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BIO 300 for Non-Small Cell Lung Cancer and Interstitial Lung Disease

This study is testing if a drug called BIO 300, when given with radiation therapy to the chest (thoracic radiation therapy), can help prevent lung inflammation (pneumonitis) in people who have non-small cell lung cancer (NSCLC) and also have interstitial lung disease (ILD). BIO 300 is made from synthetic genistein. The study aims to enroll 25 participants. To join, you must be at least 18 years old and have Stage I or II NSCLC. The main goal is to see how long people live without developing pneumonitis, with this being tracked for up to 36 months.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 25 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 36 months to track pneumonitis-free survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07323732

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~25 participants
Updated 2026-03-03 on ClinicalTrials.gov
What's tested:BIO 300

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pneumonitis free survival
Measured over Up to 36 months

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)

Explore related trials

Interstitial Lung DiseaseLung Non-Small Cell Carcinoma

Where it's being run

7 sites across 2 states
New York4
New Jersey3

Study leadership

  • Narek Shaverdian, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Narek Shaverdian, MD
[email protected]
631-212-6323
Email the study team

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Eligibility criteria

Inclusion

Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. - Patient age ≥ 18 at time of consent
Stage I - II NSCLC (as per the American Joint Commission on Cancer (AJCC) 8th edition)
Interstitial Lung Disease diagnosis (one of the below)
ILD as diagnosed and managed by a pulmonologist
ILD based on diagnostic imaging criteria and abnormal DLCO
ILD as a result of connective tissue diseases (e.g., polymyositis/dermatomyositis, rheumatoid arthritis, systemic lupus erythematosus, Sjogren's syndrome, scleroderma, mixed connective tissue disease)
ECOG performance status of 0 - 3
Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrhoeic for 12 months without an alternative medical cause. The following age-specific requirements apply:
Women \<50 years of age would be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
Women ≥50 years of age would be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \>1 year ago, had chemotherapy-induced menopause with last menses \>1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
Life expectancy of at least 6 months

Exclusion

Previous thoracic radiation
History of pneumonectomy
Major surgical procedure (e.g. intra-cranial, intra-thoracic, intra-abdominal, or intra-pelvic) within 28 days prior to enrollment.
Severe concurrent illness that may preclude timely completion of thoracic radiation or study procedures
Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
ILD exacerbation requiring hospitalization in the last 30 days
Poorly controlled cardiac arrhythmias not responding to medical therapy or a pacemaker
Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential unless they are willing to employ a highly effective non-estrogen based contraception from screening to 30 days after the last dose of BIO 300 or to abstain from sexual intercourse during these time periods.
Concomitant medications:

What this trial measures

  • Pneumonitis free survivalUp to 36 months

    The primary objective of this study is to assess the improvement in the Grade ≥ 3 pneumonitis free survival in participants with Interstitial Lung Disease/ILD treated with BIO 300 in combination with thoracic radiotherapy.