Adding high dose targeted radiation to usual treatment for advanced lung cancer
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
Run by NRG Oncology · NCT05624996 · Data updated 2026-11-12
This study is testing if adding a high dose of targeted radiation to the usual chemotherapy and immunotherapy can help people with advanced lung cancer live longer and feel better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 474 (estimated) |
| Sponsor | NRG Oncology Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, durvalumab, osimertinib |
| Locations | 477 sites (Birmingham, Alabama and 476 other locations) |
| Status | Recruiting |
| Started | July 12, 2023 |
| Main results expected | October 15, 2031 |
| Study ends | October 15, 2036 |
| Registry record updated | August 17, 2026 |
| Trial ID | NCT05624996 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with pathologically confirmed, inoperable stage IIB or III, node-positive non-small cell lung cancer.
✕Probably not a fit
Patients with operable lung cancer or those who have received extensive prior treatment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase III trial evaluates the effectiveness of adding stereotactic body radiation therapy (SBRT) to the standard treatment regimen of chemotherapy and immunotherapy for patients with locally advanced, inoperable non-small cell lung cancer (NSCLC). The study compares two treatment arms: one receiving conventional image-guided radiation therapy (IGRT) and the other receiving SBRT followed by conventional radiotherapy. The primary objectives include assessing overall survival and progression-free survival between the two groups, while secondary objectives focus on response rates, local control, and quality of life. The trial aims to determine if SBRT can improve outcomes with fewer doses and less damage to healthy tissue.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and quality of life for patients with advanced lung cancer.
How similar studies have gone: Other studies have shown promising results with SBRT in similar patient populations, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States Recruiting -
The Kirklin Clinic at Acton Road
Birmingham, Alabama, United States Recruiting -
Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis
Daphne, Alabama, United States Recruiting -
Thomas Hospital
Fairhope, Alabama, United States Recruiting -
Mobile Infirmary Medical Center
Mobile, Alabama, United States Recruiting -
Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland
Saraland, Alabama, United States Recruiting
Show 44 more locations
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Kingman Regional Medical Center
Kingman, Arizona, United States Recruiting -
Cancer Center at Saint Joseph's
Phoenix, Arizona, United States Recruiting -
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States Recruiting -
Banner University Medical Center - Tucson
Tucson, Arizona, United States Recruiting -
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States Recruiting -
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, United States Recruiting -
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States Recruiting -
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield, California, United States Recruiting -
Mills-Peninsula Medical Center
Burlingame, California, United States Recruiting -
Palo Alto Medical Foundation-Fremont
Fremont, California, United States Recruiting -
Memorial Medical Center
Modesto, California, United States Recruiting -
Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States Recruiting -
Palo Alto Medical Foundation Health Care
Palo Alto, California, United States Recruiting -
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, United States Recruiting -
Sutter Roseville Medical Center
Roseville, California, United States Recruiting -
Sutter Medical Center Sacramento
Sacramento, California, United States Recruiting -
California Pacific Medical Center-Pacific Campus
San Francisco, California, United States Recruiting -
Mills Health Center
San Mateo, California, United States Recruiting -
Sutter Pacific Medical Foundation
Santa Rosa, California, United States Recruiting -
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, United States Recruiting -
Sutter Solano Medical Center/Cancer Center
Vallejo, California, United States Recruiting -
UCHealth University of Colorado Hospital
Aurora, Colorado, United States Recruiting -
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, United States Recruiting -
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, United States Recruiting -
Memorial Hospital North
Colorado Springs, Colorado, United States Recruiting -
UCHealth - Cherry Creek
Denver, Colorado, United States Recruiting -
Poudre Valley Hospital
Fort Collins, Colorado, United States Recruiting -
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, United States Recruiting -
UCHealth Greeley Hospital
Greeley, Colorado, United States Recruiting -
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado, United States Recruiting -
UCHealth Lone Tree Health Center
Lone Tree, Colorado, United States Recruiting -
Medical Center of the Rockies
Loveland, Colorado, United States Recruiting -
Beebe Medical Center
Lewes, Delaware, United States Recruiting -
Beebe South Coastal Health Campus
Millville, Delaware, United States Recruiting -
Helen F Graham Cancer Center
Newark, Delaware, United States Recruiting -
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States Recruiting -
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States Recruiting -
Beebe Health Campus
Rehoboth Beach, Delaware, United States Recruiting -
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, United States Recruiting -
Bay Pines VA Healthcare System
Bay Pines, Florida, United States Recruiting -
Morton Plant Hospital
Clearwater, Florida, United States Recruiting -
Halifax Health Cancer Center for Hope - Daytona Beach
Daytona Beach, Florida, United States Recruiting -
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, United States Recruiting -
Mayo Clinic in Florida
Jacksonville, Florida, United States Recruiting
+427 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Charles B Simone — NRG Oncology
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Using papaverine with chemoradiation to treat advanced non-small cell lung cancer
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.