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)
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.
Detailed description
PRIMARY OBJECTIVE: I. To compare disease free survival (DFS) in stage II-IIIB non-small cell lung cancer participants who achieved a pathologic complete response (pCR) following standard of care neoadjuvant chemo-immunotherapy and are randomized to adjuvant durvalumab (MEDI4736) versus surveillance. SECONDARY OBJECTIVES: I. To compare the overall survival (OS) between the arms. II. To evaluate the frequency and severity of toxicities of adjuvant durvalumab (MEDI4736). III. To compare the event free survival (EFS) between the arms. TRANSLATIONAL MEDICINE OBJECTIVE: I. To bank specimens and images for additional future translational medicine studies. QUALITY OF LIFE (QOL) PRIMARY OBJECTIVE: I. To compare patient-reported quality of life (QOL) status between treatment arms at 6 months from randomization using the Functional Assessment of Cancer Therapy-Lung (FACT-L) Trial Outcome Index (TOI). QOL SECONDARY OBJECTIVES: I. To compare patient-reported QOL between treatment arms at 24 weeks (6 months) from randomization using the Functional Assessment of Cancer Therapy-Biologic Response Modifier (FACT-BRM) physical and mental subscale scores. II. To compare longitudinal changes in global health status between treatment arms from randomization to 48 week (12 months) using the FACT-L TOI. PATIENT REPORTED OUTCOMES-COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS (PRO-CTCAE) OBJECTIVE: I. To compare participant-reported symptoms using selected PRO-CTCAE items between treatment arms such as rash, itching, skin dryness, numbness, and tingling. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive durvalumab intravenously (IV) over 60 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) and blood sample collection throughout the trial. ARM II: Patients undergo active surveillance for 12 months on study. Patients undergo CT and blood sample collection throughout the trial. After completion of study treatment, patients are followed up annually until 10 years from randomization.
Arms & interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureComputed Tomography
Undergo CT
- BiologicalDurvalumab
Given IV
- OtherPatient Observation
Undergo active surveillance
- OtherQuestionnaire Administration
Ancillary studies
Outcome measures
Primary
Disease-free survival (DFS)
Will be assessed using a 1-sided 5% level log-rank test accounting for interim testing, stratified on the randomization stratification factors.
Time frame: From date of randomization to the earliest event defined as date of first documentation of recurrence, any new lung cancer (even in the contralateral lung), or death due to any cause, assessed up to 10 years
Secondary
Event-free survival (EFS)
Time frame: From date of randomization to date of first occurrence of EFS event, assessed up to 10 years
Overall survival (OS)
Time frame: From date of randomization to date of death due to any cause, assessed up to 10 years
Incidence of adverse events
Time frame: Up to 10 years
Eligibility criteria
Study locations (245)
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, 72401
Tower Cancer Research Foundation
Beverly Hills, California, 90211
Veterans Affairs Loma Linda Healthcare System
Loma Linda, California, 92357
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
Torrance Memorial Physician Network - Cancer Care
Torrance, California, 90505
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, 81501
Hartford HealthCare - Avon
Avon, Connecticut, 06001
Hartford Hospital
Hartford, Connecticut, 06102
Hartford HealthCare - Manchester
Manchester, Connecticut, 06042
Midstate Medical Center
Meriden, Connecticut, 06451
The Hospital of Central Connecticut
New Britain, Connecticut, 06050
Beebe South Coastal Health Campus
Millville, Delaware, 19967
Helen F Graham Cancer Center
Newark, Delaware, 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
Beebe Health Campus
Rehoboth Beach, Delaware, 19971
Moffitt Cancer Center-International Plaza
Tampa, Florida, 33607
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, 33612
Moffitt Cancer Center
Tampa, Florida, 33612
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Emory Decatur Hospital
Decatur, Georgia, 30033
Emory Johns Creek Hospital
Johns Creek, Georgia, 30097
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii, 96813
Queen's Medical Center
Honolulu, Hawaii, 96813
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, 96817
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, 96701
The Queen's Medical Center - West Oahu
‘Ewa Beach, Hawaii, 96706
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83687
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, 83864
Northwestern University
Chicago, Illinois, 60611
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, 60026
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, 60030
Northwestern Medicine Huntley Hospital
Huntley, Illinois, 60142
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045
Loyola University Medical Center
Maywood, Illinois, 60153
Northwestern Medicine Oak Brook
Oak Brook, Illinois, 60523
Northwestern Medicine Orland Park
Orland Park, Illinois, 60462
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555
IU Health West Hospital
Avon, Indiana, 46123
IU Health North Hospital
Carmel, Indiana, 46032
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, 46202
Mary Greeley Medical Center
Ames, Iowa, 50010
McFarland Clinic - Ames
Ames, Iowa, 50010
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023
McFarland Clinic - Boone
Boone, Iowa, 50036
Saint Anthony Regional Hospital
Carroll, Iowa, 51401
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309
Broadlawns Medical Center
Des Moines, Iowa, 50314
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501
UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge, Iowa, 50501
McFarland Clinic - Jefferson
Jefferson, Iowa, 50129
McFarland Clinic - Marshalltown
Marshalltown, Iowa, 50158
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, 50263
HaysMed
Hays, Kansas, 67601
Lawrence Memorial Hospital
Lawrence, Kansas, 66044
The University of Kansas Cancer Center - Olathe
Olathe, Kansas, 66061
Salina Regional Health Center
Salina, Kansas, 67401
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, 66606
University Medical Center New Orleans
New Orleans, Louisiana, 70112
Harold Alfond Center for Cancer Care
Augusta, Maine, 04330
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine, 04074
MaineHealth Cancer Care and IV Therapy - South Portland
South Portland, Maine, 04106
UM Upper Chesapeake Hematology and Oncology - Aberdeen
Aberdeen, Maryland, 21001
UPMC Western Maryland
Cumberland, Maryland, 21502
Beverly Hospital
Beverly, Massachusetts, 01915
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
Addison Gilbert Hospital
Gloucester, Massachusetts, 01930
Lahey Clinic Peabody
Peabody, Massachusetts, 01960
Baystate Medical Center
Springfield, Massachusetts, 01199
UMass Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Bronson Battle Creek
Battle Creek, Michigan, 49017
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
University of Michigan - Brighton Center for Specialty Care
Brighton, Michigan, 48116
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
Henry Ford Hospital
Detroit, Michigan, 48202
Henry Ford Health Saint John Hospital
Detroit, Michigan, 48236
Henry Ford River District Hospital
East China Township, Michigan, 48054
OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan, 49829
Cancer Hematology Centers - Flint
Flint, Michigan, 48503
Genesee Hematology Oncology PC
Flint, Michigan, 48503
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
Henry Ford Saint John Hospital - Academic
Grosse Pointe Woods, Michigan, 48236
Henry Ford Saint John Hospital - Breast
Grosse Pointe Woods, Michigan, 48236
Henry Ford Saint John Hospital - Van Elslander
Grosse Pointe Woods, Michigan, 48236
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
Henry Ford Saint John Hospital - Macomb Medical
Macomb, Michigan, 48044
Henry Ford Warren Hospital - Breast Macomb
Macomb, Michigan, 48044
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, 49120
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, 49444
Henry Ford Health Providence Novi Hospital
Novi, Michigan, 48374
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341
Corewell Health Reed City Hospital
Reed City, Michigan, 49677
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, 49085
Henry Ford Health Providence Southfield Hospital
Southfield, Michigan, 48075
Munson Medical Center
Traverse City, Michigan, 49684
Corewell Health Beaumont Troy Hospital
Troy, Michigan, 48085
Henry Ford Health Warren Hospital
Warren, Michigan, 48093
Henry Ford Madison Heights Hospital - Breast
Warren, Michigan, 48093
Henry Ford Warren Hospital - GLCMS
Warren, Michigan, 48093
University of Michigan Health - West
Wyoming, Michigan, 49519
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
Mercy Hospital
Coon Rapids, Minnesota, 55433
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Fairview Southdale Hospital
Edina, Minnesota, 55435
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
Minneapolis VA Medical Center
Minneapolis, Minnesota, 55417
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
Regions Hospital
Saint Paul, Minnesota, 55101
United Hospital
Saint Paul, Minnesota, 55102
Essentia Health Sandstone
Sandstone, Minnesota, 55072
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, 39705
Baptist Cancer Center-Grenada
Grenada, Mississippi, 38901
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi, 38652
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, 38655
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, 38671
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri, 63011
University Health Truman Medical Center
Kansas City, Missouri, 64108
Mercy Hospital South
St Louis, Missouri, 63128
Mercy Hospital Saint Louis
St Louis, Missouri, 63141
Community Hospital of Anaconda
Anaconda, Montana, 59711
Billings Clinic Cancer Center
Billings, Montana, 59101
Saint Vincent Frontier Cancer Center
Billings, Montana, 59102
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
Logan Health Medical Center
Kalispell, Montana, 59901
Community Medical Center
Missoula, Montana, 59804
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Roswell Park Cancer Institute
Buffalo, New York, 14263
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, 10461
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467
James J Peters VA Medical Center
The Bronx, New York, 10468
Duke Cancer Center Cary
Cary, North Carolina, 27518
Duke University Medical Center
Durham, North Carolina, 27710
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, 28374
Duke Cancer Center Raleigh
Raleigh, North Carolina, 27609
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, 58103
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
Aultman Health Foundation
Canton, Ohio, 44710
Miami Valley Hospital South
Centerville, Ohio, 45459
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Miami Valley Hospital
Dayton, Ohio, 45409
Miami Valley Hospital North
Dayton, Ohio, 45415
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
Miami Valley Cancer Care and Infusion
Greenville, Ohio, 45331
Upper Valley Medical Center
Troy, Ohio, 45373
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Providence Hood River Memorial Hospital
Hood River, Oregon, 97031
Providence Newberg Medical Center
Newberg, Oregon, 97132
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045
Providence Portland Medical Center
Portland, Oregon, 97213
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
Oregon Health and Science University
Portland, Oregon, 97239
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, 16505
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, 15601
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, 17109
Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania, 18201
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania, 17050
Riddle Memorial Hospital
Media, Pennsylvania, 19063
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania, 15146
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Jefferson Torresdale Hospital
Philadelphia, Pennsylvania, 19114
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232
Reading Hospital
West Reading, Pennsylvania, 19611
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341
Tidelands Georgetown Memorial Hospital
Georgetown, South Carolina, 29440
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
SMC Center for Hematology Oncology Union
Union, South Carolina, 29379
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, 38017
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120
Hematology Oncology Associates of Fredericksburg Inc
Fredericksburg, Virginia, 22408
Centra Alan B Pearson Regional Cancer Center
Lynchburg, Virginia, 24501
Virginia Cancer Institute
Richmond, Virginia, 23229
VCU Community Memorial Health Center
South Hill, Virginia, 23970
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
Swedish Medical Center-First Hill
Seattle, Washington, 98122
Edwards Comprehensive Cancer Center
Huntington, West Virginia, 25701
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409
Duluth Clinic Ashland
Ashland, Wisconsin, 54806
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
Aspirus Medford Hospital
Medford, Wisconsin, 54451
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, 54154
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin, 54501
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin, 53081
Sheboygan Physicians Group
Sheboygan, Wisconsin, 53081
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, 54481
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494