Actively Recruiting
A Phase II Study of BIO 300 with Thoracic Radiotherapy to Reduce Toxicity in Early-Stage Non-Small Cell Lung Cancer and Interstitial Lung Disease
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-03-03
25
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether BIO 300 combined with thoracic radiation therapy can help prevent pneumonitis in people who have early-stage non-small cell lung cancer (NSCLC) along with interstitial lung disease (ILD). This phase II study focuses on patients with stage I or II NSCLC and ILD, aiming to reduce lung toxicity from radiation treatment. BIO 300 is a drug containing synthetic genistein being evaluated for this purpose. Participants will receive BIO 300 along with thoracic radiation therapy. The study includes patients diagnosed with NSCLC and ILD, confirmed either pathologically or through clinical evidence with multidisciplinary agreement. Women participants must meet specific criteria regarding menopausal status or pregnancy testing. The treatment period and follow-up extend up to 36 months to monitor pneumonitis-free survival. During the study, participants will undergo regular assessments to track their lung health and response to treatment, including monitoring for signs of pneumonitis. Researchers will evaluate the primary outcome of pneumonitis-free survival over three years. Participants' overall health status and potential side effects will be monitored closely, and safety measures are in place. The total participation time may last up to three years depending on follow-up needs.
CONDITIONS
Brief Title
A Study of BIO 300 and Thoracic Radiation Therapy in People With Non-Small Cell Lung Cancer and Interstitial Lung Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give signed informed consent and comply with study requirements
- Age 18 or older at time of consent
- Stage I or II non-small cell lung cancer (NSCLC) confirmed by pathology or clinical evidence with multidisciplinary agreement
- Diagnosed interstitial lung disease (ILD) managed by a pulmonologist or based on imaging and abnormal lung function, including ILD from connective tissue diseases
- ECOG performance status between 0 and 3
- Female participants must be post-menopausal or have a negative pregnancy test if pre-menopausal, with specific age and hormonal criteria
- Life expectancy of at least 6 months
You will not qualify if you...
- Previous thoracic radiation therapy
- History of pneumonectomy
- Major surgery within 28 days before enrollment
- Severe illness preventing timely radiation or study procedures
- Allergy or hypersensitivity to study drugs or excipients
- ILD flare requiring hospitalization in last 30 days
- Poorly controlled cardiac arrhythmias or pacemaker
- Pregnant or breastfeeding women; reproductive-age participants not using effective non-estrogen contraception or abstaining from sex during study and 30 days after
- Use of investigational anticancer therapy
- Planned concurrent chemotherapy, immunotherapy, or biologic drugs targeting the immune system during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Duration of thoracic radiation therapy as per protocol
Participants receive BIO 300 along with thoracic radiation therapy as part of their treatment for early-stage non-small cell lung cancer and interstitial lung disease.
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
N
Narek Shaverdian, MD
J
Jamie Chaft, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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