Liver-Targeted Radiation and Chemo-Immunotherapy for Advanced Small Cell Lung Cancer
Sponsor: Brian Henick, MD
ClinicalTrials ID:NCT04923776
This study explores if adding liver-targeted radiation to standard treatment can improve outcomes for patients with advanced small cell lung cancer that has spread to the liver.
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Program Overview
This study is looking at whether adding radiation therapy aimed at liver tumors can be safely combined with the usual treatment for advanced small cell lung cancer (ES-SCLC). Typically, ES-SCLC is treated with chemotherapy drugs, carboplatin and etoposide, along with an immunotherapy drug called atezolizumab. However, patients whose cancer has spread to the liver often don't respond as well to this treatment. The study will see if adding radiation to the liver can help improve the effectiveness of the standard treatment. Everyone in the study will receive the same treatment, which includes both chemo-immunotherapy and radiation therapy.
Description
This study is investigating the potential benefits of combining radiation therapy with immunotherapy for patients with advanced small cell lung cancer (ES-SCLC) that has spread to the liver. While there is limited clinical evidence for this combination, previous reports and studies suggest it might enhance the body's immune response against tumors. The study will use a type of radiation called stereotactic body radiation therapy (SBRT) on liver tumors, in addition to the standard treatment of chemotherapy and immunotherapy. The goal is to see if this approach can improve the control of the cancer and extend the time patients live without the disease getting worse. Previous research supports the idea that this combination could be beneficial, and the researchers believe it might lead to better outcomes for patients with liver involvement.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older
- Diagnosed with advanced small cell lung cancer (ES-SCLC)
- No previous treatment for ES-SCLC
- Good physical health (ECOG status 0 or 1)
- If there is a history of treated brain metastases, certain conditions must be met (e.g., no ongoing steroid use, no recent brain radiation)
- At least one liver tumor that is 1 cm or larger
- Other measurable disease besides the liver tumor
- Must provide a tumor sample from the liver before starting treatment
- Must have adequate blood and organ function based on specific lab results
- Women of childbearing potential must use effective birth control or abstain from sex during treatment and for 6 months after
- Men must use condoms or abstain from sex during treatment and for 6 months after
- Negative HIV test, unless stable on treatment with undetectable viral load
- Must understand and agree to the study requirements
Exclusion Criteria
- Active or untreated brain metastases
- Untreated spinal cord compression
- Certain other diseases like leptomeningeal disease
- Previous radiation treatment for small cell lung cancer outside the brain
- Uncontrolled fluid buildup in the chest or abdomen
- Uncontrolled high calcium levels
- Recent or ongoing use of certain medications like denosumab
- Other cancers within the last 5 years, except those with low risk of spreading
- Severe liver disease
- Previous liver-directed treatments
- Pregnant or breastfeeding women
- Severe allergies to certain medications
- Autoimmune diseases, unless well-controlled
- Certain lung diseases
- Active hepatitis B or C
- Active tuberculosis
- Severe infections
- Significant heart disease
- Recent major surgery
- Previous organ transplants
- Other conditions that might interfere with the study
- Previous treatment for ES-SCLC
- Recent participation in another clinical trial
- Recent live vaccinations
- Previous treatment with certain immune therapies
- Recent use of immunosuppressive medications
- Allergies to study medications
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