AzTrials
AzTrials

Lung Non-Small Cell CarcinomaPhase 3NCT04214262

Testing the Addition of the Drug Atezolizumab to the Usual Radiation Treatment for Patients With Early Non-small Cell Lung Cancer

A Phase 3 study testing Atezolizumab, Biospecimen Collection and Computed Tomography in people with Lung Non-Small Cell Carcinoma and Stage I Lung Cancer AJCC v8, run by National Cancer Institute (NCI) at 390 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This phase III trial studies how well atezolizumab added to the usual radiation therapy works in treating patients with stage I-IIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Atezolizumab, Biospecimen Collection and Computed Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
417 participants
Where
390 sitesUnited States
Study dates
13 Aug 2020to 9 Jun 2027
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Patient must have histologically or cytologically proven stage I-IIA or limited T3N0M0 non-small cell lung cancer (NSCLC), without radiographic evidence of nodal or distant involvement (N0M0). Patient may have T3 disease with the exclusion of pericardial involvement. Patients with multifocal tumors with no more than two lesions confirmed or suspected to be synchronous early stage NSCLCs are eligible provided at least one lesion is histologically or cytologically proven to be NSCLC and meets one or more high-risk features
  • Disease must have one or more of the following high-risk features:
  • Tumor diameter >= 2 cm (inclusive of any non-solid, ground glass component) as assessed by diagnostic CT
  • Tumor standard uptake value (SUV) max >= 6.2 as assessed by FDG PET/CT
  • Moderately differentiated, poorly differentiated, or undifferentiated histology
  • Patient must have undergone diagnostic chest CT with or without contrast (IV contrast preferred) within 42 days prior to randomization. PET-CT may be used if the CT portion is of comparable diagnostic quality to a stand-alone CT. All disease must be assessed within 42 days prior to randomization
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  • Patient must have undergone FDG PET/CT of chest within 90 days prior to randomization
  • Patient must not have evidence of hilar or mediastinal nodal involvement. Any patient with radiographically suspicious hilar or mediastinal nodes (including features such as non-calcified nodes with a short axis diameter > 1 cm, abnormal morphology, and/or elevated FDG avidity) must undergo cytologic sampling of suspicious nodes to rule out involvement prior to randomization. Mediastinal nodal sampling for other patients is optional. For cases in which the treating physician/multidisciplinary opinion is used to define nodes as "non-suspicious" (such as long-standing, stable enlarged nodes from other medical causes), the rationale must be clearly documented within the medical record
  • Patient must have undergone history and physical examination within 28 days prior to randomization
  • Patient must be medically or surgically inoperable as documented by the evaluating thoracic surgeon or multi-disciplinary tumor board consensus OR patient's unwillingness to undergo surgical resection must be clearly documented
  • Patient must not have received any prior treatment for the current NSCLC diagnosis
  • Patient must not have undergone prior radiation to overlapping regions of the chest that, in the opinion of the treatment physician, will interfere with protocol treatment
  • Patient must not have received treatment with systemic immunostimulatory or immunosuppressive agents, including corticosteroids, within 14 days prior to randomization
  • Patient must be >= 18 years old
  • Patient must have Zubrod performance status of 0-2
  • Patient must have adequate liver function defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x institutional upper level of normal (IULN) within 28 days prior to randomization
  • Patient must have adequate renal function defined as calculated creatinine clearance >= 30 mL/min using the following formula. The serum creatinine value used in the calculation must have been collected within 28 days prior to randomization
  • Patient must have absolute neutrophil count (ANC), platelets, and hemoglobin measured within 28 days prior to randomization. The purpose of these tests is to collect baseline values to compare with on-treatment values
  • Patient must have thyroid-stimulating hormone (TSH) measured within 28 days prior to randomization. The purpose of this test is to collect baseline values to compare with on-treatment values
  • Patient must not have significant cardiovascular disease (New York Heart Association [NYHA] class II or greater)
  • Patient must not have myocardial infarction within 90 days prior to randomization
  • Patient must not have unstable arrhythmias or unstable angina
  • Patient must not have known left ventricular ejection fraction (LVEF) < 40% within 28 days prior to randomization
  • NOTE: Assessment of LVEF by echocardiogram or multigated acquisition (MUGA) is not an eligibility requirement, but if a standard of care echocardiogram or MUGA was clinically indicated, the LVEF must not be < 40% within 28 days prior to randomization
  • Patient must not have had an infection >= grade 3 (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) within 28 days prior to randomization
  • Patient must not have an active autoimmune disease that has required systemic treatment in past two years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
  • Patient must be tested for hepatitis B within 28 days prior to randomization. Patient must not have active (chronic or acute) hepatitis B virus (HBV) infection. Patients may have past or resolved HBV infection
  • Active HBV is defined as having a positive hepatitis B surface antigen (HBsAg) test
  • Past or resolved HBV is defined as having a negative HBsAG test and a positive total hepatitis B core antibody (HBcAb) test
  • Patient must be tested for hepatitis C within 28 days prior to randomization. Patient must not have active hepatitis C virus (HCV) infection
  • Active HCV is defined as having a positive HCV antibody test followed by a positive HCV ribonucleic acid (RNA) test
  • Patient must have pulmonary function testing to include, at a minimum, forced expiratory volume in 1 second (FEV1) and Diffusing capability of carbon monoxide (DLCO) documented within 90 days prior to randomization
  • Patients with known human immunodeficiency virus (HIV) infection must be receiving anti-retroviral therapy and have an undetectable viral load at their most recent viral load test within 6 months prior to randomization
  • Patient must not have a history of clinically significant interstitial lung disease or evidence of active pneumonitis on the screening chest CT
  • Patients must not have a prior or concurrent malignancy whose natural history or treatment has the potential (in the opinion of the treating physician) to interfere with the safety or efficacy assessment of the investigational regimen
  • Patients must not be pregnant due to the potential teratogenic side effects of the protocol treatment. Women of reproductive potential and men must have agreed to use an effective contraception method for the duration of protocol treatment, and for 5 months (150 days) after the last dose of atezolizumab. A woman is considered to be of "reproductive potential" if she has had a menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with atezolizumab, breastfeeding must be discontinued prior to randomization
  • Patients of reproductive potential must have a negative serum pregnancy test within 14 days prior to randomization
  • Patients must not have known active tuberculosis
  • Patients must not have received a live, attenuated vaccine within 28 days prior to randomization
  • NOTE: All coronavirus disease 2019 (COVID-19) vaccines that have received Food and Drug Administration (FDA) approval or FDA emergency use authorization are acceptable
  • Patients must not have a known history of allergic reactions attributed to compounds of similar chemical or biologic composition to atezolizumab
  • Patients must not have a known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric antibodies, fusion proteins, or Chinese hamster ovary cell products or to any component of the atezolizumab formulation
  • Patient must agree to have specimens submitted for translational medicine and banking
  • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
  • Patients who can complete quality of life instruments in English, French, or Spanish must agree to complete the questionnaires at the protocol-specified time points

Who cannot join

None listed.

Trial locations and contacts

390 sites in 1 country.

300 sites in 1 country

United States300 sites

  • Hawaii Cancer Care - Westridge

    ‘Aiea, Hawaii, 96701

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

  • Aspirus Cancer Care-Antigo-Volm Cancer Center

    Antigo, Wisconsin, 54409

  • Kaiser Permanente-Deer Valley Medical Center

    Antioch, California, 94531

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

  • Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton

    Appleton, Wisconsin, 54915

  • Messino Cancer Centers

    Asheville, North Carolina, 28806

  • Northwest Wisconsin Cancer Center

    Ashland, Wisconsin, 54806

  • Augusta Oncology Associates PC-D'Antignac

    Augusta, Georgia, 30901

  • Augusta University Medical Center

    Augusta, Georgia, 30912

  • Rocky Mountain Regional VA Medical Center

    Aurora, Colorado, 80045

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045

  • Rush-Copley Medical Center

    Aurora, Illinois, 60504

  • GenesisCare USA - Aventura FP

    Aventura, Florida, 33180

  • GenesisCare USA - Aventura

    Aventura, Florida, 33180

  • AIS Cancer Center at San Joaquin Community Hospital

    Bakersfield, California, 93301

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • LSU Health Baton Rouge-North Clinic

    Baton Rouge, Louisiana, 70805

  • Our Lady of the Lake Physician Group

    Baton Rouge, Louisiana, 70808

  • Louisiana Hematology Oncology Associates LLC

    Baton Rouge, Louisiana, 70809

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Nebraska Medicine-Bellevue

    Bellevue, Nebraska, 68123

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

  • Beverly Hospital

    Beverly, Massachusetts, 01915

  • Tower Cancer Research Foundation

    Beverly Hills, California, 90211

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • OSF Saint Joseph Medical Center

    Bloomington, Illinois, 61701

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Saint Joseph's/Candler - Bluffton Campus

    Bluffton, South Carolina, 29910

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

  • Trinity Health Medical Center - Brighton

    Brighton, Michigan, 48114

  • Ascension Southeast Wisconsin Hospital-Elmbrook Campus-Brookfield

    Brookfield, Wisconsin, 53045

  • New York-Presbyterian/Brooklyn Methodist Hospital

    Brooklyn, New York, 11215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Lahey Clinic

    Burlington, Massachusetts, 01805

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Trinity Health Medical Center - Canton

    Canton, Michigan, 48188

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • UNC Health Cancer Care Cary

    Cary, North Carolina, 27518

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

  • Vandalia Health/CAMC Institute for Academic Medicine

    Charleston, West Virginia, 25304

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • Chelsea Hospital

    Chelsea, Michigan, 48118

  • Jesse Brown Veterans Affairs Medical Center

    Chicago, Illinois, 60612

  • University of Illinois

    Chicago, Illinois, 60612

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Ascension Calumet Hospital-Chilton

    Chilton, Wisconsin, 53014

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Michigan Healthcare Professionals Clarkston

    Clarkston, Michigan, 48346

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic

    Clive, Iowa, 50325

  • Baptist Memorial Hospital and Cancer Center-Collierville

    Collierville, Tennessee, 38017

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • UCHealth Memorial Hospital Central

    Colorado Springs, Colorado, 80909

  • Memorial Hospital North

    Colorado Springs, Colorado, 80920

  • Baptist Memorial Hospital and Cancer Center-Golden Triangle

    Columbus, Mississippi, 39705

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • UT MD Anderson - The Woodlands

    Conroe, Texas, 77384

  • Mary Imogene Bassett Hospital

    Cooperstown, New York, 13326

  • Greater Regional Medical Center

    Creston, Iowa, 50801

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Premier Blood and Cancer Center

    Dayton, Ohio, 45409

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

  • Corewell Health Dearborn Hospital

    Dearborn, Michigan, 48124

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Kaiser Permanente-Franklin

    Denver, Colorado, 80205

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, 50314

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Henry Ford Health Saint John Hospital

    Detroit, Michigan, 48236

  • Bayhealth Hospital Kent Campus

    Dover, Delaware, 19901

  • Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • Kaiser Permanente Dublin

    Dublin, California, 94568

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

  • Durham VA Medical Center

    Durham, North Carolina, 27705

  • The Cancer Institute at Saint Francis Hospital

    East Hills, New York, 11548

  • Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

  • HSHS Sacred Heart Hospital

    Eau Claire, Wisconsin, 54701

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Arnot Ogden Medical Center/Falck Cancer Center

    Elmira, New York, 14905

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • Smilow Cancer Hospital Care Center-Fairfield

    Fairfield, Connecticut, 06824

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

  • Michigan Healthcare Professionals Farmington

    Farmington Hills, Michigan, 48334

  • Corewell Health Farmington Hills Hospital

    Farmington Hills, Michigan, 48336

  • Augusta Health Center for Cancer and Blood Disorders

    Fishersville, Virginia, 22939

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • McLeod Regional Medical Center

    Florence, South Carolina, 29506

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Cancer Care and Hematology-Fort Collins

    Fort Collins, Colorado, 80528

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Reiman Cancer Center-Ascension Wisconsin Health Center-Rawson

    Franklin, Wisconsin, 53132

  • Kaiser Permanente-Fremont

    Fremont, California, 94538

  • Kaiser Permanente-Fresno

    Fresno, California, 93720

  • Gibbs Cancer Center-Gaffney

    Gaffney, South Carolina, 29341

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • UNC Health Cancer Care Garner

    Garner, North Carolina, 27529

  • CaroMont Regional Medical Center

    Gastonia, North Carolina, 28054

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022

  • Addison Gilbert Hospital

    Gloucester, Massachusetts, 01930

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

  • Nebraska Cancer Specialists/Oncology Hematology West PC

    Grand Island, Nebraska, 68803

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Banner North Colorado Medical Center

    Greeley, Colorado, 80631

  • UCHealth Greeley Hospital

    Greeley, Colorado, 80631

  • Bellin Memorial Hospital

    Green Bay, Wisconsin, 54301

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

  • Saint Francis Cancer Center

    Greenville, South Carolina, 29607

  • Smilow Cancer Hospital Care Center at Greenwich

    Greenwich, Connecticut, 06830

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

  • Baptist Cancer Center-Grenada

    Grenada, Mississippi, 38901

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

  • Mount Carmel Grove City Hospital

    Grove City, Ohio, 43123

  • Smilow Cancer Hospital Care Center - Guilford

    Guilford, Connecticut, 06437

  • Smilow Cancer Hospital-Hamden Care Center

    Hamden, Connecticut, 06518

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • Margaret R Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • UCHealth Highlands Ranch Hospital

    Highlands Ranch, Colorado, 80129

  • Hawaii Cancer Care Inc - Waterfront Plaza

    Honolulu, Hawaii, 96813

  • Queen's Cancer Cenrer - POB I

    Honolulu, Hawaii, 96813

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

  • Queen's Cancer Center - Kuakini

    Honolulu, Hawaii, 96817

  • The Cancer Center of Hawaii-Liliha

    Honolulu, Hawaii, 96817

  • Mary Bird Perkins Cancer Center - Houma

    Houma, Louisiana, 70360

  • Terrebonne General Medical Center

    Houma, Louisiana, 70360

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

  • UT MD Anderson - West Houston

    Houston, Texas, 77079

  • Novant Health Cancer Institute - Huntersville

    Huntersville, North Carolina, 28078

  • Edwards Comprehensive Cancer Center

    Huntington, West Virginia, 25701

  • IRMC Cancer Center

    Indiana, Pennsylvania, 15701

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Community Cancer Center South

    Indianapolis, Indiana, 46227

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

    Jonesboro, Arkansas, 72401

  • Freeman Health System

    Joplin, Missouri, 64804

  • Jupiter Medical Center

    Jupiter, Florida, 33458

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Kansas City Veterans Affairs Medical Center

    Kansas City, Missouri, 64128

  • CHI Health Good Samaritan

    Kearney, Nebraska, 68847

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142

  • Novant Health Cancer Institute - Kernersville

    Kernersville, North Carolina, 27284

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Ballad Health Cancer Care - Kingsport

    Kingsport, Tennessee, 37660

  • Wellmont Holston Valley Hospital and Medical Center

    Kingsport, Tennessee, 37660

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Mayo Clinic Health System-Franciscan Healthcare

    La Crosse, Wisconsin, 54601

  • Kaiser Permanente-Rock Creek

    Lafayette, Colorado, 80026

  • Northwell Health/Center for Advanced Medicine

    Lake Success, New York, 11042

  • University of Michigan Health - Sparrow Lansing

    Lansing, Michigan, 48912

  • Cancer Centers of Southwest Oklahoma Research

    Lawton, Oklahoma, 73505

  • UT MD Anderson - League City

    League City, Texas, 77573

  • Geisinger Medical Oncology-Lewisburg

    Lewisburg, Pennsylvania, 17837

  • CommonSpirit Saint Joseph Medical Center - East Lexington

    Lexington, Kentucky, 40509

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Veterans Affairs Loma Linda Healthcare System

    Loma Linda, California, 92357

  • Kaiser Permanente-Lone Tree

    Lone Tree, Colorado, 80124

  • Tibor Rubin VA Medical Center

    Long Beach, California, 90822

  • Los Angeles General Medical Center

    Los Angeles, California, 90033

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Medical Center of the Rockies

    Loveland, Colorado, 80538

  • Banner North Colorado Medical Center - Loveland Campus

    Loveland, Colorado, 80539

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • Michigan Healthcare Professionals Macomb

    Macomb, Michigan, 48044

  • William S Middleton VA Medical Center

    Madison, Wisconsin, 53705

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

  • Aurora Bay Area Medical Group-Marinette

    Marinette, Wisconsin, 54143

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

  • Fremont - Rideout Cancer Center

    Marysville, California, 95901

  • Novant Health Cancer Institute - Matthews

    Matthews, North Carolina, 28105

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Aspirus Medford Hospital

    Medford, Wisconsin, 54451

  • Baptist Memorial Hospital and Cancer Center-Memphis

    Memphis, Tennessee, 38120

  • Ascension Columbia Saint Mary's Hospital-Ozaukee Campus-Mequon

    Mequon, Wisconsin, 53097

  • East Jefferson General Hospital

    Metairie, Louisiana, 70006

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Beebe South Coastal Health Campus

    Millville, Delaware, 19967

  • Aurora Cancer Care-Milwaukee

    Milwaukee, Wisconsin, 53209

  • Ascension Columbia Saint Mary's Hospital-Milwaukee Campus

    Milwaukee, Wisconsin, 53211

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Marshfield Medical Center - Minocqua

    Minocqua, Wisconsin, 54548

  • Memorial Medical Center

    Modesto, California, 95355

  • Kaiser Permanente-Modesto

    Modesto, California, 95356

  • UPMC Cancer Center - Monroeville

    Monroeville, Pennsylvania, 15146

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

  • ProHealth D N Greenwald Center

    Mukwonago, Wisconsin, 53149

  • Saint Alphonsus Cancer Care Center-Nampa

    Nampa, Idaho, 83687

  • Baptist Memorial Hospital and Cancer Center-Union County

    New Albany, Mississippi, 38652

  • CarolinaEast Medical Center

    New Bern, North Carolina, 28561

  • Yale University

    New Haven, Connecticut, 06520

  • ThedaCare Cancer Care - New London

    New London, Wisconsin, 54961

  • Mount Sinai Chelsea

    New York, New York, 10011

  • Mount Sinai West

    New York, New York, 10019

  • Mount Sinai Hospital

    New York, New York, 10029

  • Manhattan Eye Ear and Throat Hospital

    New York, New York, 10065

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Lenox Hill Hospital

    New York, New York, 10075

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware, 19713

  • Corewell Health Lakeland Hospitals - Niles Hospital

    Niles, Michigan, 49120

  • Yale-New Haven Hospital North Haven Medical Center

    North Haven, Connecticut, 06473

  • Ballad Health Cancer Care - Norton

    Norton, Virginia, 24273

  • Henry Ford Health Providence Novi Hospital

    Novi, Michigan, 48374

  • Kaiser Permanente-Oakland

    Oakland, California, 94611

  • ProHealth Oconomowoc Memorial Hospital

    Oconomowoc, Wisconsin, 53066

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Mercy Hospital Oklahoma City

    Oklahoma City, Oklahoma, 73120

  • Nebraska Medicine-Village Pointe

    Omaha, Nebraska, 68118

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Saint Joseph Hospital - Orange

    Orange, California, 92868

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806

  • Ascension Northeast Wisconsin-Mercy Hospital-Oshkosh

    Oshkosh, Wisconsin, 54904

  • Vince Lombardi Cancer Clinic - Oshkosh

    Oshkosh, Wisconsin, 54904

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • Baptist Memorial Hospital and Cancer Center-Oxford

    Oxford, Mississippi, 38655

  • Desert Regional Medical Center

    Palm Springs, California, 92262

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

  • Memorial Hospital West

    Pembroke Pines, Florida, 33028

  • Capital Health Medical Center-Hopewell

    Pennington, New Jersey, 08534

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • OSF Saint Francis Radiation Oncology at Peoria Cancer Center

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Jefferson Torresdale Hospital

    Philadelphia, Pennsylvania, 19114

  • FirstHealth of the Carolinas-Moore Regional Hospital

    Pinehurst, North Carolina, 28374

  • UPMC-Saint Margaret

    Pittsburgh, Pennsylvania, 15215

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • UPMC-Shadyside Hospital

    Pittsburgh, Pennsylvania, 15232

  • GenesisCare USA - Plantation

    Plantation, Florida, 33324

  • Michigan Healthcare Professionals Pontiac

    Pontiac, Michigan, 48341

  • Trinity Health Saint Joseph Mercy Oakland Hospital

    Pontiac, Michigan, 48341

  • Legacy Good Samaritan Hospital and Medical Center

    Portland, Oregon, 97210

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

  • Geisinger Cancer Services-Pottsville

    Pottsville, Pennsylvania, 17901

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Ascension All Saints Hospital-Spring Street-Racine

    Racine, Wisconsin, 53405

  • Aurora Cancer Care-Racine

    Racine, Wisconsin, 53406

  • UNC Health Cancer Care Raleigh

    Raleigh, North Carolina, 27607

  • UNC Health Cancer Care Wakefield

    Raleigh, North Carolina, 27614

  • Beebe Health Campus

    Rehoboth Beach, Delaware, 19971

  • Aspirus Cancer Care-Rhinelander-James Beck Cancer Center

    Rhinelander, Wisconsin, 54501

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin, 54868

  • Kaiser Permanente-Richmond

    Richmond, California, 94801

  • UW Health Carbone Cancer Center Rockford

    Rockford, Illinois, 61114

  • Phelps Health Delbert Day Cancer Institute

    Rolla, Missouri, 65401

  • Kaiser Permanente-Roseville

    Roseville, California, 95661

  • Sutter Cancer Centers Radiation Oncology Services-Roseville

    Roseville, California, 95661

  • Sutter Roseville Medical Center

    Roseville, California, 95661

  • The Permanente Medical Group-Roseville Radiation Oncology

    Roseville, California, 95678

  • Corewell Health William Beaumont University Hospital

    Royal Oak, Michigan, 48073

  • Kaiser Permanente Downtown Commons

    Sacramento, California, 95814

  • Sutter Medical Center Sacramento

    Sacramento, California, 95816

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Kaiser Permanente-South Sacramento

    Sacramento, California, 95823

  • MyMichigan Medical Center Saginaw

    Saginaw, Michigan, 48601

  • Oncology Hematology Associates of Saginaw Valley PC

    Saginaw, Michigan, 48604

  • Coborn Cancer Center at Saint Cloud Hospital

    Saint Cloud, Minnesota, 56303

  • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

    Saint Joseph, Michigan, 49085

  • Corewell Health Lakeland Hospitals - Saint Joseph Hospital

    Saint Joseph, Michigan, 49085

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

Other trials in United States

About this study

Official title: A Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT Versus SBRT Alone in High Risk, Early Stage NSCLC

This phase III trial studies how well atezolizumab added to the usual radiation therapy works in treating patients with stage I-IIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy, such as stereotactic body radiation therapy, uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving atezolizumab and radiation therapy may work better than radiation therapy alone in treating patients with early non-small cell lung cancer.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To compare overall survival (OS) in patients with inoperable, early stage non-small cell lung cancer (NSCLC) randomized to stereotactic body radiation therapy (SBRT) with or without atezolizumab.

SECONDARY OBJECTIVES:

  1. To compare investigator-assessed progression-free survival (IA-PFS) between the arms.

II. To compare progression free survival (PFS) by blinded independent centralized review (BIRC) between the arms in a random subset of patients.

III. To evaluate distant, locoregional, and local failure rates within each treatment arm.

IV. To evaluate the frequency and severity of toxicities within each treatment arm.

ADDITIONAL OBJECTIVE:

  1. To collect specimens for banking.

HEALTH-RELATED QUALITY OF LIFE (HRQOL) OBJECTIVE:

  1. This objective will not be met, as the study was closed following the first interim analysis.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1 of each cycle. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Starting on day 1 cycle 3, patients also undergo SBRT for 3-8 treatments every 2 days or once daily (QD) over 1-3 weeks. Patients undergo fludeoxyglucose F-18 (FDG)-positron emission tomography/computed tomography (PET/CT) during screening. Patients undergo blood sample collection and CT scans throughout the trial.

ARM B: Beginning 21 days after randomization, patients undergo SBRT for 3-8 treatments every 2 days or QD over 1-3 weeks. Patients undergo FDG-PET/CT during screening. Patients undergo blood sample collection and CT scans throughout the trial.

After completion of study treatment, patients are followed for 5 years after randomization.

Being tested
Atezolizumab, Biospecimen Collection, Computed Tomography, Fludeoxyglucose F-18, Positron Emission Tomography
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.

  • AtezolizumabDrug

    Also called MPDL 3280A, MPDL 328OA, MPDL-3280A, MPDL3280A

    Given IV

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo blood sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT or PET/CT

  • Fludeoxyglucose F-18Other

    Also called 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18

    Undergo FDG PET/CT

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • Stereotactic Body Radiation TherapyRadiation

    Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

    Undergo SBRT

Study groups in NCT04214262
Study groupRoleWhat they receive
Arm A (atezolizumab, SBRT)ExperimentalPatients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Starting on day 1 cycle 3, patients also undergo SBRT for 3-8 treatments every 2 days or QD over 1-3 weeks. Patients undergo FDG-PET/CT during screening. Patients undergo blood sample collection and CT scans throughout the trial.
Receives: Drug: Atezolizumab; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Fludeoxyglucose F-18; Procedure: Positron Emission Tomography; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Stereotactic Body Radiation Therapy
Arm B (SBRT)Active comparatorBeginning 21 days after randomization, patients undergo SBRT for 3-8 treatments every 2 days or QD over 1-3 weeks. Patients undergo FDG-PET/CT during screening. Patients undergo blood sample collection and CT scans throughout the trial.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Fludeoxyglucose F-18; Procedure: Positron Emission Tomography; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Stereotactic Body Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Count of participants who have died, measured at two years from trial registration.

    Measured: From date of registration up to two years

Secondary outcomes (4)

  1. Incidence of Adverse Events

    Only adverse events that are possibly, probably or definitely related to study drug are reported.

    Measured: Up to 5 years after registration

  2. IA-PFS

    Compare investigator-assessed progression-free survival (IA-PFS) between the arms. IA-PFS is defined as 20% increase in the longest diameter of the primary lung tumor over smallest measurement observed using the same techniques as baseline, as well as an absolute increase of at least 0.5 cm, accompanied by confirmatory study (unequivocal PET findings or biopsy) OR appearance of any new lesion/site OR death due to disease without prior documentation of progression OR unequivocal PET findings and/or biopsy confirming malignancy in the absence of growth.

    Measured: From registration up to 5 years

  3. Progression Free Survival

    Compare PFS (progression free survival) by blinded independent centralized review (BIRC) between the arms in a random subset of patients. PFS is defined as time from date of randomization to date of first documentation of progression assessed by BICR, or death due to any cause. PFS-BICR-1 for patients last known to be alive without report of progression are censored at date of last disease assessment. For patients with a missing scan (or consecutive missing scans) whose subsequent scan determines progression, the expected date of the first missing scan (as defined by the disease assessment schedule) will be used as the date of progression.

    Measured: Up to 5 years from registration

  4. Distant, Locoregional, Local Failure Rates.

    Evaluate distant, locoregional, and local failure rates within each treatment arm. Treatment failure is defined as time from date of randomization to date of first documentation of investigator-assessed progression or symptomatic deterioration (as defined above), early discontinuation of treatment, or death due to any cause. Time to treatment failure for patients last known not to have failed treatment are censored at the date of last contact.

    Measured: Up to 5 years from registration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2020
  2. Study start13 Aug 2020
  3. Primary completion24 Aug 2024
  4. Study completion9 Jun 2027 (estimated)

Resources

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
417 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04214262
Sponsor's protocol ID
NCI-2019-08627
Other IDs
NCI-2019-08627, S1914, S1914, U10CA180888
Status last verified
Jun 2026
First submitted
30 Dec 2019
Last updated
27 Oct 2026
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.

Publications

  • Daly ME, Simone CB 2nd, Redman MW, Hsieh MH, Hesketh PJ, Hu C, Monjazeb AM, Steuer CE, Ganti AK, Kashani R, Bauman JR, Feliciano JL, Moon J, Ku K, Le-Lindqwister N, Baschnagel AM, Maraboyina S, Sherwood GB, Almquist D, Higgins KA, Gray JE, Bradley JD, Kelly K. Induction and consolidation atezolizumab with stereotactic body radiation therapy versus radiation alone in high-risk, early-stage non-small-cell lung cancer (SWOG/NRG S1914): a multicentre, open-label, superiority, phase 3, randomised controlled trial. Lancet. 2026 Sep 6:S0140-6736(26)01655-7. doi: 10.1016/S0140-6736(26)01655-7. Online ahead of print.

    PubMed 42702214

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atezolizumab, Biospecimen Collection and Computed Tomography in people with Lung Non-Small Cell Carcinoma and Stage I Lung Cancer AJCC v8, run by National Cancer Institute (NCI) at 390 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 46 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 390 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: From date of registration up to two years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04214262, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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