Testar tillägget av AZD6738 (Ceralasertib) till immunterapi för att öka tiden utan cancer för patienter med icke-småcellig lungcancer
18 september 2026 uppdaterad av: National Cancer Institute (NCI)
En randomiserad fas III-studie av kontrollpunktsblockad hos lungcancerpatienter i adjuvant miljö baserat på patologisk respons efter neoadjuvant terapi (CLEAR)
This phase III trial compares the effect of adding AZD6738 to durvalumab versus durvalumab alone to increase time without cancer in patients with non-small cell lung cancer, following treatment with chemotherapy and surgery. AZD6738 may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth. Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Adding AZD6738 to durvalumab may increase time without cancer in patients with non-small cell lung cancer, following treatment with chemotherapy and surgery.
Studieöversikt
Status
Aktiv, inte rekryterande
Betingelser
Detaljerad beskrivning
PRIMARY OBJECTIVE:
I. To assess for improvement in disease free survival (DFS) in patients who do not achieve pathologic complete response (pCR) following neoadjuvant therapy and patients who receive adjuvant combination immunotherapy with durvalumab and AZD6738 (ceralasertib) compared to those who receive monotherapy with durvalumab.
SECONDARY OBJECTIVE:
I. To evaluate any difference in overall survival (OS) with patients who receive durvalumab and AZD6738 (ceralasertib) compared to those who receive monotherapy with durvalumab.
EXPLORATORY OBJECTIVES:
I. To evaluate any difference in disease free survival (DFS) with patients who receive durvalumab and AZD6738 (ceralasertib) compared to those who receive monotherapy with durvalumab according to PD-L1, stage, prior immune checkpoint inhibitor (ICI) type, and histology.
II. To evaluate any difference in overall survival (OS) with patients who receive durvalumab and AZD6738 (ceralasertib) compared to those who receive monotherapy with durvalumab according to PD-L1, stage, prior ICI type, and histology.
CORRELATIVE OBJECTIVE:
I. To perform correlative analyses on tissue and blood biospecimens collected within this trial.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Starting 4-12 weeks after surgery, patients receive durvalumab intravenously (IV) over 60 minutes on day 1 of each cycle. Cycles repeat every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan and blood sample collection throughout the study and may undergo echocardiography as clinically indicated.
ARM B: Starting 4-12 weeks after surgery, patients receive AZD6738 orally (PO) twice daily (BID) on days 1-7 and durvalumab IV over 60 minutes on day 8 of each cycle. Cycles repeat every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and blood sample collection throughout the study and may undergo echocardiography as clinically indicated.
After completion of study treatment, patients are followed up every 12 weeks for 2 years then every 24 weeks until year 5 then every 12 months until 10 years from randomization.
Studietyp
Interventionell
Inskrivning (Beräknad)
630
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Arkansas
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Jonesboro, Arkansas, Förenta staterna, 72401
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
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California
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Beverly Hills, California, Förenta staterna, 90211
- Tower Cancer Research Foundation
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Los Angeles, California, Förenta staterna, 90048
- Cedars-Sinai Medical Center
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Tarzana, California, Förenta staterna, 91356
- Cedars-Sinai Cancer - Tarzana
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Torrance, California, Förenta staterna, 90505
- Torrance Memorial Physician Network - Cancer Care
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Connecticut
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Hartford, Connecticut, Förenta staterna, 06102
- Hartford Hospital
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Meriden, Connecticut, Förenta staterna, 06451
- Midstate Medical Center
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New Britain, Connecticut, Förenta staterna, 06050
- The Hospital of Central Connecticut
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Delaware
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Millville, Delaware, Förenta staterna, 19967
- Beebe South Coastal Health Campus
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Newark, Delaware, Förenta staterna, 19713
- Helen F Graham Cancer Center
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Newark, Delaware, Förenta staterna, 19713
- Medical Oncology Hematology Consultants PA
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Rehoboth Beach, Delaware, Förenta staterna, 19971
- Beebe Health Campus
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District of Columbia
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Washington D.C., District of Columbia, Förenta staterna, 20010
- MedStar Washington Hospital Center
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Washington D.C., District of Columbia, Förenta staterna, 20007
- MedStar Georgetown University Hospital
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Georgia
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Atlanta, Georgia, Förenta staterna, 30308
- Emory University Hospital Midtown
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Atlanta, Georgia, Förenta staterna, 30322
- Emory University Hospital/Winship Cancer Institute
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Atlanta, Georgia, Förenta staterna, 30342
- Emory Saint Joseph's Hospital
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Decatur, Georgia, Förenta staterna, 30033
- Emory Decatur Hospital
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Johns Creek, Georgia, Förenta staterna, 30097
- Emory Johns Creek Hospital
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Idaho
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Boise, Idaho, Förenta staterna, 83712
- Saint Luke's Cancer Institute - Boise
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Coeur d'Alene, Idaho, Förenta staterna, 83814
- Kootenai Health - Coeur d'Alene
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Fruitland, Idaho, Förenta staterna, 83619
- Saint Luke's Cancer Institute - Fruitland
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Meridian, Idaho, Förenta staterna, 83642
- Saint Luke's Cancer Institute - Meridian
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Nampa, Idaho, Förenta staterna, 83687
- Saint Alphonsus Cancer Care Center-Nampa
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Nampa, Idaho, Förenta staterna, 83687
- Saint Luke's Cancer Institute - Nampa
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Post Falls, Idaho, Förenta staterna, 83854
- Kootenai Clinic Cancer Services - Post Falls
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Sandpoint, Idaho, Förenta staterna, 83864
- Kootenai Clinic Cancer Services - Sandpoint
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Illinois
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Bloomington, Illinois, Förenta staterna, 61704
- Illinois CancerCare-Bloomington
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Canton, Illinois, Förenta staterna, 61520
- Illinois CancerCare-Canton
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Carthage, Illinois, Förenta staterna, 62321
- Illinois CancerCare-Carthage
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Chicago, Illinois, Förenta staterna, 60611
- Northwestern University
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DeKalb, Illinois, Förenta staterna, 60115
- Northwestern Medicine Cancer Center Kishwaukee
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Decatur, Illinois, Förenta staterna, 62526
- Decatur Memorial Hospital
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Decatur, Illinois, Förenta staterna, 62526
- Cancer Care Specialists of Illinois - Decatur
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Dixon, Illinois, Förenta staterna, 61021
- Illinois CancerCare-Dixon
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Effingham, Illinois, Förenta staterna, 62401
- Crossroads Cancer Center
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Eureka, Illinois, Förenta staterna, 61530
- Illinois CancerCare-Eureka
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Galesburg, Illinois, Förenta staterna, 61401
- Illinois CancerCare-Galesburg
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Geneva, Illinois, Förenta staterna, 60134
- Northwestern Medicine Cancer Center Delnor
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Glenview, Illinois, Förenta staterna, 60026
- Northwestern Medicine Glenview Outpatient Center
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Grayslake, Illinois, Förenta staterna, 60030
- Northwestern Medicine Grayslake Outpatient Center
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Kewanee, Illinois, Förenta staterna, 61443
- Illinois CancerCare-Kewanee Clinic
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Lake Forest, Illinois, Förenta staterna, 60045
- Northwestern Medicine Lake Forest Hospital
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Macomb, Illinois, Förenta staterna, 61455
- Illinois CancerCare-Macomb
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Maywood, Illinois, Förenta staterna, 60153
- Loyola University Medical Center
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O'Fallon, Illinois, Förenta staterna, 62269
- Cancer Care Center of O'Fallon
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O'Fallon, Illinois, Förenta staterna, 62269
- HSHS Saint Elizabeth's Hospital
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Oak Brook, Illinois, Förenta staterna, 60523
- Northwestern Medicine Oak Brook
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Orland Park, Illinois, Förenta staterna, 60462
- Northwestern Medicine Orland Park
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Ottawa, Illinois, Förenta staterna, 61350
- Illinois CancerCare-Ottawa Clinic
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Pekin, Illinois, Förenta staterna, 61554
- Illinois CancerCare-Pekin
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Peoria, Illinois, Förenta staterna, 61615
- Illinois CancerCare-Peoria
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Peru, Illinois, Förenta staterna, 61354
- Illinois CancerCare-Peru
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Princeton, Illinois, Förenta staterna, 61356
- Illinois CancerCare-Princeton
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Springfield, Illinois, Förenta staterna, 62702
- Southern Illinois University School of Medicine
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Springfield, Illinois, Förenta staterna, 62702
- Springfield Clinic
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Springfield, Illinois, Förenta staterna, 62781
- Springfield Memorial Hospital
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Warrenville, Illinois, Förenta staterna, 60555
- Northwestern Medicine Cancer Center Warrenville
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Washington, Illinois, Förenta staterna, 61571
- Illinois CancerCare - Washington
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Indiana
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Indianapolis, Indiana, Förenta staterna, 46202
- Indiana University/Melvin and Bren Simon Cancer Center
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Kansas
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El Dorado, Kansas, Förenta staterna, 67042
- Cancer Center of Kansas - El Dorado
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Lawrence, Kansas, Förenta staterna, 66044
- Lawrence Memorial Hospital
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Newton, Kansas, Förenta staterna, 67114
- Cancer Center of Kansas - Newton
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Olathe, Kansas, Förenta staterna, 66061
- The University of Kansas Cancer Center - Olathe
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Salina, Kansas, Förenta staterna, 67401
- Salina Regional Health Center
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Topeka, Kansas, Förenta staterna, 66606
- University of Kansas Health System Saint Francis Campus
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Wellington, Kansas, Förenta staterna, 67152
- Cancer Center of Kansas - Wellington
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Wichita, Kansas, Förenta staterna, 67214
- Ascension Via Christi Hospitals Wichita
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Wichita, Kansas, Förenta staterna, 67208
- Cancer Center of Kansas-Wichita Medical Arts Tower
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Wichita, Kansas, Förenta staterna, 67214
- Cancer Center of Kansas - Wichita
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Winfield, Kansas, Förenta staterna, 67156
- Cancer Center of Kansas - Winfield
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Maryland
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Baltimore, Maryland, Förenta staterna, 21201
- University of Maryland/Greenebaum Cancer Center
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Glen Burnie, Maryland, Förenta staterna, 21061
- UM Baltimore Washington Medical Center/Tate Cancer Center
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Massachusetts
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Beverly, Massachusetts, Förenta staterna, 01915
- Beverly Hospital
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Burlington, Massachusetts, Förenta staterna, 01805
- Lahey Clinic
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Gloucester, Massachusetts, Förenta staterna, 01930
- Addison Gilbert Hospital
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Peabody, Massachusetts, Förenta staterna, 01960
- Lahey Clinic Peabody
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Springfield, Massachusetts, Förenta staterna, 01199
- Baystate Medical Center
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Michigan
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Battle Creek, Michigan, Förenta staterna, 49017
- Bronson Battle Creek
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Brighton, Michigan, Förenta staterna, 48114
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
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Canton, Michigan, Förenta staterna, 48188
- Trinity Health IHA Medical Group Hematology Oncology - Canton
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Chelsea, Michigan, Förenta staterna, 48118
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
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Flint, Michigan, Förenta staterna, 48503
- Hurley Medical Center
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Flint, Michigan, Förenta staterna, 48503
- Genesee Hematology Oncology PC
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Flint, Michigan, Förenta staterna, 48503
- Genesys Hurley Cancer Institute
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Flint, Michigan, Förenta staterna, 48503
- Cancer Hematology Centers - Flint
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Grand Rapids, Michigan, Förenta staterna, 49503
- Trinity Health Grand Rapids Hospital
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Grand Rapids, Michigan, Förenta staterna, 49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Kalamazoo, Michigan, Förenta staterna, 49007
- West Michigan Cancer Center
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Kalamazoo, Michigan, Förenta staterna, 49007
- Bronson Methodist Hospital
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Lansing, Michigan, Förenta staterna, 48912
- University of Michigan Health - Sparrow Lansing
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Livonia, Michigan, Förenta staterna, 48154
- Trinity Health Saint Mary Mercy Livonia Hospital
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Muskegon, Michigan, Förenta staterna, 49444
- Trinity Health Muskegon Hospital
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Niles, Michigan, Förenta staterna, 49120
- Corewell Health Lakeland Hospitals - Niles Hospital
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Norton Shores, Michigan, Förenta staterna, 49444
- Cancer and Hematology Centers of Western Michigan - Norton Shores
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Pontiac, Michigan, Förenta staterna, 48341
- Trinity Health Saint Joseph Mercy Oakland Hospital
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Reed City, Michigan, Förenta staterna, 49677
- Corewell Health Reed City Hospital
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Saint Joseph, Michigan, Förenta staterna, 49085
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
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Saint Joseph, Michigan, Förenta staterna, 49085
- Corewell Health Lakeland Hospitals - Saint Joseph Hospital
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Traverse City, Michigan, Förenta staterna, 49684
- Munson Medical Center
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Wyoming, Michigan, Förenta staterna, 49519
- University of Michigan Health - West
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Ypsilanti, Michigan, Förenta staterna, 48197
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
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Minnesota
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Brainerd, Minnesota, Förenta staterna, 56401
- Essentia Health Saint Joseph's Medical Center
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Coon Rapids, Minnesota, Förenta staterna, 55433
- Mercy Hospital
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Deer River, Minnesota, Förenta staterna, 56636
- Essentia Health - Deer River Clinic
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Duluth, Minnesota, Förenta staterna, 55805
- Essentia Health Cancer Center
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Edina, Minnesota, Förenta staterna, 55435
- Fairview Southdale Hospital
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Hibbing, Minnesota, Förenta staterna, 55746
- Essentia Health Hibbing Clinic
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Minneapolis, Minnesota, Förenta staterna, 55407
- Abbott-Northwestern Hospital
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Minneapolis, Minnesota, Förenta staterna, 55417
- Minneapolis VA Medical Center
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Saint Louis Park, Minnesota, Förenta staterna, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Paul, Minnesota, Förenta staterna, 55101
- Regions Hospital
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Saint Paul, Minnesota, Förenta staterna, 55102
- United Hospital
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Sandstone, Minnesota, Förenta staterna, 55072
- Essentia Health Sandstone
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Virginia, Minnesota, Förenta staterna, 55792
- Essentia Health Virginia Clinic
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Mississippi
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Columbus, Mississippi, Förenta staterna, 39705
- Baptist Memorial Hospital and Cancer Center-Golden Triangle
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Grenada, Mississippi, Förenta staterna, 38901
- Baptist Cancer Center-Grenada
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New Albany, Mississippi, Förenta staterna, 38652
- Baptist Memorial Hospital and Cancer Center-Union County
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Oxford, Mississippi, Förenta staterna, 38655
- Baptist Memorial Hospital and Cancer Center-Oxford
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Southhaven, Mississippi, Förenta staterna, 38671
- Baptist Memorial Hospital and Cancer Center-Desoto
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Missouri
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Cape Girardeau, Missouri, Förenta staterna, 63703
- Saint Francis Medical Center
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Farmington, Missouri, Förenta staterna, 63640
- Parkland Health Center - Farmington
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Sainte Genevieve, Missouri, Förenta staterna, 63670
- Sainte Genevieve County Memorial Hospital
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St Louis, Missouri, Förenta staterna, 63131
- Missouri Baptist Medical Center
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St Louis, Missouri, Förenta staterna, 63128
- Mercy Hospital South
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Sullivan, Missouri, Förenta staterna, 63080
- Missouri Baptist Sullivan Hospital
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Montana
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Anaconda, Montana, Förenta staterna, 59711
- Community Hospital of Anaconda
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Billings, Montana, Förenta staterna, 59101
- Billings Clinic Cancer Center
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Billings, Montana, Förenta staterna, 59102
- Saint Vincent Frontier Cancer Center
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Bozeman, Montana, Förenta staterna, 59715
- Bozeman Health Deaconess Hospital
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Great Falls, Montana, Förenta staterna, 59405
- Benefis Sletten Cancer Institute
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Missoula, Montana, Förenta staterna, 59804
- Community Medical Center
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New Hampshire
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Concord, New Hampshire, Förenta staterna, 03301
- New Hampshire Oncology Hematology PA-Concord
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Manchester, New Hampshire, Förenta staterna, 03103
- Solinsky Center for Cancer Care
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New Jersey
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Flemington, New Jersey, Förenta staterna, 08822
- Hunterdon Medical Center
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New York
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Glens Falls, New York, Förenta staterna, 12801
- Glens Falls Hospital
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The Bronx, New York, Förenta staterna, 10461
- Montefiore Medical Center-Einstein Campus
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North Carolina
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Pinehurst, North Carolina, Förenta staterna, 28374
- FirstHealth of the Carolinas-Moore Regional Hospital
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North Dakota
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Fargo, North Dakota, Förenta staterna, 58103
- Essentia Health Cancer Center-South University Clinic
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Ohio
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Canton, Ohio, Förenta staterna, 44710
- Aultman Health Foundation
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Columbus, Ohio, Förenta staterna, 43210
- Ohio State University Comprehensive Cancer Center
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73104
- University of Oklahoma Health Sciences Center
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Oregon
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Newberg, Oregon, Förenta staterna, 97132
- Providence Newberg Medical Center
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Oregon City, Oregon, Förenta staterna, 97045
- Providence Willamette Falls Medical Center
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Portland, Oregon, Förenta staterna, 97239
- Oregon Health and Science University
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Portland, Oregon, Förenta staterna, 97213
- Providence Portland Medical Center
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Portland, Oregon, Förenta staterna, 97225
- Providence Saint Vincent Medical Center
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Pennsylvania
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Allentown, Pennsylvania, Förenta staterna, 18103
- Lehigh Valley Hospital-Cedar Crest
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Bethlehem, Pennsylvania, Förenta staterna, 18017
- Lehigh Valley Hospital - Muhlenberg
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Bryn Mawr, Pennsylvania, Förenta staterna, 19010
- Bryn Mawr Hospital
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East Stroudsburg, Pennsylvania, Förenta staterna, 18301
- Pocono Medical Center
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Erie, Pennsylvania, Förenta staterna, 16505
- UPMC Hillman Cancer Center Erie
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Greensburg, Pennsylvania, Förenta staterna, 15601
- UPMC Cancer Centers - Arnold Palmer Pavilion
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Harrisburg, Pennsylvania, Förenta staterna, 17109
- UPMC Pinnacle Cancer Center/Community Osteopathic Campus
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Hazleton, Pennsylvania, Förenta staterna, 18201
- Lehigh Valley Hospital-Hazleton
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Mechanicsburg, Pennsylvania, Förenta staterna, 17050
- UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
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Media, Pennsylvania, Förenta staterna, 19063
- Riddle Memorial Hospital
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Monroeville, Pennsylvania, Förenta staterna, 15146
- UPMC Hillman Cancer Center - Monroeville
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Paoli, Pennsylvania, Förenta staterna, 19301
- Paoli Memorial Hospital
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Philadelphia, Pennsylvania, Förenta staterna, 19104
- University of Pennsylvania/Abramson Cancer Center
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Pittsburgh, Pennsylvania, Förenta staterna, 15232
- UPMC Hillman Cancer Center
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Pittsburgh, Pennsylvania, Förenta staterna, 15243
- UPMC-Saint Clair Hospital Cancer Center
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West Reading, Pennsylvania, Förenta staterna, 19611
- Reading Hospital
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Wynnewood, Pennsylvania, Förenta staterna, 19096
- Lankenau Medical Center
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South Carolina
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Georgetown, South Carolina, Förenta staterna, 29440
- Tidelands Georgetown Memorial Hospital
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Tennessee
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Collierville, Tennessee, Förenta staterna, 38017
- Baptist Memorial Hospital and Cancer Center-Collierville
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Memphis, Tennessee, Förenta staterna, 38120
- Baptist Memorial Hospital and Cancer Center-Memphis
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Nashville, Tennessee, Förenta staterna, 37232
- Vanderbilt University/Ingram Cancer Center
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Virginia
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Charlottesville, Virginia, Förenta staterna, 22908
- University of Virginia Cancer Center
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Fredericksburg, Virginia, Förenta staterna, 22408
- Hematology Oncology Associates of Fredericksburg Inc
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Richmond, Virginia, Förenta staterna, 23235
- VCU Massey Cancer Center at Stony Point
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Richmond, Virginia, Förenta staterna, 23229
- Virginia Cancer Institute
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Richmond, Virginia, Förenta staterna, 23298
- VCU Massey Comprehensive Cancer Center
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South Hill, Virginia, Förenta staterna, 23970
- VCU Community Memorial Health Center
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West Virginia
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Huntington, West Virginia, Förenta staterna, 25701
- Edwards Comprehensive Cancer Center
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Morgantown, West Virginia, Förenta staterna, 26506
- West Virginia University Healthcare
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Parkersburg, West Virginia, Förenta staterna, 26101
- Camden Clark Medical Center
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Wisconsin
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Antigo, Wisconsin, Förenta staterna, 54409
- Aspirus Cancer Care-Antigo-Volm Cancer Center
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Appleton, Wisconsin, Förenta staterna, 54911
- ThedaCare Regional Cancer Center
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Ashland, Wisconsin, Förenta staterna, 54806
- Duluth Clinic Ashland
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Hayward, Wisconsin, Förenta staterna, 54843
- Essentia Health-Hayward Clinic
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La Crosse, Wisconsin, Förenta staterna, 54601
- Gundersen Lutheran Medical Center
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Medford, Wisconsin, Förenta staterna, 54451
- Aspirus Medford Hospital
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Mukwonago, Wisconsin, Förenta staterna, 53149
- ProHealth D N Greenwald Center
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Oconomowoc, Wisconsin, Förenta staterna, 53066
- ProHealth Oconomowoc Memorial Hospital
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Rhinelander, Wisconsin, Förenta staterna, 54501
- Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
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Spooner, Wisconsin, Förenta staterna, 54801
- Essentia Health-Spooner Clinic
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Stevens Point, Wisconsin, Förenta staterna, 54481
- Aspirus Cancer Care - Stevens Point
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Superior, Wisconsin, Förenta staterna, 54880
- Essentia Health Saint Mary's Hospital - Superior
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Waukesha, Wisconsin, Förenta staterna, 53188
- UW Cancer Center at ProHealth Care
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Wausau, Wisconsin, Förenta staterna, 54401
- Aspirus Cancer Care-Wausau
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Wisconsin Rapids, Wisconsin, Förenta staterna, 54494
- Aspirus Cancer Care - Wisconsin Rapids
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
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STEP 0: Patient must be >= 18 years of age
-
STEP 0: Patient must have stage II to select stage IIIB (N2 but excluding N3) non-small cell lung cancer (NSCLC) of any histology using International Association for the Study of Lung Cancer (IASLC) 8th edition. Stage is assessed at time of initiating pre-operative chemo-immunotherapy
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STEP 0: Patient must fall into one of the following categories:
- Planning to undergo, be currently undergoing, or recently completed any standard of care neoadjuvant chemo-immunotherapy with plans to undergo surgical resection
- Recently completed any standard of care neoadjuvant chemo-immunotherapy AND completed surgical resection and are awaiting pCR status.
- Recently completed any standard of care neoadjuvant chemo-immunotherapy AND completed surgical resection with confirmed non-path complete response (CR) status.
NOTES:
-
Patient must have completed at least 3 cycles of neoadjuvant chemo-immunotherapy before surgery in order to be eligible for Step 1 randomization.
-
Patients who have completed their surgical resection prior to enrollment in step 0 registration must have their surgery date within a window that will allow initiation of EA5231 treatment (cycle 1 day 1) to commence within 4-12 weeks following surgery
- STEP 1: EA5231 CLEAR randomization for patients without a pCR post-surgery. Patient's with pCR after surgery will be offered to enroll in the SWOG study S2414 INSIGHT instead
- STEP 1: Patient must have completed R0 resection after standard of care neoadjuvant chemo-immunotherapy (minimum three cycles completed) for stage II to select stage IIIB (N2 but excluding N3) non-small cell lung cancer (NSCLC) of any histology using IASLC 8th Edition
- STEP 1: Patient must have non-pathological CR status post-surgery. The pathological CR/non-pathological CR status will be determined by local pathology using IASLC criteria and using the surgical sample tissue
- STEP 1: Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - ≤ 2 (or Karnofsky ≥ 60%)
- STEP 1: Patient must not have any known EGFR or ALK genetic alterations. Mutation negative status will be determined per local institutional practices and consistent with National Comprehensive Cancer Network (NCCN) guidelines
- STEP 1: Patient must have undergone a chest CT after surgery and within 28 days prior to step 1 randomization
- STEP 1: Patient must have recovered from clinically significant adverse events of their most recent therapy/intervention prior to step 1 randomization
- STEP 1: Patient must not have experienced a toxicity that led to the permanent discontinuation of prior immunotherapy
- STEP 1: Patient must not be receiving ongoing steroids at a dose of prednisone 10 mg or higher (or equivalent) at the time of step 1 randomization. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) are allowed. Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection) are allowed
- STEP 1: Patient must not have received or have a plan to receive post-operative radiation therapy (PORT)
- STEP 1: Patient must not have a history of treatment-related pneumonitis requiring ongoing steroids or supplemental oxygen use
- STEP 1: Patient must not have a history of interstitial lung disease (ILD)
- STEP 1: Patient must not have diagnosis of ataxia telangiectasia
- STEP 1: Patient must not have history of active primary immunodeficiency
- STEP 1: Patient must not have history of allogenic organ transplantation
- STEP 1: Patient must have body weight > 30 kg
- STEP 1: Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to Step 1 randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria:
-
Has achieved menarche at some point
-
Has not undergone a hysterectomy or bilateral oophorectomy
-
Has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
- STEP 1: Patient must not expect to conceive or father children by using highly accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study. Patients of childbearing potential must use at least 1 highly effective method of contraception in addition to a condom and continue to use it throughout their time on protocol treatment. Male patients must use a condom plus spermicide throughout their time on while on protocol treatment. In addition, all patients must continue contraception use for at least 6 months after the last dose of protocol treatment. Patients must also not breastfeed while on protocol treatment and for at least 6 months after the last dose of protocol treatment. Patients must not donate sperm while on protocol treatment and for 6 months after the last dose of protocol treatment
- STEP 1: Patient must not donate blood while on protocol treatment
- STEP 1: 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
- STEP 1: Leukocytes ≥ 3,000/mcL (these labs must be obtained ≤ 28 days prior to step 1 randomization)
- STEP 1: Hemoglobin ≥ 9.0 g/dL (these labs must be obtained ≤ 28 days prior to step 1 randomization)
- STEP 1: Absolute neutrophil count (ANC) ≥ 1,500/mcL (these labs must be obtained ≤ 28 days prior to step 1 randomization)
- STEP 1: Platelets ≥ 100,000/mcL (these labs must be obtained ≤ 28 days prior to step 1 randomization)
- STEP 1: Total bilirubin ≤ institutional upper limit of normal (ULN) (these labs must be obtained ≤ 28 days prior to step 1 randomization)
- STEP 1: Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3.0 × institutional ULN (these labs must be obtained ≤ 28 days prior to step 1 randomization)
- STEP 1: Creatinine clearance ≥ 50 mL/min (estimated using Cockcroft-Gault method or measured) (these labs must be obtained ≤ 28 days prior to step 1 randomization)
- STEP 1: Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of step 1 randomization are eligible for this trial
- STEP 1: For patients with known chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- STEP 1: 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 an undetectable HCV viral load
- STEP 1: 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
- STEP 1: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
- STEP 1: Patient must not have received live attenuated vaccine within 30 days prior to the step 1 randomization, while on protocol treatment and within 30 days after the last dose of durvalumab
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Arm A (Durvalumab)
Starting 4-12 weeks after surgery, patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and blood sample collection throughout the study and may undergo echocardiography as clinically indicated. |
Undergo blood sample collection
Andra namn:
Undergo CT scan
Andra namn:
Undergo echocardiography
Andra namn:
Given IV
Andra namn:
|
|
Experimentell: Arm B (Durvalumab and AZD6738)
Starting 4-12 weeks after surgery, patients receive AZD6738 PO BID on days 1-7 and durvalumab IV over 60 minutes on day 8 of each cycle. Cycles repeat every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and blood sample collection throughout the study and may undergo echocardiography as clinically indicated. |
Undergo blood sample collection
Andra namn:
Undergo CT scan
Andra namn:
Undergo echocardiography
Andra namn:
Given IV
Andra namn:
Given PO
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Disease free survival (DFS)
Tidsram: From randomization to the earliest event defined as the first recurrence of non-small cell lung cancer (NSCLC), any new lung cancer or death, up to 10 years
|
Will estimate DFS distributions using the Kaplan-Meier method and employ Cox proportional hazards models to estimate the treatment hazard ratios. The comparison of DFS will use a logrank test stratified on the randomization stratification factors with a one-sided type I error rate of 2.5%. Other comparisons of groups will be made using the logrank test and Cox modeling. Point estimates will be accompanied by the corresponding two-sided 95% confidence intervals. |
From randomization to the earliest event defined as the first recurrence of non-small cell lung cancer (NSCLC), any new lung cancer or death, up to 10 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall survival (OS)
Tidsram: From randomization to death from any cause, up to 10 years
|
Will estimate OS distributions using the Kaplan-Meier method and employ Cox proportional hazards models to estimate the treatment hazard ratios. The comparison of OS will use a logrank test stratified on the randomization stratification factors with a one-sided type I error rate of 2.5%. Other comparisons of groups will be made using the logrank test and Cox modeling. Point estimates will be accompanied by the corresponding two-sided 95% confidence intervals. |
From randomization to death from any cause, up to 10 years
|
|
Incidence of adverse events
Tidsram: Up to 10 years
|
Toxicity will be assessed by summaries by Common Terminology Criteria for Adverse Event grade. |
Up to 10 years
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Korrelativa analyser på vävnads-, blod- och avföringsbioprover
Tidsram: Upp till 10 år
|
Upp till 10 år
|
|
|
Estimates of treatment effect by sex
Tidsram: Up to 10 years
|
Estimates of DFS and the corresponding 95% confidence intervals (CIs) by sex. |
Up to 10 years
|
|
Estimates of treatment effect by race
Tidsram: Up to 10 years
|
Estimates of DFS and the corresponding 95% CIs by race. |
Up to 10 years
|
|
Estimates of treatment effect by ethnicity
Tidsram: Up to 10 years
|
Estimates of DFS and the corresponding 95% CIs by ethnicity. |
Up to 10 years
|
|
DFS according to PD-L1 status
Tidsram: Up to 10 years
|
Will be compared between treatment arms using the logrank test and Cox modeling. |
Up to 10 years
|
|
DFS according to stage
Tidsram: Up to 10 years
|
Will be compared between treatment arms using the logrank test and Cox modeling. |
Up to 10 years
|
|
DFS according to prior immune checkpoint inhibitor (ICI) type
Tidsram: Up to 10 years
|
Will be compared between treatment arms using the logrank test and Cox modeling. |
Up to 10 years
|
|
DFS according to histology
Tidsram: Up to 10 years
|
Will be compared between treatment arms using the logrank test and Cox modeling. |
Up to 10 years
|
|
OS according to PD-L1 status
Tidsram: Up to 10 years
|
Will be compared between treatment arms using the logrank test and Cox modeling. |
Up to 10 years
|
|
OS according to stage
Tidsram: Up to 10 years
|
Will be compared between treatment arms using the logrank test and Cox modeling. |
Up to 10 years
|
|
OS according to prior ICI type
Tidsram: Up to 10 years
|
Will be compared between treatment arms using the logrank test and Cox modeling. |
Up to 10 years
|
|
OS according to histology
Tidsram: Up to 10 years
|
Will be compared between treatment arms using the logrank test and Cox modeling. |
Up to 10 years
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Dwight H Owen, ECOG-ACRIN Cancer Research Group
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
7 augusti 2025
Primärt slutförande (Beräknad)
30 juni 2028
Avslutad studie (Beräknad)
30 juni 2028
Studieregistreringsdatum
Först inskickad
12 december 2024
Först inskickad som uppfyllde QC-kriterierna
12 december 2024
Första postat (Faktisk)
13 december 2024
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
21 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 september 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter plats
- Neoplasmer
- Luftvägssjukdomar
- Lungsjukdomar
- Neoplasmer i andningsvägarna
- Thoracic neoplasmer
- Karcinom, bronkogent
- Bronkiella neoplasmer
- Lungneoplasmer
- Karcinom, icke-småcellig lunga
- Aminosyror, peptider och proteiner
- Proteiner
- Svavelföreningar
- Organiska kemikalier
- Undersökningstekniker
- Kliniska laboratorietekniker
- Diagnostiska tekniker och procedurer
- Diagnos
- Antikroppar
- Immunglobuliner
- Immunoproteiner
- Blodproteiner
- Serumglobuliner
- Globuliner
- Oorganiska kemikalier
- Immunglobulinisotyper
- Sulfider
- Anjoner
- Joner
- Elektrolyter
- Vätesulfid
- Immunoglobulin G
- Provhantering
- ceralasertib
- durvalumab
- Disulfider
Andra studie-ID-nummer
- NCI-2024-10081
- U10CA180820 (U.S.S. NIH-anslag/kontrakt)
- NCI-2024-10081 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
- EA5231 (Annan identifierare: CTEP)
- EA5231 (Annan identifierare: ECOG-ACRIN Cancer Research Group)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .