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Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial
Sponsor: National Cancer Institute (NCI)
Summary
This phase III trial compares durvalumab to the usual approach (patient observation) after surgery for the treatment of patients with early-stage non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The usual approach for patients who are not in a study is to closely watch a patient's condition after surgery and to have regular visits with their doctor to watch for signs of the cancer coming back. Usually, patients do not receive further treatment unless the cancer returns. This study will help determine whether this different approach with durvalumab is better, the same, or worse than the usual approach of observation. Giving durvalumab may help patients live longer and prevent early-stage non-small cell lung cancer from coming back as compared to the usual approach.
Official title: Randomized Phase III Trial INcorporating Pathologic Complete ReSponse in Participants With Early StaGe Non Small Cell Lung Cancer to Optimize ImmunotHerapy in The AdjuvanT Setting (INSIGHT)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
306
Start Date
2025-04-01
Completion Date
2039-07-15
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT
Durvalumab
Given IV
Patient Observation
Undergo active surveillance
Questionnaire Administration
Ancillary studies
Locations (225)
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, United States
Tower Cancer Research Foundation
Beverly Hills, California, United States
Veterans Affairs Loma Linda Healthcare System
Loma Linda, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Torrance Memorial Physician Network - Cancer Care
Torrance, California, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States
Hartford HealthCare - Avon
Avon, Connecticut, United States
Hartford Hospital
Hartford, Connecticut, United States
Hartford HealthCare - Manchester
Manchester, Connecticut, United States
Midstate Medical Center
Meriden, Connecticut, United States
The Hospital of Central Connecticut
New Britain, Connecticut, United States
Beebe South Coastal Health Campus
Millville, Delaware, United States
Helen F Graham Cancer Center
Newark, Delaware, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States
Beebe Health Campus
Rehoboth Beach, Delaware, United States
Moffitt Cancer Center-International Plaza
Tampa, Florida, United States
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
Emory Decatur Hospital
Decatur, Georgia, United States
Emory Johns Creek Hospital
Johns Creek, Georgia, United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, United States
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii, United States
Queen's Medical Center
Honolulu, Hawaii, United States
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, United States
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, United States
The Queen's Medical Center - West Oahu
‘Ewa Beach, Hawaii, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, United States
Northwestern University
Chicago, Illinois, United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, United States
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, United States
Northwestern Medicine Huntley Hospital
Huntley, Illinois, United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Northwestern Medicine Oak Brook
Oak Brook, Illinois, United States
Northwestern Medicine Orland Park
Orland Park, Illinois, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States
IU Health West Hospital
Avon, Indiana, United States
IU Health North Hospital
Carmel, Indiana, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Mary Greeley Medical Center
Ames, Iowa, United States
McFarland Clinic - Ames
Ames, Iowa, United States
McFarland Clinic - Boone
Boone, Iowa, United States
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, United States
McFarland Clinic - Jefferson
Jefferson, Iowa, United States
McFarland Clinic - Marshalltown
Marshalltown, Iowa, United States
HaysMed
Hays, Kansas, United States
Lawrence Memorial Hospital
Lawrence, Kansas, United States
The University of Kansas Cancer Center - Olathe
Olathe, Kansas, United States
Salina Regional Health Center
Salina, Kansas, United States
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
Harold Alfond Center for Cancer Care
Augusta, Maine, United States
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine, United States
MaineHealth Cancer Care and IV Therapy - South Portland
South Portland, Maine, United States
UPMC Western Maryland
Cumberland, Maryland, United States
Beverly Hospital
Beverly, Massachusetts, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
Addison Gilbert Hospital
Gloucester, Massachusetts, United States
Lahey Medical Center-Peabody
Peabody, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Bronson Battle Creek
Battle Creek, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, United States
University of Michigan - Brighton Center for Specialty Care
Brighton, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, United States
Henry Ford Health Saint John Hospital
Detroit, Michigan, United States
Henry Ford River District Hospital
East China Township, Michigan, United States
OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan, United States
Cancer Hematology Centers - Flint
Flint, Michigan, United States
Genesee Hematology Oncology PC
Flint, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, United States
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, United States
Henry Ford Saint John Hospital - Academic
Grosse Pointe Woods, Michigan, United States
Henry Ford Saint John Hospital - Breast
Grosse Pointe Woods, Michigan, United States
Henry Ford Saint John Hospital - Van Elslander
Grosse Pointe Woods, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, United States
Henry Ford Saint John Hospital - Macomb Medical
Macomb, Michigan, United States
Henry Ford Warren Hospital - Breast Macomb
Macomb, Michigan, United States
Trinity Health Muskegon Hospital
Muskegon, Michigan, United States
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, United States
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, United States
Corewell Health Reed City Hospital
Reed City, Michigan, United States
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, United States
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, United States
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
Henry Ford Health Warren Hospital
Warren, Michigan, United States
Henry Ford Madison Heights Hospital - Breast
Warren, Michigan, United States
Henry Ford Warren Hospital - GLCMS
Warren, Michigan, United States
University of Michigan Health - West
Wyoming, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, United States
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Essentia Health - Deer River Clinic
Deer River, Minnesota, United States
Essentia Health Cancer Center
Duluth, Minnesota, United States
Fairview Southdale Hospital
Edina, Minnesota, United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States
Minneapolis VA Medical Center
Minneapolis, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
Essentia Health Sandstone
Sandstone, Minnesota, United States
Essentia Health Virginia Clinic
Virginia, Minnesota, United States
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, United States
Baptist Cancer Center-Grenada
Grenada, Mississippi, United States
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi, United States
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, United States
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, United States
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri, United States
University Health Truman Medical Center
Kansas City, Missouri, United States
Mercy Hospital South
St Louis, Missouri, United States
Mercy Hospital Saint Louis
St Louis, Missouri, United States
Community Hospital of Anaconda
Anaconda, Montana, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Saint Vincent Frontier Cancer Center
Billings, Montana, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, United States
Logan Health Medical Center
Kalispell, Montana, United States
Community Medical Center
Missoula, Montana, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
James J Peters VA Medical Center
The Bronx, New York, United States
Duke Cancer Center Cary
Cary, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, United States
Duke Cancer Center Raleigh
Raleigh, North Carolina, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, United States
Sanford Broadway Medical Center
Fargo, North Dakota, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States
Aultman Health Foundation
Canton, Ohio, United States
Miami Valley Hospital South
Centerville, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
Miami Valley Hospital North
Dayton, Ohio, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States
Miami Valley Cancer Care and Infusion
Greenville, Ohio, United States
Upper Valley Medical Center
Troy, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Providence Hood River Memorial Hospital
Hood River, Oregon, United States
Providence Newberg Medical Center
Newberg, Oregon, United States
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence Saint Vincent Medical Center
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States
Pocono Medical Center
East Stroudsburg, Pennsylvania, United States
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, United States
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, United States
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, United States
Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania, United States
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania, United States
Riddle Memorial Hospital
Media, Pennsylvania, United States
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States
Reading Hospital
West Reading, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, United States
Prisma Health Cancer Institute - Easley
Easley, South Carolina, United States
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, United States
Tidelands Georgetown Memorial Hospital
Georgetown, South Carolina, United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, United States
Spartanburg Medical Center
Spartanburg, South Carolina, United States
SMC Center for Hematology Oncology Union
Union, South Carolina, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, United States
Hematology Oncology Associates of Fredericksburg Inc
Fredericksburg, Virginia, United States
Centra Alan B Pearson Regional Cancer Center
Lynchburg, Virginia, United States
Virginia Cancer Institute
Richmond, Virginia, United States
VCU Community Memorial Health Center
South Hill, Virginia, United States
Swedish Cancer Institute-Edmonds
Edmonds, Washington, United States
Swedish Cancer Institute-Issaquah
Issaquah, Washington, United States
Swedish Medical Center-First Hill
Seattle, Washington, United States
Edwards Comprehensive Cancer Center
Huntington, West Virginia, United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, United States
Duluth Clinic Ashland
Ashland, Wisconsin, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
Aspirus Medford Hospital
Medford, Wisconsin, United States
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, United States
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin, United States
Sheboygan Physicians Group
Sheboygan, Wisconsin, United States
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, United States
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, United States