NRG-LU008 for locally advanced non-small cell lung cancer - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if stereotactic body radiation therapy (SBRT) might be beneficial for people with non-small cell lung cancer (NSCLC). We want to compare the outcomes between the standard treatment for NSCLC and the standard treatment with the addition of SBRT.
What is the Condition Being Studied?
Non-Small Cell Lung Cancer (NSCLC)
Who Can Participate in the Study?
Adults ages 18+ who:
- Are diagnosed with Stage II or Stage III NSCLC
- Have metastases to the lymph nodes in the chest
- Are not a candidate for surgery
For more information about this study, contact the study team at nick.jeffries@duke.edu.
Age Group
Adults
What is Involved?
If you choose to join this study, you will get a random assignment (like a coin flip) to 1 of 2 groups:
- Group 1: If you are in this group, you will first get the usual treatment of radiation plus chemotherapy. The radiation will be given for about 6 weeks and the chemotherapy is given at the same time. Next, you will receive the usual immune therapy, durvalumab, every 2 or 4 weeks intravenously for up to 12 months, or, if you are unable to receive immune therapy, you may receive additional doses of the same chemotherapy you received during radiation. Your study doctor will explain your treatment options.
- Group 2: If you are in this group, you will have SBRT first for about 1-2 weeks before getting the usual radiation, chemotherapy, and immune therapy (or more chemotherapy if you can't have immune therapy) described above for group 1. The SBRT will be given in 3-5 doses over several days.
Study Details
Full Title
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
Principal Investigator
Radiation Oncologist
Protocol Number
IRB:
PRO00116500
NCT:
NCT05624996
Phase
Phase
III
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment