BIO 300 for Non-Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called BIO 300, combined with thoracic radiation therapy, to determine if it can prevent pneumonitis (lung inflammation) in people with non-small cell lung cancer (NSCLC) who also have interstitial lung disease (ILD). The researchers aim to discover if this combination can protect the lungs from inflammation during cancer treatment. Individuals with early-stage NSCLC and a diagnosis of ILD might find this study suitable. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to important findings.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop all current medications, but you cannot take any investigational anticancer therapy, planned concurrent chemotherapy or immunotherapy, or certain biologic drugs targeting the immune system while participating.
Is there any evidence suggesting that BIO 300 is likely to be safe for humans?
Research has shown that BIO 300, when combined with standard radiation therapy, appears safe. Studies have found that BIO 300 can protect healthy tissues from radiation damage while still targeting cancer cells. In earlier research, patients tolerated BIO 300 well, experiencing only a few mild side effects. This suggests that BIO 300 might be a safe option for those undergoing treatment for non-small cell lung cancer (NSCLC). However, as this trial remains in the middle stages, researchers continue to gather safety information to confirm these findings. Always consult your doctor about any concerns before joining a trial.12345
Why do researchers think this study treatment might be promising for non-small cell lung cancer?
Unlike the standard treatments for non-small cell lung cancer, which typically involve chemotherapy, radiation, and targeted therapies, BIO 300 offers a promising new approach. Researchers are excited because BIO 300 is derived from rice bran and works as a radioprotectant, potentially reducing lung damage in patients with both non-small cell lung cancer and interstitial lung disease. Additionally, its unique mechanism aims to protect healthy lung tissue during cancer treatment, which might improve the overall quality of life for patients. This innovative approach could provide a significant advantage over existing treatment options by minimizing harmful side effects.
What evidence suggests that BIO 300 might be an effective treatment for non-small cell lung cancer?
Research has shown that BIO 300 might help people with non-small cell lung cancer (NSCLC). In one study, 65% of patients experienced tumor shrinkage, and in 20% of these cases, the tumors completely disappeared. The treatment proved gentle on the body, with few side effects. Lab studies suggest that BIO 300 can protect healthy tissue from radiation damage while helping radiation target cancer cells. These findings support testing BIO 300 in this trial to determine if it can prevent lung inflammation when used with radiation therapy in people with NSCLC and interstitial lung disease (ILD).13467
Who Is on the Research Team?
Narek Shaverdian, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults over 18 with Stage I-II non-small cell lung cancer (NSCLC) and interstitial lung disease (ILD). Participants need an ECOG performance status of 0-3, can give informed consent, and women must be post-menopausal or surgically sterile. A confirmed diagnosis of NSCLC is recommended but not mandatory if biopsy risks are too high.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BIO 300 in combination with thoracic radiation therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BIO 300
Trial Overview
The study tests BIO 300 combined with thoracic radiation therapy to see if it prevents pneumonitis in patients with NSCLC who also have ILD. The effectiveness of this combination treatment will be evaluated against the risk of developing pneumonitis.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants with Non-Small Cell Lung Cancer/NCSLC and Interstitial Lung Disease/ILD
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Citations
NCT02567799 | BIO 300 Non-Small Cell Lung Cancer Study
The purpose of this study is to determine the safety and effectiveness of BIO 300 Oral Suspension when used in combination with standard dose radiation therapy ...
Multicenter Phase 1b/2a Clinical Trial of Radioprotectant ...
No patient had progression as their best overall response, and a 65% tumor response rate was achieved (20% complete response rate). Conclusions: ...
Multicenter Phase 1b/2a Clinical Trial of Radioprotectant ...
The low toxicity rates, along with the pharmacodynamic results and tumor response rates, support further investigation of BIO 300 as an ...
A Study of BIO 300 and Thoracic Radiation Therapy in ...
The primary objective of this study is to assess the improvement in the Grade ≥ 3 pneumonitis free survival in participants with Interstitial ...
Non-Small Cell Lung Cancer
Nonclinical Data. Nonclinical studies confirm that BIO 300 can protect normal tissue from radiation, while acting additively with radiation to kill tumors.
NCT02567799 | BIO 300 Non-Small Cell Lung Cancer Study
The purpose of this study is to determine the safety and effectiveness of BIO 300 Oral Suspension when used in combination with standard dose radiation ...
Multicenter Phase 1b/2a Clinical Trial of Radioprotectant ...
We evaluated the clinical utility of BIO 300 Oral Suspension (BIO 300; synthetic genistein nanosuspension) in patients with NSCLC.
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