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비소세포폐암 환자의 암 없는 시간을 늘리기 위해 면역요법에 AZD6738(Ceralasertib)을 추가하는 방법 테스트

2026년 9월 18일 업데이트: National Cancer Institute (NCI)

신보조요법 후 병리학적 반응에 기초한 보조요법 환경에서 폐암 환자의 체크포인트 차단에 대한 무작위 제3상 시험(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.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

630

단계

3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

미국
- Arkansas
  - Jonesboro, Arkansas, 미국, 72401
    - NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
- California
  - Beverly Hills, California, 미국, 90211
    - Tower Cancer Research Foundation
  - Los Angeles, California, 미국, 90048
    - Cedars-Sinai Medical Center
  - Tarzana, California, 미국, 91356
    - Cedars-Sinai Cancer - Tarzana
  - Torrance, California, 미국, 90505
    - Torrance Memorial Physician Network - Cancer Care
- Connecticut
  - Hartford, Connecticut, 미국, 06102
    - Hartford Hospital
  - Meriden, Connecticut, 미국, 06451
    - Midstate Medical Center
  - New Britain, Connecticut, 미국, 06050
    - The Hospital of Central Connecticut
- Delaware
  - Millville, Delaware, 미국, 19967
    - Beebe South Coastal Health Campus
  - Newark, Delaware, 미국, 19713
    - Helen F Graham Cancer Center
  - Newark, Delaware, 미국, 19713
    - Medical Oncology Hematology Consultants PA
  - Rehoboth Beach, Delaware, 미국, 19971
    - Beebe Health Campus
- District of Columbia
  - Washington D.C., District of Columbia, 미국, 20010
    - MedStar Washington Hospital Center
  - Washington D.C., District of Columbia, 미국, 20007
    - MedStar Georgetown University Hospital
- Georgia
  - Atlanta, Georgia, 미국, 30308
    - Emory University Hospital Midtown
  - Atlanta, Georgia, 미국, 30322
    - Emory University Hospital/Winship Cancer Institute
  - Atlanta, Georgia, 미국, 30342
    - Emory Saint Joseph's Hospital
  - Decatur, Georgia, 미국, 30033
    - Emory Decatur Hospital
  - Johns Creek, Georgia, 미국, 30097
    - Emory Johns Creek Hospital
- Idaho
  - Boise, Idaho, 미국, 83712
    - Saint Luke's Cancer Institute - Boise
  - Coeur d'Alene, Idaho, 미국, 83814
    - Kootenai Health - Coeur d'Alene
  - Fruitland, Idaho, 미국, 83619
    - Saint Luke's Cancer Institute - Fruitland
  - Meridian, Idaho, 미국, 83642
    - Saint Luke's Cancer Institute - Meridian
  - Nampa, Idaho, 미국, 83687
    - Saint Alphonsus Cancer Care Center-Nampa
  - Nampa, Idaho, 미국, 83687
    - Saint Luke's Cancer Institute - Nampa
  - Post Falls, Idaho, 미국, 83854
    - Kootenai Clinic Cancer Services - Post Falls
  - Sandpoint, Idaho, 미국, 83864
    - Kootenai Clinic Cancer Services - Sandpoint
- Illinois
  - Bloomington, Illinois, 미국, 61704
    - Illinois CancerCare-Bloomington
  - Canton, Illinois, 미국, 61520
    - Illinois CancerCare-Canton
  - Carthage, Illinois, 미국, 62321
    - Illinois CancerCare-Carthage
  - Chicago, Illinois, 미국, 60611
    - Northwestern University
  - DeKalb, Illinois, 미국, 60115
    - Northwestern Medicine Cancer Center Kishwaukee
  - Decatur, Illinois, 미국, 62526
    - Decatur Memorial Hospital
  - Decatur, Illinois, 미국, 62526
    - Cancer Care Specialists of Illinois - Decatur
  - Dixon, Illinois, 미국, 61021
    - Illinois CancerCare-Dixon
  - Effingham, Illinois, 미국, 62401
    - Crossroads Cancer Center
  - Eureka, Illinois, 미국, 61530
    - Illinois CancerCare-Eureka
  - Galesburg, Illinois, 미국, 61401
    - Illinois CancerCare-Galesburg
  - Geneva, Illinois, 미국, 60134
    - Northwestern Medicine Cancer Center Delnor
  - Glenview, Illinois, 미국, 60026
    - Northwestern Medicine Glenview Outpatient Center
  - Grayslake, Illinois, 미국, 60030
    - Northwestern Medicine Grayslake Outpatient Center
  - Kewanee, Illinois, 미국, 61443
    - Illinois CancerCare-Kewanee Clinic
  - Lake Forest, Illinois, 미국, 60045
    - Northwestern Medicine Lake Forest Hospital
  - Macomb, Illinois, 미국, 61455
    - Illinois CancerCare-Macomb
  - Maywood, Illinois, 미국, 60153
    - Loyola University Medical Center
  - O'Fallon, Illinois, 미국, 62269
    - Cancer Care Center of O'Fallon
  - O'Fallon, Illinois, 미국, 62269
    - HSHS Saint Elizabeth's Hospital
  - Oak Brook, Illinois, 미국, 60523
    - Northwestern Medicine Oak Brook
  - Orland Park, Illinois, 미국, 60462
    - Northwestern Medicine Orland Park
  - Ottawa, Illinois, 미국, 61350
    - Illinois CancerCare-Ottawa Clinic
  - Pekin, Illinois, 미국, 61554
    - Illinois CancerCare-Pekin
  - Peoria, Illinois, 미국, 61615
    - Illinois CancerCare-Peoria
  - Peru, Illinois, 미국, 61354
    - Illinois CancerCare-Peru
  - Princeton, Illinois, 미국, 61356
    - Illinois CancerCare-Princeton
  - Springfield, Illinois, 미국, 62702
    - Southern Illinois University School of Medicine
  - Springfield, Illinois, 미국, 62702
    - Springfield Clinic
  - Springfield, Illinois, 미국, 62781
    - Springfield Memorial Hospital
  - Warrenville, Illinois, 미국, 60555
    - Northwestern Medicine Cancer Center Warrenville
  - Washington, Illinois, 미국, 61571
    - Illinois CancerCare - Washington
- Indiana
  - Indianapolis, Indiana, 미국, 46202
    - Indiana University/Melvin and Bren Simon Cancer Center
- Kansas
  - El Dorado, Kansas, 미국, 67042
    - Cancer Center of Kansas - El Dorado
  - Lawrence, Kansas, 미국, 66044
    - Lawrence Memorial Hospital
  - Newton, Kansas, 미국, 67114
    - Cancer Center of Kansas - Newton
  - Olathe, Kansas, 미국, 66061
    - The University of Kansas Cancer Center - Olathe
  - Salina, Kansas, 미국, 67401
    - Salina Regional Health Center
  - Topeka, Kansas, 미국, 66606
    - University of Kansas Health System Saint Francis Campus
  - Wellington, Kansas, 미국, 67152
    - Cancer Center of Kansas - Wellington
  - Wichita, Kansas, 미국, 67214
    - Ascension Via Christi Hospitals Wichita
  - Wichita, Kansas, 미국, 67208
    - Cancer Center of Kansas-Wichita Medical Arts Tower
  - Wichita, Kansas, 미국, 67214
    - Cancer Center of Kansas - Wichita
  - Winfield, Kansas, 미국, 67156
    - Cancer Center of Kansas - Winfield
- Maryland
  - Baltimore, Maryland, 미국, 21201
    - University of Maryland/Greenebaum Cancer Center
  - Glen Burnie, Maryland, 미국, 21061
    - UM Baltimore Washington Medical Center/Tate Cancer Center
- Massachusetts
  - Beverly, Massachusetts, 미국, 01915
    - Beverly Hospital
  - Burlington, Massachusetts, 미국, 01805
    - Lahey Clinic
  - Gloucester, Massachusetts, 미국, 01930
    - Addison Gilbert Hospital
  - Peabody, Massachusetts, 미국, 01960
    - Lahey Clinic Peabody
  - Springfield, Massachusetts, 미국, 01199
    - Baystate Medical Center
- Michigan
  - Battle Creek, Michigan, 미국, 49017
    - Bronson Battle Creek
  - Brighton, Michigan, 미국, 48114
    - Trinity Health IHA Medical Group Hematology Oncology - Brighton
  - Canton, Michigan, 미국, 48188
    - Trinity Health IHA Medical Group Hematology Oncology - Canton
  - Chelsea, Michigan, 미국, 48118
    - Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
  - Flint, Michigan, 미국, 48503
    - Hurley Medical Center
  - Flint, Michigan, 미국, 48503
    - Genesee Hematology Oncology PC
  - Flint, Michigan, 미국, 48503
    - Genesys Hurley Cancer Institute
  - Flint, Michigan, 미국, 48503
    - Cancer Hematology Centers - Flint
  - Grand Rapids, Michigan, 미국, 49503
    - Trinity Health Grand Rapids Hospital
  - Grand Rapids, Michigan, 미국, 49503
    - Corewell Health Grand Rapids Hospitals - Butterworth Hospital
  - Kalamazoo, Michigan, 미국, 49007
    - West Michigan Cancer Center
  - Kalamazoo, Michigan, 미국, 49007
    - Bronson Methodist Hospital
  - Lansing, Michigan, 미국, 48912
    - University of Michigan Health - Sparrow Lansing
  - Livonia, Michigan, 미국, 48154
    - Trinity Health Saint Mary Mercy Livonia Hospital
  - Muskegon, Michigan, 미국, 49444
    - Trinity Health Muskegon Hospital
  - Niles, Michigan, 미국, 49120
    - Corewell Health Lakeland Hospitals - Niles Hospital
  - Norton Shores, Michigan, 미국, 49444
    - Cancer and Hematology Centers of Western Michigan - Norton Shores
  - Pontiac, Michigan, 미국, 48341
    - Trinity Health Saint Joseph Mercy Oakland Hospital
  - Reed City, Michigan, 미국, 49677
    - Corewell Health Reed City Hospital
  - Saint Joseph, Michigan, 미국, 49085
    - Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
  - Saint Joseph, Michigan, 미국, 49085
    - Corewell Health Lakeland Hospitals - Saint Joseph Hospital
  - Traverse City, Michigan, 미국, 49684
    - Munson Medical Center
  - Wyoming, Michigan, 미국, 49519
    - University of Michigan Health - West
  - Ypsilanti, Michigan, 미국, 48197
    - Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
- Minnesota
  - Brainerd, Minnesota, 미국, 56401
    - Essentia Health Saint Joseph's Medical Center
  - Coon Rapids, Minnesota, 미국, 55433
    - Mercy Hospital
  - Deer River, Minnesota, 미국, 56636
    - Essentia Health - Deer River Clinic
  - Duluth, Minnesota, 미국, 55805
    - Essentia Health Cancer Center
  - Edina, Minnesota, 미국, 55435
    - Fairview Southdale Hospital
  - Hibbing, Minnesota, 미국, 55746
    - Essentia Health Hibbing Clinic
  - Minneapolis, Minnesota, 미국, 55407
    - Abbott-Northwestern Hospital
  - Minneapolis, Minnesota, 미국, 55417
    - Minneapolis VA Medical Center
  - Saint Louis Park, Minnesota, 미국, 55416
    - Park Nicollet Clinic - Saint Louis Park
  - Saint Paul, Minnesota, 미국, 55101
    - Regions Hospital
  - Saint Paul, Minnesota, 미국, 55102
    - United Hospital
  - Sandstone, Minnesota, 미국, 55072
    - Essentia Health Sandstone
  - Virginia, Minnesota, 미국, 55792
    - Essentia Health Virginia Clinic
- Mississippi
  - Columbus, Mississippi, 미국, 39705
    - Baptist Memorial Hospital and Cancer Center-Golden Triangle
  - Grenada, Mississippi, 미국, 38901
    - Baptist Cancer Center-Grenada
  - New Albany, Mississippi, 미국, 38652
    - Baptist Memorial Hospital and Cancer Center-Union County
  - Oxford, Mississippi, 미국, 38655
    - Baptist Memorial Hospital and Cancer Center-Oxford
  - Southhaven, Mississippi, 미국, 38671
    - Baptist Memorial Hospital and Cancer Center-Desoto
- Missouri
  - Cape Girardeau, Missouri, 미국, 63703
    - Saint Francis Medical Center
  - Farmington, Missouri, 미국, 63640
    - Parkland Health Center - Farmington
  - Sainte Genevieve, Missouri, 미국, 63670
    - Sainte Genevieve County Memorial Hospital
  - St Louis, Missouri, 미국, 63131
    - Missouri Baptist Medical Center
  - St Louis, Missouri, 미국, 63128
    - Mercy Hospital South
  - Sullivan, Missouri, 미국, 63080
    - Missouri Baptist Sullivan Hospital
- Montana
  - Anaconda, Montana, 미국, 59711
    - Community Hospital of Anaconda
  - Billings, Montana, 미국, 59101
    - Billings Clinic Cancer Center
  - Billings, Montana, 미국, 59102
    - Saint Vincent Frontier Cancer Center
  - Bozeman, Montana, 미국, 59715
    - Bozeman Health Deaconess Hospital
  - Great Falls, Montana, 미국, 59405
    - Benefis Sletten Cancer Institute
  - Missoula, Montana, 미국, 59804
    - Community Medical Center
- New Hampshire
  - Concord, New Hampshire, 미국, 03301
    - New Hampshire Oncology Hematology PA-Concord
  - Manchester, New Hampshire, 미국, 03103
    - Solinsky Center for Cancer Care
- New Jersey
  - Flemington, New Jersey, 미국, 08822
    - Hunterdon Medical Center
- New York
  - Glens Falls, New York, 미국, 12801
    - Glens Falls Hospital
  - The Bronx, New York, 미국, 10461
    - Montefiore Medical Center-Einstein Campus
- North Carolina
  - Pinehurst, North Carolina, 미국, 28374
    - FirstHealth of the Carolinas-Moore Regional Hospital
- North Dakota
  - Fargo, North Dakota, 미국, 58103
    - Essentia Health Cancer Center-South University Clinic
- Ohio
  - Canton, Ohio, 미국, 44710
    - Aultman Health Foundation
  - Columbus, Ohio, 미국, 43210
    - Ohio State University Comprehensive Cancer Center
- Oklahoma
  - Oklahoma City, Oklahoma, 미국, 73104
    - University of Oklahoma Health Sciences Center
- Oregon
  - Newberg, Oregon, 미국, 97132
    - Providence Newberg Medical Center
  - Oregon City, Oregon, 미국, 97045
    - Providence Willamette Falls Medical Center
  - Portland, Oregon, 미국, 97239
    - Oregon Health and Science University
  - Portland, Oregon, 미국, 97213
    - Providence Portland Medical Center
  - Portland, Oregon, 미국, 97225
    - Providence Saint Vincent Medical Center
- Pennsylvania
  - Allentown, Pennsylvania, 미국, 18103
    - Lehigh Valley Hospital-Cedar Crest
  - Bethlehem, Pennsylvania, 미국, 18017
    - Lehigh Valley Hospital - Muhlenberg
  - Bryn Mawr, Pennsylvania, 미국, 19010
    - Bryn Mawr Hospital
  - East Stroudsburg, Pennsylvania, 미국, 18301
    - Pocono Medical Center
  - Erie, Pennsylvania, 미국, 16505
    - UPMC Hillman Cancer Center Erie
  - Greensburg, Pennsylvania, 미국, 15601
    - UPMC Cancer Centers - Arnold Palmer Pavilion
  - Harrisburg, Pennsylvania, 미국, 17109
    - UPMC Pinnacle Cancer Center/Community Osteopathic Campus
  - Hazleton, Pennsylvania, 미국, 18201
    - Lehigh Valley Hospital-Hazleton
  - Mechanicsburg, Pennsylvania, 미국, 17050
    - UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
  - Media, Pennsylvania, 미국, 19063
    - Riddle Memorial Hospital
  - Monroeville, Pennsylvania, 미국, 15146
    - UPMC Hillman Cancer Center - Monroeville
  - Paoli, Pennsylvania, 미국, 19301
    - Paoli Memorial Hospital
  - Philadelphia, Pennsylvania, 미국, 19104
    - University of Pennsylvania/Abramson Cancer Center
  - Pittsburgh, Pennsylvania, 미국, 15232
    - UPMC Hillman Cancer Center
  - Pittsburgh, Pennsylvania, 미국, 15243
    - UPMC-Saint Clair Hospital Cancer Center
  - West Reading, Pennsylvania, 미국, 19611
    - Reading Hospital
  - Wynnewood, Pennsylvania, 미국, 19096
    - Lankenau Medical Center
- South Carolina
  - Georgetown, South Carolina, 미국, 29440
    - Tidelands Georgetown Memorial Hospital
- Tennessee
  - Collierville, Tennessee, 미국, 38017
    - Baptist Memorial Hospital and Cancer Center-Collierville
  - Memphis, Tennessee, 미국, 38120
    - Baptist Memorial Hospital and Cancer Center-Memphis
  - Nashville, Tennessee, 미국, 37232
    - Vanderbilt University/Ingram Cancer Center
- Virginia
  - Charlottesville, Virginia, 미국, 22908
    - University of Virginia Cancer Center
  - Fredericksburg, Virginia, 미국, 22408
    - Hematology Oncology Associates of Fredericksburg Inc
  - Richmond, Virginia, 미국, 23235
    - VCU Massey Cancer Center at Stony Point
  - Richmond, Virginia, 미국, 23229
    - Virginia Cancer Institute
  - Richmond, Virginia, 미국, 23298
    - VCU Massey Comprehensive Cancer Center
  - South Hill, Virginia, 미국, 23970
    - VCU Community Memorial Health Center
- West Virginia
  - Huntington, West Virginia, 미국, 25701
    - Edwards Comprehensive Cancer Center
  - Morgantown, West Virginia, 미국, 26506
    - West Virginia University Healthcare
  - Parkersburg, West Virginia, 미국, 26101
    - Camden Clark Medical Center
- Wisconsin
  - Antigo, Wisconsin, 미국, 54409
    - Aspirus Cancer Care-Antigo-Volm Cancer Center
  - Appleton, Wisconsin, 미국, 54911
    - ThedaCare Regional Cancer Center
  - Ashland, Wisconsin, 미국, 54806
    - Duluth Clinic Ashland
  - Hayward, Wisconsin, 미국, 54843
    - Essentia Health-Hayward Clinic
  - La Crosse, Wisconsin, 미국, 54601
    - Gundersen Lutheran Medical Center
  - Medford, Wisconsin, 미국, 54451
    - Aspirus Medford Hospital
  - Mukwonago, Wisconsin, 미국, 53149
    - ProHealth D N Greenwald Center
  - Oconomowoc, Wisconsin, 미국, 53066
    - ProHealth Oconomowoc Memorial Hospital
  - Rhinelander, Wisconsin, 미국, 54501
    - Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
  - Spooner, Wisconsin, 미국, 54801
    - Essentia Health-Spooner Clinic
  - Stevens Point, Wisconsin, 미국, 54481
    - Aspirus Cancer Care - Stevens Point
  - Superior, Wisconsin, 미국, 54880
    - Essentia Health Saint Mary's Hospital - Superior
  - Waukesha, Wisconsin, 미국, 53188
    - UW Cancer Center at ProHealth Care
  - Wausau, Wisconsin, 미국, 54401
    - Aspirus Cancer Care-Wausau
  - Wisconsin Rapids, Wisconsin, 미국, 54494
    - Aspirus Cancer Care - Wisconsin Rapids

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

주 목적: 치료
할당: 무작위
중재 모델: 병렬 할당
마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔 참가자 그룹 / 팔 시험 프로토콜에 따라 특정 중재/치료를 받거나 중재를 받지 않는 임상 시험 참가자 그룹 또는 하위 그룹입니다.	개입 / 치료 개입 / 치료 임상 연구의 초점이 되는 프로세스 또는 작업입니다. 개입에는 약물, 의료 기기, 절차, 백신 및 조사 중이거나 이미 사용 가능한 기타 제품이 포함됩니다. 개입에는 교육이나 식이요법 및 운동 수정과 같은 비침습적 접근법도 포함될 수 있습니다.
활성 비교기: 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.	절차: Biospecimen Collection Undergo blood sample collection 다른 이름들: 생물학적 샘플 수집 생체 표본 수집 표본 수집 샘플 수집 절차: Computed Tomography Undergo CT scan 다른 이름들: CT 고양이 고양이 스캔 컴퓨터 축 단층 촬영 전산화 단층 촬영 CT 스캔 단층 촬영 컴퓨터 축 단층 촬영(시술) 컴퓨터 단층촬영(CT) 스캔 진단 CAT 스캔 진단 CAT 스캔 서비스 유형 절차: Echocardiography Test Undergo echocardiography 다른 이름들: 심초음파 EC 생물학적: Durvalumab Given IV 다른 이름들: 임핀지 Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, 이합체 메디-4736 메디4736
실험적: 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.	절차: Biospecimen Collection Undergo blood sample collection 다른 이름들: 생물학적 샘플 수집 생체 표본 수집 표본 수집 샘플 수집 절차: Computed Tomography Undergo CT scan 다른 이름들: CT 고양이 고양이 스캔 컴퓨터 축 단층 촬영 전산화 단층 촬영 CT 스캔 단층 촬영 컴퓨터 축 단층 촬영(시술) 컴퓨터 단층촬영(CT) 스캔 진단 CAT 스캔 진단 CAT 스캔 서비스 유형 절차: Echocardiography Test Undergo echocardiography 다른 이름들: 심초음파 EC 생물학적: Durvalumab Given IV 다른 이름들: 임핀지 Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, 이합체 메디-4736 메디4736 의약품: Ceralasertib Given PO 다른 이름들: AZD6738

참가자 그룹 / 팔

개입 / 치료

활성 비교기: 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.

절차: Biospecimen Collection

Undergo blood sample collection

다른 이름들:

생물학적 샘플 수집
생체 표본 수집
표본 수집
샘플 수집

절차: Computed Tomography

Undergo CT scan

다른 이름들:

CT
고양이
고양이 스캔
컴퓨터 축 단층 촬영
전산화 단층 촬영
CT 스캔
단층 촬영
컴퓨터 축 단층 촬영(시술)
컴퓨터 단층촬영(CT) 스캔
진단 CAT 스캔
진단 CAT 스캔 서비스 유형

절차: Echocardiography Test

Undergo echocardiography

다른 이름들:

심초음파
EC

생물학적: Durvalumab

Given IV

다른 이름들:

임핀지
Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, 이합체
메디-4736
메디4736

실험적: 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.

절차: Biospecimen Collection

Undergo blood sample collection

다른 이름들:

생물학적 샘플 수집
생체 표본 수집
표본 수집
샘플 수집

절차: Computed Tomography

Undergo CT scan

다른 이름들:

CT
고양이
고양이 스캔
컴퓨터 축 단층 촬영
전산화 단층 촬영
CT 스캔
단층 촬영
컴퓨터 축 단층 촬영(시술)
컴퓨터 단층촬영(CT) 스캔
진단 CAT 스캔
진단 CAT 스캔 서비스 유형

절차: Echocardiography Test

Undergo echocardiography

다른 이름들:

심초음파
EC

생물학적: Durvalumab

Given IV

다른 이름들:

임핀지
Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, 이합체
메디-4736
메디4736

의약품: Ceralasertib

Given PO

다른 이름들:

AZD6738

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Disease free survival (DFS) 기간: 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

2차 결과 측정

결과 측정	측정값 설명	기간
Overall survival (OS) 기간: 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 기간: Up to 10 years	Toxicity will be assessed by summaries by Common Terminology Criteria for Adverse Event grade.	Up to 10 years

기타 결과 측정

결과 측정	측정값 설명	기간
조직, 혈액, 대변 생체 시료에 대한 상관 분석 기간: 최대 10년		최대 10년
Estimates of treatment effect by sex 기간: 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 기간: Up to 10 years	Estimates of DFS and the corresponding 95% CIs by race.	Up to 10 years
Estimates of treatment effect by ethnicity 기간: Up to 10 years	Estimates of DFS and the corresponding 95% CIs by ethnicity.	Up to 10 years
DFS according to PD-L1 status 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: Up to 10 years	Will be compared between treatment arms using the logrank test and Cox modeling.	Up to 10 years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

National Cancer Institute (NCI)

수사관

수석 연구원: Dwight H Owen, ECOG-ACRIN Cancer Research Group

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 8월 7일

기본 완료 (추정된)

2028년 6월 30일

연구 완료 (추정된)

2028년 6월 30일

연구 등록 날짜

최초 제출

2024년 12월 12일

QC 기준을 충족하는 최초 제출

2024년 12월 12일

처음 게시됨 (실제)

2024년 12월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 21일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 18일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

NCI-2024-10081
U10CA180820 (미국 NIH 보조금/계약)
NCI-2024-10081 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
EA5231 (기타 식별자: CTEP)
EA5231 (기타 식별자: ECOG-ACRIN Cancer Research Group)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

비소세포폐암 환자의 암 없는 시간을 늘리기 위해 면역요법에 AZD6738(Ceralasertib)을 추가하는 방법 테스트

신보조요법 후 병리학적 반응에 기초한 보조요법 환경에서 폐암 환자의 체크포인트 차단에 대한 무작위 제3상 시험(CLEAR)

연구 개요

상태

정황

개입 / 치료

상세 설명

연구 유형

등록 (추정된)

단계

연락처 및 위치

연구 장소

참여기준

자격 기준

공부할 수 있는 나이

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

설명

공부 계획

연구는 어떻게 설계됩니까?

디자인 세부사항

팔의 수

무기와 개입

참가자 그룹 / 팔

개입 / 치료

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정

측정값 설명

기간

2차 결과 측정

결과 측정

측정값 설명

기간

기타 결과 측정

결과 측정

측정값 설명

기간

공동 작업자 및 조사자

스폰서

수사관

연구 기록 날짜

연구 주요 날짜

연구 시작 (실제)

기본 완료 (추정된)

연구 완료 (추정된)

연구 등록 날짜

최초 제출

QC 기준을 충족하는 최초 제출

처음 게시됨 (실제)

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

QC 기준을 충족하는 마지막 업데이트 제출

마지막으로 확인됨

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

IPD 계획 설명

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

미국 FDA 규제 기기 제품 연구

미국에서 제조되어 미국에서 수출되는 제품