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
| Parameter | Options |
|---|
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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | 10065 | New York | New York |
| Memorial Sloan Kettering Nassau (Limited Protocol Activities) | 11553 | Uniondale | New York |
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