Phase II Study of BIO 300 with Thoracic Radiation to Reduce Lung Toxicity in Early-Stage Non-Small Cell Lung Cancer and Interstitial Lung Disease

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.

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