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.
Who Can Participate?
Eligibility
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
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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.
Locations
Duke University Hospital
Duke Raleigh Hospital
Other
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
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
Christopher
Kelsey
Protocol Number
PRO00116500
NCT ID
NCT05624996
Phase
III
Enrollment Status
Pending Open to Enrollment