RecruitingPhase 2NCT07323732

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)


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

25 participants

Start Date

Jan 6, 2026

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called BIO 300 (a natural compound from soy) combined with standard radiation therapy for people who have early-stage non-small cell lung cancer (NSCLC) and also have interstitial lung disease (ILD) — a condition where the lungs become scarred and stiff. ILD makes radiation treatment riskier, and BIO 300 may help protect the lungs from radiation damage. **You may be eligible if...** - You are 18 or older - You have early-stage NSCLC (Stage I or II) - You have been diagnosed with interstitial lung disease (either by a lung specialist, imaging, or as a result of a connective tissue disease like lupus or rheumatoid arthritis) - You are in reasonably good health (ECOG performance status 0–3) - A pregnancy test is negative (if applicable) **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have advanced-stage lung cancer - You do not have a confirmed ILD diagnosis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBIO 300

The drug product, BIO 300 consists of synthetic genistein


Locations(7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07323732


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