BIO 300 with thoracic radiation for early-stage non-small cell lung cancer and interstitial lung disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (Limited Protocol Activities)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (Limited Protocol Activities)
  East White Plains, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center (All Protocol Activities)
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Narek Shaverdian, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Narek Shaverdian, MD
• Email: shaverdn@mskcc.org
• Phone: 631-212-6323

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Understanding the diagnosis and treatment of early and locally advanced non-small cell lung cancer

  This study looks at how patients with early and locally advanced non-small cell lung cancer are diagnosed and treated after surgery or radiation to see how well different approaches work.

  Recruiting at 7 sites MSD Italia S.r.l. · San Giovanni Rotondo, FG and 24 other locations · NCT06467383

• Personalized treatment for early stage non-small cell lung cancer using blood tests

  This study is testing if a blood test for cancer DNA can help find leftover cancer in people with early stage lung cancer after treatment, and if giving them a specific immunotherapy can help reduce it.

  Recruiting Phase 2 Stanford University · Stanford, California · NCT04585477

• SI-B036 safety test in advanced and metastatic solid tumors

  This early-phase study checks whether SI-B036 is safe and tolerable in adults with advanced or metastatic solid cancers who have had prior therapy.

  Recruiting at 4 sites Phase 1 SystImmune Inc. · New Haven, Connecticut and 6 other locations · NCT07857616

• First-line treatment with pembrolizumab, pemetrexed, and platinum with or without zoldonrasib for metastatic non-squamous NSCLC

  This trial tests whether adding zoldonrasib to standard pembrolizumab and platinum chemotherapy helps people with untreated metastatic non-squamous NSCLC that has a RAS G12D mutation.

  Recruiting at 4 sites Phase 3 Revolution Medicines, Inc. · Anchorage, Alaska and 3 other locations · NCT07777822

• Adaptive Chemotherapy for PD-L1 High Resectable NSCLC: A Chemo-PHREE Trial

  This study tests cemiplimab in adults with resectable non-small cell lung cancer to see if surgery can be pursued without preceding chemotherapy for some patients.

  Recruiting Phase 2 University of Maryland, Baltimore · Indianapolis, Indiana and 4 other locations · NCT07746388

• Amivantamab with platinum chemotherapy for metastatic EGFR‑mutant non‑small cell lung cancer

  This study will try giving amivantamab together with platinum chemotherapy to adults with metastatic NSCLC who have specific EGFR mutations to see how long their cancer stays controlled and how safe the treatment is.

  Recruiting at 11 sites Groupe Francais De Pneumo-Cancerologie · Aix-en-Provence and 15 other locations · NCT07563205

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.