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BIO 300 with thoracic radiation for early-stage 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)

Phase 2 Interventional Memorial Sloan Kettering Cancer Center · NCT07323732

This trial will test whether adding BIO 300 to thoracic radiation lowers the chance of pneumonitis in people with stage I–II non-small cell lung cancer who also have interstitial lung disease.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment25 (estimated)
Ages18 Years and up
SexAll
SponsorMemorial Sloan Kettering Cancer Center Academic / other
Drugs / interventionsrituximab, tocilizumab, chemotherapy, immunotherapy, radiation
Locations7 sites (Basking Ridge, New Jersey and 6 other locations)
Trial IDNCT07323732 on ClinicalTrials.gov

What this trial studies

This Phase 2 trial gives adults with stage I–II non-small cell lung cancer and coexisting interstitial lung disease BIO 300 alongside thoracic radiation to try to prevent radiation-induced pneumonitis. Eligible participants are age 18 or older with ECOG performance status 0–3 and may have pathologic confirmation of NSCLC or clinical consensus when biopsy risk is high. The study will monitor occurrence and severity of pneumonitis as well as safety and tolerability of BIO 300. The trial is run by Memorial Sloan Kettering with limited protocol activities at three New Jersey locations.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) with stage I–II non-small cell lung cancer and a diagnosis of interstitial lung disease who are planned for thoracic radiation and have an ECOG performance status of 0–3.

Not a fit: Patients without interstitial lung disease, those with more advanced NSCLC beyond stage II, or patients not receiving thoracic radiation are unlikely to receive benefit from this approach.

Why it matters

Potential benefit: If successful, the combination could reduce radiation-induced pneumonitis and make thoracic radiation safer for patients with NSCLC and ILD.

How similar studies have performed: Preclinical data and early-phase work on BIO 300 and related radioprotective agents suggest potential lung protection, but clinical evidence in this specific patient population is limited.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Basking Ridge, New Jersey and 6 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions NSCLCNSCLC, Stage INSCLC Stage IINon Small Cell Lung CancerNon-small Cell Lung Cancer Stage INon-small Cell Lung Cancer Stage IIInterstitial Lung DiseaseInterstitial Lung Disease Due to Connective Tissue Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.