A Study of BIO 300 and Thoracic Radiation Therapy in People With Non-Small Cell Lung Cancer and Interstitial Lung Disease
A Phase II Study of BIO 300 to Reduce the Toxicity of Thoracic Radiotherapy for Patients With Early-Stage Non-Small Cell Lung Cancer and Interstitial Lung Disease (BREATHE)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether BIO 300 given with radiation to the chest can prevent pneumonitis, or lung swelling. It is for adults with stage I or II non-small cell lung cancer and interstitial lung disease, which can cause lung scarring.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18 or older, able to sign a consent form, and able to follow study rules.
- Have stage I or II non-small cell lung cancer. A biopsy is strongly advised. If a biopsy is too risky, other evidence and agreement from a team of doctors are needed.
- Have interstitial lung disease diagnosed and treated by a lung doctor, shown by scans and an abnormal test of how well gas moves from the lungs into the blood, or caused by a connective tissue disease.
- Have an ECOG activity score of 0–3, ranging from fully active to needing help with self-care and spending much of the day in bed or a chair.
- Women must meet the study’s rules for menopause or have a negative pregnancy test if they have not gone through menopause.
- Be expected to live at least 6 months.
Who can't join
- Have had radiation to the chest or surgery to remove an entire lung.
- Had major surgery within 28 days before joining.
- Have a serious illness that could keep you from finishing radiation or study procedures on time.
- Have a known allergy to a study drug or any of its ingredients.
- Were hospitalized for worsening interstitial lung disease in the past 30 days.
- Have poorly controlled, irregular heartbeats that do not respond to medicine or a pacemaker.
- Are pregnant or breastfeeding. People who could become pregnant or cause a pregnancy must use highly effective birth control without estrogen, as required by the study, or avoid sex from screening until 30 days after the last BIO 300 dose. Estrogen birth control must be stopped at least 5 days before the first dose.
- Are taking an experimental cancer treatment, or plan to receive chemotherapy, immunotherapy, or certain biologic drugs that target the immune system while taking BIO 300.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 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) ° Pathologically proven diagnosis of cancer is strongly recommended but is not required if the risk of biopsy is unacceptable. If pathological evidence is not available, there must be clinical evidence for NSCLC and multidisciplinary consensus for treatment. * 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 Criteria: * 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. 1. Effective method of non-estrogen-based contraception: condom and a diaphragm, condom and intrauterine device, condom and Depo-Provera, condom and Nexplanon, or condom and progesterone mini-pill 2. Women who have been off estrogen contraceptives for a minimum 5 days prior to the first scheduled day of study intervention dosing are eligible. * Concomitant medications: 1. Any investigational anticancer therapy. 2. Planned concurrent chemotherapy or immunotherapy 3. Biologic drugs targeting the immune system (e.g. TNFα blockers, anakinra, rituximab, abatacept, tocilizumab) planned to be use concurrently with BIO 300
Study sites (7)
NJ
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) · Basking Ridge, NJ 07920Narek Shaverdian, MD · Study contact · 631-212-6323More trials in Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) · Middletown, NJ 07748Narek Shaverdian, MD · Study contact · 631-212-6323More trials in Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) · Montvale, NJ 07645Narek Shaverdian, MD · Study contact · 631-212-6323More trials in Montvale
NY
- Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) · Commack, NY 11725Narek Shaverdian, MD · Study contact · 631-212-6323More trials in Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) · East White Plains, NY 10604Narek Shaverdian, MD · Study contact · 631-212-6323More trials in East White Plains
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) · New York, NY 10065Narek Shaverdian, MD · Study contact · 631-212-6323More trials in New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) · Uniondale, NY 11553Narek Shaverdian, MD · Study contact · 631-212-6323More trials in Uniondale