Actively Recruiting
Proton Beam Radiation Therapy in Patients With Resected N2 Non-Small Cell Lung Cancer
Led by Emory University · Updated on 2025-11-10
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This clinical trial evaluates proton beam radiation therapy in patients with non-small cell lung cancer who have had surgery to remove their tumor and have cancer involvement in the middle chest lymph nodes (N2). The study aims to assess the safety of proton beam radiation therapy and its potential benefits compared to conventional radiation after surgery, as well as to explore radiation's impact on the immune system and overall patient outcomes. Participants undergo radiation treatment planning followed by proton beam radiation therapy. Blood samples are collected during the study to analyze the radiation dose to the immune system. The study includes a single treatment phase with follow-up lasting 24 months after the first radiation dose to monitor safety, disease recurrence, and survival. Throughout the study, participants will be monitored for any adverse events up to 90 days after enrollment. Researchers will assess radiation doses to immune cells before treatment and track disease-free and overall survival for up to two years. Participants are expected to comply with scheduled visits, tests, and treatment plans during the study period, allowing researchers to gather safety and efficacy data.
CONDITIONS
Brief Title
Proton Beam Radiation Therapy After Treatment for Resected N2 Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Complete surgical resection of lung cancer with lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy plus lymph node dissection including at least three mediastinal (N2) stations
- Pathology showing complete removal of primary tumor (R0 resection) and involvement of at least one mediastinal lymph node (pN2) without tumor in highest dissected node
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less (Karnofsky 60% or higher)
- Life expectancy greater than 12 weeks
- Hemoglobin level of 9.0 g/dl or higher without recent transfusion
- White blood cell count of 2000/uL or higher without recent growth factor support or transfusion
- Platelet count of 100,000/mcL or higher without recent transfusion
- Serum creatinine of 2 mg/dL or less or glomerular filtration rate of at least 40 mL/min
- Female of child-bearing potential must have a negative pregnancy test and agree to use contraception; men must agree to contraception during and after study
- Completion of all prior cancer therapies at least 2 weeks before radiation
- Cardiac function assessed as New York Heart Association Functional Class 2B or better if history of heart disease
- Willingness and ability to comply with study visits, treatments, tests, and restrictions
- Signed informed consent acknowledging study details and risks
You will not qualify if you...
- Stage IV lung cancer
- Systemic therapy within 2 weeks before starting radiation
- Prior thoracic radiation therapy
- Previous diagnosis of non-small cell lung cancer other than current
- Small cell lung cancer diagnosis
- Tumors with targetable EGFR or ALK mutations
- Incomplete surgical resection including R1 or R2 margins or fewer than three mediastinal lymph node stations sampled
- Any positive lymph nodes left unremoved
- Malignant pleural or pericardial effusion
- Use of other investigational agents or devices within 21 days before study treatment
- Uncontrolled infections, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting study compliance
- Significant cardiovascular disease within 3 months before study, including recent heart attack or stroke, angina requiring treatment, severe peripheral vascular disease, or uncontrolled high blood pressure
- Vulnerable populations such as adults unable to consent, minors, pregnant women, and prisoners
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Short period prior to treatment start
Participants undergo radiation treatment planning to prepare for proton beam radiation therapy.
1 visit (in-person)
Duration - Up to 90 days from enrollment
Participants undergo proton beam radiation therapy and blood sample collections during treatment.
Multiple visits for radiation therapy and blood sample collection
Duration - Up to 24 months
Participants are followed for safety and efficacy outcomes including survival for up to 24 months after the first dose of radiation therapy.
Periodic visits for follow-up assessments
Trial Site Locations
Total: 1 location
1
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
B
Bill Stokes, MD
A
Aparna H. Kesarwala, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here