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ACTIVE NOT RECRUITING

NCT06732401

PHASE3

Testing the Addition of AZD6738 (Ceralasertib) to Immunotherapy to Increase Time Without Cancer for Patients With Non-Small Cell Lung Cancer

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

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. 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.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

630

Start Date

2025-08-07

Completion Date

2028-06-30

Last Updated

2026-04-09

Healthy Volunteers

Conditions

Lung Non-Small Cell Carcinoma Stage II Lung Cancer AJCC v8 Stage IIIA Lung Cancer AJCC v8 Stage IIIB Lung Cancer AJCC v8

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Ceralasertib

Given PO

PROCEDURE

Computed Tomography

Undergo CT scan

BIOLOGICAL

Durvalumab

Given IV

PROCEDURE

Echocardiography Test

Undergo echocardiography

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

Locations (193)

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, United States

Tower Cancer Research Foundation

Beverly Hills, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

Cedars-Sinai Cancer - Tarzana

Tarzana, California, United States

Torrance Memorial Physician Network - Cancer Care

Torrance, California, United States

Hartford Hospital

Hartford, Connecticut, United States

Midstate Medical Center

Meriden, Connecticut, United States

The Hospital of Central Connecticut

New Britain, Connecticut, United States

Beebe South Coastal Health Campus

Millville, Delaware, United States

Helen F Graham Cancer Center

Newark, Delaware, United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Beebe Health Campus

Rehoboth Beach, Delaware, United States

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Emory Decatur Hospital

Decatur, Georgia, United States

Emory Johns Creek Hospital

Johns Creek, Georgia, United States

Saint Luke's Cancer Institute - Boise

Boise, Idaho, United States

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, United States

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, United States

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, United States

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, United States

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, United States

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, United States

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Illinois CancerCare-Canton

Canton, Illinois, United States

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Northwestern University

Chicago, Illinois, United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, United States

Illinois CancerCare-Dixon

Dixon, Illinois, United States

Crossroads Cancer Center

Effingham, Illinois, United States

Illinois CancerCare-Eureka

Eureka, Illinois, United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, United States

Northwestern Medicine Glenview Outpatient Center

Glenview, Illinois, United States

Northwestern Medicine Grayslake Outpatient Center

Grayslake, Illinois, United States

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, United States

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

HSHS Saint Elizabeth's Hospital

O'Fallon, Illinois, United States

Northwestern Medicine Oak Brook

Oak Brook, Illinois, United States

Northwestern Medicine Orland Park

Orland Park, Illinois, United States

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Illinois CancerCare-Pekin

Pekin, Illinois, United States

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Illinois CancerCare-Peru

Peru, Illinois, United States

Illinois CancerCare-Princeton

Princeton, Illinois, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Springfield Clinic

Springfield, Illinois, United States

Springfield Memorial Hospital

Springfield, Illinois, United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States

Illinois CancerCare - Washington

Washington, Illinois, United States

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Cancer Center of Kansas - El Dorado

El Dorado, Kansas, United States

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Cancer Center of Kansas - Newton

Newton, Kansas, United States

The University of Kansas Cancer Center - Olathe

Olathe, Kansas, United States

Salina Regional Health Center

Salina, Kansas, United States

University of Kansas Health System Saint Francis Campus

Topeka, Kansas, United States

Cancer Center of Kansas - Wellington

Wellington, Kansas, United States

Cancer Center of Kansas-Wichita Medical Arts Tower

Wichita, Kansas, United States

Ascension Via Christi Hospitals Wichita

Wichita, Kansas, United States

Cancer Center of Kansas - Wichita

Wichita, Kansas, United States

Cancer Center of Kansas - Winfield

Winfield, Kansas, United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

UM Baltimore Washington Medical Center/Tate Cancer Center

Glen Burnie, Maryland, United States

Beverly Hospital

Beverly, Massachusetts, United States

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

Addison Gilbert Hospital

Gloucester, Massachusetts, United States

Lahey Medical Center-Peabody

Peabody, Massachusetts, United States

Baystate Medical Center

Springfield, Massachusetts, United States

Bronson Battle Creek

Battle Creek, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, United States

Cancer Hematology Centers - Flint

Flint, Michigan, United States

Genesee Hematology Oncology PC

Flint, Michigan, United States

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Hurley Medical Center

Flint, Michigan, United States

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, United States

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, United States

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

West Michigan Cancer Center

Kalamazoo, Michigan, United States

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

Trinity Health Muskegon Hospital

Muskegon, Michigan, United States

Corewell Health Lakeland Hospitals - Niles Hospital

Niles, Michigan, United States

Cancer and Hematology Centers of Western Michigan - Norton Shores

Norton Shores, Michigan, United States

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, United States

Corewell Health Reed City Hospital

Reed City, Michigan, United States

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Saint Joseph, Michigan, United States

Corewell Health Lakeland Hospitals - Saint Joseph Hospital

Saint Joseph, Michigan, United States

Munson Medical Center

Traverse City, Michigan, United States

University of Michigan Health - West

Wyoming, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, United States

Essentia Health Saint Joseph's Medical Center

Brainerd, Minnesota, United States

Mercy Hospital

Coon Rapids, Minnesota, United States

Essentia Health - Deer River Clinic

Deer River, Minnesota, United States

Essentia Health Cancer Center

Duluth, Minnesota, United States

Fairview Southdale Hospital

Edina, Minnesota, United States

Essentia Health Hibbing Clinic

Hibbing, Minnesota, United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Minneapolis VA Medical Center

Minneapolis, Minnesota, United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

United Hospital

Saint Paul, Minnesota, United States

Essentia Health Sandstone

Sandstone, Minnesota, United States

Essentia Health Virginia Clinic

Virginia, Minnesota, United States

Baptist Memorial Hospital and Cancer Center-Golden Triangle

Columbus, Mississippi, United States

Baptist Cancer Center-Grenada

Grenada, Mississippi, United States

Baptist Memorial Hospital and Cancer Center-Union County

New Albany, Mississippi, United States

Baptist Memorial Hospital and Cancer Center-Oxford

Oxford, Mississippi, United States

Baptist Memorial Hospital and Cancer Center-Desoto

Southhaven, Mississippi, United States

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Parkland Health Center - Farmington

Farmington, Missouri, United States

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, United States

Mercy Hospital South

St Louis, Missouri, United States

Missouri Baptist Medical Center

St Louis, Missouri, United States

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, United States

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, United States

Community Hospital of Anaconda

Anaconda, Montana, United States

Billings Clinic Cancer Center

Billings, Montana, United States

Saint Vincent Frontier Cancer Center

Billings, Montana, United States

Bozeman Health Deaconess Hospital

Bozeman, Montana, United States

Benefis Sletten Cancer Institute

Great Falls, Montana, United States

Community Medical Center

Missoula, Montana, United States

New Hampshire Oncology Hematology PA-Concord

Concord, New Hampshire, United States

Solinsky Center for Cancer Care

Manchester, New Hampshire, United States

Hunterdon Medical Center

Flemington, New Jersey, United States

Glens Falls Hospital

Glens Falls, New York, United States

Montefiore Medical Center-Einstein Campus

The Bronx, New York, United States

FirstHealth of the Carolinas-Moore Regional Hospital

Pinehurst, North Carolina, United States

Essentia Health Cancer Center-South University Clinic

Fargo, North Dakota, United States

Aultman Health Foundation

Canton, Ohio, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Providence Newberg Medical Center

Newberg, Oregon, United States

Providence Willamette Falls Medical Center

Oregon City, Oregon, United States

Providence Portland Medical Center

Portland, Oregon, United States

Providence Saint Vincent Medical Center

Portland, Oregon, United States

Oregon Health and Science University

Portland, Oregon, United States

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, United States

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, United States

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, United States

Pocono Medical Center

East Stroudsburg, Pennsylvania, United States

UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, United States

UPMC Cancer Centers - Arnold Palmer Pavilion

Greensburg, Pennsylvania, United States

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Harrisburg, Pennsylvania, United States

Lehigh Valley Hospital-Hazleton

Hazleton, Pennsylvania, United States

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Mechanicsburg, Pennsylvania, United States

Riddle Memorial Hospital

Media, Pennsylvania, United States

UPMC Hillman Cancer Center - Monroeville

Monroeville, Pennsylvania, United States

Paoli Memorial Hospital

Paoli, Pennsylvania, United States

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

UPMC-Saint Clair Hospital Cancer Center

Pittsburgh, Pennsylvania, United States

Reading Hospital

West Reading, Pennsylvania, United States

Lankenau Medical Center

Wynnewood, Pennsylvania, United States

Tidelands Georgetown Memorial Hospital

Georgetown, South Carolina, United States

Baptist Memorial Hospital and Cancer Center-Collierville

Collierville, Tennessee, United States

Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, United States

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

University of Virginia Cancer Center

Charlottesville, Virginia, United States

Hematology Oncology Associates of Fredericksburg Inc

Fredericksburg, Virginia, United States

Virginia Cancer Institute

Richmond, Virginia, United States

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, United States

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States

VCU Community Memorial Health Center

South Hill, Virginia, United States

Edwards Comprehensive Cancer Center

Huntington, West Virginia, United States

West Virginia University Healthcare

Morgantown, West Virginia, United States

Camden Clark Medical Center

Parkersburg, West Virginia, United States

Langlade Hospital and Cancer Center

Antigo, Wisconsin, United States

ThedaCare Regional Cancer Center

Appleton, Wisconsin, United States

Duluth Clinic Ashland

Ashland, Wisconsin, United States

Essentia Health-Hayward Clinic

Hayward, Wisconsin, United States

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

Aspirus Medford Hospital

Medford, Wisconsin, United States

ProHealth D N Greenwald Center

Mukwonago, Wisconsin, United States

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, United States

Aspirus Cancer Care - James Beck Cancer Center

Rhinelander, Wisconsin, United States

Essentia Health-Spooner Clinic

Spooner, Wisconsin, United States

Aspirus Cancer Care - Stevens Point

Stevens Point, Wisconsin, United States

Essentia Health Saint Mary's Hospital - Superior

Superior, Wisconsin, United States

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, United States

Aspirus Regional Cancer Center

Wausau, Wisconsin, United States

Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, United States

Clinical Research Directory

Testing the Addition of AZD6738 (Ceralasertib) to Immunotherapy to Increase Time Without Cancer for Patients With Non-Small Cell Lung Cancer

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (193)