Chemotherapy Combined With Immunotherapy Versus Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial
Sponsored by National Cancer Institute (NCI)
About this study
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.
PRIMARY OBJECTIVE: I. To evaluate whether there is an improvement in overall survival (OS) with chemotherapy combined with pembrolizumab compared to single agent pembrolizumab in this vulnerable older adult patient population. SECONDARY OBJECTIVES: I. To evaluate any difference in progression free survival (PFS) with chemotherapy combined with pembrolizumab as compared to single agent pembrolizumab. II. To evaluate the difference in PFS rate at 3 months and at 6 months with chemotherapy combined with pembrolizumab as compared to single agent pembrolizumab. III. To evaluate the difference in best objective response rate using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria to assess whether chemotherapy combined with pembrolizumab results in improved response rates c…
Where this study is enrolling (273)
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Highlands Oncology Group - Fayetteville
Fayetteville, Arkansas
- Call 800-378-9373
Mercy Hospital Fort Smith
Fort Smith, Arkansas
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Highlands Oncology Group - Rogers
Rogers, Arkansas
- I'm interested
Highlands Oncology Group
Springdale, Arkansas
- Call 203-937-3421
Veterans Affairs Connecticut Healthcare System-West Haven Campus
West Haven, Connecticut
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Show all 273 locations
- Call 203-323-8944
Stamford Hospital/Bennett Cancer Center
Stamford, Connecticut
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- Call 202-741-2210
George Washington University Medical Center
Washington D.C., District of Columbia
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Moffitt Cancer Center-International Plaza
Tampa, Florida
- Call 305-243-2647
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida
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- Call 305-243-2647
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida
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- Call 352-273-8010
UF Health Cancer Institute - Gainesville
Gainesville, Florida
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- Call 863-680-7780
The Watson Clinic
Lakeland, Florida
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- Call 813-972-2000
James A. Haley Veterans Affairs Hospital
Tampa, Florida
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Moffitt Cancer Center - McKinley Campus
Tampa, Florida
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Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida
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Moffitt Cancer Center
Tampa, Florida
- Call 305-243-2647
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida
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Malcom Randall Veterans Administration Medical Center
Gainesville, Florida
- Call 954-461-2180
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida
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- Call 305-243-2647
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida
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- Call 305-243-2647
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida
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Holy Cross Hospital
Fort Lauderdale, Florida
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Sacred Heart Hospital
Pensacola, Florida
- Call 770-400-6629
CTCA at Southeastern Regional Medical Center
Newnan, Georgia
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Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho
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Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho
- I'm interested
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho
- I'm interested
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho
- I'm interested
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho
- I'm interested
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho
- I'm interested
AMG Libertyville - Oncology
Libertyville, Illinois
- I'm interested
Rush-Copley Medical Center
Aurora, Illinois
- Call 312-355-3046
University of Illinois
Chicago, Illinois
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AMG Crystal Lake - Oncology
Crystal Lake, Illinois
- I'm interested
Carle at The Riverfront
Danville, Illinois
- I'm interested
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois
- I'm interested
Decatur Memorial Hospital
Decatur, Illinois
- I'm interested
Advocate Good Samaritan Hospital
Downers Grove, Illinois
- I'm interested
Carle Physician Group-Effingham
Effingham, Illinois
- I'm interested
Crossroads Cancer Center
Effingham, Illinois
- Call 847-429-2907
Advocate Sherman Hospital
Elgin, Illinois
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- Call 708-799-9995
Advocate South Suburban Hospital
Hazel Crest, Illinois
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Condell Memorial Hospital
Libertyville, Illinois
- I'm interested
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois
- Call 708-226-4357
Loyola University Medical Center
Maywood, Illinois
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SSM Health Good Samaritan
Mount Vernon, Illinois
- I'm interested
Cancer Care Center of O'Fallon
O'Fallon, Illinois
- Call 800-323-8622
Advocate Christ Medical Center
Oak Lawn, Illinois
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- Call 847-384-3621
Advocate Lutheran General Hospital
Park Ridge, Illinois
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UW Health Carbone Cancer Center Rockford
Rockford, Illinois
- Call 800-444-7541
Springfield Clinic
Springfield, Illinois
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Carle Cancer Center
Urbana, Illinois
- I'm interested
Advocate Outpatient Center - Aurora
Aurora, Illinois
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SIH Cancer Institute
Carterville, Illinois
- Call 217-545-7929
Southern Illinois University School of Medicine
Springfield, Illinois
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Springfield Memorial Hospital
Springfield, Illinois
- Call 847-842-4847
Advocate Good Shepherd Hospital
Barrington, Illinois
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Advocate Illinois Masonic Medical Center
Chicago, Illinois
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Rush MD Anderson Cancer Center
Chicago, Illinois
- Call 219-947-1795
Northwest Cancer Center - Hobart
Hobart, Indiana
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Northwest Cancer Center - Crown Point
Crown Point, Indiana
- Call 219-924-8178
Northwest Oncology LLC
Dyer, Indiana
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Saint Mary Medical Center
Hobart, Indiana
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Northwest Cancer Center - Valparaiso
Valparaiso, Indiana
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Women's Diagnostic Center - Munster
Munster, Indiana
- Call 219-836-3349
The Community Hospital
Munster, Indiana
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Saint Catherine Hospital
Indianapolis, Indiana
- Call 515-241-3305
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa
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- Call 515-241-3305
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa
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- Call 515-241-3305
Mercy Medical Center - Des Moines
Des Moines, Iowa
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- Call 515-241-3305
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa
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- Call 515-241-3305
Mercy Cancer Center-West Lakes
Clive, Iowa
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- Call 319-363-2690
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa
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- Call 319-365-4673
Mercy Hospital
Cedar Rapids, Iowa
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- Call 515-241-3305
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa
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- Call 515-241-3305
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa
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- Call 515-241-6727
Iowa Methodist Medical Center
Des Moines, Iowa
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- Call 502-562-3429
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky
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UofL Health Medical Center Northeast
Louisville, Kentucky
- Call 859-257-3379
University of Kentucky/Markey Cancer Center
Lexington, Kentucky
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- Call 800-987-3005
Lafayette Family Cancer Center-EMMC
Brewer, Maine
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- Call 800-888-8823
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland
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- Call 410-601-9083
Sinai Hospital of Baltimore
Baltimore, Maryland
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- Call 410-871-6400
William E Kahlert Regional Cancer Center/Sinai Hospital
Westminster, Maryland
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Tufts Medical Center
Boston, Massachusetts
- Call 877-332-4294
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
Milford, Massachusetts
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- Call 781-624-5000
Dana-Farber/Brigham and Women's Cancer Center at South Shore
South Weymouth, Massachusetts
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- Call 877-338-7425
Dana Farber-Merrimack Valley
Methuen, Massachusetts
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- Call 617-789-2903
Dana-Farber Cancer Institute at Boston Medical Center - Brighton
Brighton, Massachusetts
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- Call 877-338-7425
Dana-Farber Cancer Institute at Foxborough
Foxborough, Massachusetts
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- I'm interested
Bronson Methodist Hospital
Kalamazoo, Michigan
- I'm interested
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan
- I'm interested
Corewell Health Reed City Hospital
Reed City, Michigan
- I'm interested
MyMichigan Medical Center Saginaw
Saginaw, Michigan
- I'm interested
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan
- I'm interested
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan
- I'm interested
MyMichigan Medical Center Tawas
Tawas City, Michigan
- I'm interested
Munson Medical Center
Traverse City, Michigan
- I'm interested
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan
- I'm interested
University of Michigan Health - West
Wyoming, Michigan
- I'm interested
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan
- I'm interested
Bronson Battle Creek
Battle Creek, Michigan
- I'm interested
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan
- I'm interested
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan
- I'm interested
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan
- I'm interested
Cancer Hematology Centers - Flint
Flint, Michigan
- I'm interested
Genesys Hurley Cancer Institute
Flint, Michigan
- I'm interested
Hurley Medical Center
Flint, Michigan
- I'm interested
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan
- I'm interested
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan
- I'm interested
West Michigan Cancer Center
Kalamazoo, Michigan
- I'm interested
University of Michigan Health - Sparrow Lansing
Lansing, Michigan
- I'm interested
Trinity Health Muskegon Hospital
Muskegon, Michigan
- Call 616-391-1230
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan
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Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan
- I'm interested
Michigan Healthcare Professionals Pontiac
Pontiac, Michigan
- I'm interested
Essentia Health Virginia Clinic
Virginia, Minnesota
- I'm interested
Mercy Hospital
Coon Rapids, Minnesota
- I'm interested
Essentia Health - Deer River Clinic
Deer River, Minnesota
- I'm interested
Essentia Health Cancer Center
Duluth, Minnesota
- I'm interested
Fairview Southdale Hospital
Edina, Minnesota
- Call 218-786-3308
Essentia Health Hibbing Clinic
Hibbing, Minnesota
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- Call 855-776-0015
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota
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Saint John's Hospital - Healtheast
Maplewood, Minnesota
- I'm interested
Abbott-Northwestern Hospital
Minneapolis, Minnesota
- I'm interested
New Ulm Medical Center
New Ulm, Minnesota
- I'm interested
North Memorial Medical Health Center
Robbinsdale, Minnesota
- I'm interested
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota
- I'm interested
Regions Hospital
Saint Paul, Minnesota
- I'm interested
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota
- I'm interested
Minnesota Oncology - Burnsville
Burnsville, Minnesota
- I'm interested
United Hospital
Saint Paul, Minnesota
- I'm interested
Essentia Health Sandstone
Sandstone, Minnesota
- I'm interested
Saint Francis Regional Medical Center
Shakopee, Minnesota
- I'm interested
Saint Francis Medical Center
Cape Girardeau, Missouri
- Call 800-525-1483
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri
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Lake Regional Hospital
Osage Beach, Missouri
- I'm interested
Mercy Hospital South
St Louis, Missouri
- I'm interested
Billings Clinic Cancer Center
Billings, Montana
- I'm interested
Community Hospital of Anaconda
Anaconda, Montana
- I'm interested
Benefis Sletten Cancer Institute
Great Falls, Montana
- I'm interested
Logan Health Medical Center
Kalispell, Montana
- I'm interested
Community Medical Center
Missoula, Montana
- I'm interested
Bozeman Health Deaconess Hospital
Bozeman, Montana
- I'm interested
The Dana-Farber Cancer Institute at Londonderry
Londonderry, New Hampshire
- I'm interested
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire
- I'm interested
Sidney Kimmel Cancer Center Washington Township
Sewell, New Jersey
- I'm interested
Jefferson Cherry Hill Hospital
Cherry Hill, New Jersey
- I'm interested
Upstate Cancer Center at Verona
Verona, New York
- I'm interested
Montefiore Medical Center-Einstein Campus
The Bronx, New York
- Call 315-464-5476
SUNY Upstate Medical Center-Community Campus
Syracuse, New York
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- Call 315-464-5476
State University of New York Upstate Medical University
Syracuse, New York
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- Call 800-862-2215
Stony Brook University Medical Center
Stony Brook, New York
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- Call 585-275-5830
University of Rochester
Rochester, New York
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Upstate Cancer Center at Oswego
Oswego, New York
- Call 518-926-6700
Glens Falls Hospital
Glens Falls, New York
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Wilmot Cancer Institute at Webster
Webster, New York
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Montefiore Medical Center - Moses Campus
The Bronx, New York
- I'm interested
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina
- I'm interested
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina
- I'm interested
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina
- I'm interested
Sanford Broadway Medical Center
Fargo, North Dakota
- I'm interested
Sanford Roger Maris Cancer Center
Fargo, North Dakota
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Sanford Bismarck Medical Center
Bismarck, North Dakota
- I'm interested
Miami Valley Hospital South
Centerville, Ohio
- Call 800-641-2422
UH Seidman Cancer Center at UH Avon Health Center
Avon, Ohio
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UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio
- I'm interested
Strecker Cancer Center-Belpre
Belpre, Ohio
- I'm interested
Aultman Health Foundation
Canton, Ohio
- I'm interested
Adena Regional Medical Center
Chillicothe, Ohio
- I'm interested
Case Western Reserve University
Cleveland, Ohio
- I'm interested
MetroHealth Medical Center
Cleveland, Ohio
- I'm interested
Ohio State University Comprehensive Cancer Center
Columbus, Ohio
- I'm interested
The Mark H Zangmeister Center
Columbus, Ohio
- I'm interested
Miami Valley Hospital
Dayton, Ohio
- Call 937-276-8320
Premier Blood and Cancer Center
Dayton, Ohio
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Miami Valley Hospital North
Dayton, Ohio
- I'm interested
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio
- Call 937-569-7515
Miami Valley Cancer Care and Infusion
Greenville, Ohio
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Mount Carmel Grove City Hospital
Grove City, Ohio
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Memorial Hospital
Marysville, Ohio
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UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio
- I'm interested
Licking Memorial Hospital
Newark, Ohio
- I'm interested
Mercy Health - Perrysburg Hospital
Perrysburg, Ohio
- I'm interested
Springfield Regional Cancer Center
Springfield, Ohio
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Mercy Health - Saint Anne Hospital
Toledo, Ohio
- I'm interested
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio
- I'm interested
Knox Community Hospital
Mount Vernon, Ohio
- Call 405-752-3402
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma
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Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon
- I'm interested
ECOG-ACRIN Cancer Research Group
Philadelphia, Pennsylvania
- I'm interested
Lankenau Medical Center
Wynnewood, Pennsylvania
- I'm interested
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania
- Call 610-988-9323
Reading Hospital
West Reading, Pennsylvania
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- Call 800-836-0388
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania
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- Call 610-983-1800
Reading Hospital McGlinn Cancer Institute at Phoenixville
Phoenixville, Pennsylvania
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Jefferson Torresdale Hospital
Philadelphia, Pennsylvania
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Thomas Jefferson University Hospital
Philadelphia, Pennsylvania
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Paoli Memorial Hospital
Paoli, Pennsylvania
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Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania
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Riddle Memorial Hospital
Media, Pennsylvania
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Bryn Mawr Hospital
Bryn Mawr, Pennsylvania
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Ralph H Johnson VA Medical Center
Charleston, South Carolina
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Medical University of South Carolina
Charleston, South Carolina
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Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota
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Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota
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Rapid City Regional Hospital
Rapid City, South Dakota
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UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas
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UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas
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UT Southwestern Simmons Cancer Center - RedBird
Dallas, Texas
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Parkland Memorial Hospital
Dallas, Texas
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UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas
- Call 866-687-8387
White River Junction Veteran Administration Medical Center
White River Junction, Vermont
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Dartmouth Cancer Center - North
Saint Johnsbury, Vermont
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VCU Massey Comprehensive Cancer Center
Richmond, Virginia
- I'm interested
VCU Massey Cancer Center at Stony Point
Richmond, Virginia
- I'm interested
VCU Community Memorial Health Center
South Hill, Virginia
- I'm interested
VCU Health Tappahannock Hospital
Tappahannock, Virginia
- I'm interested
Swedish Cancer Institute-Edmonds
Edmonds, Washington
- I'm interested
Swedish Cancer Institute-Issaquah
Issaquah, Washington
- I'm interested
Swedish Medical Center-First Hill
Seattle, Washington
- I'm interested
Edwards Comprehensive Cancer Center
Huntington, West Virginia
- I'm interested
Aspirus Cancer Care-Antigo-Volm Cancer Center
Antigo, Wisconsin
- I'm interested
Aurora Medical Center in Summit
Summit, Wisconsin
- I'm interested
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin
- I'm interested
ThedaCare Regional Cancer Center
Appleton, Wisconsin
- I'm interested
ThedaCare Cancer Care - Berlin
Berlin, Wisconsin
- I'm interested
Aurora Health Care Germantown Health Center
Germantown, Wisconsin
- I'm interested
Aurora Cancer Care-Grafton
Grafton, Wisconsin
- I'm interested
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin
- I'm interested
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin
- I'm interested
Mercyhealth Hospital and Cancer Center - Janesville
Janesville, Wisconsin
- I'm interested
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin
- I'm interested
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin
- I'm interested
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin
- I'm interested
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin
- I'm interested
Gundersen Lutheran Medical Center
La Crosse, Wisconsin
- I'm interested
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin
- I'm interested
Aspirus Medford Hospital
Medford, Wisconsin
- I'm interested
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin
- I'm interested
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin
- I'm interested
Aurora Sinai Medical Center
Milwaukee, Wisconsin
- I'm interested
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin
- I'm interested
ProHealth D N Greenwald Center
Mukwonago, Wisconsin
- I'm interested
ThedaCare Regional Medical Center - Neenah
Neenah, Wisconsin
- I'm interested
ThedaCare Cancer Care - New London
New London, Wisconsin
- Call 262-928-7878
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin
This research site can be reached directly by phone. Call to ask about this study.
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- I'm interested
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin
- I'm interested
ThedaCare Cancer Care - Oshkosh
Oshkosh, Wisconsin
- I'm interested
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin
- I'm interested
Aurora Cancer Care-Racine
Racine, Wisconsin
- I'm interested
Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
Rhinelander, Wisconsin
- I'm interested
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin
- I'm interested
ThedaCare Cancer Care - Shawano
Shawano, Wisconsin
- I'm interested
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin
- I'm interested
Sheboygan Physicians Group
Sheboygan, Wisconsin
- I'm interested
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin
- I'm interested
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin
- Call 262-928-7632
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin
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- I'm interested
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin
- I'm interested
ThedaCare Cancer Care - Waupaca
Waupaca, Wisconsin
- Call 877-405-6866
Aspirus Cancer Care-Wausau
Wausau, Wisconsin
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- I'm interested
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin
- I'm interested
Aurora West Allis Medical Center
West Allis, Wisconsin
- I'm interested
Marshfield Medical Center - Weston
Weston, Wisconsin
- Call 715-422-7718
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin
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- I'm interested
Aurora BayCare Medical Center
Green Bay, Wisconsin
- Call 920-435-8326
Bellin Memorial Hospital
Green Bay, Wisconsin
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- Call 855-776-0015
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin
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- I'm interested
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin
- I'm interested
Aurora Saint Luke's South Shore
Cudahy, Wisconsin
- I'm interested
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin
- I'm interested
Duluth Clinic Ashland
Ashland, Wisconsin
Who can participate
Inclusion criteria
- ✓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 0-2
- ✓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
- ✓For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- ✓Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have undetectable HCV viral
- ✓Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- ✓Patient must be English or Spanish speaking to be eligible for the QOL component of the study
- ✓NOTE: Sites cannot translate the associated GA or QOL forms
- ✓Patient must not have symptomatic central nervous system disease (CNS) metastases. Patients with a clinical history of CNS metastases or cord compression are eligible if they have been definitively treated and are clinically stable for at least 14 days prior to Step 1 registration and off all steroids for at least 24 hours prior to Step 1 registration. Patients with asymptomatic CNS metastases are eligible
- ✓Patient must not have had any prior cytotoxic chemotherapy regimen for metastatic disease. Chemotherapy given in the setting of adjuvant therapy or locally advanced disease is allowed as long as treatment was completed, and they have fully recovered from treatment related adverse events prior to Step 1 registration
- ✓Patient must not have had any prior immunotherapy for metastatic disease. Immunotherapy given in the setting of adjuvant therapy or locally advanced disease is allowed as long as treatment was completed greater than 6 months prior to Step 1 registration
- ✓Patient must not have a history of uncontrolled autoimmune conditions with the following exceptions, which are allowed: alopecia, vitiligo, rheumatoid arthritis, psoriasis/psoriatic arthritis, Hashimoto's thyroiditis, lupus, inflammatory bowel disease
- ✓Patient must not be on immunosuppressive medication, including steroids (if doses exceed the equivalent of prednisone 10 mg daily). Short courses of steroids which are discontinued prior to randomization are acceptable. Patients on inhaled, intranasal and/or topical steroids are eligible
- ✓Patient must have baseline imaging done assessing all measurable or non-measurable sites of disease within 45 days prior to Step 1 registration
- ✓Investigator must declare their intended chemotherapy regimen should their patient be randomized to Arm B (doublet versus\[vs\] singlet)
- ✓STEP 2 RANDOMIZATION
- ✓Patient must have completed the baseline Geriatric Assessment (GA) after Step 1 registration and prior to Step 2 randomization
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.