Study on BIO 300 and Chest Radiation Therapy for People with Non-Small Cell Lung Cancer and Interstitial Lung Disease

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60

ClinicalTrials ID:NCT07323732

This clinical trial is exploring whether the combination of BIO 300 and chest radiation therapy can help prevent lung inflammation (pneumonitis) in patients with non-small cell lung cancer (NSCLC) and interstitial lung disease (ILD).

Patient Parameters

Program Overview

The aim of this study is to determine if using BIO 300 together with chest radiation therapy can effectively prevent pneumonitis, a type of lung inflammation, in patients who have non-small cell lung cancer (NSCLC) and interstitial lung disease (ILD).

Eligibility Criteria

Inclusion Criteria

  • Able to provide informed consent and follow study requirements.
  • Aged 18 or older.
  • Diagnosed with Stage I or II non-small cell lung cancer (NSCLC). A biopsy is recommended but not required if it's too risky.
  • Diagnosed with interstitial lung disease (ILD) by a lung specialist or through imaging and tests.
  • Have ILD due to connective tissue diseases like rheumatoid arthritis or lupus.
  • Have an ECOG performance status of 0 to 3, indicating varying levels of activity.
  • Women must be post-menopausal or have a negative pregnancy test if pre-menopausal.
  • Have a life expectancy of at least 6 months.

Exclusion Criteria

  • Have had previous chest radiation.
  • Have had a lung removed (pneumonectomy).
  • Have had major surgery within 28 days before joining the study.
  • Have a severe illness that might prevent completing the study.
  • Have allergies to the study drugs.
  • Have had a worsening of ILD requiring hospital stay in the last 30 days.
  • Have uncontrolled heart rhythm problems.
  • Women who are pregnant or breastfeeding, or anyone not using effective birth control.
  • Taking certain medications, including investigational cancer therapies, planned chemotherapy or immunotherapy, or immune-targeting biologic drugs.

Locations

FACILITYZIPCITYSTATE
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)07920Basking RidgeNew Jersey
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)07748MiddletownNew Jersey
Memorial Sloan Kettering Bergen (Limited Protocol Activities)07645MontvaleNew Jersey
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)11725CommackNew York
Memorial Sloan Kettering Westchester (Limited Protocol Activities)10604HarrisonNew York
Memorial Sloan Kettering Cancer Center (All Protocol Activities)10065New YorkNew York
Memorial Sloan Kettering Nassau (Limited Protocol Activities)11553UniondaleNew York

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