco, California
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Mills Health Center
San Mateo, California
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Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California
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Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California
- Call 818-981-3818
Cedars-Sinai Cancer - Tarzana
Tarzana, California
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Torrance Memorial Physician Network - Cancer Care
Torrance, California
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Palo Alto Medical Foundation-Fremont
Fremont, California
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Tower Cancer Research Foundation
Beverly Hills, California
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Sutter Auburn Faith Hospital
Auburn, California
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Kaiser Permanente-Vallejo
Vallejo, California
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Sutter Solano Medical Center/Cancer Center
Vallejo, California
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UC San Diego Moores Cancer Center
La Jolla, California
- Call 719-364-6700
Memorial Hospital North
Colorado Springs, Colorado
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- Call 970-297-6150
Poudre Valley Hospital
Fort Collins, Colorado
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Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado
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UCHealth Greeley Hospital
Greeley, Colorado
- Call 970-203-7083
Medical Center of the Rockies
Loveland, Colorado
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- Call 720-848-0650
UCHealth University of Colorado Hospital
Aurora, Colorado
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- Call 719-365-2406
UCHealth Memorial Hospital Central
Colorado Springs, Colorado
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Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut
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Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut
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Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut
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Smilow Cancer Hospital Care Center at Saint Francis
Hartford, 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
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Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut
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Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut
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Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut
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Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut
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Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut
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Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut
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Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut
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Bayhealth Hospital Sussex Campus
Milford, Delaware
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Bayhealth Hospital Kent Campus
Dover, Delaware
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Kaiser Permanente-Capitol Hill Medical Center
Washington D.C., District of Columbia
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Moffitt Cancer Center
Tampa, Florida
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Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia
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University Cancer and Blood Center LLC
Athens, Georgia
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Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho
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Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho
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Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho
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Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho
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Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho
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Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho
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Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois
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Northwestern University
Chicago, Illinois
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Illinois CancerCare-Eureka
Eureka, Illinois
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Carle Physician Group-Effingham
Effingham, 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
- Call (312) 864-0200
John H Stroger Jr Hospital of Cook County
Chicago, Illinois
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Carle at The Riverfront
Danville, Illinois
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Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois
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Decatur Memorial Hospital
Decatur, Illinois
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Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois
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Crossroads Cancer Center
Effingham, Illinois
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Illinois CancerCare-Galesburg
Galesburg, 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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Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois
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- Call 708-202-8387
Edward Hines Jr VA Hospital
Hines, Illinois
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Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois
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Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois
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Illinois CancerCare-Macomb
Macomb, Illinois
- Call 708-226-4357
Loyola University Medical Center
Maywood, Illinois
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Cancer Care Center of O'Fallon
O'Fallon, 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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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
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Memorial Hospital East
Shiloh, Illinois
- Call 217-545-7929
Southern Illinois University School of Medicine
Springfield, Illinois
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- Call 800-444-7541
Springfield Clinic
Springfield, Illinois
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Springfield Memorial Hospital
Springfield, Illinois
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Carle Cancer Center
Urbana, Illinois
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Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois
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Illinois CancerCare - Washington
Washington, Illinois
- Call 815-285-7800
Illinois CancerCare-Dixon
Dixon, Illinois
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Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana
- Call 515-956-4132
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa
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- 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 - Laurel Clinic
Des Moines, Iowa
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- Call 515-241-6727
Iowa Methodist Medical Center
Des Moines, Iowa
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UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa
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UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa
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McFarland Clinic - Ames
Ames, Iowa
- Call 515-956-4132
Mary Greeley Medical Center
Ames, 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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University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas
- Call 785-623-5774
HaysMed
Hays, Kansas
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University of Kansas Cancer Center
Kansas City, Kansas
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Lawrence Memorial Hospital
Lawrence, 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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Salina Regional Health Center
Salina, Kansas
- Call 785-295-8000
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 Clinical Research Center
Fairway, Kansas
- Call 859-257-3379
University of Kentucky/Markey Cancer Center
Lexington, Kentucky
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- Call 800-987-3005
Lafayette Family Cancer Center-EMMC
Brewer, Maine
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Kaiser Permanente Lutherville - Timonium Medical Center
Lutherville, Maryland
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Kaiser Permanente-Gaithersburg Medical Center
Gaithersburg, Maryland
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Kaiser Permanente-Woodlawn Medical Center
Baltimore, Maryland
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Kaiser Permanente - Largo Medical Center
Largo, Maryland
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UMass Memorial Medical Center - University Campus
Worcester, Massachusetts
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Trinity Health Medical Center - Brighton
Brighton, Michigan
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Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan
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Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan
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Trinity Health Medical Center - Canton
Canton, Michigan
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Chelsea Hospital
Chelsea, Michigan
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Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, 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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Hurley Medical Center
Flint, 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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Trinity Health Saint Joseph Mercy Oakland Hospital
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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Huron Gastroenterology PC
Ypsilanti, 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
- Call 218-786-3308
Essentia Health Hibbing Clinic
Hibbing, 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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Sanford Joe Lueken Cancer Center
Bemidji, Minnesota
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Essentia Health Virginia Clinic
Virginia, Minnesota
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Essentia Health Sandstone
Sandstone, Minnesota
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Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi
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Baptist Cancer Center-Grenada
Grenada, 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-Oxford
Oxford, Mississippi
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Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi
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Siteman Cancer Center-South County
St Louis, Missouri
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Siteman Cancer Center at Christian Hospital
St Louis, 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 West County Hospital
Creve Coeur, Missouri
- Call 816-404-4375
University Health Truman Medical Center
Kansas City, Missouri
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- Call 913-588-3671
University of Kansas Cancer Center - Briarcliff
Kansas City, Missouri
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Saint Francis Medical Center
Cape Girardeau, Missouri
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Mercy Hospital South
St Louis, Missouri
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Washington University School of Medicine
St Louis, Missouri
- I'm interested
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri
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University of Kansas Cancer Center - North
Kansas City, Missouri
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Community Hospital of Anaconda
Anaconda, 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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Logan Health Medical Center
Kalispell, Montana
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Community Medical Center
Missoula, Montana
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Benefis Sletten Cancer Institute
Great Falls, Montana
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OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada
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OptumCare Cancer Care at Charleston
Las Vegas, Nevada
- Call 800-339-6484
Solinsky Center for Cancer Care
Manchester, New Hampshire
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- Call 603-224-2556
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire
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- Call 212-639-7592
Memorial Sloan Kettering Monmouth
Middletown, New Jersey
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- Call 212-639-7592
Memorial Sloan Kettering Bergen
Montvale, New Jersey
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Virtua Samson Cancer Center
Moorestown, New Jersey
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Virtua Voorhees
Voorhees Township, New Jersey
- Call 212-639-7592
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey
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Memorial Sloan Kettering Nassau
Uniondale, New York
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Memorial Sloan Kettering Cancer Center
New York, New York
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- Call 212-639-7592
Memorial Sloan Kettering Westchester
Harrison, New York
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Memorial Sloan Kettering Commack
Commack, New York
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- 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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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
- Call 937-276-8320
Premier Blood and Cancer Center
Dayton, Ohio
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Aultman Health Foundation
Canton, Ohio
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Miami Valley Hospital South
Centerville, Ohio
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio
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Miami Valley Hospital
Dayton, Ohio
- Call 937-569-7515
Miami Valley Cancer Care and Infusion
Greenville, Ohio
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ProMedica Flower Hospital
Sylvania, Ohio
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Upper Valley Medical Center
Troy, Ohio
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Miami Valley Hospital North
Dayton, Ohio
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Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio
- Call 877-231-4440
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma
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University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma
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Providence Saint Vincent Medical Center
Portland, Oregon
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Kaiser Permanente Northwest
Portland, Oregon
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Oregon Health and Science University
Portland, Oregon
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Providence Newberg Medical Center
Newberg, Oregon
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Providence Willamette Falls Medical Center
Oregon City, Oregon
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Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon
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Providence Portland Medical Center
Portland, Oregon
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Geisinger Medical Center
Danville, Pennsylvania
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Geisinger Cancer Center Dickson City
Dickson City, Pennsylvania
- Call 877-441-7957
Adams Cancer Center
Gettysburg, Pennsylvania
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- Call 717-721-4840
Ephrata Cancer Center
Ephrata, Pennsylvania
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Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania
- Call 717-741-9229
Cancer Care Associates of York
York, Pennsylvania
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- Call 877-441-7957
WellSpan Health-York Cancer Center
York, Pennsylvania
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- Call 877-441-7957
WellSpan Health-York Hospital
York, Pennsylvania
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Community Medical Center
Scranton, Pennsylvania
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Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania
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Sechler Family Cancer Center
Lebanon, Pennsylvania
- Call 717-217-6020
WellSpan Medical Oncology and Hematology
Chambersburg, Pennsylvania
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AnMed Health Cancer Center
Anderson, South Carolina
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Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota
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Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota
- I'm interested
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee
- I'm interested
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee
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The Don and Sybil Harrington Cancer Center
Amarillo, Texas
- I'm interested
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah
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Kaiser Permanente-Caton Hill Medical Center
Woodbridge, Virginia
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Kaiser Permanente Tysons Corner Medical Center
McLean, Virginia
- I'm interested
Swedish Medical Center-First Hill
Seattle, Washington
- I'm interested
Swedish Cancer Institute-Issaquah
Issaquah, Washington
- I'm interested
Swedish Cancer Institute-Edmonds
Edmonds, Washington
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Edwards Comprehensive Cancer Center
Huntington, West Virginia
- I'm interested
West Virginia University Healthcare
Morgantown, West Virginia
- I'm interested
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin
- I'm interested
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin
- I'm interested
Marshfield Medical Center - Weston
Weston, Wisconsin
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Marshfield Medical Center-Marshfield
Marshfield, Wisconsin
- I'm interested
Gundersen Lutheran Medical Center
La Crosse, Wisconsin
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Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin
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Duluth Clinic Ashland
Ashland, Wisconsin
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Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin
Who can participate
Inclusion criteria
- ✓Participants must have been assigned to S1900K by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1900K is determined by the LUNGMAP protocol
- ✓Participants must have documentation of stage IV or recurrent NSCLC with a MET exon 14 skipping mutation determined by tissue-based or blood-based (circulating tumor DNA \[ctDNA\]) next generation sequencing (NGS) assay done within a laboratory with Clinical Laboratory Improvement Act (CLIA), International Organization for Standardization (ISO)/ International Electrotechnical Commission (IEC), College of American Pathologists (CAP), or similar certification. Documentation must either be:
- ✓NGS test results from tissue submitted for LUNGMAP screening, or
- ✓Submitted documentation in the LUNGMAP Rave Electronic Data Capture System of a MET exon 14 skipping mutation from a previously completed tissue or blood-based NGS test
- ✓Participants must have measurable disease documented by CT or MRI. The CT from a combined positron emission tomography (PET)/CT may be used to document measurable disease ONLY if it is of diagnostic quality, otherwise, it may be used to document non-measurable disease only. Measurable disease must be assessed within 28 days prior to sub-study 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 sub-study randomization. All known sites of 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 sub-study randomization to be considered measurable
- ✓Participants must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to sub-study randomization
- ✓Participants must not have leptomeningeal disease, spinal cord compression or brain metastases unless:
- ✓Metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 3 days following the stereotactic radiation and/or 14 days following whole brain radiation, and prior to sub-study randomization, AND
- ✓Participant has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to sub-study randomization
- ✓Participants must not have other known actionable oncogenic alterations, such as (but not limited to) EGFR sensitizing mutations, EGFR T790M mutation, ALK gene fusion, ROS1 gene rearrangement, RET gene rearrangement, NTRK rearrangement, HER2 mutation, KRAS activating mutations, and BRAF V600E mutation
- ✓Participants who have received at least one line of systemic treatment for stage IV or recurrent NSCLC must have progressed (in the opinion of the treating physician) following the most recent line of therapy. Participants who have not yet received systemic treatment for their stage IV or recurrent NSCLC are allowed
- ✓Participants may have received any number of lines of therapy for stage IV or recurrent NSCLC (including zero) and must be able to report prior treatment information
- ✓Participants must have recovered (=\< grade 1) from any side effects of prior therapy for NSCLC except alopecia and vitiligo
- ✓Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub-study randomization
- ✓Participants must not have received treatment with prior MET inhibitor therapies (e.g., crizotinib, tivantinib, savolitinib, tepotinib, cabozantinib, and foretinib).
- ✓Participants must not have received treatment with prior angiogenesis inhibitor therapies (including but not limited to bevacizumab and ramucirumab)
- ✓Participants must not have a history of interstitial lung disease that required steroid treatment
- ✓Participants must not have received any radiation therapy within 7 days prior to sub-study randomization with the exceptions of
- ✓Stereotactic radiation to CNS metastases which must have been completed at least 3 days prior to sub-study randomization and
- ✓Palliative radiotherapy to bone metastases which must have been completed at least 1 day prior to sub-study randomization
- ✓Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study
- ✓Participants must not have had a major surgery within 14 days prior to sub-study randomization. Participants must have fully recovered from the effects of prior surgery in the opinion of the treating investigator
- ✓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
- ✓Absolute neutrophil count \>= 1.5 x 10\^3/uL (within 28 days prior to sub-study randomization)
- ✓Hemoglobin \>= 9.0 g/dL (within 28 days prior to sub-study randomization)
- ✓Platelets \>= 100 x 10\^3/uL (within 28 days prior to sub-study randomization)
- ✓Total bilirubin =\< 1.5 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 sub-study randomization)
- ✓Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 × institutional ULN. Participants with history of liver metastasis must have AST and ALT =\< 5 x ULN (within 28 days prior to sub-study randomization)
- ✓Participants must have a serum creatinine =\< the institutional upper limit of normal (IULN) or calculated creatinine clearance \>= 30 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to sub-study randomization
- ✓Participants must have a cystatin C test performed to obtain baseline value within 28 days prior to sub-study randomization
- ✓Participants' most recent Zubrod performance status must be 0-1 and be documented within 28 days prior to sub-study randomization
- ✓Participants must have a completed medical history and physical exam within 28 days prior to sub-study randomization
- ✓Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better
- ✓Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy and have undetectable viral load test on the most recent test results obtained within 6 months prior to sub-study 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 sub-study 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 sub-study randomization, if indicated by the treating investigator
- ✓Participants must not have cirrhosis at a level of Child-Pugh B (or worse) OR any degree of cirrhosis AND a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis
- ✓Participants must not have grade \< 0 of peripheral edema within 28 days prior to sub-study randomization
- ✓Participants must not have experienced any arterial thromboembolic events, including but not limited to transient ischemic attack or cerebrovascular accident within 6 months prior to sub-study randomization
- ✓Participants must not have uncontrolled blood pressure and hypertension within 28 days prior to sub-study randomization
- ✓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 also be offered participation in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking 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.