NCT06008730

Proton Beam Radiation Therapy After Treatment for Resected N2 Non-Small Cell Lung Cancer

Proton Beam Radiation Therapy in Patients With Resected N2 Non-Small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial tests proton beam radiation therapy in patients with non-small cell lung cancer who have undergone surgical resection and have lymph nodes involving the middle of the chest. Proton therapy is a type of radiation treatment that kills cancer cells while avoiding surrounding healthy tissue. Proton beam therapy is sometimes used after cancer surgery to reduce the risk of cancer recurrence (coming back). Giving proton beam radiation therapy may work better than conventional radiation treatment after surgery in patients with non-small cell lung cancer.

Detailed description

PRIMARY OBJECTIVE: I. To assess the safety of proton beam radiation therapy (PBRT) for resected N2 non-small cell lung cancer (NSCLC). SECONDARY OBJECTIVES: I. To measure the radiation dose to the circulating immune compartment and explore its association with clinical endpoints. II. To assess the efficacy of PBRT for resected N2 NSCLC. OUTLINE: Patients undergo radiation treatment planning and then undergo proton beam radiation therapy on study. Patients also undergo collection of blood samples. Patients are followed up for 24 months after first dose of radiotherapy.

Conditions

• Resectable Lung Non-Small Cell Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of blood samples
RADIATION	Proton Beam Radiation Therapy	Undergo proton beam radiation therapy
OTHER	Radiology, Treatment Planning	Undergo radiation treatment planning

Timeline

• Start date: 2024-12-13
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2023-08-24
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study