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

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT07323732
Phase
PHASE2
Status
Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BIO 300 — DRUG
    The drug product, BIO 300 consists of synthetic genistein

Study Details

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).

Key Dates

Start date
Jan 6, 2026
Status verified
Mar 2026
Primary completion
Jan 6, 2029
Completion
Jan 6, 2029

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants with Non-Small Cell Lung Cancer and Interstitial Lung Disease
    Participants with Non-Small Cell Lung Cancer/NCSLC and Interstitial Lung Disease/ILD

Primary Outcome Measure

Pneumonitis free survival [ Time Frame: Up to 36 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Narek Shaverdian, MD
631-212-6323
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Narek Shaverdian, MD
631-212-6323
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Narek Shaverdian, MD
631-212-6323
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)CommackNew York11725
Narek Shaverdian, MD
631-212-6323
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Narek Shaverdian, MD
631-212-6323
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Narek Shaverdian, MD
631-212-6323
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553
Narek Shaverdian, MD
631-212-6323

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