NSCLCPhase 2NCT07323732
A Study of BIO 300 and Thoracic Radiation Therapy in People With Non-Small Cell Lung Cancer and Interstitial Lung Disease
A Phase 2 study testing BIO 300 in people with NSCLC and NSCLC, Stage I, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC, NSCLC, Stage I, NSCLC Stage II
- What is being tested?
- BIO 300
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 7 sitesUnited States
- Study dates
- 6 Jan 2026to 6 Jan 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
- 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
- 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:
- Any investigational anticancer therapy.
- Planned concurrent chemotherapy or immunotherapy
- Biologic drugs targeting the immune system (e.g. TNFα blockers, anakinra, rituximab, abatacept, tocilizumab) planned to be use concurrently with BIO 300
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jamie Chaft, MD contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Narek Shaverdian, MD, 631-212-6323
- Recruiting
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725
Narek Shaverdian, MD, 631-212-6323
- Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
East White Plains, New York, 10604
Narek Shaverdian, MD, 631-212-6323
- Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Narek Shaverdian, MD, 631-212-6323
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Narek Shaverdian, MD, 631-212-6323
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Narek Shaverdian, MD, 631-212-6323
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
Narek Shaverdian, MD, 631-212-6323
About this study
Official title: 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)
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).
- Conditions
- NSCLC, NSCLC, Stage I, NSCLC Stage II, Non Small Cell Lung Cancer, Non-small Cell Lung Cancer Stage I, Non-small Cell Lung Cancer Stage II
- Being tested
- BIO 300
- Keywords
- Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Stage I, Non Small Cell Lung Cancer Stage II, NSCLC, NSCLC Stage I, NSCLC Stage II, Interstitial Lung Disease, Interstitial Lung Disease Due to Connective Tissue Disease (Disorder), Memorial Sloan Kettering Cancer Center, 25-310
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIO 300Drug
The drug product, BIO 300 consists of synthetic genistein
| Study group | Role | What they receive |
|---|---|---|
| Participants with Non-Small Cell Lung Cancer and Interstitial Lung Disease | Experimental | Participants with Non-Small Cell Lung Cancer/NCSLC and Interstitial Lung Disease/ILD Receives: Drug: BIO 300 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start6 Jan 2026
- Primary completion6 Jan 2029 (estimated)
- Study completion6 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Narek Shaverdian, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323732
- Sponsor's protocol ID
- 25-310
- Status last verified
- Mar 2026
- First submitted
- 6 Jan 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07323732
- Acronym / sponsor ID
- 25-310
- Conditions
- NSCLC, NSCLC, Stage I, NSCLC Stage II, Non Small Cell Lung Cancer, Non-small Cell Lung Cancer Stage I, Non-small Cell Lung Cancer Stage II
- Keywords
- Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Stage I, Non Small Cell Lung Cancer Stage II, NSCLC, NSCLC Stage I, NSCLC Stage II, Interstitial Lung Disease, Interstitial Lung Disease Due to Connective Tissue Disease (Disorder)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- 6 Jan 2029 (estimated)
- Study completion
- 6 Jan 2029 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Non-Small Cell Lung Cancer and Interstitial Lung Disease | Experimental | Drug: BIO 300Participants with Non-Small Cell Lung Cancer/NCSLC and Interstitial Lung Disease/ILD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
- ECOG performance status of 0 - 3
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIO 300The drug product, BIO 300 consists of synthetic genistein | Drug | Participants with Non-Small Cell Lung Cancer and Interstitial Lung Disease |
Primary outcome
Pneumonitis free survival
Time frame: Up to 36 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jamie Chaft, MD contact
Narek Shaverdian, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BIO 300 in people with NSCLC and NSCLC, Stage I, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Narek Shaverdian, MD (631-212-6323, shaverdn@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pneumonitis free survival (time frame: Up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.