Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-small Cell Lung Cancer
Launched by NRG ONCOLOGY · Nov 14, 2022
Trial Information
Current as of June 10, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating whether adding a special type of high-dose radiation therapy called stereotactic body radiation therapy (SBRT) can improve treatment outcomes for patients with advanced non-small cell lung cancer that cannot be surgically removed. The study compares the effects of this additional radiation treatment combined with standard care— which includes image-guided radiation therapy, chemotherapy, and immunotherapy—against the standard treatment alone. SBRT aims to deliver precise radiation to tumors while minimizing damage to healthy tissue, which could potentially lead to better results.
To participate in this trial, patients must have confirmed stage II or III non-small cell lung cancer and meet certain health criteria. This includes being 18 years or older, having a primary tumor along with at least one enlarged lymph node, and being suitable for combined therapy. Participants will undergo a series of treatments and evaluations, and they can expect close monitoring throughout the study. It’s important to know that patients with prior radiation to the cancer area or those who are pregnant cannot join the trial. Overall, this study hopes to find a more effective treatment option for patients with inoperable lung cancer.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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
- Exclusion Criteria:
- • 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
About Nrg Oncology
NRG Oncology is a prominent clinical trial sponsor dedicated to advancing cancer research through innovative multi-institutional studies. Comprising a collaborative network of leading academic institutions and community hospitals, NRG Oncology focuses on enhancing patient outcomes by conducting rigorous clinical trials that evaluate new treatment strategies and improve existing therapies. With a commitment to scientific excellence and patient-centered care, the organization plays a vital role in shaping the future of oncology by integrating cutting-edge research with clinical practice, ultimately striving to translate findings into meaningful improvements in cancer care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Durham, North Carolina, United States
Cleveland, Ohio, United States
Milwaukee, Wisconsin, United States
Saint Louis, Missouri, United States
Kalamazoo, Michigan, United States
Peoria, Illinois, United States
Toms River, New Jersey, United States
Zion, Illinois, United States
Little Rock, Arkansas, United States
Oklahoma City, Oklahoma, United States
Des Moines, Iowa, United States
New York, New York, United States
Baltimore, Maryland, United States
Kalamazoo, Michigan, United States
Traverse City, Michigan, United States
Delaware, Ohio, United States
Houston, Texas, United States
Fort Collins, Colorado, United States
Lewes, Delaware, United States
Austell, Georgia, United States
Salina, Kansas, United States
Gresham, Oregon, United States
Tualatin, Oregon, United States
Urbana, Illinois, United States
Annapolis, Maryland, United States
Ann Arbor, Michigan, United States
Dayton, Ohio, United States
Grand Forks, North Dakota, United States
Effingham, Illinois, United States
Johnson Creek, Wisconsin, United States
Clearwater, Florida, United States
Springfield, Illinois, United States
Downers Grove, Illinois, United States
Roseville, California, United States
Hazel Crest, Illinois, United States
Springfield, Illinois, United States
Troy, Michigan, United States
Honolulu, Hawaii, United States
Rochester, New York, United States
Valhalla, New York, United States
Danville, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Tucson, Arizona, United States
Los Angeles, California, United States
Modesto, California, United States
Jacksonville, Florida, United States
Atlanta, Georgia, United States
Honolulu, Hawaii, United States
Detroit, Michigan, United States
Duluth, Minnesota, United States
Saint Cloud, Minnesota, United States
Saint Louis, Missouri, United States
New Brunswick, New Jersey, United States
Bronx, New York, United States
Syracuse, New York, United States
Chapel Hill, North Carolina, United States
Winston Salem, North Carolina, United States
Winston Salem, North Carolina, United States
Bismarck, North Dakota, United States
Fargo, North Dakota, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Wynnewood, Pennsylvania, United States
Burlington, Vermont, United States
Newark, Delaware, United States
Aurora, Illinois, United States
Lexington, Kentucky, United States
Camden, New Jersey, United States
Bronx, New York, United States
Charlotte, North Carolina, United States
Canton, Ohio, United States
Columbus, Ohio, United States
Morgantown, West Virginia, United States
Cape Girardeau, Missouri, United States
New Orleans, Louisiana, United States
Livingston, New Jersey, United States
Memphis, Tennessee, United States
Berlin, Vermont, United States
Omaha, Nebraska, United States
Glens Falls, New York, United States
Matthews, North Carolina, United States
Milwaukee, Wisconsin, United States
Oak Lawn, Illinois, United States
Tampa, Florida, United States
Park Ridge, Illinois, United States
Royal Oak, Michigan, United States
Stony Brook, New York, United States
Charlotte, North Carolina, United States
Sioux Falls, South Dakota, United States
Sacramento, California, United States
Orlando, Florida, United States
Augusta, Georgia, United States
Rochester, Minnesota, United States
Saint Louis, Missouri, United States
Bronx, New York, United States
Green Bay, Wisconsin, United States
Madison, Wisconsin, United States
Marshfield, Wisconsin, United States
Honolulu, Hawaii, United States
Decatur, Illinois, United States
Bloomington, Illinois, United States
Ottawa, Illinois, United States
Peoria, Illinois, United States
Peoria, Illinois, United States
Cedar Rapids, Iowa, United States
Clive, Iowa, United States
Des Moines, Iowa, United States
Lansing, Michigan, United States
Brainerd, Minnesota, United States
Duluth, Minnesota, United States
Duluth, Minnesota, United States
Rochester, New York, United States
Salisbury, North Carolina, United States
Pontiac, Michigan, United States
Wilkes Barre, Pennsylvania, United States
Spartanburg, South Carolina, United States
Kalamazoo, Michigan, United States
Canandaigua, New York, United States
Jupiter, Florida, United States
Atlanta, Georgia, United States
'Aiea, Hawaii, United States
Honolulu, Hawaii, United States
Honolulu, Hawaii, United States
Honolulu, Hawaii, United States
Galesburg, Illinois, United States
Kansas City, Kansas, United States
Topeka, Kansas, United States
Wichita, Kansas, United States
New Orleans, Louisiana, United States
Salisbury, Maryland, United States
Worcester, Massachusetts, United States
Petoskey, Michigan, United States
Bemidji, Minnesota, United States
Joplin, Missouri, United States
Springfield, Missouri, United States
Billings, Montana, United States
Reno, Nevada, United States
Akron, Ohio, United States
Canton, Ohio, United States
Cincinnati, Ohio, United States
Dayton, Ohio, United States
Franklin, Ohio, United States
Mentor, Ohio, United States
Troy, Ohio, United States
Portland, Oregon, United States
Ephrata, Pennsylvania, United States
West Reading, Pennsylvania, United States
Sioux Falls, South Dakota, United States
Burlington, Vermont, United States
Eau Claire, Wisconsin, United States
Minocqua, Wisconsin, United States
Oconomowoc, Wisconsin, United States
Rhinelander, Wisconsin, United States
Rice Lake, Wisconsin, United States
Sheboygan, Wisconsin, United States
Stevens Point, Wisconsin, United States
West Allis, Wisconsin, United States
Weston, Wisconsin, United States
Mountain View, California, United States
Palo Alto, California, United States
San Francisco, California, United States
Columbus, Ohio, United States
Columbus, Ohio, United States
York, Pennsylvania, United States
Huntington, West Virginia, United States
Antigo, Wisconsin, United States
Wausau, Wisconsin, United States
Ottawa, Ontario, Canada
Libertyville, Illinois, United States
Livonia, Michigan, United States
Mansfield, Ohio, United States
Oshkosh, Wisconsin, United States
Marysville, California, United States
Tucson, Arizona, United States
Elgin, Illinois, United States
Council Bluffs, Iowa, United States
Canton, Illinois, United States
Carthage, Illinois, United States
Eureka, Illinois, United States
Kewanee, Illinois, United States
Macomb, Illinois, United States
Peru, Illinois, United States
Princeton, Illinois, United States
Somerville, New Jersey, United States
Warrenville, Illinois, United States
Grafton, Wisconsin, United States
Atlanta, Georgia, United States
Burlingame, California, United States
Vallejo, California, United States
Colorado Springs, Colorado, United States
Bloomington, Illinois, United States
Chicago, Illinois, United States
Geneva, Illinois, United States
Pekin, Illinois, United States
Bay City, Michigan, United States
Flint, Michigan, United States
Lansing, Michigan, United States
Mount Clemens, Michigan, United States
Saint Louis, Missouri, United States
Concord, North Carolina, United States
Raleigh, North Carolina, United States
Burlington, Wisconsin, United States
Germantown, Wisconsin, United States
Green Bay, Wisconsin, United States
Kenosha, Wisconsin, United States
Marinette, Wisconsin, United States
Milwaukee, Wisconsin, United States
Racine, Wisconsin, United States
Summit, Wisconsin, United States
Wauwatosa, Wisconsin, United States
Wisconsin Rapids, Wisconsin, United States
Roseville, California, United States
Peoria, Illinois, United States
Saint Johnsbury, Vermont, United States
York, Pennsylvania, United States
Bloomington, Illinois, United States
Los Angeles, California, United States
Santa Rosa, California, United States
Gettysburg, Pennsylvania, United States
Saint Louis, Missouri, United States
Gastonia, North Carolina, United States
Sunnyvale, California, United States
Atlanta, Georgia, United States
Overland Park, Kansas, United States
Clarkston, Michigan, United States
Lapeer, Michigan, United States
Kansas City, Missouri, United States
Lee's Summit, Missouri, United States
Monroe, North Carolina, United States
Shelby, North Carolina, United States
Fargo, North Dakota, United States
Beachwood, Ohio, United States
Rock Hill, South Carolina, United States
Vancouver, Washington, United States
Springfield, Illinois, United States
Delaware, Ohio, United States
Saint Peters, Missouri, United States
Great Falls, Montana, United States
Loveland, Colorado, United States
Sugar Land, Texas, United States
Newark, Delaware, United States
Newark, Delaware, United States
Rehoboth Beach, Delaware, United States
Wilmington, Delaware, United States
Brighton, Michigan, United States
Chelsea, Michigan, United States
Farmington Hills, Michigan, United States
Pontiac, Michigan, United States
Huntersville, North Carolina, United States
Centerville, Ohio, United States
Dublin, Ohio, United States
Marion, Ohio, United States
West Chester, Ohio, United States
Lewisburg, Pennsylvania, United States
Colorado Springs, Colorado, United States
Commack, New York, United States
Centralia, Illinois, United States
Decatur, Illinois, United States
Effingham, Illinois, United States
Mattoon, Illinois, United States
O'fallon, Illinois, United States
Brighton, Michigan, United States
Chelsea, Michigan, United States
Ypsilanti, Michigan, United States
Sainte Genevieve, Missouri, United States
Sullivan, Missouri, United States
Huntersville, North Carolina, United States
Matthews, North Carolina, United States
Mooresville, North Carolina, United States
Dayton, Ohio, United States
Conroe, Texas, United States
Houston, Texas, United States
League City, Texas, United States
Sturgeon Bay, Wisconsin, United States
Montvale, New Jersey, United States
Harrison, New York, United States
Uniondale, New York, United States
Middletown, New Jersey, United States
Ames, Iowa, United States
Basking Ridge, New Jersey, United States
Bakersfield, California, United States
Westminster, Maryland, United States
Southhaven, Mississippi, United States
Creve Coeur, Missouri, United States
Saint Louis, Missouri, United States
Lebanon, Pennsylvania, United States
Gaffney, South Carolina, United States
Greer, South Carolina, United States
Union, South Carolina, United States
Eau Claire, Wisconsin, United States
Milwaukee, Wisconsin, United States
Council Bluffs, Iowa, United States
Honolulu, Hawaii, United States
Fremont, California, United States
Milwaukee, Wisconsin, United States
Menomonee Falls, Wisconsin, United States
Mukwonago, Wisconsin, United States
West Bend, Wisconsin, United States
Waukesha, Wisconsin, United States
Atlanta, Georgia, United States
Westwood, Kansas, United States
Ashland, Wisconsin, United States
Kernersville, North Carolina, United States
Mount Airy, North Carolina, United States
Thomasville, North Carolina, United States
Wilkesboro, North Carolina, United States
Rochester, New York, United States
Phoenix, Arizona, United States
Winter Haven, Florida, United States
Chambersburg, Pennsylvania, United States
Charlotte, North Carolina, United States
Phoenix, Arizona, United States
Perrysburg, Ohio, United States
Willow Grove, Pennsylvania, United States
Rock Hill, South Carolina, United States
New York, New York, United States
Dekalb, Illinois, United States
Albemarle, North Carolina, United States
Charlotte, North Carolina, United States
Stevens Point, Wisconsin, United States
Statesville, North Carolina, United States
Deer River, Minnesota, United States
Hibbing, Minnesota, United States
Sandstone, Minnesota, United States
Virginia, Minnesota, United States
Collierville, Tennessee, United States
Ashland, Wisconsin, United States
Colorado Springs, Colorado, United States
Port Huron, Michigan, United States
Honolulu, Hawaii, United States
Oak Creek, Wisconsin, United States
Chadds Ford, Pennsylvania, United States
Madison, Wisconsin, United States
Libertyville, Illinois, United States
Kingman, Arizona, United States
Washington, Illinois, United States
Farmington, Missouri, United States
San Mateo, California, United States
Fort Collins, Colorado, United States
Greeley, Colorado, United States
Wilmington, North Carolina, United States
Lancaster, South Carolina, United States
Salisbury, North Carolina, United States
Bozeman, Montana, United States
Ocean Pines, Maryland, United States
Barrington, Illinois, United States
Crystal Lake, Illinois, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Clemmons, North Carolina, United States
Statesville, North Carolina, United States
Wilkesboro, North Carolina, United States
Newnan, Georgia, United States
Lancaster, Pennsylvania, United States
Vancouver, Washington, United States
Forest City, North Carolina, United States
Cary, North Carolina, United States
Highlands Ranch, Colorado, United States
Lone Tree, Colorado, United States
Alton, Illinois, United States
Annapolis, Maryland, United States
Cary, North Carolina, United States
Hayward, Wisconsin, United States
Spooner, Wisconsin, United States
Superior, Wisconsin, United States
'Aiea, Hawaii, United States
Springfield, Illinois, United States
Perrysburg, Ohio, United States
Denver, Colorado, United States
Aurora, Colorado, United States
Shiloh, Illinois, United States
Sheboygan, Wisconsin, United States
Dalton, Georgia, United States
Matthews, North Carolina, United States
Wilmington, North Carolina, United States
Avon, Ohio, United States
Des Moines, Iowa, United States
Supply, North Carolina, United States
Lebanon, New Hampshire, United States
Wyoming, Michigan, United States
Grand Rapids, Michigan, United States
Pontiac, Michigan, United States
Ann Arbor, Michigan, United States
Brighton, Michigan, United States
Chelsea, Michigan, United States
Dayton, Ohio, United States
Webster, New York, United States
Danville, Illinois, United States
Greenville, Ohio, United States
Los Angeles, California, United States
Ames, Iowa, United States
Rhinelander, Wisconsin, United States
Stevens Point, Wisconsin, United States
Minocqua, Wisconsin, United States
Batavia, New York, United States
Palos Heights, Illinois, United States
Clarkston, Michigan, United States
Farmington Hills, Michigan, United States
Madison Heights, Michigan, United States
Macomb, Michigan, United States
Ankeny, Iowa, United States
Sunset Hills, Missouri, United States
O'fallon, Illinois, United States
Des Moines, Iowa, United States
Clive, Iowa, United States
Lansing, Michigan, United States
Rockford, Illinois, United States
Pontiac, Michigan, United States
Madison, Wisconsin, United States
Saint Johnsbury, Vermont, United States
Dayton, Ohio, United States
Dayton, Ohio, United States
Troy, Michigan, United States
Royal Oak, Michigan, United States
Johnson Creek, Wisconsin, United States
Farmington Hills, Michigan, United States
Troy, Michigan, United States
North Wilkesboro, North Carolina, United States
Millville, Delaware, United States
Madison, Wisconsin, United States
Aurora, Illinois, United States
Kalamazoo, Michigan, United States
Warren, Michigan, United States
Olathe, Kansas, United States
Ankeny, Iowa, United States
Clive, Iowa, United States
Des Moines, Iowa, United States
Des Moines, Iowa, United States
Waukee, Iowa, United States
Raleigh, North Carolina, United States
Union, South Carolina, United States
Patients applied
Trial Officials
Charles B Simone
Principal Investigator
NRG Oncology
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials