AzTrials
AzTrials

Locally Advanced Lung Non-Small Cell CarcinomaPhase 3NCT05624996

Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-Small Cell Lung Cancer

A Phase 3 study testing Carboplatin, Cisplatin and Computed Tomography in people with Locally Advanced Lung Non-Small Cell Carcinoma and Stage IIB Lung Cancer AJCC v8, run by NRG Oncology at 477 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This phase III trial compares the effect of adding stereotactic body radiation therapy (SBRT) to the usual treatment (conventional image guided radiation therapy [IGRT] and chemotherapy followed by immunotherapy with durvalumab or targeted therapy with osimertinib) versus the usual treatment alone in treating patients… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Carboplatin, Cisplatin and Computed Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
474 participants
Where
477 sitesin 2 countries
Study dates
12 Jul 2023to 15 Oct 2036
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Pathologically (histologically or cytologically) proven diagnosis of non-operable stage IIB or III, node positive (American Joint Committee on Cancer [AJCC] eighth edition) non-small cell lung cancer (NSCLC) with known PD-L1 status prior to registration
  • Patients must have an identified primary tumor and at least one nodal metastasis (peribronchial/hilar/intrapulmonary, mediastinal/subcarinal, supraclavicular/scalene)
  • Up to 4 cycles of systemic therapy received prior to registration for the current study cancer is allowable; any prior chemotherapy for a different cancer is also permissible
  • Patients who refuse surgery, in addition to those who are technically unresectable or medically inoperable, are eligible.
  • Patients with separate tumor nodules in the same lobe of the primary tumor are eligible
  • The patient must be deemed clinically appropriate for curative intent definitive combined modality therapy, based on the following staging assessments:
Show all 23Show fewer
  • History/physical examination prior to registration;
  • Magnetic resonance imaging (MRI) scan of the brain (preferred) or CT scan of the brain (if available, contrast is preferred for all neuroimaging) prior to registration;
  • CT chest with IV contrast (if contrast is available and unless contraindicated, such as for abnormal kidney function) prior to registration. PET/CT may be used if the CT portion is of identical diagnostic quality as achieved in a stand-alone CT
  • No evidence of distant metastases based on FDG PET/CT scan obtained within 60 days of registration
  • Primary tumor =< 7 cm
  • Age >= 18
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Hematologic function (e.g. platelets, leukocytes, hemoglobin) amenable, at the discretion of the treating physician, to allow for treatment with chemotherapy and concurrent radiation therapy
  • Creatinine clearance >= 25 mL/min by the Cockcroft-Gault (C-G) equation
  • Subjects with non-malignant pleural effusion are eligible provided the effusion is not known or demonstrated to be an exudative effusion
  • If a pleural effusion is present, the following criteria must be met to exclude malignant involvement:
  • When pleural fluid is visible on both the CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative;
  • Effusions that are minimal (i.e., not visible on chest x-ray) that are too small to safely tap are eligible
  • Medical history consistent with the patient being amenable, at the discretion of the treating physician, to allow for treating with consolidation immunotherapy. Patients with known EGFR/ALK/other driver mutation at the time of registration are eligible, and these patients can be treated with consolidation systemic therapy at the discretion of the treating physician
  • 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
  • Negative pregnancy test =< 14 days prior to registration for participants of childbearing potential
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information

Who cannot join

  • Prior radiotherapy to the study cancer (local recurrence). Prior radiotherapy for a different cancer/condition to the region of the study cancer that would result in overlap of radiation therapy fields that is determined by the treating physician to impede the treatment of the study malignancy
  • Patients without identifiable primary tumor and at least 1 pathologically enlarged lymph node are not eligible (T3-4N0 or T0N1-3 patients are not eligible). At least 1 radiographically-involved lymph node is required, but pathologic confirmation of involvement is not mandated
  • Centrally located primary tumor < 2 cm from involved nodal disease that would result in significant overlap of the primary SBRT and nodal radiation fields. This does not include proximity to involved segmental and subsegmental lymph nodes (levels 13 and 14) that would not result in overlap of dose to the proximal bronchial tree or esophagus. Centrally located is defined as within or touching the zone of the proximal bronchial tree, which is a volume 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus right and left lower lobe bronchi)
  • Participants who are pregnant or unwilling to discontinue nursing
  • Participants of childbearing potential (participants who may become pregnant or who may impregnate a partner) unwilling to use highly effective contraceptives during therapy and for the Food and Drug Administration (FDA)-labeled contraception timeframe required after the final dose of the selected systemic therapy regimen, because the treatment in this study may be significantly teratogenic

Trial locations and contacts

477 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

301 sites in 2 countries

United States300 sites, 277 recruiting

  • Hawaii Cancer Care - Westridge

    ‘Aiea, Hawaii, 96701

    Active, not recruiting

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

    Active, not recruiting

  • Cleveland Clinic Akron General

    Akron, Ohio, 44307

    Site Public Contact, 866-223-8100, CancerAnswer@ccf.org

    Ashok Ramalingam

    Recruiting

  • Atrium Health Stanly/LCI-Albemarle

    Albemarle, North Carolina, 28002

    Site Public Contact, 800-804-9376

    John H. Heinzerling

    Recruiting

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

    Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu

    Ramesh Gopal

    Recruiting

  • Presbyterian Kaseman Hospital

    Albuquerque, New Mexico, 87110

    Active, not recruiting

  • Alton Memorial Hospital

    Alton, Illinois, 62002

    Active, not recruiting

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

    Site Public Contact, 515-956-4132

    Joseph J. Merchant

    Recruiting

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

    Site Public Contact, 515-239-4734, ksoder@mcfarlandclinic.com

    Joseph J. Merchant

    Recruiting

  • UI Health Care Mission Cancer and Blood - Ankeny Clinic

    Ankeny, Iowa, 50023

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Luminis Health Anne Arundel Medical Center

    Annapolis, Maryland, 21401

    Active, not recruiting

  • Langlade Hospital and Cancer Center

    Antigo, Wisconsin, 54409

    Site Public Contact, 715-623-9869, Juli.Alford@aspirus.org

    Andrew J. Huang

    Recruiting

  • Duluth Clinic Ashland

    Ashland, Wisconsin, 54806

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Northwest Wisconsin Cancer Center

    Ashland, Wisconsin, 54806

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Grady Health System

    Atlanta, Georgia, 30303

    Site Public Contact, 404-778-1868

    Aparna Kesarwala

    Recruiting

  • Emory Proton Therapy Center

    Atlanta, Georgia, 30308

    Site Public Contact, 404-251-2854, allyson.anderson@emory.edu

    Aparna Kesarwala

    Recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Site Public Contact, 888-946-7447

    Aparna Kesarwala

    Recruiting

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

    Site Public Contact, 404-778-1868

    Aparna Kesarwala

    Recruiting

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

    Site Public Contact, 404-851-7115

    Aparna Kesarwala

    Recruiting

  • Augusta University Medical Center

    Augusta, Georgia, 30912

    Site Public Contact, 706-721-2388, ga_cares@augusta.edu

    William Grubb

    Recruiting

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045

    Site Public Contact, 720-848-0650

    Brian D. Kavanagh

    Recruiting

  • Rush-Copley Medical Center

    Aurora, Illinois, 60504

    Site Public Contact, 630-978-6212, RCMC_Cancer_Research@rush.edu

    Sinisa Stanic

    Recruiting

  • Advocate Outpatient Center - Aurora

    Aurora, Illinois, 60506

    Site Public Contact, ncorp@aah.org

    Jeffrey A. Kittel

    Recruiting

  • WellStar Cobb Hospital

    Austell, Georgia, 30106

    Site Public Contact, 470-793-4071, research@wellstar.org

    Mark P. McLaughlin

    Recruiting

  • UH Seidman Cancer Center at UH Avon Health Center

    Avon, Ohio, 44011

    Site Public Contact, 800-641-2422

    Pranshu Mohindra

    Recruiting

  • AIS Cancer Center at San Joaquin Community Hospital

    Bakersfield, California, 93301

    Site Public Contact, 661-323-4673

    Luis Mariscal

    Recruiting

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

    Site Public Contact, 443-849-3706

    Geoffrey A. Neuner

    Recruiting

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

    Site Public Contact, 410-601-9083

    David J. Perry

    Recruiting

  • Advocate Good Shepherd Hospital

    Barrington, Illinois, 60010

    Site Public Contact, 847-842-4847

    Jeffrey A. Kittel

    Recruiting

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

    Site Public Contact, 212-639-7592

    Jacob Shin

    Recruiting

  • Wilmot Cancer Center at Batavia

    Batavia, New York, 14020

    Suspended

  • McLaren Cancer Institute-Bay City

    Bay City, Michigan, 48706

    Site Public Contact, 313-576-9790, ctoadmin@karmanos.org

    Brian K. Yeh

    Recruiting

  • Bay Pines VA Healthcare System

    Bay Pines, Florida, 33744

    Site Public Contact, 727-398-6661, vhabayresearch@va.gov

    Ryan J. Burri

    Recruiting

  • Northwell Health Imbert Cancer Center

    Bay Shore, New York, 11706

    Site Public Contact, 516-734-8896

    Rajiv Sharma

    Recruiting

  • UHHS-Chagrin Highlands Medical Center

    Beachwood, Ohio, 44122

    Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org

    Pranshu Mohindra

    Recruiting

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

    Site Public Contact, 218-333-5000, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Central Vermont Medical Center/National Life Cancer Treatment

    Berlin Corners, Vermont, 05602

    Site Public Contact, 802-225-5400

    Christopher J. Anker

    Recruiting

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

    Site Public Contact, 800-996-2663, research@billingsclinic.org

    John M. Schallenkamp

    Recruiting

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

    Site Public Contact, gingerreeves@uabmc.edu

    Adam Kole

    Recruiting

  • The Kirklin Clinic at Acton Road

    Birmingham, Alabama, 35243

    Site Public Contact, 205-934-0220, tmyrick@uab.edu

    Adam Kole

    Recruiting

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

    Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • OSF Saint Joseph Medical Center

    Bloomington, Illinois, 61701

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Saint Joseph's/Candler - Bluffton Campus

    Bluffton, South Carolina, 29910

    Site Public Contact, 912-819-5704, underberga@sjchs.org

    John L. Mikell

    Recruiting

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Essentia Health Saint Joseph's Medical Center

    Brainerd, Minnesota, 56401

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Trinity Health Medical Center - Brighton

    Brighton, Michigan, 48114

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Henry Ford Cancer Institute-Downriver

    Brownstown, Michigan, 48183

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Eleanor M. Walker

    Recruiting

  • Mills-Peninsula Medical Center

    Burlingame, California, 94010

    Site Public Contact, clinicalresearch@sutterhealth.org

    Christopher U. Jones

    Recruiting

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

    Site Public Contact, 802-656-4101, rpo@uvm.edu

    Christopher J. Anker

    Recruiting

  • University of Vermont and State Agricultural College

    Burlington, Vermont, 05405

    Site Public Contact, 802-656-8990, rpo@uvm.edu

    Christopher J. Anker

    Recruiting

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Jeffrey A. Kittel

    Recruiting

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

    Site Public Contact, 856-325-6757

    Joseph F. Lombardo

    Recruiting

  • Sands Cancer Center

    Canandaigua, New York, 14424

    Site Public Contact, 585-396-6161

    Deepinder P. Singh

    Recruiting

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Cleveland Clinic Mercy Hospital

    Canton, Ohio, 44708

    Site Public Contact, 888-293-4673

    Edward J. Walsh

    Recruiting

  • Aultman Health Foundation

    Canton, Ohio, 44710

    Site Public Contact, 330-363-7274, ClinicalReserachDept@aultman.com

    Raza A. Khan

    Recruiting

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

    Site Public Contact, 573-334-2230, sfmc@sfmc.net

    Bryan A. Faller

    Recruiting

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Duke Cancer Center Cary

    Cary, North Carolina, 27518

    Site Public Contact, NCTNStudyTeam@dm.duke.edu

    Christopher R. Kelsey

    Recruiting

  • Saint Luke's Hospital

    Cedar Rapids, Iowa, 52402

    Site Public Contact, 319-368-5514, Rachel.varner@unitypoint.org

    Candace R. Correa

    Recruiting

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Christiana Care Health System-Concord Health Center

    Chadds Ford, Pennsylvania, 19317

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    Recruiting

  • Chambersburg Hospital

    Chambersburg, Pennsylvania, 17201

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Amit B. Shah

    Recruiting

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

    Site Public Contact, 877-668-0683, cancerclinicaltrials@med.unc.edu

    Ashley Weiner

    Recruiting

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

    Site Public Contact, 800-804-9376

    John H. Heinzerling

    Recruiting

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

    Site Public Contact, 980-201-6360, kashah@novanthealth.org

    Kevin S. Roof

    Recruiting

  • Atrium Health Pineville/LCI-Pineville

    Charlotte, North Carolina, 28210

    Site Public Contact, 980-442-2000

    John H. Heinzerling

    Recruiting

  • Atrium Health University City/LCI-University

    Charlotte, North Carolina, 28262

    Site Public Contact, 800-804-9376

    John H. Heinzerling

    Recruiting

  • Levine Cancer Institute-Ballantyne

    Charlotte, North Carolina, 28277

    Site Public Contact, 800-804-9376

    John H. Heinzerling

    Recruiting

  • Chelsea Hospital

    Chelsea, Michigan, 48118

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Jefferson Cherry Hill Hospital

    Cherry Hill, New Jersey, 08002

    Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu

    Erik S. Blomain

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Site Public Contact, 312-695-1301, cancer@northwestern.edu

    Mohamed E. Abazeed

    Recruiting

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

    Site Public Contact, 773-296-5360

    Jeffrey A. Kittel

    Recruiting

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219

    Active, not recruiting

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

    Active, not recruiting

  • McLaren Cancer Institute-Clarkston

    Clarkston, Michigan, 48346

    Site Public Contact, 313-576-9790, ctoadmin@karmanos.org

    Brian K. Yeh

    Recruiting

  • Michigan Healthcare Professionals Clarkston

    Clarkston, Michigan, 48346

    Site Public Contact, 941-833-5700, rudi.ross@profoundresearch.io

    Frank A. Vicini

    Recruiting

  • Morton Plant Hospital

    Clearwater, Florida, 33756

    Site Public Contact, 855-314-8646

    Vijaya K. Gadiyaram

    Recruiting

  • Wake Forest University at Clemmons

    Clemmons, North Carolina, 27012

    Site Public Contact, 888-716-9259

    Michael K. Farris

    Recruiting

  • Case Western Reserve University

    Cleveland, Ohio, 44106

    Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org

    Pranshu Mohindra

    Recruiting

  • Henry Ford Macomb Hospital-Clinton Township

    Clinton Township, Michigan, 48038

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Eleanor M. Walker

    Recruiting

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

    Site Public Contact, 515-241-3305

    Richard L. Deming

    Recruiting

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

    Clive, Iowa, 50325

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Baptist Memorial Hospital and Cancer Center-Collierville

    Collierville, Tennessee, 38017

    Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org

    Michael Tomblyn

    Recruiting

  • Rocky Mountain Cancer Centers-Penrose

    Colorado Springs, Colorado, 80907

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • UCHealth Memorial Hospital Central

    Colorado Springs, Colorado, 80909

    Site Public Contact, 719-365-2406

    Brian D. Kavanagh

    Recruiting

  • Memorial Hospital North

    Colorado Springs, Colorado, 80920

    Site Public Contact, 719-364-6700

    Brian D. Kavanagh

    Recruiting

  • MU Health - University Hospital/Ellis Fischel Cancer Center

    Columbia, Missouri, 65212

    Site Public Contact, 573-882-7440

    Mohamed Abdelhakiem

    Recruiting

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Andrew B. Freeman

    Recruiting

  • Grant Medical Center

    Columbus, Ohio, 43215

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Andrew B. Freeman

    Recruiting

  • Doctors Hospital

    Columbus, Ohio, 43228

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Andrew B. Freeman

    Recruiting

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

    Site Public Contact, 212-639-7592

    Jacob Shin

    Recruiting

  • Atrium Health Cabarrus/LCI-Concord

    Concord, North Carolina, 28025

    Site Public Contact, 800-804-9376

    John H. Heinzerling

    Recruiting

  • MD Anderson in The Woodlands

    Conroe, Texas, 77384

    Site Public Contact, 866-632-6789, askmdanderson@mdanderson.org

    Julianna Bronk

    Recruiting

  • Heartland Oncology and Hematology LLP

    Council Bluffs, Iowa, 51503

    Site Public Contact, 712-322-4136

    Tien-Shew W. Huang

    Recruiting

  • Methodist Jennie Edmundson Hospital

    Council Bluffs, Iowa, 51503

    Site Public Contact, 402-354-7939, kathryn.bartz@nmhs.org

    Tien-Shew W. Huang

    Recruiting

  • Greater Regional Medical Center

    Creston, Iowa, 50801

    Site Public Contact, 515-241-3305

    Richard L. Deming

    Recruiting

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

    Active, not recruiting

  • Northwest Cancer Center - Crown Point

    Crown Point, Indiana, 46307

    Site Public Contact, 219-836-6879, CancerResearch@powershealth.org

    Sinisa Stanic

    Recruiting

  • AMG Crystal Lake - Oncology

    Crystal Lake, Illinois, 60014

    Site Public Contact, 630-929-6129, advocateresearch@advocate.com

    Jeffrey A. Kittel

    Recruiting

  • Aurora Saint Luke's South Shore

    Cudahy, Wisconsin, 53110

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Jeffrey A. Kittel

    Recruiting

  • Hamilton Medical Center - Peeples Cancer Institute

    Dalton, Georgia, 30720

    Site Public Contact, 706-226-8950, crogers@hhcs.org

    Arif N. Ali

    Recruiting

  • Noyes Memorial Hospital/Myers Cancer Center

    Dansville, New York, 14437

    Site Public Contact, WCICTOresearch@urmc.rochester.edu

    Deepinder P. Singh

    Recruiting

  • Carle at The Riverfront

    Danville, Illinois, 61832

    Site Public Contact, 800-446-5532, Research@Carle.com

    Sinisa Stanic

    Recruiting

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

    Site Public Contact, 570-271-5251, HemonCCTrials@geisinger.edu

    Fiori Alite

    Recruiting

  • Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis

    Daphne, Alabama, 36526

    Site Public Contact, 251-435-2273, donna.goggins@infirmaryhealth.org

    John D. Roveda

    Recruiting

  • Miami Valley Hospital

    Dayton, Ohio, 45409

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • Premier Blood and Cancer Center

    Dayton, Ohio, 45409

    Site Public Contact, 937-276-8320

    Tarek M. Sabagh

    Recruiting

  • Dayton Physician LLC - Englewood

    Dayton, Ohio, 45415

    Active, not recruiting

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • Halifax Health Cancer Center for Hope - Daytona Beach

    Daytona Beach, Florida, 32114

    Site Public Contact, 386-425-4213

    Ruby Anne E. Deveras

    Recruiting

  • Henry Ford Medical Center-Fairlane

    Dearborn, Michigan, 48126

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Eleanor M. Walker

    Recruiting

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Essentia Health - Deer River Clinic

    Deer River, Minnesota, 56636

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    Mohamed E. Abazeed

    Recruiting

  • Delaware Health Center-Grady Cancer Center

    Delaware, Ohio, 43015

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Andrew B. Freeman

    Recruiting

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Andrew B. Freeman

    Recruiting

  • UCHealth - Cherry Creek

    Denver, Colorado, 80206

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Brian D. Kavanagh

    Recruiting

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-6727

    Seema Harichand-Herdt

    Recruiting

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

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

    Site Public Contact, 515-241-3305

    Richard L. Deming

    Recruiting

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, 50314

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Site Public Contact, 800-527-6266, ctoadmin@karmanos.org

    Brian K. Yeh

    Recruiting

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Eleanor M. Walker

    Recruiting

  • Geisinger Cancer Center Dickson City

    Dickson City, Pennsylvania, 18519

    Site Public Contact, 877-204-6081, hemoncctrials@geisinger.edu

    Fiori Alite

    Recruiting

  • Advocate Good Samaritan Hospital

    Downers Grove, Illinois, 60515

    Site Public Contact, 630-275-1270, Barbara.barhamand@advocatehealth.com

    Jeffrey A. Kittel

    Recruiting

  • Dublin Methodist Hospital

    Dublin, Ohio, 43016

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Andrew B. Freeman

    Recruiting

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Essentia Health Saint Mary's Medical Center

    Duluth, Minnesota, 55805

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Site Public Contact, 888-275-3853

    Christopher R. Kelsey

    Recruiting

  • Northwest Oncology LLC

    Dyer, Indiana, 46311

    Site Public Contact, 219-924-8178

    Sinisa Stanic

    Recruiting

  • HSHS Sacred Heart Hospital

    Eau Claire, Wisconsin, 54701

    Suspended

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Anderson A. Bauer

    Recruiting

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

    Site Public Contact, 800-446-5532, Research@carle.com

    Sinisa Stanic

    Recruiting

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Advocate Sherman Hospital

    Elgin, Illinois, 60123

    Site Public Contact, 847-429-2907

    Jeffrey A. Kittel

    Recruiting

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

    Site Public Contact, 201-894-3456

    Malay S. Rao

    Recruiting

  • Ephrata Cancer Center

    Ephrata, Pennsylvania, 17522

    Site Public Contact, 717-721-4840

    Amit B. Shah

    Recruiting

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Thomas Hospital

    Fairhope, Alabama, 36532

    Site Public Contact, 251-435-4584

    John D. Roveda

    Recruiting

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

    Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

    Site Public Contact, 701-234-6161, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

    Site Public Contact, 314-996-5569

    Bryan A. Faller

    Recruiting

  • Michigan Healthcare Professionals Farmington

    Farmington Hills, Michigan, 48334

    Site Public Contact, 941-833-5700, rudi.ross@profoundresearch.io

    Frank A. Vicini

    Recruiting

  • Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334

    Site Public Contact, 313-576-9790, ctoadmin@karmanos.org

    Brian K. Yeh

    Recruiting

  • Corewell Health Farmington Hills Hospital

    Farmington Hills, Michigan, 48336

    Site Public Contact, 248-551-7695

    Inga S. Grills

    Recruiting

  • McLaren Cancer Institute-Flint

    Flint, Michigan, 48532

    Site Public Contact, 313-576-9790, ctoadmin@karmanos.org

    Brian K. Yeh

    Recruiting

  • Levine Cancer Institute - Rutherford

    Forest City, North Carolina, 28043

    Site Public Contact, 800-804-9376

    John H. Heinzerling

    Recruiting

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

    Site Public Contact, 970-297-6150

    Brian D. Kavanagh

    Recruiting

  • Cancer Care and Hematology-Fort Collins

    Fort Collins, Colorado, 80528

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Brian D. Kavanagh

    Recruiting

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • Palo Alto Medical Foundation-Fremont

    Fremont, California, 94538

    Site Public Contact, clinicalresearch@sutterhealth.org

    Christopher U. Jones

    Recruiting

  • Gibbs Cancer Center-Gaffney

    Gaffney, South Carolina, 29341

    Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org

    Jeremy M. Kilburn

    Recruiting

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • CaroMont Regional Medical Center

    Gastonia, North Carolina, 28054

    Site Public Contact, 704-834-2810, tammy.cozad@caromonthealth.org

    Jeffrey G. Kuremsky

    Recruiting

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    Mohamed E. Abazeed

    Recruiting

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Jeffrey A. Kittel

    Recruiting

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

    Site Public Contact, 877-441-7957

    Amit B. Shah

    Recruiting

  • Glens Falls Hospital

    Glens Falls, New York, 12801

    Site Public Contact, 518-926-6700

    Aqeel A. Gillani

    Recruiting

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Jeffrey A. Kittel

    Recruiting

  • Altru Cancer Center

    Grand Forks, North Dakota, 58201

    Site Public Contact, 701-780-6520

    Grant R. Seeger

    Recruiting

  • Trinity Health Grand Rapids Hospital

    Grand Rapids, Michigan, 49503

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • UCHealth Greeley Hospital

    Greeley, Colorado, 80631

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Brian D. Kavanagh

    Recruiting

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

    Site Public Contact, 920-433-8889, WI_research_admin@hshs.org

    Matthew L. Ryan

    Recruiting

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Jeffrey A. Kittel

    Recruiting

  • Northwell Health Cancer Institute at Huntington

    Greenlawn, New York, 11740

    Site Public Contact, 516-734-8896

    Rajiv Sharma

    Recruiting

  • Novant Health Breast Surgery - Greensboro

    Greensboro, North Carolina, 27403

    Site Public Contact, 336-718-8335, pjordan@novanthealth.org

    Andrew S. Dothard

    Recruiting

  • Miami Valley Cancer Care and Infusion

    Greenville, Ohio, 45331

    Site Public Contact, 937-569-7515

    Tarek M. Sabagh

    Recruiting

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

    Site Public Contact, 864-603-6234, Heather_Rich@bshsi.org

    Jennifer Vogel

    Recruiting

  • Saint Francis Cancer Center

    Greenville, South Carolina, 29607

    Site Public Contact, 864-603-6234, Heather_Rich@bshsi.org

    Jennifer Vogel

    Recruiting

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

    Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org

    Jeremy M. Kilburn

    Recruiting

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

    Site Public Contact, 503-413-2150

    Andrew Y. Kee

    Recruiting

  • The Cancer Institute of New Jersey Hamilton

    Hamilton, New Jersey, 08690

    Site Public Contact, 609-631-6946

    Salma K. Jabbour

    Recruiting

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

    Site Public Contact, 212-639-7592

    Jacob Shin

    Recruiting

  • Essentia Health-Hayward Clinic

    Hayward, Wisconsin, 54843

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Advocate South Suburban Hospital

    Hazel Crest, Illinois, 60429

    Site Public Contact, 708-799-9995

    Jeffrey A. Kittel

    Recruiting

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

    Site Public Contact, 717-531-3779, CTO@hmc.psu.edu

    Joseph A. Miccio

    Recruiting

  • Essentia Health Hibbing Clinic

    Hibbing, Minnesota, 55746

    Site Public Contact, 218-786-3308

    Bret E. Friday

    Recruiting

  • Hayworth Cancer Center

    High Point, North Carolina, 27262

    Site Public Contact, 336-802-2500

    Michael K. Farris

    Recruiting

  • UCHealth Highlands Ranch Hospital

    Highlands Ranch, Colorado, 80129

    Site Public Contact, 720-848-0650

    Brian D. Kavanagh

    Recruiting

  • Northwest Cancer Center - Hobart

    Hobart, Indiana, 46342

    Site Public Contact, 219-947-1795

    Sinisa Stanic

    Recruiting

  • Saint Mary Medical Center

    Hobart, Indiana, 46342

    Site Public Contact, 219-836-6875, CancerResearch@COMHS.org

    Sinisa Stanic

    Recruiting

  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital

    Hollywood, Florida, 33021

    Site Public Contact, 954-265-1847, OHR@mhs.net

    Aaron Falchook

    Recruiting

  • Hawaii Cancer Care Inc - Waterfront Plaza

    Honolulu, Hawaii, 96813

    Active, not recruiting

  • Queen's Cancer Cenrer - POB I

    Honolulu, Hawaii, 96813

    Active, not recruiting

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

    Active, not recruiting

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

    Active, not recruiting

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

    Active, not recruiting

  • Kuakini Medical Center

    Honolulu, Hawaii, 96817

    Active, not recruiting

  • Queen's Cancer Center - Kuakini

    Honolulu, Hawaii, 96817

    Active, not recruiting

  • The Cancer Center of Hawaii-Liliha

    Honolulu, Hawaii, 96817

    Suspended

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    Houston, Texas, 77030

    Site Public Contact, 713-798-1354, burton@bcm.edu

    Zaid A. Siddiqui

    Recruiting

  • Ben Taub General Hospital

    Houston, Texas, 77030

    Site Public Contact, 713-873-2000

    Zaid A. Siddiqui

    Recruiting

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

    Site Public Contact, 866-632-6789, askmdanderson@mdanderson.org

    Julianna Bronk

    Recruiting

  • MD Anderson West Houston

    Houston, Texas, 77079

    Site Public Contact, 877-632-6789, askmdanderson@mdanderson.org

    Julianna Bronk

    Recruiting

  • Novant Health Cancer Institute - Huntersville

    Huntersville, North Carolina, 28078

    Site Public Contact, 980-201-6360, kashah@novanthealth.org

    Kevin S. Roof

    Recruiting

  • Novant Health Presbyterian Medical Center Huntersville

    Huntersville, North Carolina, 28078

    Site Public Contact, 980-201-6360, kashah@novanthealth.org

    Kevin S. Roof

    Recruiting

  • Edwards Comprehensive Cancer Center

    Huntington, West Virginia, 25701

    Site Public Contact, 304-399-6566, Christina.Cole@chhi.org

    Toni O. Pacioles

    Recruiting

  • Allegiance Health

    Jackson, Michigan, 49201

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Eleanor M. Walker

    Recruiting

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

    Site Public Contact, 855-776-0015

    Bradford S. Hoppe

    Recruiting

  • Jersey City Medical Center

    Jersey City, New Jersey, 07302

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Salma K. Jabbour

    Recruiting

  • University of Wisconsin Carbone Cancer Center - Johnson Creek

    Johnson Creek, Wisconsin, 53038

    Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu

    Andrew M. Baschnagel

    Recruiting

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

    Jonesboro, Arkansas, 72401

    Site Public Contact, 870-936-7066, Emily.Carvell@bmhcc.org

    Michael Tomblyn

    Recruiting

  • Freeman Health System

    Joplin, Missouri, 64804

    Site Public Contact, 417-347-4030, LJCrockett@freemanhealth.com

    Jay W. Carlson

    Recruiting

  • Jupiter Medical Center

    Jupiter, Florida, 33458

    Site Public Contact, 561-263-5791, clinicaltrials@jupitermed.com

    Nathan Tennyson

    Recruiting

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Beacon Kalamazoo

    Kalamazoo, Michigan, 49048

    Site Public Contact, 574-647-7370

    Kathleen Y. Butler

    Recruiting

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Krishna Reddy

    Recruiting

  • University of Kansas Cancer Center - Briarcliff

    Kansas City, Missouri, 64116

    Site Public Contact, 913-588-3671

    Krishna Reddy

    Recruiting

  • University of Kansas Cancer Center - North

    Kansas City, Missouri, 64154

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Krishna Reddy

    Recruiting

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Jeffrey A. Kittel

    Recruiting

  • Novant Health Cancer Institute - Kernersville

    Kernersville, North Carolina, 27284

    Site Public Contact, 336-718-8335, asmarrs@novanthealth.org

    Andrew S. Dothard

    Recruiting

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Kingman Regional Medical Center

    Kingman, Arizona, 86401

    Site Public Contact, 702-384-0013, research@sncrf.org

    John A. Ellerton

    Recruiting

  • University of Tennessee - Knoxville

    Knoxville, Tennessee, 37920

    Site Public Contact, 865-544-9773

    James N. Cantrell

    Recruiting

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

    Site Public Contact, 608-775-2385, cancerctr@gundersenhealth.org

    Collin D. Driscoll

    Recruiting

  • Northwell Health/Center for Advanced Medicine

    Lake Success, New York, 11042

    Site Public Contact, 516-734-8896

    Rajiv Sharma

    Recruiting

  • Monmouth Medical Center Southern Campus

    Lakewood, New Jersey, 08701

    Site Public Contact, 732-923-6564, mary.danish@rwjbh.org

    Salma K. Jabbour

    Recruiting

  • Lancaster General Ann B Barshinger Cancer Institute

    Lancaster, Pennsylvania, 17601

    Site Public Contact, 215-349-8245, PMCancerResearch@pennmedicine.upenn.edu

    Jeffrey D. Bradley

    Recruiting

  • Lancaster Radiation Therapy Center

    Lancaster, South Carolina, 29720

    Site Public Contact, 800-804-9376

    John H. Heinzerling

    Recruiting

  • Karmanos Cancer Institute at McLaren Greater Lansing

    Lansing, Michigan, 48910

    Site Public Contact, 313-576-9790, ctoadmin@karmanos.org

    Brian K. Yeh

    Recruiting

  • University of Michigan Health - Sparrow Lansing

    Lansing, Michigan, 48912

    Site Public Contact, 517-364-3712, harsha.trivedi@umhsparrow.org

    Samir Narayan

    Recruiting

  • McLaren Cancer Institute-Lapeer Region

    Lapeer, Michigan, 48446

    Site Public Contact, 313-576-9790, ctoadmin@karmanos.org

    Brian K. Yeh

    Recruiting

  • Memorial Medical Center-Las Cruces

    Las Cruces, New Mexico, 88011

    Site Public Contact, 575-556-6545, Deborah.Brown@LPNT.net

    Ramesh Gopal

    Recruiting

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

    Site Public Contact, 785-505-2800, Stephanie.Norris@LMH.ORG

    Krishna Reddy

    Recruiting

  • UT MD Anderson - League City

    League City, Texas, 77573

    Site Public Contact, 877-632-6789, askmdanderson@mdanderson.org

    Julianna Bronk

    Recruiting

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756

    Site Public Contact, 800-639-6918, cancer.research.nurse@dartmouth.edu

    Gregory A. Russo

    Recruiting

  • Sechler Family Cancer Center

    Lebanon, Pennsylvania, 17042

    Site Public Contact, 717-741-8303, doxenberg@wellspan.org

    Amit B. Shah

    Recruiting

  • University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri, 64064

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Krishna Reddy

    Recruiting

  • Beebe Medical Center

    Lewes, Delaware, 19958

    Site Public Contact, 302-291-6730, research@beebehealthcare.org

    Gregory A. Masters

    Recruiting

  • Geisinger Medical Oncology-Lewisburg

    Lewisburg, Pennsylvania, 17837

    Site Public Contact, 570-374-8555, HemonCCTrials@geisinger.edu

    Fiori Alite

    Recruiting

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

    Active, not recruiting

  • AMG Libertyville - Oncology

    Libertyville, Illinois, 60048

    Site Public Contact, 630-929-6129, advocateresearch@advocatehealth.com

    Jeffrey A. Kittel

    Recruiting

  • Condell Memorial Hospital

    Libertyville, Illinois, 60048

    Site Public Contact, 630-929-6129, advocateresearch@advocatehealth.com

    Jeffrey A. Kittel

    Recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

    Site Public Contact, 501-686-8274

    Mausam Patel

    Recruiting

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07039

    Site Public Contact, 973-322-2934, joanne.loeb@rwjbh.org

    Salma K. Jabbour

    Recruiting

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • UCHealth Lone Tree Health Center

    Lone Tree, Colorado, 80124

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Brian D. Kavanagh

    Recruiting

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740

    Site Public Contact, 732-923-6564, mary.danish@rwjbh.org

    Salma K. Jabbour

    Recruiting

  • Los Angeles General Medical Center

    Los Angeles, California, 90033

    Active, not recruiting

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

    Active, not recruiting

  • Medical Center of the Rockies

    Loveland, Colorado, 80538

    Site Public Contact, 970-203-7083

    Brian D. Kavanagh

    Recruiting

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Michigan Healthcare Professionals Macomb

    Macomb, Michigan, 48044

    Site Public Contact, rudi.ross@profoundresearch.io

    Frank A. Vicini

    Recruiting

  • William S Middleton VA Medical Center

    Madison, Wisconsin, 53705

    Site Public Contact, 608-256-1901 ext. 17007

    Jessica M. Schuster

    Recruiting

  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

    Madison, Wisconsin, 53718

    Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu

    Andrew M. Baschnagel

    Recruiting

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

    Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu

    Andrew M. Baschnagel

    Recruiting

  • Michigan Healthcare Professionals Madison Heights

    Madison Heights, Michigan, 48071

    Site Public Contact, 941-833-5700, rudi.ross@profoundresearch.io

    Frank A. Vicini

    Recruiting

  • OhioHealth Mansfield Hospital

    Mansfield, Ohio, 44903

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Andrew B. Freeman

    Recruiting

  • Wellstar Kennestone Hospital

    Marietta, Georgia, 30060

    Site Public Contact, 470-793-4071, research@wellstar.org

    Mark P. McLaughlin

    Recruiting

  • Aurora Bay Area Medical Group-Marinette

    Marinette, Wisconsin, 54143

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Jeffrey A. Kittel

    Recruiting

  • OhioHealth Marion General Hospital

    Marion, Ohio, 43302

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Andrew B. Freeman

    Recruiting

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Anderson A. Bauer

    Recruiting

  • Fremont - Rideout Cancer Center

    Marysville, California, 95901

    Terminated

  • Levine Cancer Institute - Union West

    Matthews, North Carolina, 28104

    Site Public Contact, 980-442-0600

    John H. Heinzerling

    Recruiting

  • Matthews Radiation Oncology Center

    Matthews, North Carolina, 28105

    Site Public Contact, 980-201-6360, kashah@novanthealth.org

    Kevin S. Roof

    Recruiting

  • Novant Health Cancer Institute - Matthews

    Matthews, North Carolina, 28105

    Site Public Contact, 980-201-6360, kashah@novanthealth.org

    Kevin S. Roof

    Recruiting

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

    Site Public Contact, 800-446-5532, Research@carle.com

    Sinisa Stanic

    Recruiting

  • Baptist Memorial Hospital and Cancer Center-Memphis

    Memphis, Tennessee, 38120

    Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org

    Michael Tomblyn

    Recruiting

  • Froedtert Menomonee Falls Hospital

    Menomonee Falls, Wisconsin, 53051

    Site Public Contact, 262-257-5100

    Jonathan R. Thompson

    Recruiting

  • UH Seidman Cancer Center at Lake Health Mentor Campus

    Mentor, Ohio, 44060

    Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org

    Pranshu Mohindra

    Recruiting

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

    Site Public Contact, 212-639-7592

    Jacob Shin

    Recruiting

  • Beebe South Coastal Health Campus

    Millville, Delaware, 19967

    Site Public Contact, 302-291-6730, research@beebehealthcare.org

    Gregory A. Masters

    Recruiting

  • Aurora Cancer Care-Milwaukee

    Milwaukee, Wisconsin, 53209

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Jeffrey A. Kittel

    Recruiting

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Jeffrey A. Kittel

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Site Public Contact, 414-805-3666

    Jonathan R. Thompson

    Recruiting

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Jeffrey A. Kittel

    Recruiting

  • Zablocki Veterans Administration Medical Center

    Milwaukee, Wisconsin, 53295

    Site Public Contact, 888-469-6614

    Adam D. Currey

    Recruiting

  • Marshfield Medical Center - Minocqua

    Minocqua, Wisconsin, 54548

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Anderson A. Bauer

    Recruiting

  • Mobile Infirmary Medical Center

    Mobile, Alabama, 36607

    Site Public Contact, 251-435-3942

    John D. Roveda

    Recruiting

  • Memorial Medical Center

    Modesto, California, 95355

    Site Public Contact, clinicalresearch@sutterhealth.org

    Christopher U. Jones

    Recruiting

  • Atrium Health Union/LCI-Union

    Monroe, North Carolina, 28112

    Site Public Contact, 980-442-2000

    John H. Heinzerling

    Recruiting

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

    Site Public Contact, 212-639-7592

    Jacob Shin

    Recruiting

  • Novant Health Cancer Institute - Mooresville

    Mooresville, North Carolina, 28117

    Site Public Contact, 980-201-6360, kashah@novanthealth.org

    Kevin S. Roof

    Recruiting

  • West Virginia University Healthcare

    Morgantown, West Virginia, 26506

    Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu

    Phillip M. Pifer

    Recruiting

  • Novant Health Cancer Institute - Mount Airy

    Mount Airy, North Carolina, 27030

    Site Public Contact, 336-718-8335, asmarrs@novanthealth.org

    Andrew S. Dothard

    Recruiting

  • McLaren Cancer Institute-Macomb

    Mount Clemens, Michigan, 48043

    Site Public Contact, 313-576-9790, ctoadmin@karmanos.org

    Brian K. Yeh

    Recruiting

  • McLaren Cancer Institute-Central Michigan

    Mount Pleasant, Michigan, 48858

    Site Public Contact, 313-576-9790, ctoadmin@karmanos.org

    Brian K. Yeh

    Recruiting

  • Palo Alto Medical Foundation-Camino Division

    Mountain View, California, 94040

    Site Public Contact, clinicalresearch@sutterhealth.org

    Christopher U. Jones

    Recruiting

  • ProHealth D N Greenwald Center

    Mukwonago, Wisconsin, 53149

    Site Public Contact, research.institute@phci.org

    Timothy R. Wassenaar

    Recruiting

  • The Community Hospital

    Munster, Indiana, 46321

    Site Public Contact, 219-836-3349

    Sinisa Stanic

    Recruiting

  • Women's Diagnostic Center - Munster

    Munster, Indiana, 46321

    Site Public Contact, 219-934-8869, mnicholson@comhs.org

    Sinisa Stanic

    Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

    Site Public Contact, 732-235-7356

    Salma K. Jabbour

    Recruiting

  • Louisiana State University Health Science Center

    New Orleans, Louisiana, 70112

    Site Public Contact, 504-210-3539, emede1@lsuhsc.edu

    Brian C. Boulmay

    Recruiting

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112

    Site Public Contact, 504-210-3539, emede1@lsuhsc.edu

    Brian C. Boulmay

    Recruiting

  • Touro Infirmary

    New Orleans, Louisiana, 70115

    Site Public Contact, 504-210-3539, emede1@lsuhsc.edu

    Brian C. Boulmay

    Recruiting

  • New York Proton Center

    New York, New York, 10035

    Site Public Contact, 646-968-9031, ichoi@nyproton.com

    Charles B. Simone

    Recruiting

  • Manhattan Eye Ear and Throat Hospital

    New York, New York, 10065

    Site Public Contact, 212-434-4460

    Rajiv Sharma

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Site Public Contact, 212-639-7592

    Jacob Shin

    Recruiting

  • Lenox Hill Hospital

    New York, New York, 10075

    Site Public Contact, 516-734-8896

    Rajiv Sharma

    Recruiting

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    Recruiting

Other trials in United States

Canada1 site

  • Ottawa Hospital and Cancer Center-General Campus

    Ottawa, Ontario, K1H 8L6

    Suspended

Other trials in Canada

About this study

Official title: Phase III Prospective Randomized Trial of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed by Concurrent Mediastinal Chemoradiation for Locally-Advanced Non-Small Cell Lung Cancer

This phase III trial compares the effect of adding stereotactic body radiation therapy (SBRT) to the usual treatment (conventional image guided radiation therapy [IGRT] and chemotherapy followed by immunotherapy with durvalumab or targeted therapy with osimertinib) versus the usual treatment alone in treating patients with non-small cell lung cancer that has spread to nearby tissue or lymph nodes (locally advanced) and cannot be treated by surgery (inoperable). SBRT uses special equipment to position a patient and deliver radiation therapy to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. IGRT is a type of radiation therapy that creates a picture of the tumor to help guide the radiation beam during therapy, making it more accurate and causing less damage to healthy tissue. Usual chemotherapy used in this trial consists of combinations of the following drugs: cisplatin, carboplatin, paclitaxel, nab-paclitaxel, pemetrexed, and etoposide. Cisplatin and carboplatin are in a class of medications known as platinum-containing compounds. Cisplatin works by killing, stopping, or slowing the growth of tumor cells. Carboplatin works in a way similar to the anticancer drug cisplatin but may be better tolerated than cisplatin. Carboplatin works by killing, stopping, or slowing the growth of tumor cells as well. Paclitaxel is in a class of medications called antimicrotubule agents. It works by stopping the growth and spread of tumor cells. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by blocking the action of a certain substance in the body that may help tumor cells multiply. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair and may kill tumor cells. Immunotherapy with durvalumab can induce changes in the body's immune system and can interfere with the ability of tumor cells to grow and spread. Osimertinib is in a class of medications called kinase inhibitors. It works by blocking the action of a protein called EGFR that signals cancer cells to multiply. This helps slow or stop the spread of tumor cells. Adding SBRT to the usual treatment of IGRT with chemotherapy and immunotherapy may be more effective at treating patients with locally-advanced non-small cell lung cancer than giving the usual treatment alone.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To compare the overall survival in patients with stage II-IIIC inoperable node-positive non-small cell lung cancer (NSCLC) after image guided, motion-managed conventional radiotherapy to the primary tumor and nodal metastases (Arm 1) or after image guided, motion-managed stereotactic body radiation therapy (SBRT) to the primary tumor followed by conventionally fractionated radiotherapy to nodal metastases (Arm 2) both given with concurrent platinum-based chemotherapy.

II. To compare progression-free survival between the experimental arm (Arm 2) and control arm (Arm 1).

SECONDARY OBJECTIVES:

  1. To compare objective response rate (as defined by Response Evaluation Criteria in Solid Tumors [RECIST] version [v] 1.1) between the experimental arm and control arm.

II. To compare the rate of local control between the experimental arm and control arm.

III. To compare patterns of failure (primary, locoregional, or distant) between the experimental arm and control arm.

IV. To compare changes in pulmonary function (forced expiratory volume in 1 second [FEV1] and diffusion capacity of the lung for carbon monoxide [DLCO] assessed at randomization and at 6- and 12- months following completion of radiation therapy) between the experimental arm and control arm.

  1. To compare changes in quality of life and patient-reported outcomes assessed from pre-treatment to 3 months following radiation therapy of each treatment arm.

VI. To determine acute and late toxicity profiles of each treatment arm as measured by the Common Terminology Criteria for Adverse Events (CTCAE) v5.

EXPLORATORY OBJECTIVES:

  1. To characterize and compare longitudinal quality of life and patient-reported outcomes of each treatment arm.

II. To collect biospecimens at baseline, after SBRT (for Arm 2 patients), during last 2 weeks of chemoradiation, and after first dose of consolidation therapy, to allow for future analyses.

III. To collect 4-dimensional (4D) computed tomography (CT) planning scans and radiation dose to calculate regional lung ventilation and explore pre-treatment 4D-CT based ventilation to predict pulmonary toxicity.

IV. To characterize clinical outcomes, toxicities and changes in pulmonary function and quality of life among patients receiving proton and photon radiotherapy.

  1. To develop and characterize a machine learning/artificial intelligence algorithm for radiotherapy planning and/or quality assurance.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo conventional IGRT and receive usual care chemotherapy consisting of paclitaxel intravenously (IV) followed by carboplatin IV weekly (Q7D) during radiotherapy or pemetrexed IV followed by carboplatin IV every 21 days during radiotherapy or etoposide IV on days 1 to 5 and days 29 to 33 followed by cisplatin IV on days 1, 8, 29, and 36 or pemetrexed IV followed by cisplatin IV every 21 days during radiotherapy. Patients then receive consolidation durvalumab IV every 2 or 4 weeks for up to one year or osimertinib orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or positron emission tomography (PET)/CT during follow-up.

ARM II: Patients undergo SBRT and conventional IGRT and then receive standard-of-care chemotherapy consisting of paclitaxel IV followed by carboplatin IV Q7D during radiotherapy or pemetrexed IV followed by carboplatin IV every 21 days during radiotherapy or etoposide IV on days 1 to 5 and days 29 to 33 followed by cisplatin IV on days 1, 8, 29, and 36 or pemetrexed IV followed by cisplatin IV every 21 days during radiotherapy. Patients then receive consolidation durvalumab IV every 2 or 4 weeks for up to one year or osimertinib PO QD in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or PET/CT during follow-up.

Patients are followed up every 3 months for 1 year, every 6 months during years 2 and 3, and then yearly after that for the duration of the study.

Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given IV

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Given IV

  • Computed TomographyProcedure or surgery

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

    Undergo CT and/or PET/CT

  • 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

  • EtoposideDrug

    Also called Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar

    Given IV

  • Image Guided Radiation TherapyRadiation

    Also called IGRT, Image Guided Radiotherapy, image-guided radiation therapy, Image-Guided Radiotherapy

    Undergo IGRT

  • Nab-paclitaxelDrug

    Also called ABI 007, ABI-007, ABI007, Abraxane

    Given IV

  • OsimertinibDrug

    Also called AZD 9291, AZD-9291, AZD9291, Mereletinib

    Given PO

  • PaclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Given IV

  • PemetrexedDrug

    Also called MTA, Multitargeted Antifolate, Pemfexy

    Given IV

  • Positron Emission TomographyProcedure or surgery

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

    Undergo PET/CT

  • Questionnaire AdministrationOther

    Ancillary studies

  • Stereotactic Body Radiation TherapyRadiation

    Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

    Undergo SBRT

Study groups in NCT05624996
Study groupRoleWhat they receive
Arm I (image guided RT, chemotherapy, immunotherapy)Active comparatorPatients undergo conventional IGRT and receive usual care chemotherapy consisting of paclitaxel IV followed by carboplatin IV Q7D during radiotherapy or pemetrexed IV followed by carboplatin IV every 21 days during radiotherapy or etoposide IV on days 1 to 5 and days 29 to 33 followed by cisplatin IV on days 1, 8, 29, and 36 or pemetrexed IV followed by cisplatin IV every 21 days during radiotherapy. Patients then receive consolidation durvalumab IV every 2 or 4 weeks for up to one year or osimertinib PO QD in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or PET/CT during follow-up.
Receives: Drug: Carboplatin; Drug: Cisplatin; Procedure: Computed Tomography; Biological: Durvalumab; Drug: Etoposide; Radiation: Image Guided Radiation Therapy; Drug: Nab-paclitaxel; Drug: Osimertinib; Drug: Paclitaxel; Drug: Pemetrexed; Procedure: Positron Emission Tomography; Other: Questionnaire Administration
Arm II (SBRT, image guided RT, chemotherapy, immunotherapy)ExperimentalPatients undergo SBRT and conventional IGRT and then receive standard-of-care chemotherapy consisting of paclitaxel IV followed by carboplatin IV Q7D during radiotherapy or pemetrexed IV followed by carboplatin IV every 21 days during radiotherapy or etoposide IV on days 1 to 5 and days 29 to 33 followed by cisplatin IV on days 1, 8, 29, and 36 or pemetrexed IV followed by cisplatin IV every 21 days during radiotherapy. Patients then receive consolidation durvalumab IV every 2 or 4 weeks for up to one year or osimertinib PO QD in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or PET/CT during follow-up.
Receives: Drug: Carboplatin; Drug: Cisplatin; Procedure: Computed Tomography; Biological: Durvalumab; Drug: Etoposide; Radiation: Image Guided Radiation Therapy; Drug: Nab-paclitaxel; Drug: Osimertinib; Drug: Paclitaxel; Drug: Pemetrexed; Procedure: Positron Emission Tomography; 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 (OS)

    Non-inferiority (NI) between arm 2 and arm 1 (reference level) will be evaluated by comparing the upper bound of the 95% confidence interval for the hazard ratio to the pre-specified NI margin. NI of arm 2 will be concluded if the upper bound of the confidence interval is equal to, or falls below, the pre-specified margin at the final analysis. When evaluating the NI of arm 2 in OS, a Cox proportional hazards (PH) model stratified by stratification factors will be used to compute the hazard ratio and associated 95% confidence interval (CI). OS rates will be estimated using the Kaplan-Meier method. If the NI of arm 2 in OS is demonstrated, the superiority of arm 1 in OS will be tested at 1-sided significance level of 0.025 using a stratified log-rank test by adjusting for stratification factors.

    Measured: Time between date of randomization and date of death due to any cause, assessed up to 8 years

  2. Progression-free survival (PFS)

    The PFS analysis will be conducted using the same methods and stratification factors as the OS analysis. The superiority of arm 2 in PFS will be tested at 1-sided significance level of 0.025 using a stratified log-rank test by adjusting for stratification factors. In the event that the NI of OS is not established, statistical inference of PFS will be considered exploratory in nature only. A Cox PH model stratified by stratification factors will be used to compute the hazard ratio and associated 95% CI.

    Measured: Time between date of randomization and first date of documented progression or death due to any cause, assessed up to 8 years

Secondary outcomes (8)

  1. Objective response rate (ORR)

    ORR (per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) is defined as the number (%) of patients with at least 1 visit response of complete response (CR) or partial response (PR) and will be based on all randomized patients who have measurable disease. Therefore, data obtained up until progression, or the last evaluable assessment in the absence of progression, will be included in the assessment of ORR. The ORR will be compared between arm 2 versus arm 1 using a Fisher's exact test. A binary response variable for ORR will be used for the analysis with the categories of CR and PR versus stable disease, progressive disease and inevaluable.

    Measured: Up to 8 years

  2. Time to progression

    Local control also known as time to progression will be defined as freedom from local progression, in which a failure is defined as intrathoracic tumor progression (failure in the lobe of the primary tumor or mediastinal lymph nodes) by RECIST 1.1 criteria. Local control will be analyzed as competing risks data based on cause-specific hazards approaches, where deaths without local failure will be considered as a competing event and analyzed as "censoring" of local failure. The rates at various timepoints (e.g., every 6 months after randomization) and medians of PFS for each arm will be estimated using the Kaplan-Meier method. The associated 95% CI will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function. Results from an unstratified analysis will also be provided.

    Measured: Up to 8 years

  3. Time to primary, locoregional, or distant failure

    Competing risks analysis will be used to analyze times to primary failure, locoregional failure and distant failure as the first failure. Competing events include primary failure, locoregional failure, distant failure and deaths without any failures. Rates at various timepoints (i.e., every 6 months after randomization) for each arm will be estimated using the cumulative incidence function. The associated 95% CI will be calculated using the Delta method and based on a log-log transformation applied on the estimated cumulative incidence functions. Statistical inferences of the development of each failure between arms will be based on cause-specific hazards using the log-rank test and Cox proportional hazard model. In addition, Gray's test and the Fine-Gray model will also be used to provide statistical inferences between arms based on cumulative incidence functions and subdistribution hazards.

    Measured: Up to 8 years

  4. Changes in pulmonary function

    Includes forced expiratory volume in 1 second (FEV1) and diffusion capacity of the lung for carbon monoxide (DLCO). Changes in pulmonary function (FEV1 and DLCO) will be summarized with descriptive statistics, and compared with Wilcoxon rank-sum test. The descriptive statistics of changes in FEV1 and diffusion capacity before and after treatment will be reported by treatment arm and by response categories (complete response; partial response; stable disease; progressive disease). Linear regression will be used to model changes with adjustment for treatment arms and possibly other baseline covariates, if applicable. The grade 3-5 NRG Oncology Pulmonary Toxicity Scale for changes will be reported with the frequency and grade by arm. Logistic regression will be used to model the distribution of the NRG Oncology Pulmonary Toxicity Scale by arms with and without adjustment for covariates.

    Measured: From randomization to 6 months or 12 months

  5. Patient reported outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    Adverse events will also be assessed using PRO-CTCAE items. The PRO-CTCAE is a patient-reported outcome measurement system developed to characterize the frequency, severity, and interference of symptomatic treatment toxicities. Items are scored on a Likert scale. For each symptom and each domain (i.e., frequency, severity, and interference), counts and frequencies will be summarized for the worst score experienced by the patient by the treatment arm. In addition, a composite grading algorithm (Basch 2021) will be used to derive a single numerical grade for each adverse event scored using PRO-CTCAE. PRO-CTCAE, the frequency of acute grade >= 3 patient-reported toxicity will be compared to the corresponding rate of clinician-scored toxicity using a chi-square test or Fisher exact test, as appropriate. Distributions of clinician-reported and patient-reported adverse events will also be compared across study arms.

    Measured: At 3, 12, and 24 months

  6. Functional Assessment of Cancer Therapy Lung (FACT-L) and Trial Outcome Index (TOI)

    FACT-L and TOI is a measure that sums the functional well-being (FWB - 7 items), physical well-being (PWB - 7), and the lung cancer subscale (LCS - 9 items) of FACT-L. Questionnaire trial outcome index deterioration rates at 3 months and associated 95% confidence interval will be calculated for each treatment group, based on all randomized subjects. In addition, to explore if higher QOL scores will be maintained at 12 and 24 months from the end of radiotherapy as well, longitudinal data analysis will also be performed to characterize the trend of scores over time across the two treatment groups using hierarchical formulation of the linear mixed model. The Clopper-Pearson method will be used for calculating 95% CI. The deterioration rates of each arm will also be compared using Cochran-Mantel-Haenszel Test, stratified by PD-L1 expression and T-stage.

    Measured: At 3, 12, and 24 months

  7. European Quality of Life Five Dimension (EQ-5D) scale

    Subjects' overall health state on a visual analog scale (EQ-VAS) at each assessment time point will be summarized using descriptive statistics by treatment group, as randomized. Proportion of subjects reporting problems for the five EQ-5D dimensions at each assessment time point will be summarized by level of problem and by treatment group, as randomized. Percentages will be based on number subjects assessed at assessment time point.

    Measured: At 3, 12, and 24 months

  8. Incidence of adverse events

    For each patient, the maximum severity reported will be used in the summaries. Adverse events will be summarized regardless of relationship to protocol treatment as assessed by the investigator. Treatment-related adverse events using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) will be presented in statistical analysis reports/publications in CTCAE version 5. Adverse event rates will be reported with the frequency and severity (e.g., type, grade, and attribution) by arm.

    Measured: Up to 8 years

Timeline

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

  1. First posted22 Nov 2022
  2. Study start12 Jul 2023
  3. Primary completion15 Oct 2031 (estimated)
  4. Study completion15 Oct 2036 (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
474 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05624996
Sponsor's protocol ID
NRG-LU008
Other IDs
NCI-2022-08263, NRG-LU008, NRG-LU008, U10CA180868
Status last verified
Aug 2026
First submitted
4 Nov 2022
Last updated
17 Aug 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.

Publications

  • Heinzerling JH, Mileham KF, Robinson MM, Symanowski JT, Induru RR, Brouse GM, Corso CD, Prabhu RS, Haggstrom DE, Moeller BJ, Bobo WE, Fasola CE, Thakkar VV, Pal SE, Gregory JM, Norek SL, Begic XJ, Kesarwala AH, Burri SH, Simone CB 2nd. Primary lung tumour stereotactic body radiotherapy followed by concurrent mediastinal chemoradiotherapy and adjuvant immunotherapy for locally advanced non-small-cell lung cancer: a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2025 Jan;26(1):85-97. doi: 10.1016/S1470-2045(24)00573-4. Epub 2024 Nov 29.

    PubMed 39615497

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Carboplatin, Cisplatin and Computed Tomography in people with Locally Advanced Lung Non-Small Cell Carcinoma and Stage IIB Lung Cancer AJCC v8, run by NRG Oncology at 477 sites in 2 countries.

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 23 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 477 sites in United States, Canada. 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?

This study is still under way. Results are not available in the source record yet.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: Time between date of randomization and date of death due to any cause, assessed up to 8 years). The study lists 2 primary outcomes in all. 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 NCT05624996, 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 17 Aug 2026.

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