NCT06262321

Thoracic Radiotherapy for Patients With Metastatic (Stage IV) Non-Small Cell Lung Cancer at High Risk of Symptomatic Progression Within the Thorax

Phase II Trial of Thoracic Radiotherapy for Patients With Metastatic (Stage IV) Non-Small Cell Lung Cancer at High Risk of Symptomatic Progression Within the Thorax

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with metastatic non small cell lung cancer with high risk location or size are treated with prophylactic radiation therapy in conjunction with standard of care systemic therapy.

Detailed description

This will be a single-cohort Phase II single center, prospective trial. Patients with stage IV NSCLC are eligible. Patients may receive standard of care systemic therapy (chemotherapy and/or immunotherapy). Radiotherapy will be directed at high-risk disease (primary cancer, nodal metastases, and metastases) in the thorax. Treatment of other sites of extrathoracic metastases would be allowed as per standard of care. Standard chest radiation dosing and normal tissue exposures (based on published or ongoing studies) will be applied. There is no plan to escalate the chest radiation dose (i.e., no Phase I component) as palliative regimens for NSCLC have been routinely used for many decades.

Conditions

• Stage 4 NSCLC
• Radiotherapy

Interventions

Type	Name	Description
RADIATION	Prophylactic Palliative Radiotherapy	Prophylactic Palliative Radiotherapy

Timeline

• Start date: 2024-05-15
• Primary completion: 2029-02-01
• Completion: 2029-02-01
• First posted: 2024-02-16
• Last updated: 2025-09-08

Locations

1 site across 1 country: United States