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

Status: Recruiting
Location: See all (439) locations...
Intervention Type: Procedure, Drug, Biological, Radiation, Other
Study Type: Interventional
Study Phase: Phase 3
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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:

‣ 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

Locations
United States
Alabama
The Kirklin Clinic at Acton Road
RECRUITING
Birmingham
University of Alabama at Birmingham Cancer Center
RECRUITING
Birmingham
Arkansas
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
RECRUITING
Jonesboro
University of Arkansas for Medical Sciences
RECRUITING
Little Rock
Arizona
Kingman Regional Medical Center
RECRUITING
Kingman
Cancer Center at Saint Joseph's
RECRUITING
Phoenix
Mayo Clinic Hospital in Arizona
NOT_YET_RECRUITING
Phoenix
Banner University Medical Center - Tucson
RECRUITING
Tucson
University of Arizona Cancer Center-North Campus
RECRUITING
Tucson
California
AIS Cancer Center at San Joaquin Community Hospital
RECRUITING
Bakersfield
Mills-Peninsula Medical Center
RECRUITING
Burlingame
Palo Alto Medical Foundation-Fremont
RECRUITING
Fremont
Los Angeles General Medical Center
SUSPENDED
Los Angeles
USC / Norris Comprehensive Cancer Center
SUSPENDED
Los Angeles
Fremont - Rideout Cancer Center
ACTIVE_NOT_RECRUITING
Marysville
Memorial Medical Center
RECRUITING
Modesto
Palo Alto Medical Foundation-Camino Division
RECRUITING
Mountain View
Palo Alto Medical Foundation Health Care
RECRUITING
Palo Alto
Sutter Cancer Centers Radiation Oncology Services-Roseville
RECRUITING
Roseville
Sutter Roseville Medical Center
RECRUITING
Roseville
Sutter Medical Center Sacramento
RECRUITING
Sacramento
California Pacific Medical Center-Pacific Campus
RECRUITING
San Francisco
Mills Health Center
RECRUITING
San Mateo
Sutter Pacific Medical Foundation
RECRUITING
Santa Rosa
Palo Alto Medical Foundation-Sunnyvale
RECRUITING
Sunnyvale
Sutter Solano Medical Center/Cancer Center
RECRUITING
Vallejo
Colorado
UCHealth University of Colorado Hospital
RECRUITING
Aurora
Memorial Hospital North
RECRUITING
Colorado Springs
Rocky Mountain Cancer Centers-Penrose
RECRUITING
Colorado Springs
UCHealth Memorial Hospital Central
RECRUITING
Colorado Springs
UCHealth - Cherry Creek
RECRUITING
Denver
Cancer Care and Hematology-Fort Collins
RECRUITING
Fort Collins
Poudre Valley Hospital
RECRUITING
Fort Collins
UCHealth Greeley Hospital
RECRUITING
Greeley
UCHealth Highlands Ranch Hospital
RECRUITING
Highlands Ranch
UCHealth Lone Tree Health Center
RECRUITING
Lone Tree
Medical Center of the Rockies
RECRUITING
Loveland
Delaware
Beebe Medical Center
RECRUITING
Lewes
Beebe South Coastal Health Campus
RECRUITING
Millville
Christiana Care Health System-Christiana Hospital
RECRUITING
Newark
Helen F Graham Cancer Center
RECRUITING
Newark
Medical Oncology Hematology Consultants PA
RECRUITING
Newark
Beebe Health Campus
RECRUITING
Rehoboth Beach
Christiana Care Health System-Wilmington Hospital
RECRUITING
Wilmington
Florida
Morton Plant Hospital
RECRUITING
Clearwater
Halifax Health Medical Center-Centers for Oncology
RECRUITING
Daytona Beach
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
RECRUITING
Hollywood
Mayo Clinic in Florida
RECRUITING
Jacksonville
Jupiter Medical Center
RECRUITING
Jupiter
Orlando Health Cancer Institute
RECRUITING
Orlando
Memorial Hospital West
RECRUITING
Pembroke Pines
Saint Joseph's Hospital/Children's Hospital-Tampa
RECRUITING
Tampa
Winter Haven Hospital
RECRUITING
Winter Haven
Georgia
Emory Proton Therapy Center
RECRUITING
Atlanta
Emory Saint Joseph's Hospital
RECRUITING
Atlanta
Emory University Hospital Midtown
RECRUITING
Atlanta
Emory University Hospital/Winship Cancer Institute
RECRUITING
Atlanta
Grady Health System
RECRUITING
Atlanta
Augusta University Medical Center
RECRUITING
Augusta
WellStar Cobb Hospital
RECRUITING
Austell
Hamilton Medical Center - Peeples Cancer Institute
RECRUITING
Dalton
Wellstar Kennestone Hospital
RECRUITING
Marietta
CTCA at Southeastern Regional Medical Center
RECRUITING
Newnan
Hawaii
Hawaii Cancer Care - Westridge
RECRUITING
‘aiea
Pali Momi Medical Center
RECRUITING
‘aiea
Hawaii Cancer Care Inc - Waterfront Plaza
RECRUITING
Honolulu
Kuakini Medical Center
RECRUITING
Honolulu
Queen's Cancer Cenrer - POB I
RECRUITING
Honolulu
Queen's Cancer Center - Kuakini
RECRUITING
Honolulu
Queen's Medical Center
RECRUITING
Honolulu
Straub Clinic and Hospital
RECRUITING
Honolulu
The Cancer Center of Hawaii-Liliha
RECRUITING
Honolulu
University of Hawaii Cancer Center
RECRUITING
Honolulu
Iowa
Mary Greeley Medical Center
RECRUITING
Ames
McFarland Clinic - Ames
RECRUITING
Ames
UI Health Care Mission Cancer and Blood - Ankeny Clinic
RECRUITING
Ankeny
Saint Luke's Hospital
RECRUITING
Cedar Rapids
Mercy Cancer Center-West Lakes
RECRUITING
Clive
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
RECRUITING
Clive
Heartland Oncology and Hematology LLP
RECRUITING
Council Bluffs
Methodist Jennie Edmundson Hospital
RECRUITING
Council Bluffs
Greater Regional Medical Center
RECRUITING
Creston
Iowa Methodist Medical Center
RECRUITING
Des Moines
Mercy Medical Center - Des Moines
RECRUITING
Des Moines
UI Health Care Mission Cancer and Blood - Des Moines Clinic
RECRUITING
Des Moines
UI Health Care Mission Cancer and Blood - Laurel Clinic
RECRUITING
Des Moines
UI Health Care Mission Cancer and Blood - Waukee Clinic
RECRUITING
Waukee
Mercy Medical Center-West Lakes
RECRUITING
West Des Moines
Illinois
Alton Memorial Hospital
RECRUITING
Alton
Advocate Outpatient Center - Aurora
RECRUITING
Aurora
Rush-Copley Medical Center
RECRUITING
Aurora
Advocate Good Shepherd Hospital
RECRUITING
Barrington
Illinois CancerCare-Bloomington
RECRUITING
Bloomington
OSF Saint Joseph Medical Center
RECRUITING
Bloomington
Illinois CancerCare-Canton
RECRUITING
Canton
Illinois CancerCare-Carthage
RECRUITING
Carthage
Centralia Oncology Clinic
RECRUITING
Centralia
Advocate Illinois Masonic Medical Center
RECRUITING
Chicago
Northwestern University
RECRUITING
Chicago
AMG Crystal Lake - Oncology
RECRUITING
Crystal Lake
Carle at The Riverfront
RECRUITING
Danville
Cancer Care Specialists of Illinois - Decatur
RECRUITING
Decatur
Decatur Memorial Hospital
RECRUITING
Decatur
Northwestern Medicine Cancer Center Kishwaukee
RECRUITING
Dekalb
Advocate Good Samaritan Hospital
RECRUITING
Downers Grove
Carle Physician Group-Effingham
RECRUITING
Effingham
Crossroads Cancer Center
RECRUITING
Effingham
Advocate Sherman Hospital
RECRUITING
Elgin
Illinois CancerCare-Eureka
RECRUITING
Eureka
Illinois CancerCare-Galesburg
RECRUITING
Galesburg
Northwestern Medicine Cancer Center Delnor
RECRUITING
Geneva
Advocate South Suburban Hospital
RECRUITING
Hazel Crest
Illinois CancerCare-Kewanee Clinic
RECRUITING
Kewanee
AMG Libertyville - Oncology
RECRUITING
Libertyville
Condell Memorial Hospital
RECRUITING
Libertyville
Illinois CancerCare-Macomb
RECRUITING
Macomb
Carle Physician Group-Mattoon/Charleston
RECRUITING
Mattoon
Cancer Care Center of O'Fallon
RECRUITING
O'fallon
HSHS Saint Elizabeth's Hospital
RECRUITING
O'fallon
Advocate Christ Medical Center
RECRUITING
Oak Lawn
Illinois CancerCare-Ottawa Clinic
RECRUITING
Ottawa
Advocate High Tech Medical Park
RECRUITING
Palos Heights
Advocate Lutheran General Hospital
RECRUITING
Park Ridge
Illinois CancerCare-Pekin
RECRUITING
Pekin
Illinois CancerCare-Peoria
RECRUITING
Peoria
Methodist Medical Center of Illinois
RECRUITING
Peoria
OSF Saint Francis Medical Center
RECRUITING
Peoria
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
RECRUITING
Peoria
Illinois CancerCare-Peru
RECRUITING
Peru
Illinois CancerCare-Princeton
RECRUITING
Princeton
UW Health Carbone Cancer Center Rockford
RECRUITING
Rockford
Memorial Hospital East
RECRUITING
Shiloh
Southern Illinois University School of Medicine
RECRUITING
Springfield
Springfield Clinic
RECRUITING
Springfield
Springfield Memorial Hospital
RECRUITING
Springfield
Carle Cancer Center
RECRUITING
Urbana
Northwestern Medicine Cancer Center Warrenville
RECRUITING
Warrenville
Illinois CancerCare - Washington
RECRUITING
Washington
Midwestern Regional Medical Center
RECRUITING
Zion
Indiana
Northwest Cancer Center - Main Campus
RECRUITING
Crown Point
Northwest Oncology LLC
RECRUITING
Dyer
Northwest Cancer Center - Hobart
RECRUITING
Hobart
Saint Mary Medical Center
RECRUITING
Hobart
The Community Hospital
RECRUITING
Munster
Women's Diagnostic Center - Munster
RECRUITING
Munster
Northwest Cancer Center - Valparaiso
RECRUITING
Valparaiso
Kansas
University of Kansas Cancer Center
RECRUITING
Kansas City
The University of Kansas Cancer Center - Olathe
RECRUITING
Olathe
University of Kansas Cancer Center-Overland Park
RECRUITING
Overland Park
Salina Regional Health Center
RECRUITING
Salina
University of Kansas Health System Saint Francis Campus
RECRUITING
Topeka
University of Kansas Hospital-Westwood Cancer Center
RECRUITING
Westwood
Ascension Via Christi Hospitals Wichita
RECRUITING
Wichita
Kentucky
University of Kentucky/Markey Cancer Center
RECRUITING
Lexington
Louisiana
Louisiana State University Health Science Center
RECRUITING
New Orleans
University Medical Center New Orleans
RECRUITING
New Orleans
Massachusetts
UMass Memorial Medical Center - University Campus
RECRUITING
Worcester
Maryland
Luminis Health Anne Arundel Medical Center
ACTIVE_NOT_RECRUITING
Annapolis
Greater Baltimore Medical Center
RECRUITING
Baltimore
Sinai Hospital of Baltimore
RECRUITING
Baltimore
TidalHealth Richard A Henson Cancer Institute
RECRUITING
Ocean Pines
TidalHealth Peninsula Regional
RECRUITING
Salisbury
William E Kahlert Regional Cancer Center/Sinai Hospital
RECRUITING
Westminster
Maine
MaineHealth Maine Medical Center - Portland
RECRUITING
Portland
MaineHealth Cancer Care Center of York County
RECRUITING
Sanford
MaineHealth Maine Medical Center- Scarborough
RECRUITING
Scarborough
MaineHealth Cancer Care and IV Therapy - South Portland
RECRUITING
South Portland
Michigan
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
RECRUITING
Ann Arbor
McLaren Cancer Institute-Bay City
RECRUITING
Bay City
Trinity Health IHA Medical Group Hematology Oncology - Brighton
RECRUITING
Brighton
Trinity Health Medical Center - Brighton
RECRUITING
Brighton
Chelsea Hospital
RECRUITING
Chelsea
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
RECRUITING
Chelsea
McLaren Cancer Institute-Clarkston
RECRUITING
Clarkston
Michigan Healthcare Professionals Clarkston
RECRUITING
Clarkston
Wayne State University/Karmanos Cancer Institute
RECRUITING
Detroit
Corewell Health Farmington Hills Hospital
RECRUITING
Farmington Hills
Michigan Healthcare Professionals Farmington
RECRUITING
Farmington Hills
Weisberg Cancer Treatment Center
RECRUITING
Farmington Hills
McLaren Cancer Institute-Flint
RECRUITING
Flint
Trinity Health Grand Rapids Hospital
RECRUITING
Grand Rapids
Beacon Kalamazoo
RECRUITING
Kalamazoo
Bronson Methodist Hospital
RECRUITING
Kalamazoo
West Michigan Cancer Center
RECRUITING
Kalamazoo
Karmanos Cancer Institute at McLaren Greater Lansing
RECRUITING
Lansing
University of Michigan Health - Sparrow Lansing
RECRUITING
Lansing
McLaren Cancer Institute-Lapeer Region
RECRUITING
Lapeer
Trinity Health Saint Mary Mercy Livonia Hospital
RECRUITING
Livonia
Michigan Healthcare Professionals Macomb
RECRUITING
Macomb
Michigan Healthcare Professionals Madison Heights
RECRUITING
Madison Heights
McLaren Cancer Institute-Macomb
RECRUITING
Mount Clemens
McLaren Cancer Institute-Northern Michigan
RECRUITING
Petoskey
Michigan Healthcare Professionals Pontiac
RECRUITING
Pontiac
Trinity Health Saint Joseph Mercy Oakland Hospital
RECRUITING
Pontiac
McLaren-Port Huron
RECRUITING
Port Huron
Corewell Health William Beaumont University Hospital
RECRUITING
Royal Oak
Munson Medical Center
RECRUITING
Traverse City
Corewell Health Beaumont Troy Hospital
RECRUITING
Troy
Michigan Healthcare Professionals Troy
RECRUITING
Troy
Henry Ford Health Warren Hospital
RECRUITING
Warren
University of Michigan Health - West
RECRUITING
Wyoming
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
RECRUITING
Ypsilanti
Minnesota
Sanford Joe Lueken Cancer Center
RECRUITING
Bemidji
Essentia Health Saint Joseph's Medical Center
RECRUITING
Brainerd
Essentia Health - Deer River Clinic
RECRUITING
Deer River
Essentia Health Cancer Center
RECRUITING
Duluth
Essentia Health Saint Mary's Medical Center
RECRUITING
Duluth
Miller-Dwan Hospital
RECRUITING
Duluth
Essentia Health Hibbing Clinic
RECRUITING
Hibbing
Mayo Clinic in Rochester
RECRUITING
Rochester
Coborn Cancer Center at Saint Cloud Hospital
RECRUITING
Saint Cloud
Essentia Health Sandstone
RECRUITING
Sandstone
Essentia Health Virginia Clinic
RECRUITING
Virginia
Missouri
Saint Francis Medical Center
RECRUITING
Cape Girardeau
Siteman Cancer Center at Saint Peters Hospital
RECRUITING
City Of Saint Peters
MU Health - University Hospital/Ellis Fischel Cancer Center
RECRUITING
Columbia
Siteman Cancer Center at West County Hospital
RECRUITING
Creve Coeur
Parkland Health Center - Farmington
RECRUITING
Farmington
Freeman Health System
RECRUITING
Joplin
University of Kansas Cancer Center - North
RECRUITING
Kansas City
University of Kansas Cancer Center - Lee's Summit
RECRUITING
Lee's Summit
Sainte Genevieve County Memorial Hospital
RECRUITING
Sainte Genevieve
Mercy Hospital Springfield
RECRUITING
Springfield
Mercy Hospital Saint Louis
RECRUITING
St Louis
Mercy Hospital South
RECRUITING
St Louis
Missouri Baptist Medical Center
RECRUITING
St Louis
Siteman Cancer Center at Christian Hospital
RECRUITING
St Louis
Siteman Cancer Center-South County
RECRUITING
St Louis
Washington University School of Medicine
RECRUITING
St Louis
Missouri Baptist Sullivan Hospital
RECRUITING
Sullivan
BJC Outpatient Center at Sunset Hills
RECRUITING
Sunset Hills
Mississippi
Baptist Memorial Hospital and Cancer Center-Desoto
RECRUITING
Southhaven
Montana
Billings Clinic Cancer Center
RECRUITING
Billings
Bozeman Health Deaconess Hospital
RECRUITING
Bozeman
Benefis Sletten Cancer Institute
RECRUITING
Great Falls
North Carolina
Atrium Health Stanly/LCI-Albemarle
RECRUITING
Albemarle
Duke Cancer Center Cary
RECRUITING
Cary
UNC Lineberger Comprehensive Cancer Center
RECRUITING
Chapel Hill
Atrium Health Pineville/LCI-Pineville
RECRUITING
Charlotte
Atrium Health University City/LCI-University
RECRUITING
Charlotte
Carolinas Medical Center/Levine Cancer Institute
RECRUITING
Charlotte
Levine Cancer Institute-Ballantyne
RECRUITING
Charlotte
Novant Health Presbyterian Medical Center
RECRUITING
Charlotte
Wake Forest University at Clemmons
RECRUITING
Clemmons
Atrium Health Cabarrus/LCI-Concord
RECRUITING
Concord
Duke University Medical Center
RECRUITING
Durham
Levine Cancer Institute - Rutherford
RECRUITING
Forest City
CaroMont Regional Medical Center
RECRUITING
Gastonia
Novant Health Breast Surgery - Greensboro
RECRUITING
Greensboro
Novant Health Cancer Institute - Huntersville
RECRUITING
Huntersville
Novant Health Presbyterian Medical Center Huntersville
RECRUITING
Huntersville
Novant Health Cancer Institute - Kernersville
RECRUITING
Kernersville
Levine Cancer Institute - Union West
RECRUITING
Matthews
Matthews Radiation Oncology Center
RECRUITING
Matthews
Novant Health Cancer Institute - Matthews
RECRUITING
Matthews
Atrium Health Union/LCI-Union
RECRUITING
Monroe
Novant Health Cancer Institute - Mooresville
RECRUITING
Mooresville
Novant Health Cancer Institute - Mount Airy
RECRUITING
Mount Airy
Novant Health Cancer Institute - Wilkesboro
RECRUITING
North Wilkesboro
Duke Cancer Center Raleigh
RECRUITING
Raleigh
Novant Health Cancer Institute - Rowan
RECRUITING
Salisbury
Rowan Regional Medical Center
RECRUITING
Salisbury
Atrium Health Cleveland/LCI-Cleveland
RECRUITING
Shelby
Novant Health Cancer Institute - Statesville
RECRUITING
Statesville
Wake Forest Baptist Health - Hematology Oncology - Statesville
RECRUITING
Statesville
Novant Cancer Institute Radiation Oncology - Supply
RECRUITING
Supply
Novant Health Cancer Institute - Thomasville
RECRUITING
Thomasville
Wake Forest Baptist Health - Wilkes Medical Center
RECRUITING
Wilkesboro
Novant Health Cancer Institute Radiation Oncology - Wilmington
RECRUITING
Wilmington
Novant Health New Hanover Regional Medical Center
RECRUITING
Wilmington
Novant Health Forsyth Medical Center
RECRUITING
Winston-salem
Wake Forest University Health Sciences
RECRUITING
Winston-salem
North Dakota
Sanford Bismarck Medical Center
RECRUITING
Bismarck
Sanford Broadway Medical Center
RECRUITING
Fargo
Sanford Roger Maris Cancer Center
RECRUITING
Fargo
Altru Cancer Center
RECRUITING
Grand Forks
Nebraska
Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
RECRUITING
Omaha
Nebraska Methodist Hospital
RECRUITING
Omaha
Oncology Associates PC
SUSPENDED
Omaha
New Hampshire
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
RECRUITING
Lebanon
New Jersey
Memorial Sloan Kettering Basking Ridge
RECRUITING
Basking Ridge
Cooper Hospital University Medical Center
RECRUITING
Camden
The Cancer Institute of New Jersey Hamilton
RECRUITING
Hamilton
Jersey City Medical Center
RECRUITING
Jersey City
Monmouth Medical Center Southern Campus
RECRUITING
Lakewood
Saint Barnabas Medical Center
RECRUITING
Livingston
Monmouth Medical Center
RECRUITING
Long Branch
Memorial Sloan Kettering Monmouth
RECRUITING
Middletown
Memorial Sloan Kettering Bergen
RECRUITING
Montvale
Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
Rutgers New Jersey Medical School
RECRUITING
Newark
Sidney Kimmel Cancer Center Washington Township
RECRUITING
Sewell
Robert Wood Johnson University Hospital Somerset
RECRUITING
Somerville
Community Medical Center
RECRUITING
Toms River
New Mexico
Presbyterian Kaseman Hospital
RECRUITING
Albuquerque
University of New Mexico Cancer Center
RECRUITING
Albuquerque
Memorial Medical Center-Las Cruces
RECRUITING
Las Cruces
Presbyterian Rust Medical Center/Jorgensen Cancer Center
RECRUITING
Rio Rancho
Nevada
Renown Regional Medical Center
RECRUITING
Reno
New York
Wilmot Cancer Center at Batavia
SUSPENDED
Batavia
Sands Cancer Center
RECRUITING
Canandaigua
Memorial Sloan Kettering Commack
RECRUITING
Commack
Glens Falls Hospital
RECRUITING
Glens Falls
Memorial Sloan Kettering Westchester
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
New York Proton Center
RECRUITING
New York
Highland Hospital
RECRUITING
Rochester
University of Rochester
RECRUITING
Rochester
Wilmot Cancer Institute Radiation Oncology at Greece
RECRUITING
Rochester
Stony Brook University Medical Center
RECRUITING
Stony Brook
State University of New York Upstate Medical University
RECRUITING
Syracuse
Montefiore Medical Center - Moses Campus
RECRUITING
The Bronx
Montefiore Medical Center-Einstein Campus
RECRUITING
The Bronx
Montefiore Medical Center-Weiler Hospital
RECRUITING
The Bronx
Memorial Sloan Kettering Nassau
RECRUITING
Uniondale
Westchester Medical Center
RECRUITING
Valhalla
Wilmot Cancer Institute at Webster
RECRUITING
Webster
Ohio
Cleveland Clinic Akron General
RECRUITING
Akron
UH Seidman Cancer Center at UH Avon Health Center
RECRUITING
Avon
UHHS-Chagrin Highlands Medical Center
RECRUITING
Beachwood
Aultman Health Foundation
RECRUITING
Canton
Cleveland Clinic Mercy Hospital
RECRUITING
Canton
Miami Valley Hospital South
RECRUITING
Centerville
University of Cincinnati Cancer Center-UC Medical Center
ACTIVE_NOT_RECRUITING
Cincinnati
Case Western Reserve University
RECRUITING
Cleveland
Doctors Hospital
RECRUITING
Columbus
Grant Medical Center
RECRUITING
Columbus
Riverside Methodist Hospital
RECRUITING
Columbus
Dayton Physician LLC - Englewood
ACTIVE_NOT_RECRUITING
Dayton
Miami Valley Hospital
RECRUITING
Dayton
Miami Valley Hospital North
RECRUITING
Dayton
Premier Blood and Cancer Center
RECRUITING
Dayton
Delaware Health Center-Grady Cancer Center
RECRUITING
Delaware
Grady Memorial Hospital
RECRUITING
Delaware
Dublin Methodist Hospital
RECRUITING
Dublin
Atrium Medical Center-Middletown Regional Hospital
RECRUITING
Franklin
Miami Valley Cancer Care and Infusion
RECRUITING
Greenville
OhioHealth Mansfield Hospital
RECRUITING
Mansfield
OhioHealth Marion General Hospital
RECRUITING
Marion
UH Seidman Cancer Center at Lake Health Mentor Campus
RECRUITING
Mentor
Mercy Health - Perrysburg Hospital
RECRUITING
Perrysburg
Upper Valley Medical Center
RECRUITING
Troy
University of Cincinnati Cancer Center-West Chester
ACTIVE_NOT_RECRUITING
West Chester
Oklahoma
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Oregon
Legacy Mount Hood Medical Center
RECRUITING
Gresham
Legacy Good Samaritan Hospital and Medical Center
RECRUITING
Portland
Legacy Meridian Park Hospital
RECRUITING
Tualatin
Pennsylvania
Christiana Care Health System-Concord Health Center
RECRUITING
Chadds Ford
Chambersburg Hospital
RECRUITING
Chambersburg
Geisinger Medical Center
RECRUITING
Danville
Ephrata Cancer Center
RECRUITING
Ephrata
Adams Cancer Center
RECRUITING
Gettysburg
Penn State Milton S Hershey Medical Center
RECRUITING
Hershey
Lancaster General Ann B Barshinger Cancer Institute
RECRUITING
Lancaster
Sechler Family Cancer Center
RECRUITING
Lebanon
Geisinger Medical Oncology-Lewisburg
RECRUITING
Lewisburg
Fox Chase Cancer Center
RECRUITING
Philadelphia
Temple University Hospital
RECRUITING
Philadelphia
Thomas Jefferson University Hospital
RECRUITING
Philadelphia
University of Pennsylvania/Abramson Cancer Center
RECRUITING
Philadelphia
Reading Hospital
RECRUITING
West Reading
Geisinger Wyoming Valley/Henry Cancer Center
RECRUITING
Wilkes-barre
Asplundh Cancer Pavilion
RECRUITING
Willow Grove
Lankenau Medical Center
RECRUITING
Wynnewood
WellSpan Health-York Cancer Center
RECRUITING
York
WellSpan Health-York Hospital
RECRUITING
York
South Carolina
Gibbs Cancer Center-Gaffney
RECRUITING
Gaffney
Gibbs Cancer Center-Pelham
RECRUITING
Greer
Lancaster Radiation Therapy Center
RECRUITING
Lancaster
Levine Cancer Institute-Rock Hill
RECRUITING
Rock Hill
Rock Hill Radiation Therapy Center
RECRUITING
Rock Hill
Spartanburg Medical Center
RECRUITING
Spartanburg
SMC Center for Hematology Oncology Union
RECRUITING
Union
Lexington Medical Center
RECRUITING
West Columbia
South Dakota
Sanford Cancer Center Oncology Clinic
RECRUITING
Sioux Falls
Sanford USD Medical Center - Sioux Falls
RECRUITING
Sioux Falls
Tennessee
Baptist Memorial Hospital and Cancer Center-Collierville
RECRUITING
Collierville
Baptist Memorial Hospital and Cancer Center-Memphis
RECRUITING
Memphis
Texas
MD Anderson in The Woodlands
RECRUITING
Conroe
M D Anderson Cancer Center
RECRUITING
Houston
MD Anderson West Houston
RECRUITING
Houston
MD Anderson League City
RECRUITING
League City
MD Anderson in Sugar Land
RECRUITING
Sugar Land
Vermont
Central Vermont Medical Center/National Life Cancer Treatment
RECRUITING
Berlin Corners
University of Vermont and State Agricultural College
RECRUITING
Burlington
University of Vermont Medical Center
RECRUITING
Burlington
Dartmouth Cancer Center - North
RECRUITING
Saint Johnsbury
Washington
Legacy Cancer Institute Medical Oncology and Day Treatment
RECRUITING
Vancouver
Legacy Salmon Creek Hospital
RECRUITING
Vancouver
Wisconsin
Langlade Hospital and Cancer Center
RECRUITING
Antigo
Duluth Clinic Ashland
RECRUITING
Ashland
Northwest Wisconsin Cancer Center
RECRUITING
Ashland
Aurora Cancer Care-Southern Lakes VLCC
RECRUITING
Burlington
HSHS Sacred Heart Hospital
SUSPENDED
Eau Claire
Marshfield Medical Center-EC Cancer Center
RECRUITING
Eau Claire
Aurora Health Care Germantown Health Center
RECRUITING
Germantown
Aurora Cancer Care-Grafton
RECRUITING
Grafton
Aurora BayCare Medical Center
RECRUITING
Green Bay
Saint Vincent Hospital Cancer Center Green Bay
RECRUITING
Green Bay
Essentia Health-Hayward Clinic
RECRUITING
Hayward
University of Wisconsin Carbone Cancer Center - Johnson Creek
RECRUITING
Johnson Creek
Aurora Cancer Care-Kenosha South
RECRUITING
Kenosha
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
RECRUITING
Madison
University of Wisconsin Carbone Cancer Center - University Hospital
RECRUITING
Madison
William S Middleton VA Medical Center
RECRUITING
Madison
Aurora Bay Area Medical Group-Marinette
RECRUITING
Marinette
Marshfield Medical Center-Marshfield
RECRUITING
Marshfield
Froedtert Menomonee Falls Hospital
RECRUITING
Menomonee Falls
Aurora Cancer Care-Milwaukee
RECRUITING
Milwaukee
Aurora Saint Luke's Medical Center
RECRUITING
Milwaukee
Aurora Sinai Medical Center
RECRUITING
Milwaukee
Medical College of Wisconsin
RECRUITING
Milwaukee
Zablocki Veterans Administration Medical Center
RECRUITING
Milwaukee
Marshfield Medical Center - Minocqua
RECRUITING
Minocqua
ProHealth D N Greenwald Center
RECRUITING
Mukwonago
Drexel Town Square Health Center
RECRUITING
Oak Creek
ProHealth Oconomowoc Memorial Hospital
RECRUITING
Oconomowoc
Vince Lombardi Cancer Clinic - Oshkosh
RECRUITING
Oshkosh
Aurora Cancer Care-Racine
RECRUITING
Racine
Aspirus Cancer Care - James Beck Cancer Center
RECRUITING
Rhinelander
Marshfield Medical Center-Rice Lake
RECRUITING
Rice Lake
Saint Vincent Hospital Cancer Center at Sheboygan
RECRUITING
Sheboygan
Vince Lombardi Cancer Clinic-Sheboygan
RECRUITING
Sheboygan
Essentia Health-Spooner Clinic
RECRUITING
Spooner
Aspirus Cancer Care - Stevens Point
RECRUITING
Stevens Point
Marshfield Medical Center-River Region at Stevens Point
RECRUITING
Stevens Point
Saint Vincent Hospital Cancer Center at Sturgeon Bay
RECRUITING
Sturgeon Bay
Aurora Medical Center in Summit
RECRUITING
Summit
Essentia Health Saint Mary's Hospital - Superior
RECRUITING
Superior
UW Cancer Center at ProHealth Care
RECRUITING
Waukesha
Aspirus Regional Cancer Center
RECRUITING
Wausau
Aurora Cancer Care-Milwaukee West
RECRUITING
Wauwatosa
Aurora West Allis Medical Center
RECRUITING
West Allis
Froedtert West Bend Hospital/Kraemer Cancer Center
RECRUITING
West Bend
Marshfield Medical Center - Weston
RECRUITING
Weston
Aspirus Cancer Care - Wisconsin Rapids
RECRUITING
Wisconsin Rapids
West Virginia
Edwards Comprehensive Cancer Center
RECRUITING
Huntington
West Virginia University Healthcare
RECRUITING
Morgantown
Other Locations
Canada
Ottawa Hospital and Cancer Center-General Campus
RECRUITING
Ottawa
Time Frame
Start Date: 2023-07-12
Estimated Completion Date: 2031-10-15
Participants
Target number of participants: 474
Treatments
Active_comparator: Arm I (image guided RT, chemotherapy, immunotherapy)
Patients 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.
Experimental: Arm II (SBRT, image guided RT, chemotherapy, immunotherapy)
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.
Sponsors
Leads: NRG Oncology

This content was sourced from clinicaltrials.gov

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