Testing the Use of Combination Immunotherapy Treatment (N-803 [ALT-803] Plus Pembrolizumab) Against the Usual Treatment for Advanced Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial)
A Phase II/III Study of N-803 (ALT-803) Plus Pembrolizumab Versus Standard of Care in Participants With Stage IV or Recurrent Non-Small Cell Lung Cancer Previously Treated With Anti-PD-1 or Anti-PD-L1 Therapy (Lung-MAP Non-Match Sub-Study)
3 other identifiers
interventional
82
1 country
350
Brief Summary
This phase II/III Lung-MAP trial studies how well immunotherapy treatment with N-803 (ALT-803) and pembrolizumab working in treating patients with non-small cell lung cancer that has spread to other places in the body (advanced). Natural killer cells, part of our immune system, are always on alert and ready to defend our bodies from many kinds of infection or rogue cells, such as those that cause cancer. N-803 (ALT-803) may activate natural killer cells so that they can stimulate an immune response to help fight cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving N-803 (ALT-803) and pembrolizumab may help shrink and stabilize lung cancer or prevent it from returning.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2022
Longer than P75 for phase_2
350 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2021
CompletedFirst Posted
Study publicly available on registry
October 27, 2021
CompletedStudy Start
First participant enrolled
March 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
May 15, 2025
May 1, 2025
4.9 years
October 14, 2021
May 12, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival
Will be compared between the arms using the combination weighted/unweighted log-rank test statistic (as utilized in S1800A) with statistical significance at the 1-sided 10% level.
Up to 2 years
Secondary Outcomes (2)
Investigator-assessed progression-free survival (IA-PFS)
From date of sub-study randomization to date of first documentation of potential immune-response confirmed progression, or death due to any cause, assessed up to 2 years
Duration of response (DoR)
From date of first documentation of response (complete response or partial response) to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause, assessed up to 2 years
Study Arms (2)
Arm A (standard of care)
ACTIVE COMPARATORPatients receive standard of care consisting of docetaxel IV over 30-60 minutes on day 1; gemcitabine IV over 30 minutes on days 1 and 8; pemetrexed IV over 10 minutes on day 1; or ramucirumab IV over 30-60 minutes and docetaxel IV over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Arm B (pembrolizumab, nogapendekin alfa)
EXPERIMENTALPatients receive pembrolizumab IV over 30 minutes and nogapendekin alfa SC on day 1. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients then receive nogapendekin alfa SC on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions
Given intramuscularly
Given orally (PO)
Given IV
Given PO
Given SC
Given IV
Given IV
Eligibility Criteria
You may qualify if:
- Participants must have been assigned to S1800D by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1800D is determined by the LUNGMAP or S1400 protocol
- Participants must have measurable or non-measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI). Measurable disease must be assessed within 28 days prior to randomization. Non-measurable disease must be assessed within 42 days prior to randomization. The CT from a combined positron emission tomography (PET)/CT may be used only if it is of diagnostic quality. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1)
- 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 with spinal cord compression or brain metastases must have received local treatment to these metastases and remained clinically controlled and asymptomatic for at least 7 days following stereotactic radiation and/or 14 days following whole brain radiation, and prior to sub-study randomization
- Participants with spinal cord compression or brain metastases must not have residual neurological dysfunction, unless no further recovery is expected, and the participant has been stable on weaning doses of corticosteroids (=\< 10 mg daily prednisone or equivalent) prior to sub-study randomization
- Participants must have progressed (in the opinion of the treating investigator) following the most recent line of therapy for non-small cell lung cancer (NSCLC)
- Participants with a known sensitizing mutation for which an FDA-approved targeted therapy for NSCLC exists (e.g. EGFR, ALK gene fusions, ROS1, BRAF, RET, NTRK, and MET sensitizing mutations), must have previously received at least one of the approved therapy(s)
- Participants must have received exactly one line of anti-PD-1 or anti-PD-L1 therapy for advanced disease (stage IV or recurrent, or stage III in certain circumstances outlined below) given alone or in combination with platinum-based chemotherapy. Participants must have experienced disease progression during or after this regimen
- Continuing the same agent(s) after progression counts as a single line of therapy. However, a change or addition in agent(s) after progression (e.g. the addition of chemotherapy to anti-PD-1 monotherapy after progression) counts as a subsequent line of therapy and would exclude the participant
- For participants who received consolidation anti-PD-1 or anti-PD-L1 therapy following concurrent chemoradiation for Stage III disease as their only line of anti-PD-1 or anti-PD-L1 therapy:
- If they experienced disease progression less than (\<) 365 days from the first date of anti-PD-1 or anti-PD-L1 therapy, this counts as the single line of anti-PD-1 or anti-PD-L1 therapy for advanced disease
- If they experienced disease progression more than or equal to (\>=) 365 days from the first date of anti-PD-1 or anti-PD-L1 therapy, this is not considered a line of anti-PD-1 or anti-PD-L1 therapy for advanced disease
- Participants must have recovered (=\< grade 1) from any side effects of prior therapy, except for alopecia
- Participants must be able to safely receive at least one of the investigator's choice of standard of care regimens, per the current FDA-approved package insert
- Note: Pemetrexed is not FDA-approved for squamous cell NSCLC and must not be used to treat participants with squamous cell NSCLC
- +12 more criteria
You may not qualify if:
- Participants must not have leptomeningeal disease that requires CNS-specific treatment prior to registration and must not be planning to receive the CNS-specific treatment through the first cycle of the protocol therapy
- Participants must not have experienced the following:
- Any grade 3 or worse immune-related adverse event (irAE). Exception: asymptomatic nonbullous/nonexfoliative rash
- Any unresolved grade 2 irAE
- Any toxicity that led to permanent discontinuation of prior anti-PD-1/PD-L1 immunotherapy
- Exception to the above: Toxicities of any grade that requires replacement therapy and has stabilized on therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are allowed
- Participants must not have any history of organ transplant that requires use of immunosuppressives
- Participants must not have history of (non-infectious) pneumonitis that required steroids or current pneumonitis/interstitial lung disease
- Participants must not have any known allergy or reaction to any component of the investigational formulations. If there is a known allergy or reaction to standard of care formulations, participants must be able to safely receive at least one of the standard of care options
- Participants must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., participants with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months prior to sub-study randomization, or serious uncontrolled cardiac arrhythmia
- Participants must not have experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to sub-study randomization
- Participants must not have an active or uncontrolled infection in the opinion of the treating investigator
- Participants must not have a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen
- Participants must not have any of following:
- Cirrhosis at a level of Child-Pugh B (or worse)
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SWOG Cancer Research Networklead
- National Cancer Institute (NCI)collaborator
Study Sites (350)
Veterans Administration Medical Center - Birmingham
Birmingham, Alabama, 35233, United States
CTCA at Western Regional Medical Center
Goodyear, Arizona, 85338, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Kaiser Permanente-Anaheim
Anaheim, California, 92806, United States
PCR Oncology
Arroyo Grande, California, 93420, United States
Sutter Auburn Faith Hospital
Auburn, California, 95602, United States
Kaiser Permanente-Baldwin Park
Baldwin Park, California, 91706, United States
Kaiser Permanente-Bellflower
Bellflower, California, 90706, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704, United States
Tower Cancer Research Foundation
Beverly Hills, California, 90211, United States
Kaiser Permanente-Fontana
Fontana, California, 92335, United States
Palo Alto Medical Foundation-Fremont
Fremont, California, 94538, United States
Kaiser Permanente - Harbor City
Harbor City, California, 90710, United States
Kaiser Permanente-Irvine
Irvine, California, 92618, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
Kaiser Permanente West Los Angeles
Los Angeles, California, 90034, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Memorial Medical Center
Modesto, California, 95355, United States
Kaiser Permanente-Oakland
Oakland, California, 94611, United States
Kaiser Permanente-Ontario
Ontario, California, 91761, United States
Palo Alto Medical Foundation Health Care
Palo Alto, California, 94301, United States
Kaiser Permanente - Panorama City
Panorama City, California, 91402, United States
Eisenhower Medical Center
Rancho Mirage, California, 92270, United States
Kaiser Permanente-Riverside
Riverside, California, 92505, United States
Kaiser Permanente-Roseville
Roseville, California, 95661, United States
Sutter Roseville Medical Center
Roseville, California, 95661, United States
Kaiser Permanente Downtown Commons
Sacramento, California, 95814, United States
Sutter Medical Center Sacramento
Sacramento, California, 95816, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
Kaiser Permanente-San Diego Zion
San Diego, California, 92120, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, 94115, United States
Kaiser Permanente-San Francisco
San Francisco, California, 94115, United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121, United States
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, 95119, United States
Kaiser Permanente San Leandro
San Leandro, California, 94577, United States
Kaiser Permanente-San Marcos
San Marcos, California, 92078, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051, United States
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California, 95065, United States
Kaiser Permanente-South San Francisco
South San Francisco, California, 94080, United States
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, 94086, United States
Torrance Memorial Physician Network - Cancer Care
Torrance, California, 90505, United States
Kaiser Permanente-Vallejo
Vallejo, California, 94589, United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California, 94589, United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California, 94596, United States
Presbyterian Intercommunity Hospital
Whittier, California, 90602, United States
Kaiser Permanente-Woodland Hills
Woodland Hills, California, 91367, United States
Veterans Affairs Connecticut Healthcare System-West Haven Campus
West Haven, Connecticut, 06516, United States
Bayhealth Hospital Kent Campus
Dover, Delaware, 19901, United States
Beebe South Coastal Health Campus
Frankford, Delaware, 19945, United States
Bayhealth Hospital Sussex Campus
Milford, Delaware, 19963, United States
Helen F Graham Cancer Center
Newark, Delaware, 19713, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713, United States
Beebe Health Campus
Rehoboth Beach, Delaware, 19971, United States
Kaiser Permanente-Capitol Hill Medical Center
Washington D.C., District of Columbia, 20002, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Northside Hospital - Duluth
Duluth, Georgia, 30096, United States
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia, 30501, United States
Northside Hospital - Gwinnett
Lawrenceville, Georgia, 30046, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712, United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619, United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642, United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83686, United States
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, 83301, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704, United States
Illinois CancerCare-Canton
Canton, Illinois, 61520, United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321, United States
Centralia Oncology Clinic
Centralia, Illinois, 62801, United States
Northwestern University
Chicago, Illinois, 60611, United States
Carle on Vermilion
Danville, Illinois, 61832, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526, United States
Illinois CancerCare-Dixon
Dixon, Illinois, 61021, United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
Edward Hines Jr VA Hospital
Hines, Illinois, 60141, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443, United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045, United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Illinois CancerCare-Peru
Peru, Illinois, 61354, United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356, United States
Mercyhealth Javon Bea Hospital - Rockton
Rockford, Illinois, 61103, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Springfield Clinic
Springfield, Illinois, 62702, United States
Memorial Medical Center
Springfield, Illinois, 62781, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
The Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Illinois CancerCare - Washington
Washington, Illinois, 61571, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Mary Greeley Medical Center
Ames, Iowa, 50010, United States
McFarland Clinic PC - Ames
Ames, Iowa, 50010, United States
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa, 52722, United States
McFarland Clinic PC-Boone
Boone, Iowa, 50036, United States
Mercy Hospital
Cedar Rapids, Iowa, 52403, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403, United States
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, 50325, United States
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325, United States
Greater Regional Medical Center
Creston, Iowa, 50801, United States
Mission Cancer and Blood - Laurel
Des Moines, Iowa, 50314, United States
McFarland Clinic PC-Trinity Cancer Center
Fort Dodge, Iowa, 50501, United States
McFarland Clinic PC-Jefferson
Jefferson, Iowa, 50129, United States
McFarland Clinic PC-Marshalltown
Marshalltown, Iowa, 50158, United States
Mercy Medical Center-West Lakes
West Des Moines, Iowa, 50266, United States
HaysMed University of Kansas Health System
Hays, Kansas, 67601, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
Olathe Health Cancer Center
Olathe, Kansas, 66061, United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210, United States
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, 66211, United States
Salina Regional Health Center
Salina, Kansas, 67401, United States
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, 66606, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, 67208, United States
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, 67214, United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, 67214, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536, United States
Owensboro Health Mitchell Memorial Cancer Center
Owensboro, Kentucky, 42303, United States
Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana, 70809, United States
Harold Alfond Center for Cancer Care
Augusta, Maine, 04330, United States
MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
Biddeford, Maine, 04005, United States
Lafayette Family Cancer Center-EMMC
Brewer, Maine, 04412, United States
MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
Sanford, Maine, 04073, United States
Kaiser Permanente-Woodlawn Medical Center
Baltimore, Maryland, 21244, United States
UPMC Western Maryland
Cumberland, Maryland, 21502, United States
Kaiser Permanente-Gaithersburg Medical Center
Gaithersburg, Maryland, 20879, United States
Kaiser Permanente - Kensington Medical Center
Kensington, Maryland, 20895, United States
Kaiser Permanente - Largo Medical Center
Largo, Maryland, 20774, United States
William E Kahlert Regional Cancer Center/Sinai Hospital
Westminster, Maryland, 21157, United States
Beverly Hospital
Beverly, Massachusetts, 01915, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805, United States
Addison Gilbert Hospital
Gloucester, Massachusetts, 01930, United States
Lahey Medical Center-Peabody
Peabody, Massachusetts, 01960, United States
UMass Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Bronson Battle Creek
Battle Creek, Michigan, 49017, United States
Saint Joseph Mercy Brighton
Brighton, Michigan, 48114, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114, United States
Saint Joseph Mercy Canton
Canton, Michigan, 48188, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188, United States
Saint Joseph Mercy Chelsea
Chelsea, Michigan, 48118, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118, United States
Ascension Saint John Hospital
Detroit, Michigan, 48236, United States
Great Lakes Cancer Management Specialists-Doctors Park
East China Township, Michigan, 48054, United States
Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan, 48503, United States
Genesee Hematology Oncology PC
Flint, Michigan, 48503, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Academic Hematology Oncology Specialists
Grosse Pointe Woods, Michigan, 48236, United States
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods, Michigan, 48236, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Ascension Borgess Cancer Center
Kalamazoo, Michigan, 49009, United States
Sparrow Hospital
Lansing, Michigan, 48912, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154, United States
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb, Michigan, 48044, United States
Ascension Providence Hospitals - Novi
Novi, Michigan, 48374, United States
Ascension Saint Mary's Hospital
Saginaw, Michigan, 48601, United States
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan, 48604, United States
Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085, United States
Ascension Providence Hospitals - Southfield
Southfield, Michigan, 48075, United States
Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights, Michigan, 48312, United States
Ascension Saint Joseph Hospital
Tawas City, Michigan, 48764, United States
Great Lakes Cancer Management Specialists-Macomb Professional Building
Warren, Michigan, 48093, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, 48093, United States
Huron Gastroenterology PC
Ypsilanti, Michigan, 48106, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601, United States
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636, United States
Essentia Health Cancer Center
Duluth, Minnesota, 55805, United States
Unity Hospital
Fridley, Minnesota, 55432, United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Minneapolis VA Medical Center
Minneapolis, Minnesota, 55417, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
Essentia Health Sandstone
Sandstone, Minnesota, 55072, United States
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141, United States
Parkland Health Center - Farmington
Farmington, Missouri, 63640, United States
Truman Medical Centers
Kansas City, Missouri, 64108, United States
University of Kansas Cancer Center - North
Kansas City, Missouri, 64154, United States
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064, United States
University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City, Missouri, 64116, United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Siteman Cancer Center-South County
St Louis, Missouri, 63129, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136, United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080, United States
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri, 63127, United States
Bozeman Deaconess Hospital
Bozeman, Montana, 59715, United States
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, 89102, United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89148, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire, 03301, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Solinsky Center for Cancer Care
Manchester, New Hampshire, 03103, United States
Virtua Samson Cancer Center
Moorestown, New Jersey, 08057, United States
Virtua Voorhees
Voorhees Township, New Jersey, 08043, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102, United States
Presbyterian Kaseman Hospital
Albuquerque, New Mexico, 87110, United States
Memorial Medical Center - Las Cruces
Las Cruces, New Mexico, 88011, United States
Presbyterian Rust Medical Center/Jorgensen Cancer Center
Rio Rancho, New Mexico, 87124, United States
Mary Imogene Bassett Hospital
Cooperstown, New York, 13326, United States
Cancer Institute at Saint Francis Hospital
East Hills, New York, 11548, United States
Arnot Ogden Medical Center/Falck Cancer Center
Elmira, New York, 14905, United States
University of Rochester
Rochester, New York, 14642, United States
Good Samaritan Hospital Medical Center
West Islip, New York, 11795, United States
Randolph Hospital
Asheboro, North Carolina, 27203, United States
AdventHealth Infusion Center Asheville
Asheville, North Carolina, 28803, United States
Cone Health Cancer Center at Alamance Regional
Burlington, North Carolina, 27215, United States
AdventHealth Infusion Center Haywood
Clyde, North Carolina, 28721, United States
Durham VA Medical Center
Durham, North Carolina, 27705, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cone Health Cancer Center
Greensboro, North Carolina, 27403, United States
AdventHealth Hendersonville
Hendersonville, North Carolina, 28792, United States
Cone Heath Cancer Center at Mebane
Mebane, North Carolina, 27302, United States
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, 28374, United States
Duke Women's Cancer Care Raleigh
Raleigh, North Carolina, 27607, United States
Duke Raleigh Hospital
Raleigh, North Carolina, 27609, United States
Annie Penn Memorial Hospital
Reidsville, North Carolina, 27320, United States
AdventHealth Infusion Center Weaverville
Weaverville, North Carolina, 28787, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714, United States
Cleveland Clinic Mercy Hospital
Canton, Ohio, 44708, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, 43214, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Grant Medical Center
Columbus, Ohio, 43215, United States
The Mark H Zangmeister Center
Columbus, Ohio, 43219, United States
Doctors Hospital
Columbus, Ohio, 43228, United States
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015, United States
Cleveland Clinic Cancer Center Mansfield
Mansfield, Ohio, 44906, United States
OhioHealth Marion General Hospital
Marion, Ohio, 43302, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, 44124, United States
Knox Community Hospital
Mount Vernon, Ohio, 43050, United States
Licking Memorial Hospital
Newark, Ohio, 43055, United States
Southern Ohio Medical Center
Portsmouth, Ohio, 45662, United States
North Coast Cancer Care
Sandusky, Ohio, 44870, United States
Springfield Regional Cancer Center
Springfield, Ohio, 45504, United States
Springfield Regional Medical Center
Springfield, Ohio, 45505, United States
Trinity's Tony Teramana Cancer Center
Steubenville, Ohio, 43952, United States
Cleveland Clinic Cancer Center Strongsville
Strongsville, Ohio, 44136, United States
ProMedica Flower Hospital
Sylvania, Ohio, 43560, United States
South Pointe Hospital
Warrensville Heights, Ohio, 44122, United States
Saint Ann's Hospital
Westerville, Ohio, 43081, United States
Cleveland Clinic Wooster Family Health and Surgery Center
Wooster, Ohio, 44691, United States
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, 43701, United States
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma, 73505, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120, United States
Kaiser Permanente Northwest
Portland, Oregon, 97227, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
UPMC Altoona
Altoona, Pennsylvania, 16601, United States
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania, 15009, United States
UPMC Hillman Cancer Center at Butler Health System
Butler, Pennsylvania, 16001, United States
UPMC Camp Hill
Camp Hill, Pennsylvania, 17011, United States
Carlisle Regional Cancer Center
Carlisle, Pennsylvania, 17015, United States
WellSpan Medical Oncology and Hematology
Chambersburg, Pennsylvania, 17201, United States
UPMC Hillman Cancer Center - Passavant - Cranberry
Cranberry Township, Pennsylvania, 16066, United States
Ephrata Cancer Center
Ephrata, Pennsylvania, 17522, United States
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, 16505, United States
UPMC Cancer Center at UPMC Horizon
Farrell, Pennsylvania, 16121, United States
Adams Cancer Center
Gettysburg, Pennsylvania, 17325, United States
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, 15601, United States
Oncology Hematology Associates
Greenville, Pennsylvania, 16125, United States
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, 17109, United States
IRMC Cancer Center
Indiana, Pennsylvania, 15701, United States
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania, 15901, United States
Sechler Family Cancer Center
Lebanon, Pennsylvania, 17042, United States
UPMC Cancer Center at UPMC McKeesport
McKeesport, Pennsylvania, 15132, United States
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania, 17050, United States
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania, 15146, United States
UPMC-Coraopolis/Heritage Valley Radiation Oncology
Moon Township, Pennsylvania, 15108, United States
UPMC Hillman Cancer Center - Part of Frick Hospital
Mount Pleasant, Pennsylvania, 15666, United States
Arnold Palmer Cancer Center Medical Oncology Norwin
N. Huntingdon, Pennsylvania, 15642, United States
UPMC Cancer Center-Natrona Heights
Natrona Heights, Pennsylvania, 15065, United States
UPMC Hillman Cancer Center - New Castle
New Castle, Pennsylvania, 16105, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
UPMC-Mercy Hospital
Pittsburgh, Pennsylvania, 15219, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232, United States
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, 15237, United States
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania, 15243, United States
Pottstown Hospital
Pottstown, Pennsylvania, 19464, United States
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania, 16346, United States
UPMC Cancer Center-Uniontown
Uniontown, Pennsylvania, 15401, United States
UPMC Cancer Center-Washington
Washington, Pennsylvania, 15301, United States
UPMC West Mifflin-Cancer Center Jefferson
West Mifflin, Pennsylvania, 15122, United States
Divine Providence Hospital
Williamsport, Pennsylvania, 17754, United States
Cancer Care Associates of York
York, Pennsylvania, 17403, United States
WellSpan Health-York Cancer Center
York, Pennsylvania, 17403, United States
WellSpan Health-York Hospital
York, Pennsylvania, 17403, United States
UPMC Memorial
York, Pennsylvania, 17408, United States
AnMed Health Cancer Center
Anderson, South Carolina, 29621, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316, United States
Ralph H Johnson VA Medical Center
Charleston, South Carolina, 29401, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640, United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615, United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
The Don and Sybil Harrington Cancer Center
Amarillo, Texas, 79106, United States
Parkland Memorial Hospital
Dallas, Texas, 75235, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas, 76104, United States
UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas, 75080, United States
Kaiser Permanente-Burke Medical Center
Burke, Virginia, 22015, United States
Kaiser Permanente Tysons Corner Medical Center
McLean, Virginia, 22102, United States
West Virginia University Charleston Division
Charleston, West Virginia, 25304, United States
Edwards Comprehensive Cancer Center
Huntington, West Virginia, 25701, United States
West Virginia University Healthcare
Morgantown, West Virginia, 26506, United States
Duluth Clinic Ashland
Ashland, Wisconsin, 54806, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303, United States
Mercyhealth Hospital and Cancer Center - Janesville
Janesville, Wisconsin, 53548, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792, United States
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233, United States
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495, United States
Aurora Medical Center in Summit
Summit, Wisconsin, 53066, United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, 53226, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227, United States
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, 53095, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John M Wrangle
SWOG Cancer Research Network
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2021
First Posted
October 27, 2021
Study Start
March 15, 2022
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
May 15, 2025
Record last verified: 2025-05