Health Trials

A Study of BIO 300 and Thoracic Radiation Therapy in People With Non-Small Cell Lung Cancer and Interstitial Lung Disease

ConditionsNSCLCNSCLC, 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 (Disorder)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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).

Eligibility criteria

Qualifiers

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)

Interstitial Lung Disease diagnosis (one of the below)

ILD as diagnosed and managed by a pulmonologist

Disqualifiers

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

Trial design

Treatments tested in this trial

  • BIO 300

Treatment groups

25 Participants
are divided into 1 treatment group

Sponsors and collaborators

Memorial Sloan Kettering Cancer Center

Lead sponsor

Source ClinicalTrials.gov