NCT07323732

A Study of BIO 300 and Thoracic Radiation Therapy in People With Non-Small Cell Lung Cancer and Interstitial Lung Disease

A Phase II Study of BIO 300 to Reduce the Toxicity of Thoracic Radiotherapy for Patients With Early-Stage Non-Small Cell Lung Cancer and Interstitial Lung Disease (BREATHE)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study to find out whether giving BIO 300 in combination with thoracic radiation therapy is effective in preventing pneumonitis in people with non-small cell lung cancer (NSCLC) and interstitial lung disease (ILD).

Conditions

• NSCLC
• NSCLC, Stage I
• NSCLC Stage II
• Non Small Cell Lung Cancer
• Non-small Cell Lung Cancer Stage I
• Non-small Cell Lung Cancer Stage II
• Interstitial Lung Disease
• Interstitial Lung Disease Due to Connective Tissue Disease (Disorder)

Interventions

Type	Name	Description
DRUG	BIO 300	The drug product, BIO 300 consists of synthetic genistein

Timeline

• Start date: 2026-01-06
• Primary completion: 2029-01-06
• Completion: 2029-01-06
• First posted: 2026-01-07
• Last updated: 2026-03-03

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study