Lung Non-Small Cell CarcinomaPhase 3NCT06732401
Testing the Addition of AZD6738 (Ceralasertib) to Immunotherapy to Increase Time Without Cancer for Patients With Non-Small Cell Lung Cancer
A Phase 3 study testing Biospecimen Collection, Ceralasertib and Computed Tomography in people with Lung Non-Small Cell Carcinoma and Stage II Lung Cancer AJCC v8, run by National Cancer Institute (NCI) at 192 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8
- What is being tested?
- Biospecimen Collection, Ceralasertib and Computed Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 630 participants
- Where
- 192 sitesUnited States
- Study dates
- 7 Aug 2025to 30 Jun 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
None listed.
Trial locations and contacts
192 sites in 1 country.
192 sites in 1 country
United States192 sites
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
Community Hospital of Anaconda
Anaconda, Montana, 59711
Aspirus Cancer Care-Antigo-Volm Cancer Center
Antigo, Wisconsin, 54409
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
Duluth Clinic Ashland
Ashland, Wisconsin, 54806
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
Bronson Battle Creek
Battle Creek, Michigan, 49017
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017
Beverly Hospital
Beverly, Massachusetts, 01915
Tower Cancer Research Foundation
Beverly Hills, California, 90211
Billings Clinic Cancer Center
Billings, Montana, 59101
Saint Vincent Frontier Cancer Center
Billings, Montana, 59102
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
Lahey Clinic
Burlington, Massachusetts, 01805
Illinois CancerCare-Canton
Canton, Illinois, 61520
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
Aultman Health Foundation
Canton, Ohio, 44710
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
Northwestern University
Chicago, Illinois, 60611
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, 38017
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, 39705
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire, 03301
Mercy Hospital
Coon Rapids, Minnesota, 55433
Emory Decatur Hospital
Decatur, Georgia, 30033
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Decatur Memorial Hospital
Decatur, Illinois, 62526
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301
Fairview Southdale Hospital
Edina, Minnesota, 55435
Crossroads Cancer Center
Effingham, Illinois, 62401
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, 67042
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, 16505
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, 58103
Parkland Health Center - Farmington
Farmington, Missouri, 63640
Hunterdon Medical Center
Flemington, New Jersey, 08822
Cancer Hematology Centers - Flint
Flint, Michigan, 48503
Genesee Hematology Oncology PC
Flint, Michigan, 48503
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Hurley Medical Center
Flint, Michigan, 48503
Hematology Oncology Associates of Fredericksburg Inc
Fredericksburg, Virginia, 22408
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134
Tidelands Georgetown Memorial Hospital
Georgetown, South Carolina, 29440
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland, 21061
Glens Falls Hospital
Glens Falls, New York, 12801
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, 60026
Addison Gilbert Hospital
Gloucester, Massachusetts, 01930
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, 60030
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, 15601
Baptist Cancer Center-Grenada
Grenada, Mississippi, 38901
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, 17109
Hartford Hospital
Hartford, Connecticut, 06102
Essentia Health-Hayward Clinic
Hayward, Wisconsin, 54843
Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania, 18201
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
Edwards Comprehensive Cancer Center
Huntington, West Virginia, 25701
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Emory Johns Creek Hospital
Johns Creek, Georgia, 30097
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, 72401
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912
Lawrence Memorial Hospital
Lawrence, Kansas, 66044
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
Solinsky Center for Cancer Care
Manchester, New Hampshire, 03103
Loyola University Medical Center
Maywood, Illinois, 60153
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania, 17050
Aspirus Medford Hospital
Medford, Wisconsin, 54451
Riddle Memorial Hospital
Media, Pennsylvania, 19063
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120
Midstate Medical Center
Meriden, Connecticut, 06451
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642
Beebe South Coastal Health Campus
Millville, Delaware, 19967
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
Minneapolis VA Medical Center
Minneapolis, Minnesota, 55417
Community Medical Center
Missoula, Montana, 59804
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania, 15146
West Virginia University Healthcare
Morgantown, West Virginia, 26506
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83687
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi, 38652
The Hospital of Central Connecticut
New Britain, Connecticut, 06050
Helen F Graham Cancer Center
Newark, Delaware, 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
Providence Newberg Medical Center
Newberg, Oregon, 97132
Cancer Center of Kansas - Newton
Newton, Kansas, 67114
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, 49120
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, 49444
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, 62269
Northwestern Medicine Oak Brook
Oak Brook, Illinois, 60523
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
The University of Kansas Cancer Center - Olathe
Olathe, Kansas, 66061
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045
Northwestern Medicine Orland Park
Orland Park, Illinois, 60462
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, 38655
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301
Camden Clark Medical Center
Parkersburg, West Virginia, 26101
Lahey Clinic Peabody
Peabody, Massachusetts, 01960
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
Illinois CancerCare-Peru
Peru, Illinois, 61354
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, 28374
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania, 15243
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341
Providence Portland Medical Center
Portland, Oregon, 97213
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
Oregon Health and Science University
Portland, Oregon, 97239
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
Corewell Health Reed City Hospital
Reed City, Michigan, 49677
Beebe Health Campus
Rehoboth Beach, Delaware, 19971
Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
Rhinelander, Wisconsin, 54501
Virginia Cancer Institute
Richmond, Virginia, 23229
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, 49085
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
Regions Hospital
Saint Paul, Minnesota, 55101
United Hospital
Saint Paul, Minnesota, 55102
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670
Salina Regional Health Center
Salina, Kansas, 67401
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, 83864
Essentia Health Sandstone
Sandstone, Minnesota, 55072
VCU Community Memorial Health Center
South Hill, Virginia, 23970
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, 38671
Essentia Health-Spooner Clinic
Spooner, Wisconsin, 54801
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Springfield Clinic
Springfield, Illinois, 62702
Springfield Memorial Hospital
Springfield, Illinois, 62781
Baystate Medical Center
Springfield, Massachusetts, 01199
Mercy Hospital South
St Louis, Missouri, 63128
Missouri Baptist Medical Center
St Louis, Missouri, 63131
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, 54481
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080
Essentia Health Saint Mary's Hospital - Superior
Superior, Wisconsin, 54880
Cedars-Sinai Cancer - Tarzana
Tarzana, California, 91356
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, 66606
Torrance Memorial Physician Network - Cancer Care
Torrance, California, 90505
Munson Medical Center
Traverse City, Michigan, 49684
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555
Illinois CancerCare - Washington
Washington, Illinois, 61571
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188
Aspirus Cancer Care-Wausau
Wausau, Wisconsin, 54401
Cancer Center of Kansas - Wellington
Wellington, Kansas, 67152
Reading Hospital
West Reading, Pennsylvania, 19611
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, 67208
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, 67214
Cancer Center of Kansas - Wichita
Wichita, Kansas, 67214
Cancer Center of Kansas - Winfield
Winfield, Kansas, 67156
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
University of Michigan Health - West
Wyoming, Michigan, 49519
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197
About this study
Official title: A Randomized Phase III Trial of Checkpoint Blockade in Lung CancEr Patients in the Adjuvant Setting Based on Pathologic Response Following Neoadjuvant Therapy (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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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:
- 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.
- Conditions
- Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8
- Being tested
- Biospecimen Collection, Ceralasertib, Computed Tomography, Durvalumab, Echocardiography Test
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo blood sample collection
CeralasertibDrug
Also called AZD6738
Given PO
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT scan
DurvalumabBiological
Also called Imfinzi, Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer, MEDI 4736, MEDI-4736
Given IV
Echocardiography TestProcedure or surgery
Also called EC, Echocardiography
Undergo echocardiography
| Study group | Role | What they receive |
|---|---|---|
| Arm A (Durvalumab) | Active comparator | 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. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Biological: Durvalumab; Procedure: Echocardiography Test |
| Arm B (Durvalumab and AZD6738) | Experimental | 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. Receives: Procedure: Biospecimen Collection; Drug: Ceralasertib; Procedure: Computed Tomography; Biological: Durvalumab; Procedure: Echocardiography Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival (DFS)
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.
Measured: 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
Secondary outcomes (2)
Overall survival (OS)
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.
Measured: From randomization to death from any cause, up to 10 years
Incidence of adverse events
Toxicity will be assessed by summaries by Common Terminology Criteria for Adverse Event grade.
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start7 Aug 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Non-Small Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 630 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Dwight H Owen, Principal investigator, ECOG-ACRIN Cancer Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732401
- Sponsor's protocol ID
- NCI-2024-10081
- Other IDs
- NCI-2024-10081, EA5231, EA5231, U10CA180820
- Status last verified
- Aug 2026
- First submitted
- 12 Dec 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.