Testování přidání AZD6738 (Ceralasertib) k imunoterapii pro prodloužení doby bez rakoviny u pacientů s nemalobuněčným karcinomem plic
18. září 2026 aktualizováno: National Cancer Institute (NCI)
Randomizovaná studie fáze III blokády kontrolních bodů u pacientů s rakovinou plic v adjuvantním prostředí na základě patologické odpovědi po neoadjuvantní terapii (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.
Přehled studie
Postavení
Postavení
Aktivní, ne nábor
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
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.
Typ studie
Typ studie
Intervenční
Zápis (Odhadovaný)
Zápis
630
Fáze
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
Arkansas
-
Jonesboro, Arkansas, Spojené státy, 72401
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
-
-
California
-
Beverly Hills, California, Spojené státy, 90211
- Tower Cancer Research Foundation
-
Los Angeles, California, Spojené státy, 90048
- Cedars-Sinai Medical Center
-
Tarzana, California, Spojené státy, 91356
- Cedars-Sinai Cancer - Tarzana
-
Torrance, California, Spojené státy, 90505
- Torrance Memorial Physician Network - Cancer Care
-
-
Connecticut
-
Hartford, Connecticut, Spojené státy, 06102
- Hartford Hospital
-
Meriden, Connecticut, Spojené státy, 06451
- Midstate Medical Center
-
New Britain, Connecticut, Spojené státy, 06050
- The Hospital of Central Connecticut
-
-
Delaware
-
Millville, Delaware, Spojené státy, 19967
- Beebe South Coastal Health Campus
-
Newark, Delaware, Spojené státy, 19713
- Helen F Graham Cancer Center
-
Newark, Delaware, Spojené státy, 19713
- Medical Oncology Hematology Consultants PA
-
Rehoboth Beach, Delaware, Spojené státy, 19971
- Beebe Health Campus
-
-
District of Columbia
-
Washington D.C., District of Columbia, Spojené státy, 20010
- MedStar Washington Hospital Center
-
Washington D.C., District of Columbia, Spojené státy, 20007
- MedStar Georgetown University Hospital
-
-
Georgia
-
Atlanta, Georgia, Spojené státy, 30308
- Emory University Hospital Midtown
-
Atlanta, Georgia, Spojené státy, 30322
- Emory University Hospital/Winship Cancer Institute
-
Atlanta, Georgia, Spojené státy, 30342
- Emory Saint Joseph's Hospital
-
Decatur, Georgia, Spojené státy, 30033
- Emory Decatur Hospital
-
Johns Creek, Georgia, Spojené státy, 30097
- Emory Johns Creek Hospital
-
-
Idaho
-
Boise, Idaho, Spojené státy, 83712
- Saint Luke's Cancer Institute - Boise
-
Coeur d'Alene, Idaho, Spojené státy, 83814
- Kootenai Health - Coeur d'Alene
-
Fruitland, Idaho, Spojené státy, 83619
- Saint Luke's Cancer Institute - Fruitland
-
Meridian, Idaho, Spojené státy, 83642
- Saint Luke's Cancer Institute - Meridian
-
Nampa, Idaho, Spojené státy, 83687
- Saint Alphonsus Cancer Care Center-Nampa
-
Nampa, Idaho, Spojené státy, 83687
- Saint Luke's Cancer Institute - Nampa
-
Post Falls, Idaho, Spojené státy, 83854
- Kootenai Clinic Cancer Services - Post Falls
-
Sandpoint, Idaho, Spojené státy, 83864
- Kootenai Clinic Cancer Services - Sandpoint
-
-
Illinois
-
Bloomington, Illinois, Spojené státy, 61704
- Illinois CancerCare-Bloomington
-
Canton, Illinois, Spojené státy, 61520
- Illinois CancerCare-Canton
-
Carthage, Illinois, Spojené státy, 62321
- Illinois CancerCare-Carthage
-
Chicago, Illinois, Spojené státy, 60611
- Northwestern University
-
DeKalb, Illinois, Spojené státy, 60115
- Northwestern Medicine Cancer Center Kishwaukee
-
Decatur, Illinois, Spojené státy, 62526
- Decatur Memorial Hospital
-
Decatur, Illinois, Spojené státy, 62526
- Cancer Care Specialists of Illinois - Decatur
-
Dixon, Illinois, Spojené státy, 61021
- Illinois CancerCare-Dixon
-
Effingham, Illinois, Spojené státy, 62401
- Crossroads Cancer Center
-
Eureka, Illinois, Spojené státy, 61530
- Illinois CancerCare-Eureka
-
Galesburg, Illinois, Spojené státy, 61401
- Illinois CancerCare-Galesburg
-
Geneva, Illinois, Spojené státy, 60134
- Northwestern Medicine Cancer Center Delnor
-
Glenview, Illinois, Spojené státy, 60026
- Northwestern Medicine Glenview Outpatient Center
-
Grayslake, Illinois, Spojené státy, 60030
- Northwestern Medicine Grayslake Outpatient Center
-
Kewanee, Illinois, Spojené státy, 61443
- Illinois CancerCare-Kewanee Clinic
-
Lake Forest, Illinois, Spojené státy, 60045
- Northwestern Medicine Lake Forest Hospital
-
Macomb, Illinois, Spojené státy, 61455
- Illinois CancerCare-Macomb
-
Maywood, Illinois, Spojené státy, 60153
- Loyola University Medical Center
-
O'Fallon, Illinois, Spojené státy, 62269
- Cancer Care Center of O'Fallon
-
O'Fallon, Illinois, Spojené státy, 62269
- HSHS Saint Elizabeth's Hospital
-
Oak Brook, Illinois, Spojené státy, 60523
- Northwestern Medicine Oak Brook
-
Orland Park, Illinois, Spojené státy, 60462
- Northwestern Medicine Orland Park
-
Ottawa, Illinois, Spojené státy, 61350
- Illinois CancerCare-Ottawa Clinic
-
Pekin, Illinois, Spojené státy, 61554
- Illinois CancerCare-Pekin
-
Peoria, Illinois, Spojené státy, 61615
- Illinois CancerCare-Peoria
-
Peru, Illinois, Spojené státy, 61354
- Illinois CancerCare-Peru
-
Princeton, Illinois, Spojené státy, 61356
- Illinois CancerCare-Princeton
-
Springfield, Illinois, Spojené státy, 62702
- Southern Illinois University School of Medicine
-
Springfield, Illinois, Spojené státy, 62702
- Springfield Clinic
-
Springfield, Illinois, Spojené státy, 62781
- Springfield Memorial Hospital
-
Warrenville, Illinois, Spojené státy, 60555
- Northwestern Medicine Cancer Center Warrenville
-
Washington, Illinois, Spojené státy, 61571
- Illinois CancerCare - Washington
-
-
Indiana
-
Indianapolis, Indiana, Spojené státy, 46202
- Indiana University/Melvin and Bren Simon Cancer Center
-
-
Kansas
-
El Dorado, Kansas, Spojené státy, 67042
- Cancer Center of Kansas - El Dorado
-
Lawrence, Kansas, Spojené státy, 66044
- Lawrence Memorial Hospital
-
Newton, Kansas, Spojené státy, 67114
- Cancer Center of Kansas - Newton
-
Olathe, Kansas, Spojené státy, 66061
- The University of Kansas Cancer Center - Olathe
-
Salina, Kansas, Spojené státy, 67401
- Salina Regional Health Center
-
Topeka, Kansas, Spojené státy, 66606
- University of Kansas Health System Saint Francis Campus
-
Wellington, Kansas, Spojené státy, 67152
- Cancer Center of Kansas - Wellington
-
Wichita, Kansas, Spojené státy, 67214
- Ascension Via Christi Hospitals Wichita
-
Wichita, Kansas, Spojené státy, 67208
- Cancer Center of Kansas-Wichita Medical Arts Tower
-
Wichita, Kansas, Spojené státy, 67214
- Cancer Center of Kansas - Wichita
-
Winfield, Kansas, Spojené státy, 67156
- Cancer Center of Kansas - Winfield
-
-
Maryland
-
Baltimore, Maryland, Spojené státy, 21201
- University of Maryland/Greenebaum Cancer Center
-
Glen Burnie, Maryland, Spojené státy, 21061
- UM Baltimore Washington Medical Center/Tate Cancer Center
-
-
Massachusetts
-
Beverly, Massachusetts, Spojené státy, 01915
- Beverly Hospital
-
Burlington, Massachusetts, Spojené státy, 01805
- Lahey Clinic
-
Gloucester, Massachusetts, Spojené státy, 01930
- Addison Gilbert Hospital
-
Peabody, Massachusetts, Spojené státy, 01960
- Lahey Clinic Peabody
-
Springfield, Massachusetts, Spojené státy, 01199
- Baystate Medical Center
-
-
Michigan
-
Battle Creek, Michigan, Spojené státy, 49017
- Bronson Battle Creek
-
Brighton, Michigan, Spojené státy, 48114
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
-
Canton, Michigan, Spojené státy, 48188
- Trinity Health IHA Medical Group Hematology Oncology - Canton
-
Chelsea, Michigan, Spojené státy, 48118
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
-
Flint, Michigan, Spojené státy, 48503
- Hurley Medical Center
-
Flint, Michigan, Spojené státy, 48503
- Genesee Hematology Oncology PC
-
Flint, Michigan, Spojené státy, 48503
- Genesys Hurley Cancer Institute
-
Flint, Michigan, Spojené státy, 48503
- Cancer Hematology Centers - Flint
-
Grand Rapids, Michigan, Spojené státy, 49503
- Trinity Health Grand Rapids Hospital
-
Grand Rapids, Michigan, Spojené státy, 49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
-
Kalamazoo, Michigan, Spojené státy, 49007
- West Michigan Cancer Center
-
Kalamazoo, Michigan, Spojené státy, 49007
- Bronson Methodist Hospital
-
Lansing, Michigan, Spojené státy, 48912
- University of Michigan Health - Sparrow Lansing
-
Livonia, Michigan, Spojené státy, 48154
- Trinity Health Saint Mary Mercy Livonia Hospital
-
Muskegon, Michigan, Spojené státy, 49444
- Trinity Health Muskegon Hospital
-
Niles, Michigan, Spojené státy, 49120
- Corewell Health Lakeland Hospitals - Niles Hospital
-
Norton Shores, Michigan, Spojené státy, 49444
- Cancer and Hematology Centers of Western Michigan - Norton Shores
-
Pontiac, Michigan, Spojené státy, 48341
- Trinity Health Saint Joseph Mercy Oakland Hospital
-
Reed City, Michigan, Spojené státy, 49677
- Corewell Health Reed City Hospital
-
Saint Joseph, Michigan, Spojené státy, 49085
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
-
Saint Joseph, Michigan, Spojené státy, 49085
- Corewell Health Lakeland Hospitals - Saint Joseph Hospital
-
Traverse City, Michigan, Spojené státy, 49684
- Munson Medical Center
-
Wyoming, Michigan, Spojené státy, 49519
- University of Michigan Health - West
-
Ypsilanti, Michigan, Spojené státy, 48197
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
-
-
Minnesota
-
Brainerd, Minnesota, Spojené státy, 56401
- Essentia Health Saint Joseph's Medical Center
-
Coon Rapids, Minnesota, Spojené státy, 55433
- Mercy Hospital
-
Deer River, Minnesota, Spojené státy, 56636
- Essentia Health - Deer River Clinic
-
Duluth, Minnesota, Spojené státy, 55805
- Essentia Health Cancer Center
-
Edina, Minnesota, Spojené státy, 55435
- Fairview Southdale Hospital
-
Hibbing, Minnesota, Spojené státy, 55746
- Essentia Health Hibbing Clinic
-
Minneapolis, Minnesota, Spojené státy, 55407
- Abbott-Northwestern Hospital
-
Minneapolis, Minnesota, Spojené státy, 55417
- Minneapolis VA Medical Center
-
Saint Louis Park, Minnesota, Spojené státy, 55416
- Park Nicollet Clinic - Saint Louis Park
-
Saint Paul, Minnesota, Spojené státy, 55101
- Regions Hospital
-
Saint Paul, Minnesota, Spojené státy, 55102
- United Hospital
-
Sandstone, Minnesota, Spojené státy, 55072
- Essentia Health Sandstone
-
Virginia, Minnesota, Spojené státy, 55792
- Essentia Health Virginia Clinic
-
-
Mississippi
-
Columbus, Mississippi, Spojené státy, 39705
- Baptist Memorial Hospital and Cancer Center-Golden Triangle
-
Grenada, Mississippi, Spojené státy, 38901
- Baptist Cancer Center-Grenada
-
New Albany, Mississippi, Spojené státy, 38652
- Baptist Memorial Hospital and Cancer Center-Union County
-
Oxford, Mississippi, Spojené státy, 38655
- Baptist Memorial Hospital and Cancer Center-Oxford
-
Southhaven, Mississippi, Spojené státy, 38671
- Baptist Memorial Hospital and Cancer Center-Desoto
-
-
Missouri
-
Cape Girardeau, Missouri, Spojené státy, 63703
- Saint Francis Medical Center
-
Farmington, Missouri, Spojené státy, 63640
- Parkland Health Center - Farmington
-
Sainte Genevieve, Missouri, Spojené státy, 63670
- Sainte Genevieve County Memorial Hospital
-
St Louis, Missouri, Spojené státy, 63131
- Missouri Baptist Medical Center
-
St Louis, Missouri, Spojené státy, 63128
- Mercy Hospital South
-
Sullivan, Missouri, Spojené státy, 63080
- Missouri Baptist Sullivan Hospital
-
-
Montana
-
Anaconda, Montana, Spojené státy, 59711
- Community Hospital of Anaconda
-
Billings, Montana, Spojené státy, 59101
- Billings Clinic Cancer Center
-
Billings, Montana, Spojené státy, 59102
- Saint Vincent Frontier Cancer Center
-
Bozeman, Montana, Spojené státy, 59715
- Bozeman Health Deaconess Hospital
-
Great Falls, Montana, Spojené státy, 59405
- Benefis Sletten Cancer Institute
-
Missoula, Montana, Spojené státy, 59804
- Community Medical Center
-
-
New Hampshire
-
Concord, New Hampshire, Spojené státy, 03301
- New Hampshire Oncology Hematology PA-Concord
-
Manchester, New Hampshire, Spojené státy, 03103
- Solinsky Center for Cancer Care
-
-
New Jersey
-
Flemington, New Jersey, Spojené státy, 08822
- Hunterdon Medical Center
-
-
New York
-
Glens Falls, New York, Spojené státy, 12801
- Glens Falls Hospital
-
The Bronx, New York, Spojené státy, 10461
- Montefiore Medical Center-Einstein Campus
-
-
North Carolina
-
Pinehurst, North Carolina, Spojené státy, 28374
- FirstHealth of the Carolinas-Moore Regional Hospital
-
-
North Dakota
-
Fargo, North Dakota, Spojené státy, 58103
- Essentia Health Cancer Center-South University Clinic
-
-
Ohio
-
Canton, Ohio, Spojené státy, 44710
- Aultman Health Foundation
-
Columbus, Ohio, Spojené státy, 43210
- Ohio State University Comprehensive Cancer Center
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Spojené státy, 73104
- University of Oklahoma Health Sciences Center
-
-
Oregon
-
Newberg, Oregon, Spojené státy, 97132
- Providence Newberg Medical Center
-
Oregon City, Oregon, Spojené státy, 97045
- Providence Willamette Falls Medical Center
-
Portland, Oregon, Spojené státy, 97239
- Oregon Health and Science University
-
Portland, Oregon, Spojené státy, 97213
- Providence Portland Medical Center
-
Portland, Oregon, Spojené státy, 97225
- Providence Saint Vincent Medical Center
-
-
Pennsylvania
-
Allentown, Pennsylvania, Spojené státy, 18103
- Lehigh Valley Hospital-Cedar Crest
-
Bethlehem, Pennsylvania, Spojené státy, 18017
- Lehigh Valley Hospital - Muhlenberg
-
Bryn Mawr, Pennsylvania, Spojené státy, 19010
- Bryn Mawr Hospital
-
East Stroudsburg, Pennsylvania, Spojené státy, 18301
- Pocono Medical Center
-
Erie, Pennsylvania, Spojené státy, 16505
- UPMC Hillman Cancer Center Erie
-
Greensburg, Pennsylvania, Spojené státy, 15601
- UPMC Cancer Centers - Arnold Palmer Pavilion
-
Harrisburg, Pennsylvania, Spojené státy, 17109
- UPMC Pinnacle Cancer Center/Community Osteopathic Campus
-
Hazleton, Pennsylvania, Spojené státy, 18201
- Lehigh Valley Hospital-Hazleton
-
Mechanicsburg, Pennsylvania, Spojené státy, 17050
- UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
-
Media, Pennsylvania, Spojené státy, 19063
- Riddle Memorial Hospital
-
Monroeville, Pennsylvania, Spojené státy, 15146
- UPMC Hillman Cancer Center - Monroeville
-
Paoli, Pennsylvania, Spojené státy, 19301
- Paoli Memorial Hospital
-
Philadelphia, Pennsylvania, Spojené státy, 19104
- University of Pennsylvania/Abramson Cancer Center
-
Pittsburgh, Pennsylvania, Spojené státy, 15232
- UPMC Hillman Cancer Center
-
Pittsburgh, Pennsylvania, Spojené státy, 15243
- UPMC-Saint Clair Hospital Cancer Center
-
West Reading, Pennsylvania, Spojené státy, 19611
- Reading Hospital
-
Wynnewood, Pennsylvania, Spojené státy, 19096
- Lankenau Medical Center
-
-
South Carolina
-
Georgetown, South Carolina, Spojené státy, 29440
- Tidelands Georgetown Memorial Hospital
-
-
Tennessee
-
Collierville, Tennessee, Spojené státy, 38017
- Baptist Memorial Hospital and Cancer Center-Collierville
-
Memphis, Tennessee, Spojené státy, 38120
- Baptist Memorial Hospital and Cancer Center-Memphis
-
Nashville, Tennessee, Spojené státy, 37232
- Vanderbilt University/Ingram Cancer Center
-
-
Virginia
-
Charlottesville, Virginia, Spojené státy, 22908
- University of Virginia Cancer Center
-
Fredericksburg, Virginia, Spojené státy, 22408
- Hematology Oncology Associates of Fredericksburg Inc
-
Richmond, Virginia, Spojené státy, 23235
- VCU Massey Cancer Center at Stony Point
-
Richmond, Virginia, Spojené státy, 23229
- Virginia Cancer Institute
-
Richmond, Virginia, Spojené státy, 23298
- VCU Massey Comprehensive Cancer Center
-
South Hill, Virginia, Spojené státy, 23970
- VCU Community Memorial Health Center
-
-
West Virginia
-
Huntington, West Virginia, Spojené státy, 25701
- Edwards Comprehensive Cancer Center
-
Morgantown, West Virginia, Spojené státy, 26506
- West Virginia University Healthcare
-
Parkersburg, West Virginia, Spojené státy, 26101
- Camden Clark Medical Center
-
-
Wisconsin
-
Antigo, Wisconsin, Spojené státy, 54409
- Aspirus Cancer Care-Antigo-Volm Cancer Center
-
Appleton, Wisconsin, Spojené státy, 54911
- ThedaCare Regional Cancer Center
-
Ashland, Wisconsin, Spojené státy, 54806
- Duluth Clinic Ashland
-
Hayward, Wisconsin, Spojené státy, 54843
- Essentia Health-Hayward Clinic
-
La Crosse, Wisconsin, Spojené státy, 54601
- Gundersen Lutheran Medical Center
-
Medford, Wisconsin, Spojené státy, 54451
- Aspirus Medford Hospital
-
Mukwonago, Wisconsin, Spojené státy, 53149
- ProHealth D N Greenwald Center
-
Oconomowoc, Wisconsin, Spojené státy, 53066
- ProHealth Oconomowoc Memorial Hospital
-
Rhinelander, Wisconsin, Spojené státy, 54501
- Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
-
Spooner, Wisconsin, Spojené státy, 54801
- Essentia Health-Spooner Clinic
-
Stevens Point, Wisconsin, Spojené státy, 54481
- Aspirus Cancer Care - Stevens Point
-
Superior, Wisconsin, Spojené státy, 54880
- Essentia Health Saint Mary's Hospital - Superior
-
Waukesha, Wisconsin, Spojené státy, 53188
- UW Cancer Center at ProHealth Care
-
Wausau, Wisconsin, Spojené státy, 54401
- Aspirus Cancer Care-Wausau
-
Wisconsin Rapids, Wisconsin, Spojené státy, 54494
- Aspirus Cancer Care - Wisconsin Rapids
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Počet zbraní
2
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
|
Aktivní komparátor: 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
Ostatní jména:
Undergo CT scan
Ostatní jména:
Undergo echocardiography
Ostatní jména:
Given IV
Ostatní jména:
|
|
Experimentální: 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
Ostatní jména:
Undergo CT scan
Ostatní jména:
Undergo echocardiography
Ostatní jména:
Given IV
Ostatní jména:
Given PO
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Disease free survival (DFS)
Časové okno: 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
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Overall survival (OS)
Časové okno: 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
Časové okno: Up to 10 years
|
Toxicity will be assessed by summaries by Common Terminology Criteria for Adverse Event grade. |
Up to 10 years
|
Další výstupní opatření
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Korelační analýzy biovzorků tkáně, krve a stolice
Časové okno: Až 10 let
|
Až 10 let
|
|
|
Estimates of treatment effect by sex
Časové okno: 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
Časové okno: Up to 10 years
|
Estimates of DFS and the corresponding 95% CIs by race. |
Up to 10 years
|
|
Estimates of treatment effect by ethnicity
Časové okno: Up to 10 years
|
Estimates of DFS and the corresponding 95% CIs by ethnicity. |
Up to 10 years
|
|
DFS according to PD-L1 status
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Up to 10 years
|
Will be compared between treatment arms using the logrank test and Cox modeling. |
Up to 10 years
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Sponzor
Vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Dwight H Owen, ECOG-ACRIN Cancer Research Group
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
7. srpna 2025
Primární dokončení (Odhadovaný)
Primární dokončení
30. června 2028
Dokončení studie (Odhadovaný)
Dokončení studie
30. června 2028
Termíny zápisu do studia
První předloženo
První předloženo
12. prosince 2024
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
12. prosince 2024
První zveřejněno (Aktuální)
První zveřejněno
13. prosince 2024
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
21. září 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
18. září 2026
Naposledy ověřeno
Naposledy ověřeno
1. srpna 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Novotvary podle místa
- Novotvary
- Nemoci dýchacích cest
- Plicní onemocnění
- Novotvary dýchacího traktu
- Novotvary hrudníku
- Karcinom, Bronchogenní
- Bronchiální novotvary
- Novotvary plic
- Karcinom, nemalobuněčné plíce
- Aminokyseliny, peptidy a proteiny
- Proteiny
- Sloučeniny síry
- Organické chemikálie
- Vyšetřovací techniky
- Klinické laboratorní techniky
- Diagnostické techniky a postupy
- Diagnóza
- Protilátky
- Imunoglobuliny
- Imunoproteiny
- Krevní proteiny
- Sérové globuliny
- Globuliny
- Anorganické chemikálie
- Izotypy imunoglobulinu
- Sulfidy
- Anionty
- Ionty
- Elektrolyty
- Sirovodík
- Imunoglobulin G
- Manipulace se vzorkem
- ceralasertib
- Durvalumab
- Disulfidy
Další identifikační čísla studie
Další identifikační čísla studie
- NCI-2024-10081
- U10CA180820 (Grant/smlouva NIH USA)
- NCI-2024-10081 (Identifikátor registru: CTRP (Clinical Trial Reporting Program))
- EA5231 (Jiný identifikátor: CTEP)
- EA5231 (Jiný identifikátor: ECOG-ACRIN Cancer Research Group)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu 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.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ano
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .