非小細胞肺がん患者のがんのない期間を延ばすための免疫療法へのAZD6738（セララサーチブ）の追加を試験
術前補助療法後の病理学的反応に基づく術後補助療法中の肺がん患者におけるチェックポイント遮断のランダム化第 III 相試験 (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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究場所
-
-
Arkansas
-
Jonesboro、Arkansas、アメリカ、72401
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
-
-
California
-
Beverly Hills、California、アメリカ、90211
- Tower Cancer Research Foundation
-
Los Angeles、California、アメリカ、90048
- Cedars-Sinai Medical Center
-
Tarzana、California、アメリカ、91356
- Cedars-Sinai Cancer - Tarzana
-
Torrance、California、アメリカ、90505
- Torrance Memorial Physician Network - Cancer Care
-
-
Connecticut
-
Hartford、Connecticut、アメリカ、06102
- Hartford Hospital
-
Meriden、Connecticut、アメリカ、06451
- Midstate Medical Center
-
New Britain、Connecticut、アメリカ、06050
- The Hospital of Central Connecticut
-
-
Delaware
-
Millville、Delaware、アメリカ、19967
- Beebe South Coastal Health Campus
-
Newark、Delaware、アメリカ、19713
- Helen F Graham Cancer Center
-
Newark、Delaware、アメリカ、19713
- Medical Oncology Hematology Consultants PA
-
Rehoboth Beach、Delaware、アメリカ、19971
- Beebe Health Campus
-
-
District of Columbia
-
Washington D.C.、District of Columbia、アメリカ、20010
- MedStar Washington Hospital Center
-
Washington D.C.、District of Columbia、アメリカ、20007
- MedStar Georgetown University Hospital
-
-
Georgia
-
Atlanta、Georgia、アメリカ、30308
- Emory University Hospital Midtown
-
Atlanta、Georgia、アメリカ、30322
- Emory University Hospital/Winship Cancer Institute
-
Atlanta、Georgia、アメリカ、30342
- Emory Saint Joseph's Hospital
-
Decatur、Georgia、アメリカ、30033
- Emory Decatur Hospital
-
Johns Creek、Georgia、アメリカ、30097
- Emory Johns Creek Hospital
-
-
Idaho
-
Boise、Idaho、アメリカ、83712
- Saint Luke's Cancer Institute - Boise
-
Coeur d'Alene、Idaho、アメリカ、83814
- Kootenai Health - Coeur d'Alene
-
Fruitland、Idaho、アメリカ、83619
- Saint Luke's Cancer Institute - Fruitland
-
Meridian、Idaho、アメリカ、83642
- Saint Luke's Cancer Institute - Meridian
-
Nampa、Idaho、アメリカ、83687
- Saint Alphonsus Cancer Care Center-Nampa
-
Nampa、Idaho、アメリカ、83687
- Saint Luke's Cancer Institute - Nampa
-
Post Falls、Idaho、アメリカ、83854
- Kootenai Clinic Cancer Services - Post Falls
-
Sandpoint、Idaho、アメリカ、83864
- Kootenai Clinic Cancer Services - Sandpoint
-
-
Illinois
-
Bloomington、Illinois、アメリカ、61704
- Illinois CancerCare-Bloomington
-
Canton、Illinois、アメリカ、61520
- Illinois CancerCare-Canton
-
Carthage、Illinois、アメリカ、62321
- Illinois CancerCare-Carthage
-
Chicago、Illinois、アメリカ、60611
- Northwestern University
-
DeKalb、Illinois、アメリカ、60115
- Northwestern Medicine Cancer Center Kishwaukee
-
Decatur、Illinois、アメリカ、62526
- Decatur Memorial Hospital
-
Decatur、Illinois、アメリカ、62526
- Cancer Care Specialists of Illinois - Decatur
-
Dixon、Illinois、アメリカ、61021
- Illinois CancerCare-Dixon
-
Effingham、Illinois、アメリカ、62401
- Crossroads Cancer Center
-
Eureka、Illinois、アメリカ、61530
- Illinois CancerCare-Eureka
-
Galesburg、Illinois、アメリカ、61401
- Illinois CancerCare-Galesburg
-
Geneva、Illinois、アメリカ、60134
- Northwestern Medicine Cancer Center Delnor
-
Glenview、Illinois、アメリカ、60026
- Northwestern Medicine Glenview Outpatient Center
-
Grayslake、Illinois、アメリカ、60030
- Northwestern Medicine Grayslake Outpatient Center
-
Kewanee、Illinois、アメリカ、61443
- Illinois CancerCare-Kewanee Clinic
-
Lake Forest、Illinois、アメリカ、60045
- Northwestern Medicine Lake Forest Hospital
-
Macomb、Illinois、アメリカ、61455
- Illinois CancerCare-Macomb
-
Maywood、Illinois、アメリカ、60153
- Loyola University Medical Center
-
O'Fallon、Illinois、アメリカ、62269
- Cancer Care Center of O'Fallon
-
O'Fallon、Illinois、アメリカ、62269
- HSHS Saint Elizabeth's Hospital
-
Oak Brook、Illinois、アメリカ、60523
- Northwestern Medicine Oak Brook
-
Orland Park、Illinois、アメリカ、60462
- Northwestern Medicine Orland Park
-
Ottawa、Illinois、アメリカ、61350
- Illinois CancerCare-Ottawa Clinic
-
Pekin、Illinois、アメリカ、61554
- Illinois CancerCare-Pekin
-
Peoria、Illinois、アメリカ、61615
- Illinois CancerCare-Peoria
-
Peru、Illinois、アメリカ、61354
- Illinois CancerCare-Peru
-
Princeton、Illinois、アメリカ、61356
- Illinois CancerCare-Princeton
-
Springfield、Illinois、アメリカ、62702
- Southern Illinois University School of Medicine
-
Springfield、Illinois、アメリカ、62702
- Springfield Clinic
-
Springfield、Illinois、アメリカ、62781
- Springfield Memorial Hospital
-
Warrenville、Illinois、アメリカ、60555
- Northwestern Medicine Cancer Center Warrenville
-
Washington、Illinois、アメリカ、61571
- Illinois CancerCare - Washington
-
-
Indiana
-
Indianapolis、Indiana、アメリカ、46202
- Indiana University/Melvin and Bren Simon Cancer Center
-
-
Kansas
-
El Dorado、Kansas、アメリカ、67042
- Cancer Center of Kansas - El Dorado
-
Lawrence、Kansas、アメリカ、66044
- Lawrence Memorial Hospital
-
Newton、Kansas、アメリカ、67114
- Cancer Center of Kansas - Newton
-
Olathe、Kansas、アメリカ、66061
- The University of Kansas Cancer Center - Olathe
-
Salina、Kansas、アメリカ、67401
- Salina Regional Health Center
-
Topeka、Kansas、アメリカ、66606
- University of Kansas Health System Saint Francis Campus
-
Wellington、Kansas、アメリカ、67152
- Cancer Center of Kansas - Wellington
-
Wichita、Kansas、アメリカ、67214
- Ascension Via Christi Hospitals Wichita
-
Wichita、Kansas、アメリカ、67208
- Cancer Center of Kansas-Wichita Medical Arts Tower
-
Wichita、Kansas、アメリカ、67214
- Cancer Center of Kansas - Wichita
-
Winfield、Kansas、アメリカ、67156
- Cancer Center of Kansas - Winfield
-
-
Maryland
-
Baltimore、Maryland、アメリカ、21201
- University of Maryland/Greenebaum Cancer Center
-
Glen Burnie、Maryland、アメリカ、21061
- UM Baltimore Washington Medical Center/Tate Cancer Center
-
-
Massachusetts
-
Beverly、Massachusetts、アメリカ、01915
- Beverly Hospital
-
Burlington、Massachusetts、アメリカ、01805
- Lahey Clinic
-
Gloucester、Massachusetts、アメリカ、01930
- Addison Gilbert Hospital
-
Peabody、Massachusetts、アメリカ、01960
- Lahey Clinic Peabody
-
Springfield、Massachusetts、アメリカ、01199
- Baystate Medical Center
-
-
Michigan
-
Battle Creek、Michigan、アメリカ、49017
- Bronson Battle Creek
-
Brighton、Michigan、アメリカ、48114
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
-
Canton、Michigan、アメリカ、48188
- Trinity Health IHA Medical Group Hematology Oncology - Canton
-
Chelsea、Michigan、アメリカ、48118
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
-
Flint、Michigan、アメリカ、48503
- Hurley Medical Center
-
Flint、Michigan、アメリカ、48503
- Genesee Hematology Oncology PC
-
Flint、Michigan、アメリカ、48503
- Genesys Hurley Cancer Institute
-
Flint、Michigan、アメリカ、48503
- Cancer Hematology Centers - Flint
-
Grand Rapids、Michigan、アメリカ、49503
- Trinity Health Grand Rapids Hospital
-
Grand Rapids、Michigan、アメリカ、49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
-
Kalamazoo、Michigan、アメリカ、49007
- West Michigan Cancer Center
-
Kalamazoo、Michigan、アメリカ、49007
- Bronson Methodist Hospital
-
Lansing、Michigan、アメリカ、48912
- University of Michigan Health - Sparrow Lansing
-
Livonia、Michigan、アメリカ、48154
- Trinity Health Saint Mary Mercy Livonia Hospital
-
Muskegon、Michigan、アメリカ、49444
- Trinity Health Muskegon Hospital
-
Niles、Michigan、アメリカ、49120
- Corewell Health Lakeland Hospitals - Niles Hospital
-
Norton Shores、Michigan、アメリカ、49444
- Cancer and Hematology Centers of Western Michigan - Norton Shores
-
Pontiac、Michigan、アメリカ、48341
- Trinity Health Saint Joseph Mercy Oakland Hospital
-
Reed City、Michigan、アメリカ、49677
- Corewell Health Reed City Hospital
-
Saint Joseph、Michigan、アメリカ、49085
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
-
Saint Joseph、Michigan、アメリカ、49085
- Corewell Health Lakeland Hospitals - Saint Joseph Hospital
-
Traverse City、Michigan、アメリカ、49684
- Munson Medical Center
-
Wyoming、Michigan、アメリカ、49519
- University of Michigan Health - West
-
Ypsilanti、Michigan、アメリカ、48197
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
-
-
Minnesota
-
Brainerd、Minnesota、アメリカ、56401
- Essentia Health Saint Joseph's Medical Center
-
Coon Rapids、Minnesota、アメリカ、55433
- Mercy Hospital
-
Deer River、Minnesota、アメリカ、56636
- Essentia Health - Deer River Clinic
-
Duluth、Minnesota、アメリカ、55805
- Essentia Health Cancer Center
-
Edina、Minnesota、アメリカ、55435
- Fairview Southdale Hospital
-
Hibbing、Minnesota、アメリカ、55746
- Essentia Health Hibbing Clinic
-
Minneapolis、Minnesota、アメリカ、55407
- Abbott-Northwestern Hospital
-
Minneapolis、Minnesota、アメリカ、55417
- Minneapolis VA Medical Center
-
Saint Louis Park、Minnesota、アメリカ、55416
- Park Nicollet Clinic - Saint Louis Park
-
Saint Paul、Minnesota、アメリカ、55101
- Regions Hospital
-
Saint Paul、Minnesota、アメリカ、55102
- United Hospital
-
Sandstone、Minnesota、アメリカ、55072
- Essentia Health Sandstone
-
Virginia、Minnesota、アメリカ、55792
- Essentia Health Virginia Clinic
-
-
Mississippi
-
Columbus、Mississippi、アメリカ、39705
- Baptist Memorial Hospital and Cancer Center-Golden Triangle
-
Grenada、Mississippi、アメリカ、38901
- Baptist Cancer Center-Grenada
-
New Albany、Mississippi、アメリカ、38652
- Baptist Memorial Hospital and Cancer Center-Union County
-
Oxford、Mississippi、アメリカ、38655
- Baptist Memorial Hospital and Cancer Center-Oxford
-
Southhaven、Mississippi、アメリカ、38671
- Baptist Memorial Hospital and Cancer Center-Desoto
-
-
Missouri
-
Cape Girardeau、Missouri、アメリカ、63703
- Saint Francis Medical Center
-
Farmington、Missouri、アメリカ、63640
- Parkland Health Center - Farmington
-
Sainte Genevieve、Missouri、アメリカ、63670
- Sainte Genevieve County Memorial Hospital
-
St Louis、Missouri、アメリカ、63131
- Missouri Baptist Medical Center
-
St Louis、Missouri、アメリカ、63128
- Mercy Hospital South
-
Sullivan、Missouri、アメリカ、63080
- Missouri Baptist Sullivan Hospital
-
-
Montana
-
Anaconda、Montana、アメリカ、59711
- Community Hospital of Anaconda
-
Billings、Montana、アメリカ、59101
- Billings Clinic Cancer Center
-
Billings、Montana、アメリカ、59102
- Saint Vincent Frontier Cancer Center
-
Bozeman、Montana、アメリカ、59715
- Bozeman Health Deaconess Hospital
-
Great Falls、Montana、アメリカ、59405
- Benefis Sletten Cancer Institute
-
Missoula、Montana、アメリカ、59804
- Community Medical Center
-
-
New Hampshire
-
Concord、New Hampshire、アメリカ、03301
- New Hampshire Oncology Hematology PA-Concord
-
Manchester、New Hampshire、アメリカ、03103
- Solinsky Center for Cancer Care
-
-
New Jersey
-
Flemington、New Jersey、アメリカ、08822
- Hunterdon Medical Center
-
-
New York
-
Glens Falls、New York、アメリカ、12801
- Glens Falls Hospital
-
The Bronx、New York、アメリカ、10461
- Montefiore Medical Center-Einstein Campus
-
-
North Carolina
-
Pinehurst、North Carolina、アメリカ、28374
- FirstHealth of the Carolinas-Moore Regional Hospital
-
-
North Dakota
-
Fargo、North Dakota、アメリカ、58103
- Essentia Health Cancer Center-South University Clinic
-
-
Ohio
-
Canton、Ohio、アメリカ、44710
- Aultman Health Foundation
-
Columbus、Ohio、アメリカ、43210
- Ohio State University Comprehensive Cancer Center
-
-
Oklahoma
-
Oklahoma City、Oklahoma、アメリカ、73104
- University of Oklahoma Health Sciences Center
-
-
Oregon
-
Newberg、Oregon、アメリカ、97132
- Providence Newberg Medical Center
-
Oregon City、Oregon、アメリカ、97045
- Providence Willamette Falls Medical Center
-
Portland、Oregon、アメリカ、97239
- Oregon Health and Science University
-
Portland、Oregon、アメリカ、97213
- Providence Portland Medical Center
-
Portland、Oregon、アメリカ、97225
- Providence Saint Vincent Medical Center
-
-
Pennsylvania
-
Allentown、Pennsylvania、アメリカ、18103
- Lehigh Valley Hospital-Cedar Crest
-
Bethlehem、Pennsylvania、アメリカ、18017
- Lehigh Valley Hospital - Muhlenberg
-
Bryn Mawr、Pennsylvania、アメリカ、19010
- Bryn Mawr Hospital
-
East Stroudsburg、Pennsylvania、アメリカ、18301
- Pocono Medical Center
-
Erie、Pennsylvania、アメリカ、16505
- UPMC Hillman Cancer Center Erie
-
Greensburg、Pennsylvania、アメリカ、15601
- UPMC Cancer Centers - Arnold Palmer Pavilion
-
Harrisburg、Pennsylvania、アメリカ、17109
- UPMC Pinnacle Cancer Center/Community Osteopathic Campus
-
Hazleton、Pennsylvania、アメリカ、18201
- Lehigh Valley Hospital-Hazleton
-
Mechanicsburg、Pennsylvania、アメリカ、17050
- UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
-
Media、Pennsylvania、アメリカ、19063
- Riddle Memorial Hospital
-
Monroeville、Pennsylvania、アメリカ、15146
- UPMC Hillman Cancer Center - Monroeville
-
Paoli、Pennsylvania、アメリカ、19301
- Paoli Memorial Hospital
-
Philadelphia、Pennsylvania、アメリカ、19104
- University of Pennsylvania/Abramson Cancer Center
-
Pittsburgh、Pennsylvania、アメリカ、15232
- UPMC Hillman Cancer Center
-
Pittsburgh、Pennsylvania、アメリカ、15243
- UPMC-Saint Clair Hospital Cancer Center
-
West Reading、Pennsylvania、アメリカ、19611
- Reading Hospital
-
Wynnewood、Pennsylvania、アメリカ、19096
- Lankenau Medical Center
-
-
South Carolina
-
Georgetown、South Carolina、アメリカ、29440
- Tidelands Georgetown Memorial Hospital
-
-
Tennessee
-
Collierville、Tennessee、アメリカ、38017
- Baptist Memorial Hospital and Cancer Center-Collierville
-
Memphis、Tennessee、アメリカ、38120
- Baptist Memorial Hospital and Cancer Center-Memphis
-
Nashville、Tennessee、アメリカ、37232
- Vanderbilt University/Ingram Cancer Center
-
-
Virginia
-
Charlottesville、Virginia、アメリカ、22908
- University of Virginia Cancer Center
-
Fredericksburg、Virginia、アメリカ、22408
- Hematology Oncology Associates of Fredericksburg Inc
-
Richmond、Virginia、アメリカ、23235
- VCU Massey Cancer Center at Stony Point
-
Richmond、Virginia、アメリカ、23229
- Virginia Cancer Institute
-
Richmond、Virginia、アメリカ、23298
- VCU Massey Comprehensive Cancer Center
-
South Hill、Virginia、アメリカ、23970
- VCU Community Memorial Health Center
-
-
West Virginia
-
Huntington、West Virginia、アメリカ、25701
- Edwards Comprehensive Cancer Center
-
Morgantown、West Virginia、アメリカ、26506
- West Virginia University Healthcare
-
Parkersburg、West Virginia、アメリカ、26101
- Camden Clark Medical Center
-
-
Wisconsin
-
Antigo、Wisconsin、アメリカ、54409
- Aspirus Cancer Care-Antigo-Volm Cancer Center
-
Appleton、Wisconsin、アメリカ、54911
- ThedaCare Regional Cancer Center
-
Ashland、Wisconsin、アメリカ、54806
- Duluth Clinic Ashland
-
Hayward、Wisconsin、アメリカ、54843
- Essentia Health-Hayward Clinic
-
La Crosse、Wisconsin、アメリカ、54601
- Gundersen Lutheran Medical Center
-
Medford、Wisconsin、アメリカ、54451
- Aspirus Medford Hospital
-
Mukwonago、Wisconsin、アメリカ、53149
- ProHealth D N Greenwald Center
-
Oconomowoc、Wisconsin、アメリカ、53066
- ProHealth Oconomowoc Memorial Hospital
-
Rhinelander、Wisconsin、アメリカ、54501
- Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
-
Spooner、Wisconsin、アメリカ、54801
- Essentia Health-Spooner Clinic
-
Stevens Point、Wisconsin、アメリカ、54481
- Aspirus Cancer Care - Stevens Point
-
Superior、Wisconsin、アメリカ、54880
- Essentia Health Saint Mary's Hospital - Superior
-
Waukesha、Wisconsin、アメリカ、53188
- UW Cancer Center at ProHealth Care
-
Wausau、Wisconsin、アメリカ、54401
- Aspirus Cancer Care-Wausau
-
Wisconsin Rapids、Wisconsin、アメリカ、54494
- Aspirus Cancer Care - Wisconsin Rapids
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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
他の名前：
Undergo CT scan
他の名前：
Undergo echocardiography
他の名前：
Given IV
他の名前：
|
|
実験的：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
他の名前：
Undergo CT scan
他の名前：
Undergo echocardiography
他の名前：
Given IV
他の名前：
Given PO
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Disease free survival (DFS)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall survival (OS)
時間枠：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
時間枠：Up to 10 years
|
Toxicity will be assessed by summaries by Common Terminology Criteria for Adverse Event grade. |
Up to 10 years
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
組織、血液、便の生体試料の相関分析
時間枠：最長10年
|
最長10年
|
|
|
Estimates of treatment effect by sex
時間枠：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
時間枠：Up to 10 years
|
Estimates of DFS and the corresponding 95% CIs by race. |
Up to 10 years
|
|
Estimates of treatment effect by ethnicity
時間枠：Up to 10 years
|
Estimates of DFS and the corresponding 95% CIs by ethnicity. |
Up to 10 years
|
|
DFS according to PD-L1 status
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Up to 10 years
|
Will be compared between treatment arms using the logrank test and Cox modeling. |
Up to 10 years
|
協力者と研究者
捜査官
- 主任研究者：Dwight H Owen、ECOG-ACRIN Cancer Research Group
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- NCI-2024-10081
- U10CA180820 (米国 NIH グラント/契約)
- NCI-2024-10081 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
- EA5231 (その他の識別子：CTEP)
- EA5231 (その他の識別子：ECOG-ACRIN Cancer Research Group)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。