Prueba de la adición de AZD6738 (Ceralasertib) a la inmunoterapia para aumentar el tiempo sin cáncer en pacientes con cáncer de pulmón de células no pequeñas
18 de septiembre de 2026 actualizado por: National Cancer Institute (NCI)
Un ensayo aleatorizado de fase III de bloqueo de puntos de control en pacientes con cáncer de pulmón en el entorno adyuvante basado en la respuesta patológica después de la terapia neoadyuvante (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.
Descripción general del estudio
Estado
Activo, no reclutando
Condiciones
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
630
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Arkansas
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Jonesboro, Arkansas, Estados Unidos, 72401
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
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California
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Beverly Hills, California, Estados Unidos, 90211
- Tower Cancer Research Foundation
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Los Angeles, California, Estados Unidos, 90048
- Cedars-Sinai Medical Center
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Tarzana, California, Estados Unidos, 91356
- Cedars-Sinai Cancer - Tarzana
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Torrance, California, Estados Unidos, 90505
- Torrance Memorial Physician Network - Cancer Care
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Connecticut
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Hartford, Connecticut, Estados Unidos, 06102
- Hartford Hospital
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Meriden, Connecticut, Estados Unidos, 06451
- Midstate Medical Center
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New Britain, Connecticut, Estados Unidos, 06050
- The Hospital of Central Connecticut
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Delaware
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Millville, Delaware, Estados Unidos, 19967
- Beebe South Coastal Health Campus
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Newark, Delaware, Estados Unidos, 19713
- Helen F Graham Cancer Center
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Newark, Delaware, Estados Unidos, 19713
- Medical Oncology Hematology Consultants PA
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Rehoboth Beach, Delaware, Estados Unidos, 19971
- Beebe Health Campus
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District of Columbia
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Washington D.C., District of Columbia, Estados Unidos, 20010
- MedStar Washington Hospital Center
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Washington D.C., District of Columbia, Estados Unidos, 20007
- MedStar Georgetown University Hospital
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Georgia
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Atlanta, Georgia, Estados Unidos, 30308
- Emory University Hospital Midtown
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Atlanta, Georgia, Estados Unidos, 30322
- Emory University Hospital/Winship Cancer Institute
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Atlanta, Georgia, Estados Unidos, 30342
- Emory Saint Joseph's Hospital
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Decatur, Georgia, Estados Unidos, 30033
- Emory Decatur Hospital
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Johns Creek, Georgia, Estados Unidos, 30097
- Emory Johns Creek Hospital
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Idaho
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Boise, Idaho, Estados Unidos, 83712
- Saint Luke's Cancer Institute - Boise
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Coeur d'Alene, Idaho, Estados Unidos, 83814
- Kootenai Health - Coeur d'Alene
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Fruitland, Idaho, Estados Unidos, 83619
- Saint Luke's Cancer Institute - Fruitland
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Meridian, Idaho, Estados Unidos, 83642
- Saint Luke's Cancer Institute - Meridian
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Nampa, Idaho, Estados Unidos, 83687
- Saint Alphonsus Cancer Care Center-Nampa
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Nampa, Idaho, Estados Unidos, 83687
- Saint Luke's Cancer Institute - Nampa
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Post Falls, Idaho, Estados Unidos, 83854
- Kootenai Clinic Cancer Services - Post Falls
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Sandpoint, Idaho, Estados Unidos, 83864
- Kootenai Clinic Cancer Services - Sandpoint
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Illinois
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Bloomington, Illinois, Estados Unidos, 61704
- Illinois CancerCare-Bloomington
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Canton, Illinois, Estados Unidos, 61520
- Illinois CancerCare-Canton
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Carthage, Illinois, Estados Unidos, 62321
- Illinois CancerCare-Carthage
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern University
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DeKalb, Illinois, Estados Unidos, 60115
- Northwestern Medicine Cancer Center Kishwaukee
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Decatur, Illinois, Estados Unidos, 62526
- Decatur Memorial Hospital
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Decatur, Illinois, Estados Unidos, 62526
- Cancer Care Specialists of Illinois - Decatur
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Dixon, Illinois, Estados Unidos, 61021
- Illinois CancerCare-Dixon
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Effingham, Illinois, Estados Unidos, 62401
- Crossroads Cancer Center
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Eureka, Illinois, Estados Unidos, 61530
- Illinois CancerCare-Eureka
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Galesburg, Illinois, Estados Unidos, 61401
- Illinois CancerCare-Galesburg
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Geneva, Illinois, Estados Unidos, 60134
- Northwestern Medicine Cancer Center Delnor
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Glenview, Illinois, Estados Unidos, 60026
- Northwestern Medicine Glenview Outpatient Center
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Grayslake, Illinois, Estados Unidos, 60030
- Northwestern Medicine Grayslake Outpatient Center
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Kewanee, Illinois, Estados Unidos, 61443
- Illinois CancerCare-Kewanee Clinic
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Lake Forest, Illinois, Estados Unidos, 60045
- Northwestern Medicine Lake Forest Hospital
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Macomb, Illinois, Estados Unidos, 61455
- Illinois CancerCare-Macomb
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Maywood, Illinois, Estados Unidos, 60153
- Loyola University Medical Center
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O'Fallon, Illinois, Estados Unidos, 62269
- Cancer Care Center of O'Fallon
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O'Fallon, Illinois, Estados Unidos, 62269
- HSHS Saint Elizabeth's Hospital
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Oak Brook, Illinois, Estados Unidos, 60523
- Northwestern Medicine Oak Brook
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Orland Park, Illinois, Estados Unidos, 60462
- Northwestern Medicine Orland Park
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Ottawa, Illinois, Estados Unidos, 61350
- Illinois CancerCare-Ottawa Clinic
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Pekin, Illinois, Estados Unidos, 61554
- Illinois CancerCare-Pekin
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Peoria, Illinois, Estados Unidos, 61615
- Illinois CancerCare-Peoria
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Peru, Illinois, Estados Unidos, 61354
- Illinois CancerCare-Peru
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Princeton, Illinois, Estados Unidos, 61356
- Illinois CancerCare-Princeton
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Springfield, Illinois, Estados Unidos, 62702
- Southern Illinois University School of Medicine
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Springfield, Illinois, Estados Unidos, 62702
- Springfield Clinic
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Springfield, Illinois, Estados Unidos, 62781
- Springfield Memorial Hospital
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Warrenville, Illinois, Estados Unidos, 60555
- Northwestern Medicine Cancer Center Warrenville
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Washington, Illinois, Estados Unidos, 61571
- Illinois CancerCare - Washington
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Indiana University/Melvin and Bren Simon Cancer Center
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Kansas
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El Dorado, Kansas, Estados Unidos, 67042
- Cancer Center of Kansas - El Dorado
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Lawrence, Kansas, Estados Unidos, 66044
- Lawrence Memorial Hospital
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Newton, Kansas, Estados Unidos, 67114
- Cancer Center of Kansas - Newton
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Olathe, Kansas, Estados Unidos, 66061
- The University of Kansas Cancer Center - Olathe
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Salina, Kansas, Estados Unidos, 67401
- Salina Regional Health Center
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Topeka, Kansas, Estados Unidos, 66606
- University of Kansas Health System Saint Francis Campus
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Wellington, Kansas, Estados Unidos, 67152
- Cancer Center of Kansas - Wellington
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Wichita, Kansas, Estados Unidos, 67214
- Ascension Via Christi Hospitals Wichita
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Wichita, Kansas, Estados Unidos, 67208
- Cancer Center of Kansas-Wichita Medical Arts Tower
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Wichita, Kansas, Estados Unidos, 67214
- Cancer Center of Kansas - Wichita
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Winfield, Kansas, Estados Unidos, 67156
- Cancer Center of Kansas - Winfield
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Maryland
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Baltimore, Maryland, Estados Unidos, 21201
- University of Maryland/Greenebaum Cancer Center
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Glen Burnie, Maryland, Estados Unidos, 21061
- UM Baltimore Washington Medical Center/Tate Cancer Center
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Massachusetts
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Beverly, Massachusetts, Estados Unidos, 01915
- Beverly Hospital
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Burlington, Massachusetts, Estados Unidos, 01805
- Lahey Clinic
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Gloucester, Massachusetts, Estados Unidos, 01930
- Addison Gilbert Hospital
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Peabody, Massachusetts, Estados Unidos, 01960
- Lahey Clinic Peabody
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Springfield, Massachusetts, Estados Unidos, 01199
- Baystate Medical Center
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Michigan
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Battle Creek, Michigan, Estados Unidos, 49017
- Bronson Battle Creek
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Brighton, Michigan, Estados Unidos, 48114
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
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Canton, Michigan, Estados Unidos, 48188
- Trinity Health IHA Medical Group Hematology Oncology - Canton
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Chelsea, Michigan, Estados Unidos, 48118
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
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Flint, Michigan, Estados Unidos, 48503
- Hurley Medical Center
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Flint, Michigan, Estados Unidos, 48503
- Genesee Hematology Oncology PC
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Flint, Michigan, Estados Unidos, 48503
- Genesys Hurley Cancer Institute
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Flint, Michigan, Estados Unidos, 48503
- Cancer Hematology Centers - Flint
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Grand Rapids, Michigan, Estados Unidos, 49503
- Trinity Health Grand Rapids Hospital
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Grand Rapids, Michigan, Estados Unidos, 49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Kalamazoo, Michigan, Estados Unidos, 49007
- West Michigan Cancer Center
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Kalamazoo, Michigan, Estados Unidos, 49007
- Bronson Methodist Hospital
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Lansing, Michigan, Estados Unidos, 48912
- University of Michigan Health - Sparrow Lansing
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Livonia, Michigan, Estados Unidos, 48154
- Trinity Health Saint Mary Mercy Livonia Hospital
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Muskegon, Michigan, Estados Unidos, 49444
- Trinity Health Muskegon Hospital
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Niles, Michigan, Estados Unidos, 49120
- Corewell Health Lakeland Hospitals - Niles Hospital
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Norton Shores, Michigan, Estados Unidos, 49444
- Cancer and Hematology Centers of Western Michigan - Norton Shores
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Pontiac, Michigan, Estados Unidos, 48341
- Trinity Health Saint Joseph Mercy Oakland Hospital
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Reed City, Michigan, Estados Unidos, 49677
- Corewell Health Reed City Hospital
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Saint Joseph, Michigan, Estados Unidos, 49085
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
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Saint Joseph, Michigan, Estados Unidos, 49085
- Corewell Health Lakeland Hospitals - Saint Joseph Hospital
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Traverse City, Michigan, Estados Unidos, 49684
- Munson Medical Center
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Wyoming, Michigan, Estados Unidos, 49519
- University of Michigan Health - West
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Ypsilanti, Michigan, Estados Unidos, 48197
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
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Minnesota
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Brainerd, Minnesota, Estados Unidos, 56401
- Essentia Health Saint Joseph's Medical Center
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Coon Rapids, Minnesota, Estados Unidos, 55433
- Mercy Hospital
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Deer River, Minnesota, Estados Unidos, 56636
- Essentia Health - Deer River Clinic
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Duluth, Minnesota, Estados Unidos, 55805
- Essentia Health Cancer Center
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Edina, Minnesota, Estados Unidos, 55435
- Fairview Southdale Hospital
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Hibbing, Minnesota, Estados Unidos, 55746
- Essentia Health Hibbing Clinic
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Minneapolis, Minnesota, Estados Unidos, 55407
- Abbott-Northwestern Hospital
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Minneapolis, Minnesota, Estados Unidos, 55417
- Minneapolis VA Medical Center
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Saint Louis Park, Minnesota, Estados Unidos, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Paul, Minnesota, Estados Unidos, 55101
- Regions Hospital
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Saint Paul, Minnesota, Estados Unidos, 55102
- United Hospital
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Sandstone, Minnesota, Estados Unidos, 55072
- Essentia Health Sandstone
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Virginia, Minnesota, Estados Unidos, 55792
- Essentia Health Virginia Clinic
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Mississippi
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Columbus, Mississippi, Estados Unidos, 39705
- Baptist Memorial Hospital and Cancer Center-Golden Triangle
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Grenada, Mississippi, Estados Unidos, 38901
- Baptist Cancer Center-Grenada
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New Albany, Mississippi, Estados Unidos, 38652
- Baptist Memorial Hospital and Cancer Center-Union County
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Oxford, Mississippi, Estados Unidos, 38655
- Baptist Memorial Hospital and Cancer Center-Oxford
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Southhaven, Mississippi, Estados Unidos, 38671
- Baptist Memorial Hospital and Cancer Center-Desoto
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Missouri
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Cape Girardeau, Missouri, Estados Unidos, 63703
- Saint Francis Medical Center
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Farmington, Missouri, Estados Unidos, 63640
- Parkland Health Center - Farmington
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Sainte Genevieve, Missouri, Estados Unidos, 63670
- Sainte Genevieve County Memorial Hospital
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St Louis, Missouri, Estados Unidos, 63131
- Missouri Baptist Medical Center
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St Louis, Missouri, Estados Unidos, 63128
- Mercy Hospital South
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Sullivan, Missouri, Estados Unidos, 63080
- Missouri Baptist Sullivan Hospital
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Montana
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Anaconda, Montana, Estados Unidos, 59711
- Community Hospital of Anaconda
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Billings, Montana, Estados Unidos, 59101
- Billings Clinic Cancer Center
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Billings, Montana, Estados Unidos, 59102
- Saint Vincent Frontier Cancer Center
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Bozeman, Montana, Estados Unidos, 59715
- Bozeman Health Deaconess Hospital
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Great Falls, Montana, Estados Unidos, 59405
- Benefis Sletten Cancer Institute
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Missoula, Montana, Estados Unidos, 59804
- Community Medical Center
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New Hampshire
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Concord, New Hampshire, Estados Unidos, 03301
- New Hampshire Oncology Hematology PA-Concord
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Manchester, New Hampshire, Estados Unidos, 03103
- Solinsky Center for Cancer Care
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New Jersey
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Flemington, New Jersey, Estados Unidos, 08822
- Hunterdon Medical Center
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New York
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Glens Falls, New York, Estados Unidos, 12801
- Glens Falls Hospital
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The Bronx, New York, Estados Unidos, 10461
- Montefiore Medical Center-Einstein Campus
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North Carolina
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Pinehurst, North Carolina, Estados Unidos, 28374
- FirstHealth of the Carolinas-Moore Regional Hospital
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North Dakota
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Fargo, North Dakota, Estados Unidos, 58103
- Essentia Health Cancer Center-South University Clinic
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Ohio
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Canton, Ohio, Estados Unidos, 44710
- Aultman Health Foundation
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Columbus, Ohio, Estados Unidos, 43210
- Ohio State University Comprehensive Cancer Center
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73104
- University of Oklahoma Health Sciences Center
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Oregon
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Newberg, Oregon, Estados Unidos, 97132
- Providence Newberg Medical Center
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Oregon City, Oregon, Estados Unidos, 97045
- Providence Willamette Falls Medical Center
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Portland, Oregon, Estados Unidos, 97239
- Oregon Health and Science University
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Portland, Oregon, Estados Unidos, 97213
- Providence Portland Medical Center
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Portland, Oregon, Estados Unidos, 97225
- Providence Saint Vincent Medical Center
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Pennsylvania
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Allentown, Pennsylvania, Estados Unidos, 18103
- Lehigh Valley Hospital-Cedar Crest
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Bethlehem, Pennsylvania, Estados Unidos, 18017
- Lehigh Valley Hospital - Muhlenberg
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Bryn Mawr, Pennsylvania, Estados Unidos, 19010
- Bryn Mawr Hospital
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East Stroudsburg, Pennsylvania, Estados Unidos, 18301
- Pocono Medical Center
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Erie, Pennsylvania, Estados Unidos, 16505
- UPMC Hillman Cancer Center Erie
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Greensburg, Pennsylvania, Estados Unidos, 15601
- UPMC Cancer Centers - Arnold Palmer Pavilion
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Harrisburg, Pennsylvania, Estados Unidos, 17109
- UPMC Pinnacle Cancer Center/Community Osteopathic Campus
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Hazleton, Pennsylvania, Estados Unidos, 18201
- Lehigh Valley Hospital-Hazleton
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Mechanicsburg, Pennsylvania, Estados Unidos, 17050
- UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
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Media, Pennsylvania, Estados Unidos, 19063
- Riddle Memorial Hospital
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Monroeville, Pennsylvania, Estados Unidos, 15146
- UPMC Hillman Cancer Center - Monroeville
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Paoli, Pennsylvania, Estados Unidos, 19301
- Paoli Memorial Hospital
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- University of Pennsylvania/Abramson Cancer Center
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Pittsburgh, Pennsylvania, Estados Unidos, 15232
- UPMC Hillman Cancer Center
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Pittsburgh, Pennsylvania, Estados Unidos, 15243
- UPMC-Saint Clair Hospital Cancer Center
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West Reading, Pennsylvania, Estados Unidos, 19611
- Reading Hospital
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Wynnewood, Pennsylvania, Estados Unidos, 19096
- Lankenau Medical Center
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South Carolina
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Georgetown, South Carolina, Estados Unidos, 29440
- Tidelands Georgetown Memorial Hospital
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Tennessee
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Collierville, Tennessee, Estados Unidos, 38017
- Baptist Memorial Hospital and Cancer Center-Collierville
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Memphis, Tennessee, Estados Unidos, 38120
- Baptist Memorial Hospital and Cancer Center-Memphis
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Nashville, Tennessee, Estados Unidos, 37232
- Vanderbilt University/Ingram Cancer Center
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22908
- University of Virginia Cancer Center
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Fredericksburg, Virginia, Estados Unidos, 22408
- Hematology Oncology Associates of Fredericksburg Inc
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Richmond, Virginia, Estados Unidos, 23235
- VCU Massey Cancer Center at Stony Point
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Richmond, Virginia, Estados Unidos, 23229
- Virginia Cancer Institute
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Richmond, Virginia, Estados Unidos, 23298
- VCU Massey Comprehensive Cancer Center
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South Hill, Virginia, Estados Unidos, 23970
- VCU Community Memorial Health Center
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West Virginia
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Huntington, West Virginia, Estados Unidos, 25701
- Edwards Comprehensive Cancer Center
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Morgantown, West Virginia, Estados Unidos, 26506
- West Virginia University Healthcare
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Parkersburg, West Virginia, Estados Unidos, 26101
- Camden Clark Medical Center
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Wisconsin
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Antigo, Wisconsin, Estados Unidos, 54409
- Aspirus Cancer Care-Antigo-Volm Cancer Center
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Appleton, Wisconsin, Estados Unidos, 54911
- ThedaCare Regional Cancer Center
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Ashland, Wisconsin, Estados Unidos, 54806
- Duluth Clinic Ashland
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Hayward, Wisconsin, Estados Unidos, 54843
- Essentia Health-Hayward Clinic
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La Crosse, Wisconsin, Estados Unidos, 54601
- Gundersen Lutheran Medical Center
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Medford, Wisconsin, Estados Unidos, 54451
- Aspirus Medford Hospital
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Mukwonago, Wisconsin, Estados Unidos, 53149
- ProHealth D N Greenwald Center
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Oconomowoc, Wisconsin, Estados Unidos, 53066
- ProHealth Oconomowoc Memorial Hospital
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Rhinelander, Wisconsin, Estados Unidos, 54501
- Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
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Spooner, Wisconsin, Estados Unidos, 54801
- Essentia Health-Spooner Clinic
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Stevens Point, Wisconsin, Estados Unidos, 54481
- Aspirus Cancer Care - Stevens Point
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Superior, Wisconsin, Estados Unidos, 54880
- Essentia Health Saint Mary's Hospital - Superior
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Waukesha, Wisconsin, Estados Unidos, 53188
- UW Cancer Center at ProHealth Care
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Wausau, Wisconsin, Estados Unidos, 54401
- Aspirus Cancer Care-Wausau
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Wisconsin Rapids, Wisconsin, Estados Unidos, 54494
- Aspirus Cancer Care - Wisconsin Rapids
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
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STEP 0: Patient must be >= 18 years of age
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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:
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Patient must have completed at least 3 cycles of neoadjuvant chemo-immunotherapy before surgery in order to be eligible for Step 1 randomization.
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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:
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Has achieved menarche at some point
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Has not undergone a hysterectomy or bilateral oophorectomy
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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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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
Otros nombres:
Undergo CT scan
Otros nombres:
Undergo echocardiography
Otros nombres:
Given IV
Otros nombres:
|
|
Experimental: 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
Otros nombres:
Undergo CT scan
Otros nombres:
Undergo echocardiography
Otros nombres:
Given IV
Otros nombres:
Given PO
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Disease free survival (DFS)
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Overall survival (OS)
Periodo de tiempo: 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
Periodo de tiempo: Up to 10 years
|
Toxicity will be assessed by summaries by Common Terminology Criteria for Adverse Event grade. |
Up to 10 years
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Análisis correlativos de muestras biológicas de tejido, sangre y heces.
Periodo de tiempo: Hasta 10 años
|
Hasta 10 años
|
|
|
Estimates of treatment effect by sex
Periodo de tiempo: 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
Periodo de tiempo: Up to 10 years
|
Estimates of DFS and the corresponding 95% CIs by race. |
Up to 10 years
|
|
Estimates of treatment effect by ethnicity
Periodo de tiempo: Up to 10 years
|
Estimates of DFS and the corresponding 95% CIs by ethnicity. |
Up to 10 years
|
|
DFS according to PD-L1 status
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Up to 10 years
|
Will be compared between treatment arms using the logrank test and Cox modeling. |
Up to 10 years
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Dwight H Owen, ECOG-ACRIN Cancer Research Group
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
7 de agosto de 2025
Finalización primaria (Estimado)
30 de junio de 2028
Finalización del estudio (Estimado)
30 de junio de 2028
Fechas de registro del estudio
Enviado por primera vez
12 de diciembre de 2024
Primero enviado que cumplió con los criterios de control de calidad
12 de diciembre de 2024
Publicado por primera vez (Actual)
13 de diciembre de 2024
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
21 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
18 de septiembre de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Neoplasias Pulmonares
- Carcinoma de pulmón de células no pequeñas
- Aminoácidos, péptidos y proteínas
- Proteínas
- Compuestos de azufre
- Químicos orgánicos
- Técnicas de investigación
- Técnicas de laboratorio clínico
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Anticuerpos
- Inmunoglobulinas
- Inmunoproteínas
- Proteínas de la sangre
- Globulinas séricas
- Globulinas
- Químicos inorgánicos
- Isotipos de inmunoglobulina
- Sulfuros
- Aniones
- Iones
- Electrolitos
- Sulfuro de hidrógeno
- Inmunoglobulina G
- Manejo de muestras
- ceralestib
- durvalumab
- Disulfides
Otros números de identificación del estudio
- NCI-2024-10081
- U10CA180820 (Subvención/contrato del NIH de EE. UU.)
- NCI-2024-10081 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- EA5231 (Otro identificador: CTEP)
- EA5231 (Otro identificador: ECOG-ACRIN Cancer Research Group)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .