Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has Increased Copies of the MET Gene (An Expanded Lung-MAP Treatment Trial)
Sponsored by SWOG Cancer Research Network
About this study
This phase II Expanded Lung-MAP treatment trial tests how well amivantamab-subcutaneous (SC) works in treating patients patients with MET amplification non-small cell lung cancer. Amivantamab-SC is a drug that reduces extra copies of the MET gene, a change present in your tumor. Giving amivantamab-SC may lower the chance of the growth or spread of advanced non-small cell lung cancer that has extra copies of the MET gene in the tumor.
PRIMARY OBJECTIVE: I. To evaluate the objective response rate (ORR) (confirmed and unconfirmed, complete and partial) in participants with MET amplification-positive non-small cell lung cancer (NSCLC) treated with amivantamab-SC within each cohort. SECONDARY OBJECTIVES: I. To evaluate progression-free survival (PFS) within each cohort. II. To evaluate overall survival (OS) within each cohort. III. To evaluate the duration of response among responders within each cohort. IV. To evaluate the frequency and severity of toxicities within each cohort and combined across all study participants. TRANSLATIONAL MEDICINE OBJECTIVES: I. To collect, process, and bank cell-free deoxyribonucleic acid (cfDNA) prior to treatment on Cycle 1 Day 1, Cycle 3 Day 1, and at first progression for future deve…
Where this study is enrolling (243)
- Call 501-686-8274
University of Arkansas for Medical Sciences
Little Rock, Arkansas
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NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas
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Sutter Solano Medical Center/Cancer Center
Vallejo, California
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Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California
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Sutter Medical Center Sacramento
Sacramento, California
Show all 243 locations
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Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California
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Palo Alto Medical Foundation-Fremont
Fremont, California
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UC San Diego Moores Cancer Center
La Jolla, California
- Call 909-558-4050
Loma Linda University Medical Center
Loma Linda, California
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- 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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Sutter Roseville Medical Center
Roseville, California
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Mills Health Center
San Mateo, California
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Sutter Pacific Medical Foundation
Santa Rosa, California
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Memorial Medical Center
Modesto, California
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Sutter Auburn Faith Hospital
Auburn, California
- Call 760-834-3798
Eisenhower Medical Center
Rancho Mirage, California
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- 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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UCHealth Greeley Hospital
Greeley, Colorado
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Medical Center of the Rockies
Loveland, Colorado
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Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado
- Call 888-336-8262
Rocky Mountain Regional VA Medical Center
Aurora, Colorado
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UCHealth Memorial Hospital Central
Colorado Springs, Colorado
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Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut
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Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut
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Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut
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Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut
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Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut
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Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut
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Yale University
New Haven, 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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Malcom Randall Veterans Administration Medical Center
Gainesville, Florida
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Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia
- Call 808-532-0315
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii
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Queen's Medical Center
Honolulu, Hawaii
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Straub Clinic and Hospital
Honolulu, Hawaii
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Queen's Cancer Center - Kuakini
Honolulu, Hawaii
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Kapiolani Medical Center for Women and Children
Honolulu, Hawaii
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Hawaii Cancer Care - Westridge
‘Aiea, Hawaii
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Pali Momi Medical Center
‘Aiea, Hawaii
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The Queen's Medical Center - West Oahu
‘Ewa Beach, Hawaii
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Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii
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Kootenai Clinic Cancer Services - Post Falls
Post Falls, 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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Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho
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Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho
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Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho
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Advocate Outpatient Center - Oak Lawn
Oak Lawn, Illinois
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Advocate Illinois Masonic Medical Center
Chicago, Illinois
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Northwestern University
Chicago, Illinois
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Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois
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Condell Memorial Hospital
Libertyville, Illinois
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Advocate Outpatient Center - Aurora
Aurora, Illinois
- Call 847-842-4847
Advocate Good Shepherd Hospital
Barrington, Illinois
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Illinois CancerCare-Bloomington
Bloomington, Illinois
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Illinois CancerCare-Canton
Canton, Illinois
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Illinois CancerCare-Carthage
Carthage, Illinois
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AMG Crystal Lake - Oncology
Crystal Lake, 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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Illinois CancerCare-Dixon
Dixon, Illinois
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Advocate Good Samaritan Hospital
Downers Grove, Illinois
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Carle Physician Group-Effingham
Effingham, Illinois
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Crossroads Cancer Center
Effingham, Illinois
- Call 847-429-2907
Advocate Sherman Hospital
Elgin, Illinois
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Illinois CancerCare-Eureka
Eureka, Illinois
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Galesburg, Illinois
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Northwestern Medicine Cancer Center Delnor
Geneva, Illinois
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Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois
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Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois
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Advocate South Suburban Hospital
Hazel Crest, Illinois
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Edward Hines Jr VA Hospital
Hines, Illinois
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Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois
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AMG Libertyville - Oncology
Libertyville, Illinois
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Illinois CancerCare-Macomb
Macomb, Illinois
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Carle Physician Group-Mattoon/Charleston
Mattoon, 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
- Call 800-323-8622
Advocate Christ Medical Center
Oak Lawn, 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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Advocate High Tech Medical Park
Palos Heights, Illinois
- Call 847-384-3621
Advocate Lutheran General Hospital
Park Ridge, Illinois
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Illinois CancerCare-Pekin
Pekin, Illinois
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Illinois CancerCare-Peoria
Peoria, Illinois
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Illinois CancerCare-Peru
Peru, Illinois
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Illinois CancerCare-Princeton
Princeton, Illinois
- Call 217-545-7929
Southern Illinois University School of Medicine
Springfield, Illinois
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- 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
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Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana
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McFarland Clinic - Ames
Ames, Iowa
- Call 515-956-4132
Mary Greeley Medical Center
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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- Call 785-295-8000
University of Kansas Health System Saint Francis Campus
Topeka, Kansas
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University of Kansas Cancer Center
Kansas City, Kansas
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University of Kansas Hospital-Westwood Cancer Center
Westwood, 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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University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas
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Salina Regional Health Center
Salina, Kansas
- Call 785-623-5774
HaysMed
Hays, 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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Lahey Medical Center-Peabody
Peabody, Massachusetts
- Call 978-922-3000
Beverly Hospital
Beverly, Massachusetts
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Lahey Hospital and Medical Center
Burlington, Massachusetts
- Call 978-283-4000
Addison Gilbert Hospital
Gloucester, Massachusetts
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Baystate Medical Center
Springfield, Massachusetts
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UMass Memorial Medical Center - University Campus
Worcester, Massachusetts
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Cancer Hematology Centers - Flint
Flint, Michigan
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Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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
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Henry Ford Cancer Institute-Downriver
Brownstown, Michigan
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Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan
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Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan
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Henry Ford Medical Center-Fairlane
Dearborn, Michigan
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Henry Ford Hospital
Detroit, Michigan
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Genesys Hurley Cancer Institute
Flint, Michigan
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Hurley Medical Center
Flint, Michigan
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Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan
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Allegiance Health
Jackson, 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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Trinity Health Muskegon Hospital
Muskegon, Michigan
- Call 616-391-1230
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan
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Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan
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Henry Ford Medical Center-Columbus
Novi, Michigan
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Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan
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Corewell Health Reed City Hospital
Reed City, Michigan
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Munson Medical Center
Traverse City, Michigan
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Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan
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Henry Ford Wyandotte Hospital
Wyandotte, Michigan
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University of Michigan Health - West
Wyoming, Michigan
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Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan
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Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan
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Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan
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Essentia Health Sandstone
Sandstone, Minnesota
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Essentia Health Cancer Center
Duluth, Minnesota
- Call 218-786-3308
Essentia Health Hibbing Clinic
Hibbing, Minnesota
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Essentia Health - Deer River Clinic
Deer River, Minnesota
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Essentia Health Virginia Clinic
Virginia, Minnesota
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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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Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi
- Call 314-996-5569
Missouri Baptist Medical Center
St Louis, Missouri
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University of Kansas Cancer Center - North
Kansas City, Missouri
- Call 913-588-3671
University of Kansas Cancer Center - Briarcliff
Kansas City, Missouri
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University Health Truman Medical Center
Kansas City, Missouri
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Parkland Health Center - Farmington
Farmington, Missouri
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Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri
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University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri
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BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri
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Missouri Baptist Sullivan Hospital
Sullivan, 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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Community Medical Center
Missoula, Montana
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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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Benefis Sletten Cancer Institute
Great Falls, Montana
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Logan Health Medical Center
Kalispell, 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 603-224-2556
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire
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- Call 800-339-6484
Solinsky Center for Cancer Care
Manchester, New Hampshire
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Virtua Samson Cancer Center
Moorestown, New Jersey
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Virtua Voorhees
Voorhees Township, New Jersey
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio
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ProMedica Flower Hospital
Sylvania, Ohio
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Aultman Health Foundation
Canton, Ohio
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University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma
- Call 877-231-4440
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma
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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 Saint Vincent Medical Center
Portland, Oregon
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Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon
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Providence Willamette Falls Medical Center
Oregon City, Oregon
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Providence Portland Medical Center
Portland, Oregon
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Kaiser Permanente Northwest
Portland, Oregon
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Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania
- Call 717-217-6020
WellSpan Medical Oncology and Hematology
Chambersburg, Pennsylvania
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Geisinger Medical Center
Danville, Pennsylvania
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Geisinger Cancer Center Dickson City
Dickson City, Pennsylvania
- Call 717-721-4840
Ephrata Cancer Center
Ephrata, Pennsylvania
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Adams Cancer Center
Gettysburg, Pennsylvania
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Sechler Family Cancer Center
Lebanon, 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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WellSpan Health-York Cancer Center
York, Pennsylvania
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Community Medical Center
Scranton, Pennsylvania
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Ralph H Johnson VA Medical Center
Charleston, South Carolina
- I'm interested
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee
- I'm interested
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee
- I'm interested
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah
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VCU Community Memorial Health Center
South Hill, Virginia
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VCU Massey Comprehensive Cancer Center
Richmond, Virginia
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VCU Massey Cancer Center at Stony Point
Richmond, Virginia
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Virginia Cancer Institute
Richmond, Virginia
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University of Virginia Cancer Center
Charlottesville, Virginia
- I'm interested
Swedish Medical Center-First Hill
Seattle, Washington
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Swedish Cancer Institute-Issaquah
Issaquah, Washington
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Swedish Cancer Institute-Edmonds
Edmonds, Washington
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West Virginia University Healthcare
Morgantown, West Virginia
- I'm interested
Edwards Comprehensive Cancer Center
Huntington, West Virginia
- I'm interested
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin
- I'm interested
Aurora West Allis Medical Center
West Allis, Wisconsin
- I'm interested
Marshfield Medical Center - Weston
Weston, Wisconsin
- I'm interested
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin
- I'm interested
Duluth Clinic Ashland
Ashland, Wisconsin
- I'm interested
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin
- I'm interested
Aurora Health Care Germantown Health Center
Germantown, Wisconsin
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Aurora Saint Luke's South Shore
Cudahy, Wisconsin
- I'm interested
Aurora Cancer Care-Grafton
Grafton, Wisconsin
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Aurora BayCare Medical Center
Green Bay, Wisconsin
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Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin
- I'm interested
Gundersen Lutheran Medical Center
La Crosse, Wisconsin
- I'm interested
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin
- I'm interested
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin
- I'm interested
Aurora Sinai Medical Center
Milwaukee, Wisconsin
- I'm interested
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin
- I'm interested
Aurora Cancer Care-Racine
Racine, Wisconsin
- I'm interested
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin
- I'm interested
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin
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Aurora Medical Center in Summit
Summit, Wisconsin
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Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin
Who can participate
Inclusion criteria
- ✓Participants must have been assigned to S1900J by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1900J is determined by the LUNGMAP protocol
- ✓Participants must have documentation of NSCLC with MET amplification determined by FMI tissue-based next generation sequencing (NGS) assay
- ✓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 registration. 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 registration. 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 registration 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 registration
- ✓Participants with asymptomatic CNS metastasis (brain metastases or leptomeningeal disease) must be clinically stable and asymptomatic for at least 14 days prior to sub-study registration
- ✓NOTE: Participants can be on a low-dose corticosteroid treatment (≤ 10 mg prednisone or equivalent) for at least 14 days prior to study treatment
- ✓Participants must not have other known actionable oncogenic alterations, such as (but not limited to) EGFR sensitizing mutations, EGFR T790M mutation, MET Exon-14 skipping mutant NSCLC, ALK gene fusion, ROS1 gene rearrangement, RET gene rearrangement, NTRK rearrangement, HER2 mutation, KRAS activating mutations, and BRAF V600E mutation
- ✓Participants must have progressed (in the opinion of the treating physician) following the most recent line of therapy
- ✓Participants must have received at least one line of systemic treatment for Stage IV or recurrent NSCLC
- ✓Participants must have recovered (≤ Grade 1) from any side effects of prior therapy. The exception is if a side effect from a prior treatment is known to be permanent without expected further recovery or resolution (i.e., endocrinopathy from immunotherapy or cisplatin neurotoxicity)
- ✓Participants must not have been previously treated for any cancer with MET tyrosine kinase inhibitors (TKIs) such as tepotinib, capmatinib, and crizotinib
- ✓Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub-study registration
- ✓Participants must not have a prior treatment with anti-PD-1 or anti-PD-L1 antibody within 6 weeks of sub-study registration
- ✓Participants must not have received any radiation therapy within 14 days prior to sub-study registration
- ✓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 major surgery excluding placement of vascular access or tumor biopsy, or had significant traumatic injury within 28 days prior to sub-study registration, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
- ✓NOTE: Participants with planned surgical procedures to be conducted under local anesthesia may participate
- ✓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 registration)
- ✓Hemoglobin \>= 10.0 g/dL (within 28 days prior to sub-study registration)
- ✓Platelets ≥ 75 x 10\^3/uL (within 28 days prior to sub-study registration)
- ✓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 registration)
- ✓Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × institutional ULN. Participants with history of liver metastasis must have AST and ALT ≤ 5 x ULN (within 28 days prior to sub-study registration)
- ✓Participants must have a serum creatinine ≤ the institutional upper limit of normal (IULN) or calculated creatinine clearance ≥ 45 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to sub-study registration. For creatinine clearance formula see the tools on the CRA Workbench
- ✓Participants' most recent Zubrod performance status must be 0-2 and be documented within 28 days prior to sub-study registration
- ✓Participants must have a completed medical history and physical exam within 28 days prior to sub-study registration
- ✓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 registration
- ✓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 registration
- ✓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 registration
- ✓Participants with known diabetes as determined by the treating investigator must show evidence of controlled disease within 14 days prior to sub-study registration
- ✓Participants of reproductive potential must have a negative serum pregnancy test within 7 days prior to sub-study registration
- ✓Participants must not have other clinically active infectious liver disease
- ✓Participants must not have clinically significant hypertension within 28 days prior to sub-study registration as determined by the treating investigator
- ✓Participants must not have a history of pneumonitis that required drug therapy or an active symptomatic interstitial lung disease (ILD)/pneumonitis, including drug-induced or radiation ILD/pneumonitis
- ✓Participants must not have ongoing or active infection or be diagnosed or suspected viral infection as determined by the treating investigator. NOTE: Participants that have an infection requiring antimicrobial therapy will be required to complete antibiotics 1 week prior to starting treatment
- ✓Participants must not have active bleeding diathesis as determined by the treating investigator
- ✓Participants must not have impaired oxygenation requiring continuous oxygen supplementation as determined by the treating investigator
- ✓Participants must not have psychiatric illness, social situation, or any other circumstances that would limit compliance with study requirements as determined by the treating investigator
- ✓Participants must not have any ophthalmologic condition that is unstable in the opinion of the treating investigator
- ✓Participants must not be pregnant or breastfeeding (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
- ✓Participants must agree to have blood specimens submitted for circulating tumor DNA (ctDNA)
- ✓Participants must 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.