Lung Cancer
NRG-LU008: 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
Description
This is a 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.
Inclusion Notes
For a full description of this trial, please go to the listing on www.clinicaltrials.gov
Eligibility Criteria
A patient cannot be considered eligible for this study unless ALL of the following conditions are met.
Pathologically (histologically or cytologically) proven diagnosis of non-operable Stage IIB or III, node positive, (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;
- 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;
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;
Adequate renal function: Creatinine clearance ≥ 25 mL/min by the Cockcroft-Gault (CG) 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 U.S., authorization permitting release of personal health information.
Start Date
Wednesday, October 8, 2025
Principal / Contact Name
John Mikell, MD