Chemotherapy Combined With Immunotherapy Versus Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial
A Randomized Phase III Trial of Chemo-Immunotherapy vs Immunotherapy Alone for the Vulnerable Older Adult With Advanced Non-Small Cell Lung Cancer: The ACHIEVE Study
3 other identifiers
interventional
304
1 country
318
Brief Summary
This phase III trial compares the effect of adding chemotherapy to immunotherapy (pembrolizumab) versus immunotherapy alone in treating patients with stage IIIB-IV lung 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. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab and chemotherapy may help stabilize lung cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2024
318 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 21, 2023
CompletedFirst Posted
Study publicly available on registry
October 24, 2023
CompletedStudy Start
First participant enrolled
July 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
April 28, 2026
November 1, 2025
1.9 years
October 21, 2023
April 25, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival (OS)
Will be estimated using the Kaplan-Meier method, and Cox proportional hazards models will be used to estimate hazard ratios. Comparison of OS will use a logrank test stratified on the randomization stratification factors with a one-sided type I error rate of 0.025. Other comparisons of groups will be made using the log rank test and Cox modeling.
From randomization to death from any cause, and patients who are alive at the time of final analysis will be censored at the last date of contact, assessed up to 5 years
Secondary Outcomes (5)
Progression free survival (PFS)
From randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or death from any cause, whichever occurs first, assessed up to 5 years
Six month PFS
From randomization to documented disease progression per RECIST 1.1 or death from any cause, whichever occurs first, assessed at 6 months
Best objective response
Up to 5 years
Incidence of adverse events
Up to 2 years
Evaluation of quality of life (QOL) measures
Baseline up to 6 months
Other Outcomes (1)
Gut microbe abundances
Baseline and after 4 cycles of initial treatment (Cycles = 21 days)
Study Arms (2)
Arm A (pembrolizumab)
ACTIVE COMPARATORINDUCTION: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 or 42 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo MRI at baseline and CT and/or PET on the trial at baseline and throughout the trial.
Arm B (pembrolizumab, chemotherapy)
EXPERIMENTALSee Detailed Description
Interventions
Ancillary studies
Given IV
Undergo CT scan
Given IV
Given IV
Undergo MRI
Given IV
Given IV
Undergo PET
Eligibility Criteria
You may qualify if:
- STEP 1 REGISTRATION
- Patient must be ≥ 70 years of age
- Patient must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with PD-L1 Tumor Proportion Score (TPS) range of 1-49%
- Patient must have Stage IIIB, IIIC or IV disease and not be candidates for combined chemo-radiation. NOTE: Prior chemo-radiation therapy (RT) for stage III with recurrence is allowed
- Patient must have a tumor that is negative for EGFR mutation/ALK translocations or other actionable first line mutations in which patients would receive first-line oral tyrosine kinase inhibitors
- Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 2
- Patient must agree not to father children while on study and for 6 months after the last dose of protocol treatment
- Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
- Absolute neutrophil count (ANC) ≥ 1,500/uL (obtained within 14 days prior to Step 1 registration)
- Platelets ≥ 75,000/uL (obtained within 14 days prior to Step 1 registration)
- Hemoglobin (Hgb) ≥ 8.0 g/dL (obtained within 14 days prior to Step 1 registration)
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (obtained within 14 days prior to Step 1 registration)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ 3.0 × institutional ULN (obtained within 14 days prior to Step 1 registration)
- Creatinine clearance (CrCL) ≥ 45 mL/min (estimated using Cockcroft-Gault method with actual body weight or measured) (obtained within 14 days prior to Step 1 registration)
- Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months of Step 1 registration are eligible for this trial
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (318)
Highlands Oncology Group - Fayetteville
Fayetteville, Arkansas, 72703, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903, United States
Highlands Oncology Group - Rogers
Rogers, Arkansas, 72758, United States
Highlands Oncology Group
Springdale, Arkansas, 72762, United States
Kaiser Permanente Dublin
Dublin, California, 94568, United States
Kaiser Permanente-Fremont
Fremont, California, 94538, United States
Kaiser Permanente Fresno Orchard Plaza
Fresno, California, 93720, United States
Kaiser Permanente-Fresno
Fresno, California, 93720, United States
Kaiser Permanente- Modesto MOB II
Modesto, California, 95356, United States
Kaiser Permanente-Modesto
Modesto, California, 95356, United States
Kaiser Permanente-Oakland
Oakland, California, 94611, United States
VA Palo Alto Health Care System
Palo Alto, California, 94304, United States
Kaiser Permanente-Roseville
Roseville, California, 95661, United States
Kaiser Permanente Downtown Commons
Sacramento, California, 95814, United States
Kaiser Permanente-South Sacramento
Sacramento, California, 95823, United States
Kaiser Permanente-San Francisco
San Francisco, California, 94115, 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 San Rafael-Gallinas
San Rafael, California, 94903, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051, United States
Kaiser Permanente-Santa Rosa
Santa Rosa, California, 95403, United States
Kaiser Permanente-South San Francisco
South San Francisco, California, 94080, United States
Kaiser Permanente-Vallejo
Vallejo, California, 94589, United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California, 94596, United States
Stamford Hospital/Bennett Cancer Center
Stamford, Connecticut, 06904, United States
Veterans Affairs Connecticut Healthcare System-West Haven Campus
West Haven, Connecticut, 06516, United States
George Washington University Medical Center
Washington D.C., District of Columbia, 20037, United States
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, 33180, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, 33146, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Malcom Randall Veterans Administration Medical Center
Gainesville, Florida, 32610, United States
UF Health Cancer Institute - Gainesville
Gainesville, Florida, 32610, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, 33176, United States
Sacred Heart Hospital
Pensacola, Florida, 32504, United States
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, 33324, United States
Moffitt Cancer Center-International Plaza
Tampa, Florida, 33607, United States
James A. Haley Veterans Affairs Hospital
Tampa, Florida, 33612, United States
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, 33612, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida, 33544, United States
CTCA at Southeastern Regional Medical Center
Newnan, Georgia, 30265, United States
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, 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 Alphonsus Cancer Care Center-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
Rush-Copley Medical Center
Aurora, Illinois, 60504, United States
Advocate Outpatient Center - Aurora
Aurora, Illinois, 60506, United States
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010, United States
SIH Cancer Institute
Carterville, Illinois, 62918, United States
University of Illinois
Chicago, Illinois, 60612, 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
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
Advocate South Suburban Hospital
Hazel Crest, Illinois, 60429, United States
AMG Libertyville - Oncology
Libertyville, Illinois, 60048, United States
Condell Memorial Hospital
Libertyville, Illinois, 60048, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
SSM Health Good Samaritan
Mount Vernon, Illinois, 62864, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453-2699, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068, United States
UW Health Carbone Cancer Center Rockford
Rockford, Illinois, 61114, 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
Northwest Cancer Center - Crown Point
Crown Point, Indiana, 46307, United States
Northwest Oncology LLC
Dyer, Indiana, 46311, United States
Northwest Cancer Center - Hobart
Hobart, Indiana, 46342, United States
Saint Mary Medical Center
Hobart, Indiana, 46342, United States
Saint Catherine Hospital
Indianapolis, Indiana, 46312, United States
The Community Hospital
Munster, Indiana, 46321, United States
Women's Diagnostic Center - Munster
Munster, Indiana, 46321, United States
Northwest Cancer Center - Valparaiso
Valparaiso, Indiana, 46383, United States
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023, United States
Mercy Hospital
Cedar Rapids, Iowa, 52403, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403, United States
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314, United States
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, 50263, 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
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202, United States
UofL Health Medical Center Northeast
Louisville, Kentucky, 40245, United States
Lafayette Family Cancer Center-EMMC
Brewer, Maine, 04412, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
William E Kahlert Regional Cancer Center/Sinai Hospital
Westminster, Maryland, 21157, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Dana-Farber Cancer Institute at Boston Medical Center - Brighton
Brighton, Massachusetts, 02135, United States
Dana-Farber Cancer Institute at Foxborough
Foxborough, Massachusetts, 02035, United States
Dana Farber-Merrimack Valley
Methuen, Massachusetts, 01844, United States
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
Milford, Massachusetts, 01757, United States
Dana-Farber/Brigham and Women's Cancer Center at South Shore
South Weymouth, Massachusetts, 02190, United States
UMass Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655, United States
Bronson Battle Creek
Battle Creek, Michigan, 49017, 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
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
Hurley Medical Center
Flint, Michigan, 48503, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503, United States
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, 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 Muskegon Hospital
Muskegon, Michigan, 49444, United States
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, 49120, United States
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, 49444, United States
Michigan Healthcare Professionals Pontiac
Pontiac, Michigan, 48341, United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341, United States
Corewell Health Reed City Hospital
Reed City, Michigan, 49677, United States
MyMichigan Medical Center Saginaw
Saginaw, Michigan, 48601, United States
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan, 48604, United States
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085, United States
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, 49085, United States
MyMichigan Medical Center Tawas
Tawas City, Michigan, 48764, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan, 48661, United States
University of Michigan Health - West
Wyoming, Michigan, 49519, 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
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337, 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
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, 56001, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
New Ulm Medical Center
New Ulm, Minnesota, 56073, 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
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792, 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
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
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
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136, 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
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756, United States
The Dana-Farber Cancer Institute at Londonderry
Londonderry, New Hampshire, 03053, United States
Jefferson Cherry Hill Hospital
Cherry Hill, New Jersey, 08002, United States
Inspira Medical Center Mullica Hill
Mullica Hill, New Jersey, 08062, United States
Penn Medicine Princeton Health
Plainsboro, New Jersey, 08536, United States
Sidney Kimmel Cancer Center Washington Township
Sewell, New Jersey, 08080, United States
Glens Falls Hospital
Glens Falls, New York, 12801, United States
Upstate Cancer Center at Oswego
Oswego, New York, 13126, United States
University of Rochester
Rochester, New York, 14642, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
SUNY Upstate Medical Center-Community Campus
Syracuse, New York, 13215, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467, United States
Upstate Cancer Center at Verona
Verona, New York, 13478, United States
Wilmot Cancer Institute at Webster
Webster, New York, 14580, United States
Durham VA Medical Center
Durham, North Carolina, 27705, 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
UH Seidman Cancer Center at UH Avon Health Center
Avon, Ohio, 44011, United States
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122, United States
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714, United States
Aultman Health Foundation
Canton, Ohio, 44710, United States
Miami Valley Hospital South
Centerville, Ohio, 45459, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
The Mark H Zangmeister Center
Columbus, Ohio, 43219, 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
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Miami Valley Cancer Care and Infusion
Greenville, Ohio, 45331, United States
Mount Carmel Grove City Hospital
Grove City, Ohio, 43123, United States
Memorial Hospital
Marysville, Ohio, 43040, United States
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, 44060, United States
Knox Community Hospital
Mount Vernon, Ohio, 43050, United States
Licking Memorial Hospital
Newark, Ohio, 43055, United States
Mercy Health - Perrysburg Hospital
Perrysburg, Ohio, 43551, United States
Springfield Regional Cancer Center
Springfield, Ohio, 45504, United States
Mercy Health - Saint Anne Hospital
Toledo, Ohio, 43623, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, 43701, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120, United States
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, 97914, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Lancaster General Ann B Barshinger Cancer Institute
Lancaster, Pennsylvania, 17601, United States
Riddle Memorial Hospital
Media, Pennsylvania, 19063, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301, United States
ECOG-ACRIN Cancer Research Group
Philadelphia, Pennsylvania, 19103, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Jefferson Torresdale Hospital
Philadelphia, Pennsylvania, 19114, United States
Reading Hospital McGlinn Cancer Institute at Phoenixville
Phoenixville, Pennsylvania, 19460, United States
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, 18840, United States
Reading Hospital
West Reading, Pennsylvania, 19611, United States
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19090, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096, 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
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
Parkland Memorial Hospital
Dallas, Texas, 75235, United States
UT Southwestern Simmons Cancer Center - RedBird
Dallas, Texas, 75237, 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
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
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
VCU Health Tappahannock Hospital
Tappahannock, Virginia, 22560, United States
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026, United States
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029, United States
Swedish Medical Center-First Hill
Seattle, Washington, 98122, United States
Edwards Comprehensive Cancer Center
Huntington, West Virginia, 25701, United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409, United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911, United States
Duluth Clinic Ashland
Ashland, Wisconsin, 54806, United States
ThedaCare Cancer Care - Berlin
Berlin, Wisconsin, 54923, United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105, United States
Aurora Saint Luke's South Shore
Cudahy, Wisconsin, 53110, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701, United States
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin, 54701, United States
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024, United States
Bellin Memorial Hospital
Green Bay, Wisconsin, 54301, 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
Mercyhealth Hospital and Cancer Center - Janesville
Janesville, Wisconsin, 53548, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
Aspirus Medford Hospital
Medford, Wisconsin, 54451, 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
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548, United States
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149, United States
ThedaCare Regional Medical Center - Neenah
Neenah, Wisconsin, 54956, United States
ThedaCare Cancer Care - New London
New London, Wisconsin, 54961, United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066, United States
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
ThedaCare Cancer Care - Oshkosh
Oshkosh, Wisconsin, 54904, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904, United States
Aurora Cancer Care-Racine
Racine, Wisconsin, 53406, United States
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin, 54501, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868, United States
ThedaCare Cancer Care - Shawano
Shawano, Wisconsin, 54166, 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
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, 54481, 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
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188, United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188, United States
ThedaCare Cancer Care - Waupaca
Waupaca, Wisconsin, 54981, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401, 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
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Megan A Baumgart
ECOG-ACRIN Cancer Research Group
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2023
First Posted
October 24, 2023
Study Start
July 19, 2024
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
April 28, 2026
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
"NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page."