Test af tilføjelsen af AZD6738 (Ceralasertib) til immunterapi for at øge tiden uden kræft for patienter med ikke-småcellet lungekræft
18. september 2026 opdateret af: National Cancer Institute (NCI)
Et randomiseret fase III-forsøg med kontrolpunktblokade hos lungekræftpatienter i adjuverende omgivelser baseret på patologisk respons efter neoadjuverende 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.
Studieoversigt
Status
Status
Aktiv, ikke rekrutterende
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
Tilmelding
630
Fase
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Arkansas
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Jonesboro, Arkansas, Forenede Stater, 72401
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
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California
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Beverly Hills, California, Forenede Stater, 90211
- Tower Cancer Research Foundation
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Los Angeles, California, Forenede Stater, 90048
- Cedars-Sinai Medical Center
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Tarzana, California, Forenede Stater, 91356
- Cedars-Sinai Cancer - Tarzana
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Torrance, California, Forenede Stater, 90505
- Torrance Memorial Physician Network - Cancer Care
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Connecticut
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Hartford, Connecticut, Forenede Stater, 06102
- Hartford Hospital
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Meriden, Connecticut, Forenede Stater, 06451
- Midstate Medical Center
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New Britain, Connecticut, Forenede Stater, 06050
- The Hospital of Central Connecticut
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Delaware
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Millville, Delaware, Forenede Stater, 19967
- Beebe South Coastal Health Campus
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Newark, Delaware, Forenede Stater, 19713
- Helen F Graham Cancer Center
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Newark, Delaware, Forenede Stater, 19713
- Medical Oncology Hematology Consultants PA
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Rehoboth Beach, Delaware, Forenede Stater, 19971
- Beebe Health Campus
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20010
- MedStar Washington Hospital Center
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Washington D.C., District of Columbia, Forenede Stater, 20007
- MedStar Georgetown University Hospital
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Georgia
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Atlanta, Georgia, Forenede Stater, 30308
- Emory University Hospital Midtown
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Atlanta, Georgia, Forenede Stater, 30322
- Emory University Hospital/Winship Cancer Institute
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Atlanta, Georgia, Forenede Stater, 30342
- Emory Saint Joseph's Hospital
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Decatur, Georgia, Forenede Stater, 30033
- Emory Decatur Hospital
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Johns Creek, Georgia, Forenede Stater, 30097
- Emory Johns Creek Hospital
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Idaho
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Boise, Idaho, Forenede Stater, 83712
- Saint Luke's Cancer Institute - Boise
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Coeur d'Alene, Idaho, Forenede Stater, 83814
- Kootenai Health - Coeur d'Alene
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Fruitland, Idaho, Forenede Stater, 83619
- Saint Luke's Cancer Institute - Fruitland
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Meridian, Idaho, Forenede Stater, 83642
- Saint Luke's Cancer Institute - Meridian
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Nampa, Idaho, Forenede Stater, 83687
- Saint Alphonsus Cancer Care Center-Nampa
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Nampa, Idaho, Forenede Stater, 83687
- Saint Luke's Cancer Institute - Nampa
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Post Falls, Idaho, Forenede Stater, 83854
- Kootenai Clinic Cancer Services - Post Falls
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Sandpoint, Idaho, Forenede Stater, 83864
- Kootenai Clinic Cancer Services - Sandpoint
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Illinois
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Bloomington, Illinois, Forenede Stater, 61704
- Illinois CancerCare-Bloomington
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Canton, Illinois, Forenede Stater, 61520
- Illinois CancerCare-Canton
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Carthage, Illinois, Forenede Stater, 62321
- Illinois CancerCare-Carthage
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Chicago, Illinois, Forenede Stater, 60611
- Northwestern University
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DeKalb, Illinois, Forenede Stater, 60115
- Northwestern Medicine Cancer Center Kishwaukee
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Decatur, Illinois, Forenede Stater, 62526
- Decatur Memorial Hospital
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Decatur, Illinois, Forenede Stater, 62526
- Cancer Care Specialists of Illinois - Decatur
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Dixon, Illinois, Forenede Stater, 61021
- Illinois CancerCare-Dixon
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Effingham, Illinois, Forenede Stater, 62401
- Crossroads Cancer Center
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Eureka, Illinois, Forenede Stater, 61530
- Illinois CancerCare-Eureka
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Galesburg, Illinois, Forenede Stater, 61401
- Illinois CancerCare-Galesburg
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Geneva, Illinois, Forenede Stater, 60134
- Northwestern Medicine Cancer Center Delnor
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Glenview, Illinois, Forenede Stater, 60026
- Northwestern Medicine Glenview Outpatient Center
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Grayslake, Illinois, Forenede Stater, 60030
- Northwestern Medicine Grayslake Outpatient Center
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Kewanee, Illinois, Forenede Stater, 61443
- Illinois CancerCare-Kewanee Clinic
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Lake Forest, Illinois, Forenede Stater, 60045
- Northwestern Medicine Lake Forest Hospital
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Macomb, Illinois, Forenede Stater, 61455
- Illinois CancerCare-Macomb
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Maywood, Illinois, Forenede Stater, 60153
- Loyola University Medical Center
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O'Fallon, Illinois, Forenede Stater, 62269
- Cancer Care Center of O'Fallon
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O'Fallon, Illinois, Forenede Stater, 62269
- HSHS Saint Elizabeth's Hospital
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Oak Brook, Illinois, Forenede Stater, 60523
- Northwestern Medicine Oak Brook
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Orland Park, Illinois, Forenede Stater, 60462
- Northwestern Medicine Orland Park
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Ottawa, Illinois, Forenede Stater, 61350
- Illinois CancerCare-Ottawa Clinic
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Pekin, Illinois, Forenede Stater, 61554
- Illinois CancerCare-Pekin
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Peoria, Illinois, Forenede Stater, 61615
- Illinois CancerCare-Peoria
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Peru, Illinois, Forenede Stater, 61354
- Illinois CancerCare-Peru
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Princeton, Illinois, Forenede Stater, 61356
- Illinois CancerCare-Princeton
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Springfield, Illinois, Forenede Stater, 62702
- Southern Illinois University School of Medicine
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Springfield, Illinois, Forenede Stater, 62702
- Springfield Clinic
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Springfield, Illinois, Forenede Stater, 62781
- Springfield Memorial Hospital
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Warrenville, Illinois, Forenede Stater, 60555
- Northwestern Medicine Cancer Center Warrenville
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Washington, Illinois, Forenede Stater, 61571
- Illinois CancerCare - Washington
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46202
- Indiana University/Melvin and Bren Simon Cancer Center
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Kansas
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El Dorado, Kansas, Forenede Stater, 67042
- Cancer Center of Kansas - El Dorado
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Lawrence, Kansas, Forenede Stater, 66044
- Lawrence Memorial Hospital
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Newton, Kansas, Forenede Stater, 67114
- Cancer Center of Kansas - Newton
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Olathe, Kansas, Forenede Stater, 66061
- The University of Kansas Cancer Center - Olathe
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Salina, Kansas, Forenede Stater, 67401
- Salina Regional Health Center
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Topeka, Kansas, Forenede Stater, 66606
- University of Kansas Health System Saint Francis Campus
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Wellington, Kansas, Forenede Stater, 67152
- Cancer Center of Kansas - Wellington
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Wichita, Kansas, Forenede Stater, 67214
- Ascension Via Christi Hospitals Wichita
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Wichita, Kansas, Forenede Stater, 67208
- Cancer Center of Kansas-Wichita Medical Arts Tower
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Wichita, Kansas, Forenede Stater, 67214
- Cancer Center of Kansas - Wichita
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Winfield, Kansas, Forenede Stater, 67156
- Cancer Center of Kansas - Winfield
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Maryland
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Baltimore, Maryland, Forenede Stater, 21201
- University of Maryland/Greenebaum Cancer Center
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Glen Burnie, Maryland, Forenede Stater, 21061
- UM Baltimore Washington Medical Center/Tate Cancer Center
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Massachusetts
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Beverly, Massachusetts, Forenede Stater, 01915
- Beverly Hospital
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Burlington, Massachusetts, Forenede Stater, 01805
- Lahey Clinic
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Gloucester, Massachusetts, Forenede Stater, 01930
- Addison Gilbert Hospital
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Peabody, Massachusetts, Forenede Stater, 01960
- Lahey Clinic Peabody
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Springfield, Massachusetts, Forenede Stater, 01199
- Baystate Medical Center
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Michigan
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Battle Creek, Michigan, Forenede Stater, 49017
- Bronson Battle Creek
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Brighton, Michigan, Forenede Stater, 48114
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
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Canton, Michigan, Forenede Stater, 48188
- Trinity Health IHA Medical Group Hematology Oncology - Canton
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Chelsea, Michigan, Forenede Stater, 48118
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
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Flint, Michigan, Forenede Stater, 48503
- Hurley Medical Center
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Flint, Michigan, Forenede Stater, 48503
- Genesee Hematology Oncology PC
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Flint, Michigan, Forenede Stater, 48503
- Genesys Hurley Cancer Institute
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Flint, Michigan, Forenede Stater, 48503
- Cancer Hematology Centers - Flint
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Grand Rapids, Michigan, Forenede Stater, 49503
- Trinity Health Grand Rapids Hospital
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Grand Rapids, Michigan, Forenede Stater, 49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Kalamazoo, Michigan, Forenede Stater, 49007
- West Michigan Cancer Center
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Kalamazoo, Michigan, Forenede Stater, 49007
- Bronson Methodist Hospital
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Lansing, Michigan, Forenede Stater, 48912
- University of Michigan Health - Sparrow Lansing
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Livonia, Michigan, Forenede Stater, 48154
- Trinity Health Saint Mary Mercy Livonia Hospital
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Muskegon, Michigan, Forenede Stater, 49444
- Trinity Health Muskegon Hospital
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Niles, Michigan, Forenede Stater, 49120
- Corewell Health Lakeland Hospitals - Niles Hospital
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Norton Shores, Michigan, Forenede Stater, 49444
- Cancer and Hematology Centers of Western Michigan - Norton Shores
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Pontiac, Michigan, Forenede Stater, 48341
- Trinity Health Saint Joseph Mercy Oakland Hospital
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Reed City, Michigan, Forenede Stater, 49677
- Corewell Health Reed City Hospital
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Saint Joseph, Michigan, Forenede Stater, 49085
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
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Saint Joseph, Michigan, Forenede Stater, 49085
- Corewell Health Lakeland Hospitals - Saint Joseph Hospital
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Traverse City, Michigan, Forenede Stater, 49684
- Munson Medical Center
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Wyoming, Michigan, Forenede Stater, 49519
- University of Michigan Health - West
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Ypsilanti, Michigan, Forenede Stater, 48197
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
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Minnesota
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Brainerd, Minnesota, Forenede Stater, 56401
- Essentia Health Saint Joseph's Medical Center
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Coon Rapids, Minnesota, Forenede Stater, 55433
- Mercy Hospital
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Deer River, Minnesota, Forenede Stater, 56636
- Essentia Health - Deer River Clinic
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Duluth, Minnesota, Forenede Stater, 55805
- Essentia Health Cancer Center
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Edina, Minnesota, Forenede Stater, 55435
- Fairview Southdale Hospital
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Hibbing, Minnesota, Forenede Stater, 55746
- Essentia Health Hibbing Clinic
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Minneapolis, Minnesota, Forenede Stater, 55407
- Abbott-Northwestern Hospital
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Minneapolis, Minnesota, Forenede Stater, 55417
- Minneapolis VA Medical Center
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Saint Louis Park, Minnesota, Forenede Stater, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Paul, Minnesota, Forenede Stater, 55101
- Regions Hospital
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Saint Paul, Minnesota, Forenede Stater, 55102
- United Hospital
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Sandstone, Minnesota, Forenede Stater, 55072
- Essentia Health Sandstone
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Virginia, Minnesota, Forenede Stater, 55792
- Essentia Health Virginia Clinic
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Mississippi
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Columbus, Mississippi, Forenede Stater, 39705
- Baptist Memorial Hospital and Cancer Center-Golden Triangle
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Grenada, Mississippi, Forenede Stater, 38901
- Baptist Cancer Center-Grenada
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New Albany, Mississippi, Forenede Stater, 38652
- Baptist Memorial Hospital and Cancer Center-Union County
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Oxford, Mississippi, Forenede Stater, 38655
- Baptist Memorial Hospital and Cancer Center-Oxford
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Southhaven, Mississippi, Forenede Stater, 38671
- Baptist Memorial Hospital and Cancer Center-Desoto
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Missouri
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Cape Girardeau, Missouri, Forenede Stater, 63703
- Saint Francis Medical Center
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Farmington, Missouri, Forenede Stater, 63640
- Parkland Health Center - Farmington
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Sainte Genevieve, Missouri, Forenede Stater, 63670
- Sainte Genevieve County Memorial Hospital
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St Louis, Missouri, Forenede Stater, 63131
- Missouri Baptist Medical Center
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St Louis, Missouri, Forenede Stater, 63128
- Mercy Hospital South
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Sullivan, Missouri, Forenede Stater, 63080
- Missouri Baptist Sullivan Hospital
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Montana
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Anaconda, Montana, Forenede Stater, 59711
- Community Hospital of Anaconda
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Billings, Montana, Forenede Stater, 59101
- Billings Clinic Cancer Center
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Billings, Montana, Forenede Stater, 59102
- Saint Vincent Frontier Cancer Center
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Bozeman, Montana, Forenede Stater, 59715
- Bozeman Health Deaconess Hospital
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Great Falls, Montana, Forenede Stater, 59405
- Benefis Sletten Cancer Institute
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Missoula, Montana, Forenede Stater, 59804
- Community Medical Center
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New Hampshire
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Concord, New Hampshire, Forenede Stater, 03301
- New Hampshire Oncology Hematology PA-Concord
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Manchester, New Hampshire, Forenede Stater, 03103
- Solinsky Center for Cancer Care
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New Jersey
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Flemington, New Jersey, Forenede Stater, 08822
- Hunterdon Medical Center
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New York
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Glens Falls, New York, Forenede Stater, 12801
- Glens Falls Hospital
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The Bronx, New York, Forenede Stater, 10461
- Montefiore Medical Center-Einstein Campus
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North Carolina
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Pinehurst, North Carolina, Forenede Stater, 28374
- FirstHealth of the Carolinas-Moore Regional Hospital
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North Dakota
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Fargo, North Dakota, Forenede Stater, 58103
- Essentia Health Cancer Center-South University Clinic
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Ohio
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Canton, Ohio, Forenede Stater, 44710
- Aultman Health Foundation
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Columbus, Ohio, Forenede Stater, 43210
- Ohio State University Comprehensive Cancer Center
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- University of Oklahoma Health Sciences Center
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Oregon
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Newberg, Oregon, Forenede Stater, 97132
- Providence Newberg Medical Center
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Oregon City, Oregon, Forenede Stater, 97045
- Providence Willamette Falls Medical Center
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Portland, Oregon, Forenede Stater, 97239
- Oregon Health and Science University
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Portland, Oregon, Forenede Stater, 97213
- Providence Portland Medical Center
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Portland, Oregon, Forenede Stater, 97225
- Providence Saint Vincent Medical Center
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Pennsylvania
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Allentown, Pennsylvania, Forenede Stater, 18103
- Lehigh Valley Hospital-Cedar Crest
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Bethlehem, Pennsylvania, Forenede Stater, 18017
- Lehigh Valley Hospital - Muhlenberg
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Bryn Mawr, Pennsylvania, Forenede Stater, 19010
- Bryn Mawr Hospital
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East Stroudsburg, Pennsylvania, Forenede Stater, 18301
- Pocono Medical Center
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Erie, Pennsylvania, Forenede Stater, 16505
- UPMC Hillman Cancer Center Erie
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Greensburg, Pennsylvania, Forenede Stater, 15601
- UPMC Cancer Centers - Arnold Palmer Pavilion
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Harrisburg, Pennsylvania, Forenede Stater, 17109
- UPMC Pinnacle Cancer Center/Community Osteopathic Campus
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Hazleton, Pennsylvania, Forenede Stater, 18201
- Lehigh Valley Hospital-Hazleton
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Mechanicsburg, Pennsylvania, Forenede Stater, 17050
- UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
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Media, Pennsylvania, Forenede Stater, 19063
- Riddle Memorial Hospital
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Monroeville, Pennsylvania, Forenede Stater, 15146
- UPMC Hillman Cancer Center - Monroeville
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Paoli, Pennsylvania, Forenede Stater, 19301
- Paoli Memorial Hospital
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- University of Pennsylvania/Abramson Cancer Center
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Pittsburgh, Pennsylvania, Forenede Stater, 15232
- UPMC Hillman Cancer Center
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Pittsburgh, Pennsylvania, Forenede Stater, 15243
- UPMC-Saint Clair Hospital Cancer Center
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West Reading, Pennsylvania, Forenede Stater, 19611
- Reading Hospital
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Wynnewood, Pennsylvania, Forenede Stater, 19096
- Lankenau Medical Center
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South Carolina
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Georgetown, South Carolina, Forenede Stater, 29440
- Tidelands Georgetown Memorial Hospital
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Tennessee
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Collierville, Tennessee, Forenede Stater, 38017
- Baptist Memorial Hospital and Cancer Center-Collierville
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Memphis, Tennessee, Forenede Stater, 38120
- Baptist Memorial Hospital and Cancer Center-Memphis
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Nashville, Tennessee, Forenede Stater, 37232
- Vanderbilt University/Ingram Cancer Center
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22908
- University of Virginia Cancer Center
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Fredericksburg, Virginia, Forenede Stater, 22408
- Hematology Oncology Associates of Fredericksburg Inc
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Richmond, Virginia, Forenede Stater, 23235
- VCU Massey Cancer Center at Stony Point
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Richmond, Virginia, Forenede Stater, 23229
- Virginia Cancer Institute
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Richmond, Virginia, Forenede Stater, 23298
- VCU Massey Comprehensive Cancer Center
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South Hill, Virginia, Forenede Stater, 23970
- VCU Community Memorial Health Center
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West Virginia
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Huntington, West Virginia, Forenede Stater, 25701
- Edwards Comprehensive Cancer Center
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Morgantown, West Virginia, Forenede Stater, 26506
- West Virginia University Healthcare
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Parkersburg, West Virginia, Forenede Stater, 26101
- Camden Clark Medical Center
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Wisconsin
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Antigo, Wisconsin, Forenede Stater, 54409
- Aspirus Cancer Care-Antigo-Volm Cancer Center
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Appleton, Wisconsin, Forenede Stater, 54911
- ThedaCare Regional Cancer Center
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Ashland, Wisconsin, Forenede Stater, 54806
- Duluth Clinic Ashland
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Hayward, Wisconsin, Forenede Stater, 54843
- Essentia Health-Hayward Clinic
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La Crosse, Wisconsin, Forenede Stater, 54601
- Gundersen Lutheran Medical Center
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Medford, Wisconsin, Forenede Stater, 54451
- Aspirus Medford Hospital
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Mukwonago, Wisconsin, Forenede Stater, 53149
- ProHealth D N Greenwald Center
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Oconomowoc, Wisconsin, Forenede Stater, 53066
- ProHealth Oconomowoc Memorial Hospital
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Rhinelander, Wisconsin, Forenede Stater, 54501
- Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
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Spooner, Wisconsin, Forenede Stater, 54801
- Essentia Health-Spooner Clinic
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Stevens Point, Wisconsin, Forenede Stater, 54481
- Aspirus Cancer Care - Stevens Point
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Superior, Wisconsin, Forenede Stater, 54880
- Essentia Health Saint Mary's Hospital - Superior
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Waukesha, Wisconsin, Forenede Stater, 53188
- UW Cancer Center at ProHealth Care
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Wausau, Wisconsin, Forenede Stater, 54401
- Aspirus Cancer Care-Wausau
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Wisconsin Rapids, Wisconsin, Forenede Stater, 54494
- Aspirus Cancer Care - Wisconsin Rapids
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
-
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
-
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Antal våben
2
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / 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
Andre navne:
Undergo CT scan
Andre navne:
Undergo echocardiography
Andre navne:
Given IV
Andre navne:
|
|
Eksperimentel: 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
Andre navne:
Undergo CT scan
Andre navne:
Undergo echocardiography
Andre navne:
Given IV
Andre navne:
Given PO
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Disease free survival (DFS)
Tidsramme: 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
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall survival (OS)
Tidsramme: 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
Tidsramme: Up to 10 years
|
Toxicity will be assessed by summaries by Common Terminology Criteria for Adverse Event grade. |
Up to 10 years
|
Andre resultatmål
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Korrelative analyser på vævs-, blod- og afføringsbioprøver
Tidsramme: Op til 10 år
|
Op til 10 år
|
|
|
Estimates of treatment effect by sex
Tidsramme: 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
Tidsramme: Up to 10 years
|
Estimates of DFS and the corresponding 95% CIs by race. |
Up to 10 years
|
|
Estimates of treatment effect by ethnicity
Tidsramme: Up to 10 years
|
Estimates of DFS and the corresponding 95% CIs by ethnicity. |
Up to 10 years
|
|
DFS according to PD-L1 status
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 10 years
|
Will be compared between treatment arms using the logrank test and Cox modeling. |
Up to 10 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Efterforskere
Efterforskere
- Ledende efterforsker: Dwight H Owen, ECOG-ACRIN Cancer Research Group
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
Studiestart
7. august 2025
Primær færdiggørelse (Anslået)
Primær færdiggørelse
30. juni 2028
Studieafslutning (Anslået)
Studieafslutning
30. juni 2028
Datoer for studieregistrering
Først indsendt
Først indsendt
12. december 2024
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
12. december 2024
Først opslået (Faktiske)
Først opslået
13. december 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
21. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. september 2026
Sidst verificeret
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter sted
- Neoplasmer
- Luftvejssygdomme
- Lungesygdomme
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karcinom, ikke-småcellet lunge
- Aminosyrer, peptider og proteiner
- Proteiner
- Svovlforbindelser
- Organiske kemikalier
- Undersøgelsesteknikker
- Kliniske laboratorieteknikker
- Diagnostiske teknikker og procedurer
- Diagnose
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serum globuliner
- Globuliner
- Uorganiske kemikalier
- Immunoglobulin -isotyper
- Sulfider
- Anioner
- Ioner
- Elektrolytter
- Hydrogensulfid
- Immunoglobulin G
- Håndtering af eksemplar
- Ceralasertib
- Durvalumab
- Disulfider
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- NCI-2024-10081
- U10CA180820 (U.S. NIH-bevilling/kontrakt)
- NCI-2024-10081 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- EA5231 (Anden identifikator: CTEP)
- EA5231 (Anden identifikator: ECOG-ACRIN Cancer Research Group)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .