Adding the Immunotherapy Drug Cemiplimab to Usual Treatment for People With Advanced Non-Small Cell Lung Cancer Who Had Previous Treatment With Platinum Chemotherapy and Immunotherapy (An Expanded Lung-MAP Treatment Trial)
A Randomized Phase II/III Study of Docetaxel and Ramucirumab With or Without Cemiplimab for Participants Previously Treated With Platinum-Based Chemotherapy and Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Non-Matched Sub-Study)
3 other identifiers
interventional
378
1 country
386
Brief Summary
This phase II/III Expanded Lung-MAP treatment trial compares the effect of adding cemiplimab to docetaxel and ramucirumab versus docetaxel and ramucirumab alone in treating patients with non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Cemiplimab is a monoclonal antibody that stimulates the immune system by blocking the PD-1 pathway. Tumors use the PD-1 pathway to escape attacks from the immune system. By blocking the PD-1 pathway, cemiplimab may help the immune system recognize and attack tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Adding cemiplimab to usual treatment, docetaxel and ramucirumab, may kill more tumor cells compared to docetaxel and ramucirumab alone in treating patients with stage IV or recurrent non-small cell lung cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2025
Typical duration for phase_2
386 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
August 27, 2024
CompletedFirst Posted
Study publicly available on registry
September 27, 2024
CompletedStudy Start
First participant enrolled
May 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
May 5, 2026
May 1, 2026
2.6 years
August 27, 2024
May 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival (OS)
OS will be compared between arms and within the subgroups defined by the stratification factors and by PD-L1 subgroups. Distributions of OS will be estimated using the method of Kaplan-Meier. Hazard ratios for comparisons of OS will be estimated using a Cox Proportional Hazards regression model, with baseline hazard stratification using the stratification factors. Testing will be done using a stratified log-rank test. Confidence intervals (CIs) about medians will be estimated using the method of Brookmeyer-Crowley. For point estimates at landmark times, the associated CIs will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function.
From date of randomization to date of death due to any cause, assessed up to 3 years
Secondary Outcomes (5)
Progression-free survival (PFS)
From date of randomization to date of first documentation of progression, symptomatic deterioration, or death, whichever comes first, assessed up to 3 years
Response rates
Up to 3 years
Disease control rates
Up to 3 years
Duration of response (DOR)
From date of first documentation of response by RECIST 1.1 (CR or PR, confirmed or unconfirmed) to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years
Incidence of adverse events
Up to 90 days after last dose of study treatment
Other Outcomes (2)
Cell-free deoxyribonucleic acid
At baseline, cycle 3 day 1 and at progression up to 3 years (each cycle is 21 days)
Tissue/blood repository
Up to 3 years
Study Arms (2)
Arm I (ramucirumab, docetaxel)
ACTIVE COMPARATORPatients receive dexamethasone PO BID on days 0-2, ramucirumab IV over 30-60 minutes on day 1 and docetaxel IV over 60 minutes on day 1 of each cycle (each cycle is 21 days). Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, and CT or MRI throughout the study.
Arm II (cemiplimab, ramucirumab, docetaxel)
EXPERIMENTALPatients receive dexamethasone PO BID on days 0-2, ramucirumab IV over 30-60 minutes on day 1, docetaxel IV over 60 minutes on day 1, and cemiplimab IV over 30 minutes on day 1 of each cycle (each cycle is 21 days). Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, and CT or MRI throughout the study.
Interventions
Undergo MRI
Undergo blood sample collection
Given IV
Undergo CT
Given PO
Given IV
Given IV
Eligibility Criteria
You may qualify if:
- Participants must have been assigned to S1800E by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1800E is determined by the LUNGMAP protocol
- Participants must have measurable or non-measurable disease documented by CT or MRI. The CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality. Measurable disease must be assessed within 28 days prior to randomization. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non-measurable disease must be assessed within 42 days prior to randomization. All 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 registration
- Participants must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to randomization
- Participants must have received exactly one anti-PD-1 or anti-PD-L1 therapy for advanced disease (stage IV or recurrent disease, or stage I-III disease in certain circumstances outlined below). Anti-PD-1 or anti-PD-L1 therapy may have been given alone or in combination with other therapy. For participants who received neoadjuvant, adjuvant, and/or consolidation anti-PD-1 or anti-PD-L1 therapy for stage I-III disease:
- If they experienced disease progression within (≤) 365 days from initiation (cycle 1 day 1) or anti-PD-1 or anti-PD-L1 therapy, this counts as the single allowed anti-PD-1 or anti-PD-L1 therapy for advanced disease
- If they experienced disease progression more than (\>) 365 days from initiation (cycle 1 day 1) or anti-PD-1 or anti-PD-L1 therapy, this is not considered anti-PD-1 or anti-PD-L1 therapy for advance disease. These participants must have received anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease
- Participants must have experienced disease progression (in the opinion of the treating investigator) more than (\>) 84 days following initiation (cycle 1 day 1) of their most recent anti-PD-1 or anti-PD-L1 therapy
- Participants who received anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease must have had a best response of stable disease, partial response or complete response (in the opinion of the treating investigator) on the anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease
- Participants must have received platinum-based chemotherapy and experienced disease progression (in the opinion of the treating investigator) during or after this regimen
- Participants with a known sensitizing molecular alteration for which a Food and Drug Administration (FDA)-approved targeted therapy for NSCLC exists (e.g., EGFR, ALK, ROS1, BRAF, RET, NTRK, KRAS, HER2, and MET sensitizing mutations), must have previously received at least one of the approved therapy(s). Prior targeted therapy for participants with targetable alterations is allowed if all other eligibility criteria are also met
- Participants must have recovered (≤ grade 1) from any side effects from the most recent anti-cancer treatment prior to randomization
- Participants must not have received prior therapy with docetaxel for this disease
- Participants must not have received any palliative radiation therapy within 14 days (or palliative bone radiation therapy within 7 days) prior to randomization
- Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, or biologic therapy for cancer treatment while receiving treatment on this study
- Participants must not have undergone major surgery within 28 days prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization. Participants must not have postoperative bleeding complications or wound complications from a surgical procedure performed within 2 months prior to randomization. The participant must not have elective or planned major surgery to be performed during the course of this study
- +37 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SWOG Cancer Research Networklead
- Regeneron Pharmaceuticalscollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (386)
Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis
Daphne, Alabama, 36526, United States
Thomas Hospital
Fairhope, Alabama, 36532, United States
Mobile Infirmary Medical Center
Mobile, Alabama, 36607, United States
Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland
Saraland, Alabama, 36571, United States
Katmai Oncology Group
Anchorage, Alaska, 99508, United States
Banner University Medical Center - Tucson
Tucson, Arizona, 85719, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719, United States
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, 72401, United States
Kaiser Permanente-Anaheim
Anaheim, California, 92806, United States
Kaiser Permanente-Baldwin Park
Baldwin Park, California, 91706, United States
Kaiser Permanente-Bellflower
Bellflower, California, 90706, United States
Tower Cancer Research Foundation
Beverly Hills, California, 90211, United States
Enloe Medical Center
Chico, California, 95926, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
Kaiser Permanente-Fontana
Fontana, California, 92335, United States
Kaiser Permanente Fresno Orchard Plaza
Fresno, California, 93720, United States
Kaiser Permanente-Fresno
Fresno, California, 93720, United States
Kaiser Permanente South Bay
Harbor City, California, 90710, United States
City of Hope at Irvine Lennar
Irvine, California, 92618, United States
Kaiser Permanente-Irvine
Irvine, California, 92618, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
City of Hope Antelope Valley
Lancaster, California, 93534, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, 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
Fremont - Rideout Cancer Center
Marysville, California, 95901, United States
Mather Veteran Affairs Medical Center
Mather, California, 95655, United States
Kaiser Permanente-Oakland
Oakland, California, 94611, United States
Kaiser Permanente-Ontario
Ontario, California, 91761, United States
VA Palo Alto Health Care System
Palo Alto, California, 94304, 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
Kaiser Permanente Downtown Commons
Sacramento, California, 95814, 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
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
Mills Health Center
San Mateo, California, 94401, United States
Kaiser San Rafael-Gallinas
San Rafael, California, 94903, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051, United States
Kaiser Permanente-South San Francisco
South San Francisco, California, 94080, United States
Cedars-Sinai Cancer - Tarzana
Tarzana, California, 91356, United States
City of Hope South Bay
Torrance, California, 90503, United States
Torrance Memorial Physician Network - Cancer Care
Torrance, California, 90505, United States
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California, 96161, United States
City of Hope Upland
Upland, California, 91786, United States
Kaiser Permanente-Vallejo
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
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, 06418, United States
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, 06824, United States
Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut, 06033, United States
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, 06830, United States
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, 06437, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105, United States
Yale University
New Haven, Connecticut, 06520, United States
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, 06473, United States
Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut, 06902, United States
Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut, 06790, United States
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, 06611, United States
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut, 06708, United States
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, 06385, United States
Beebe South Coastal Health Campus
Millville, Delaware, 19967, 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
Malcom Randall Veterans Administration Medical Center
Gainesville, Florida, 32610, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Grady Health System
Atlanta, Georgia, 30303, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Atlanta VA Medical Center
Decatur, Georgia, 30033, United States
Northside Hospital - Duluth
Duluth, Georgia, 30096, United States
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia, 30501, United States
Emory Johns Creek Hospital
Johns Creek, Georgia, 30097, 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 Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605, United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814, United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619, United States
Idaho Urologic Institute-Meridian
Meridian, Idaho, 83642, United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642, United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687, United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83687, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854, United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, 83864, United States
Advocate Outpatient Center - Aurora
Aurora, Illinois, 60506, United States
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010, 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
Northwestern University
Chicago, Illinois, 60611, United States
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657, United States
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, 60014, United States
Carle at The Riverfront
Danville, Illinois, 61832, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115, United States
Illinois CancerCare-Dixon
Dixon, Illinois, 61021, United States
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515, United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Advocate Sherman Hospital
Elgin, Illinois, 60123, United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134, United States
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, 60026, United States
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, 60030, United States
Advocate South Suburban Hospital
Hazel Crest, Illinois, 60429, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443, United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045, United States
AMG Libertyville - Oncology
Libertyville, Illinois, 60048, United States
Condell Memorial Hospital
Libertyville, Illinois, 60048, United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Carle BroMenn Medical Center
Normal, Illinois, 61761, United States
Carle Cancer Institute Normal
Normal, Illinois, 61761, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269, United States
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, 62269, United States
Northwestern Medicine Oak Brook
Oak Brook, Illinois, 60523, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453-2699, United States
Advocate Outpatient Center - Oak Lawn
Oak Lawn, Illinois, 60453, United States
Northwestern Medicine Orland Park
Orland Park, Illinois, 60462, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
Advocate High Tech Medical Park
Palos Heights, Illinois, 60463, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068, 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
Memorial Hospital East
Shiloh, Illinois, 62269, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Springfield Clinic
Springfield, Illinois, 62702, United States
Springfield Memorial Hospital
Springfield, Illinois, 62781, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555, United States
Illinois CancerCare - Washington
Washington, Illinois, 61571, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Richard L. Roudebush Veterans Affairs Medical Center
Indianapolis, Indiana, 46202, United States
University of Kansas Clinical Research Center
Fairway, Kansas, 66205, United States
HaysMed
Hays, Kansas, 67601, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
Veteran Administration Eastern Kansas Healthcare
Leavenworth, Kansas, 66048, United States
The University of Kansas Cancer Center - Olathe
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
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536, United States
Harold Alfond Center for Cancer Care
Augusta, Maine, 04330, United States
MaineHealth Waldo Hospital
Belfast, Maine, 04915, United States
Lafayette Family Cancer Center-EMMC
Brewer, Maine, 04412, United States
MaineHealth Cancer Care and IV Therapy - Brunswick
Brunswick, Maine, 04011, United States
MaineHealth LincolnHealth Hospital
Damariscotta, Maine, 04543, United States
Penobscot Bay Medical Center
Rockport, Maine, 04856, United States
MaineHealth Cancer Care Center of York County
Sanford, Maine, 04073, United States
MaineHealth Cancer Care and IV Therapy - South Portland
South Portland, Maine, 04106, United States
Saint Agnes Hospital
Baltimore, Maryland, 21229, 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 - Largo Medical Center
Largo, Maryland, 20774, United States
Kaiser Permanente Lutherville - Timonium Medical Center
Lutherville, Maryland, 21093, 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
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
UMass Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118, United States
OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan, 49829, United States
Cancer Hematology Centers - Flint
Flint, Michigan, 48503, United States
Genesee Hematology Oncology PC
Flint, Michigan, 48503, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154, United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341, 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 Saint Joseph's Medical Center
Brainerd, Minnesota, 56401, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636, United States
Essentia Health Cancer Center
Duluth, Minnesota, 55805, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Essentia Health Sandstone
Sandstone, Minnesota, 55072, United States
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
Sanford Cancer Center Worthington
Worthington, Minnesota, 56187, United States
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, 39705, United States
Baptist Cancer Center-Grenada
Grenada, Mississippi, 38901, United States
Gulfport Memorial Hospital
Gulfport, Mississippi, 39502, United States
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi, 38652, United States
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, 38655, United States
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, 38671, 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
University Health Truman Medical Center
Kansas City, Missouri, 64108, United States
University of Kansas Cancer Center - Briarcliff
Kansas City, Missouri, 64116, United States
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, 64128, 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
Lake Regional Hospital
Osage Beach, Missouri, 65065, United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Mercy Hospital South
St Louis, Missouri, 63128, 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
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, 63127, United States
Community Hospital of Anaconda
Anaconda, Montana, 59711, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Logan Health Medical Center
Kalispell, Montana, 59901, United States
Community Medical Center
Missoula, Montana, 59804, United States
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire, 03301, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer 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, 87106, United States
The Cancer Institute at Saint Francis Hospital
East Hills, New York, 11548, United States
University of Rochester
Rochester, New York, 14642, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461, United States
James J Peters VA Medical Center
The Bronx, New York, 10468, United States
Wilmot Cancer Institute at Webster
Webster, New York, 14580, United States
Good Samaritan University Hospital
West Islip, New York, 11795, United States
Durham VA Medical Center
Durham, North Carolina, 27705, United States
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, 28374, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, 58103, United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
OhioHealth O'Bleness Hospital
Athens, Ohio, 45701, United States
Aultman Health Foundation
Canton, Ohio, 44710, United States
Miami Valley Hospital South
Centerville, Ohio, 45459, 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
Doctors Hospital
Columbus, Ohio, 43228, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Premier Blood and Cancer Center
Dayton, Ohio, 45409, United States
Miami Valley Hospital North
Dayton, Ohio, 45415, United States
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015, United States
Grady Memorial Hospital
Delaware, Ohio, 43015, United States
Columbus Oncology and Hematology Associates
Dublin, Ohio, 43016, United States
Dublin Methodist Hospital
Dublin, Ohio, 43016, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Miami Valley Cancer Care and Infusion
Greenville, Ohio, 45331, United States
OhioHealth Mansfield Hospital
Mansfield, Ohio, 44903, United States
OhioHealth Marion General Hospital
Marion, Ohio, 43302, United States
OhioHealth Pickerington Methodist Hospital
Pickerington, Ohio, 43147, United States
ProMedica Flower Hospital
Sylvania, Ohio, 43560, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
OhioHealth Westerville Medical Campus/Westerville Cancer Center
Westerville, Ohio, 43082, 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
Integris Southwest Medical Center
Oklahoma City, Oklahoma, 73109, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120, United States
Saint Alphonsus Cancer Care Center-Baker City
Baker City, Oregon, 97814, United States
Providence Newberg Medical Center
Newberg, Oregon, 97132, United States
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, 97914, United States
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Salem Hospital
Salem, Oregon, 97301, 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
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
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 Hillman Cancer Center in Coraopolis
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-Saint Margaret
Pittsburgh, Pennsylvania, 15215, 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
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 Susquehanna
Williamsport, Pennsylvania, 17701, United States
Divine Providence Hospital
Williamsport, Pennsylvania, 17754, United States
Cancer Care Associates of York
York, Pennsylvania, 17403, United States
AnMed Health Cancer Center
Anderson, South Carolina, 29621, United States
Saint Joseph's/Candler - Bluffton Campus
Bluffton, South Carolina, 29910, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651, United States
South Carolina Cancer Specialists PC
Hilton Head Island, South Carolina, 29926-3827, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
SMC Center for Hematology Oncology Union
Union, South Carolina, 29379, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57701, 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
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, 38017, United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120, United States
The Don and Sybil Harrington Cancer Center
Amarillo, Texas, 79106, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont, 05819, United States
White River Junction Veteran Administration Medical Center
White River Junction, Vermont, 05009, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
Centra Alan B Pearson Regional Cancer Center
Lynchburg, Virginia, 24501, United States
Kaiser Permanente Tysons Corner Medical Center
McLean, Virginia, 22102, United States
Virginia Cancer Institute
Richmond, Virginia, 23229, United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298, United States
VCU Community Memorial Health Center
South Hill, Virginia, 23970, United States
Kaiser Permanente-Caton Hill Medical Center
Woodbridge, Virginia, 22192, United States
United Hospital Center
Bridgeport, West Virginia, 26330, United States
Edwards Comprehensive Cancer Center
Huntington, West Virginia, 25701, United States
WVUH-Berkely Medical Center
Martinsburg, West Virginia, 25401, United States
West Virginia University Healthcare
Morgantown, West Virginia, 26506, United States
Camden Clark Medical Center
Parkersburg, West Virginia, 26101, United States
Wheeling Hospital/Schiffler Cancer Center
Wheeling, West Virginia, 26003, United States
Duluth Clinic Ashland
Ashland, Wisconsin, 54806, United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105, United States
Aurora Saint Luke's South Shore
Cudahy, Wisconsin, 53110, United States
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022, 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
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, 53718, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792, United States
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143, United States
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, 53209, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, 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
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904, United States
Aurora Cancer Care-Racine
Racine, Wisconsin, 53406, United States
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin, 53081, United States
Sheboygan Physicians Group
Sheboygan, Wisconsin, 53081, United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081, United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482, 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
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, 54241, United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, 53226, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Saiama N Waqar
SWOG Cancer Research Network
Central Study Contacts
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
August 27, 2024
First Posted
September 27, 2024
Study Start
May 22, 2025
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2028
Last Updated
May 5, 2026
Record last verified: 2026-05