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).
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
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
Single group
BIO 300
DrugThe drug product, BIO 300 consists of synthetic genistein
Pneumonitis free survival
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.
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