A Phase II Study of Amivantamab SC (Subcutaneous) in Participants With MET Amplification-Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP SUB-STUDY)
Summary
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.
Detailed description
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 development of a proposal to evaluate comprehensive next-generation sequencing of circulating tumor deoxyribonucleic acid (ctDNA). II. To establish a tissue/blood repository from participants with refractory non-small cell lung cancer (NSCLC). OUTLINE: Patients receive amivantamab subcutaneously (SC) on days 1, 8, 15, and 22 of cycle 1 and then on days 1 and 15 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo computerized tomography (CT) or magnetic resonance imaging (MRI) and collection of blood samples throughout the trial. After completion of study treatment, patients are followed up for up to 3 years.
Arms & interventions
- BiologicalAmivantamab
Given amivantamab-SC
- ProcedureBiospecimen Collection
Undergo collection of blood samples
- ProcedureComputed Tomography
Undergo CT scan
- ProcedureMagnetic Resonance Imaging
Undergo MRI
Outcome measures
Primary
Response rate for amivantamab-subcutaneous
Response rates and associated confidence intervals will be calculated.
Time frame: Up to 3 years
Secondary
Overall survival
Time frame: Up to 3 years
Progression free survival
Time frame: Up to 3 years
Duration of response
Time frame: Up to 3 years
Incidence of adverse events
Time frame: Up to 28 days
Eligibility criteria
Study locations (248)
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, 72401
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Sutter Auburn Faith Hospital
Auburn, California, 95602
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704
Palo Alto Medical Foundation-Fremont
Fremont, California, 94538
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Loma Linda University Medical Center
Loma Linda, California, 92354
Memorial Medical Center
Modesto, California, 95355
Palo Alto Medical Foundation Health Care
Palo Alto, California, 94301
Eisenhower Medical Center
Rancho Mirage, California, 92270
Sutter Roseville Medical Center
Roseville, California, 95661
Sutter Medical Center Sacramento
Sacramento, California, 95816
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
California Pacific Medical Center-Pacific Campus
San Francisco, California, 94115
Mills Health Center
San Mateo, California, 94401
Sutter Pacific Medical Foundation
Santa Rosa, California, 95403
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, 94086
Sutter Solano Medical Center/Cancer Center
Vallejo, California, 94589
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, 80045
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909
Memorial Hospital North
Colorado Springs, Colorado, 80920
Poudre Valley Hospital
Fort Collins, Colorado, 80524
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, 80528
UCHealth Greeley Hospital
Greeley, Colorado, 80631
Medical Center of the Rockies
Loveland, Colorado, 80538
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, 06418
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, 06824
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, 06437
Yale University
New Haven, Connecticut, 06520
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, 06473
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, 06611
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut, 06708
Bayhealth Hospital Kent Campus
Dover, Delaware, 19901
Bayhealth Hospital Sussex Campus
Milford, Delaware, 19963
Malcom Randall Veterans Administration Medical Center
Gainesville, Florida, 32610
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia, 30501
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii, 96813
Queen's Medical Center
Honolulu, Hawaii, 96813
Straub Clinic and Hospital
Honolulu, Hawaii, 96813
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, 96817
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, 96701
Pali Momi Medical Center
‘Aiea, Hawaii, 96701
The Queen's Medical Center - West Oahu
‘Ewa Beach, Hawaii, 96706
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, 83864
Advocate Outpatient Center - Aurora
Aurora, Illinois, 60506
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Illinois CancerCare-Canton
Canton, Illinois, 61520
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Northwestern University
Chicago, Illinois, 60611
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, 60014
Carle at The Riverfront
Danville, Illinois, 61832
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Decatur Memorial Hospital
Decatur, Illinois, 62526
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Crossroads Cancer Center
Effingham, Illinois, 62401
Advocate Sherman Hospital
Elgin, Illinois, 60123
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, 60026
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, 60030
Advocate South Suburban Hospital
Hazel Crest, Illinois, 60429
Edward Hines Jr VA Hospital
Hines, Illinois, 60141
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045
AMG Libertyville - Oncology
Libertyville, Illinois, 60048
Condell Memorial Hospital
Libertyville, Illinois, 60048
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Loyola University Medical Center
Maywood, Illinois, 60153
SSM Health Good Samaritan
Mount Vernon, Illinois, 62864
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
Northwestern Medicine Oak Brook
Oak Brook, Illinois, 60523
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453-2699
Advocate Outpatient Center - Oak Lawn
Oak Lawn, Illinois, 60453
Northwestern Medicine Orland Park
Orland Park, Illinois, 60462
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
Advocate High Tech Medical Park
Palos Heights, Illinois, 60463
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
Illinois CancerCare-Peru
Peru, Illinois, 61354
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Springfield Clinic
Springfield, Illinois, 62702
Springfield Memorial Hospital
Springfield, Illinois, 62781
Carle Cancer Center
Urbana, Illinois, 61801
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555
Illinois CancerCare - Washington
Washington, Illinois, 61571
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Mary Greeley Medical Center
Ames, Iowa, 50010
McFarland Clinic - Ames
Ames, Iowa, 50010
McFarland Clinic - Boone
Boone, Iowa, 50036
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501
McFarland Clinic - Jefferson
Jefferson, Iowa, 50129
McFarland Clinic - Marshalltown
Marshalltown, Iowa, 50158
University of Kansas Clinical Research Center
Fairway, Kansas, 66205
HaysMed
Hays, Kansas, 67601
University of Kansas Cancer Center
Kansas City, Kansas, 66160
Lawrence Memorial Hospital
Lawrence, Kansas, 66044
The University of Kansas Cancer Center - Olathe
Olathe, Kansas, 66061
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, 66211
Salina Regional Health Center
Salina, Kansas, 67401
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, 66606
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
Lafayette Family Cancer Center-EMMC
Brewer, Maine, 04412
Beverly Hospital
Beverly, Massachusetts, 01915
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
Addison Gilbert Hospital
Gloucester, Massachusetts, 01930
Lahey Medical Center-Peabody
Peabody, Massachusetts, 01960
Baystate Medical Center
Springfield, Massachusetts, 01199
UMass Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
Bronson Battle Creek
Battle Creek, Michigan, 49017
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, 48183
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, 48126
Henry Ford Hospital
Detroit, Michigan, 48202
Cancer Hematology Centers - Flint
Flint, Michigan, 48503
Genesee Hematology Oncology PC
Flint, Michigan, 48503
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Hurley Medical Center
Flint, Michigan, 48503
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
Allegiance Health
Jackson, Michigan, 49201
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, 49120
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, 49444
Henry Ford Medical Center-Columbus
Novi, Michigan, 48377
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341
Corewell Health Reed City Hospital
Reed City, Michigan, 49677
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085
Munson Medical Center
Traverse City, Michigan, 49684
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322
Henry Ford Wyandotte Hospital
Wyandotte, Michigan, 48192
University of Michigan Health - West
Wyoming, Michigan, 49519
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
Essentia Health Sandstone
Sandstone, Minnesota, 55072
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, 39705
Baptist Cancer Center-Grenada
Grenada, Mississippi, 38901
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi, 38652
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, 38655
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, 38671
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Parkland Health Center - Farmington
Farmington, Missouri, 63640
University Health Truman Medical Center
Kansas City, Missouri, 64108
University of Kansas Cancer Center - Briarcliff
Kansas City, Missouri, 64116
University of Kansas Cancer Center - North
Kansas City, Missouri, 64154
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670
Mercy Hospital South
St Louis, Missouri, 63128
Missouri Baptist Medical Center
St Louis, Missouri, 63131
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, 63127
Community Hospital of Anaconda
Anaconda, Montana, 59711
Billings Clinic Cancer Center
Billings, Montana, 59101
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
Logan Health Medical Center
Kalispell, Montana, 59901
Community Medical Center
Missoula, Montana, 59804
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, 89102
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89183
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire, 03301
Solinsky Center for Cancer Care
Manchester, New Hampshire, 03103
Virtua Samson Cancer Center
Moorestown, New Jersey, 08057
Virtua Voorhees
Voorhees Township, New Jersey, 08043
Aultman Health Foundation
Canton, Ohio, 44710
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
ProMedica Flower Hospital
Sylvania, Ohio, 43560
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma, 73505
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Providence Newberg Medical Center
Newberg, Oregon, 97132
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, 97914
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045
Providence Portland Medical Center
Portland, Oregon, 97213
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
Kaiser Permanente Northwest
Portland, Oregon, 97227
Oregon Health and Science University
Portland, Oregon, 97239
WellSpan Medical Oncology and Hematology
Chambersburg, Pennsylvania, 17201
Geisinger Medical Center
Danville, Pennsylvania, 17822
Geisinger Cancer Center Dickson City
Dickson City, Pennsylvania, 18519
Ephrata Cancer Center
Ephrata, Pennsylvania, 17522
Adams Cancer Center
Gettysburg, Pennsylvania, 17325
Sechler Family Cancer Center
Lebanon, Pennsylvania, 17042
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837
Community Medical Center
Scranton, Pennsylvania, 18510
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711
Cancer Care Associates of York
York, Pennsylvania, 17403
WellSpan Health-York Cancer Center
York, Pennsylvania, 17403
Ralph H Johnson VA Medical Center
Charleston, South Carolina, 29401
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, 38017
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
Virginia Cancer Institute
Richmond, Virginia, 23229
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
VCU Community Memorial Health Center
South Hill, Virginia, 23970
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
Swedish Medical Center-First Hill
Seattle, Washington, 98122
Edwards Comprehensive Cancer Center
Huntington, West Virginia, 25701
West Virginia University Healthcare
Morgantown, West Virginia, 26506
Duluth Clinic Ashland
Ashland, Wisconsin, 54806
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105
Aurora Saint Luke's South Shore
Cudahy, Wisconsin, 53110
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, 53209
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904
Aurora Cancer Care-Racine
Racine, Wisconsin, 53406
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
Aurora Medical Center in Summit
Summit, Wisconsin, 53066
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, 54241
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, 53226
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476