This phase II trial studies whether giving BIO 300 with thoracic radiation therapy works to lower a type of lung inflammation (pneumonitis) in patients with non-small cell lung cancer (NSCLC) and interstitial lung disease (ILD). ILD is another type of lung inflammation that causes scarring and stiffness in the lungs, leading to difficulty breathing and lung damage. About 10% of people with NSCLC also have ILD. People with NSCLC and ILD can sometimes be limited in their treatment options because surgery and certain medications are not recommended for people with ILD. People with NSCLC and ILD can receive thoracic radiation therapy-high-energy radiation that targets and destroys cancer cells in the chest area. However, this therapy can cause lung-related side effects, including pneumonitis, another type of lung inflammation with symptoms that include coughing, difficulty breathing, shortness of breath, and chest pain. The main ingredient in BIO 300 is genistein, which is found in soy. Genistein works as an estrogen receptor beta (ERβ) agonist. This means it attaches to and activates ERβ, a protein found in the body, including inside the lungs. When genistein activates ERβ, it can help control inflammation, slow down cell growth, and protect lung tissue from damage. BIO 300 may be an effective way to lower pneumonitis in patients with NSCLC and ILD.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07323732.
Locations matching your search criteria
United States
New York
New York
Memorial Sloan Kettering Cancer CenterStatus: Active
Contact: Narek Shaverdian
Phone: 631-212-6323
PRIMARY OBJECTIVE:
I. To assess the improvement in the grade ≥ 3 pneumonitis free survival in patients with ILD treated with genistein-based BIO 300 (BIO 300) in combination with thoracic radiotherapy.
SECONDARY OBJECTIVES:
I. To assess time to Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5.0 grade ≥ 2 pneumonitis.
II. To assess tolerability of BIO 300 (by CTACE v 5.0).
III. To assess patient reported quality of life.
IV. To assess pulmonary function.
EXPLORATORY OBJECTIVES:
I. To assess 1-year disease control (local failure, progression-free survival) and overall survival.
II. To assess 2-year disease control (local failure, progression-free survival) and overall survival.
III. To assess blood biomarker correlatives for local failure and toxicity.
OUTLINE:
Patients undergo standard of care (SOC) thoracic radiation therapy every other day (QOD) for 5 treatment fractions or once daily (QD) for 8 or 15 treatment fractions in the absence of disease progression or unacceptable toxicity. Starting up to 7 days prior to thoracic radiation therapy, patients receive BIO 300 orally (PO) QD continuously up to 6 weeks post-completion of thoracic radiation therapy in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and computed tomography (CT) throughout the study.
After completion of study treatment, patients are followed up at 3 and 9 months post radiation therapy.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorNarek Shaverdian
