A Study of Targeted Radiation Therapy in People With Non-Small Cell Lung Cancer (NSCLC)

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Dec 12, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for people with advanced non-small cell lung cancer (NSCLC) that has spread to the liver. The researchers want to find out if adding a special type of targeted radiation therapy, called liver stereotactic ablative radiotherapy (L-SABR), to the usual drug therapy improves treatment outcomes compared to drug therapy alone. This study is currently looking for participants aged 18 and older who have been diagnosed with stage IV NSCLC, especially those with liver metastases, and who plan to start standard immunotherapy or chemotherapy.

Participants in this trial can expect to receive either the usual drug treatment or the drug treatment combined with L-SABR. To be eligible, patients should have good overall health (measured by a performance scale) and meet specific liver function criteria. It's important to note that those with other active cancers, severe liver issues, or certain infections like Hepatitis B or C, as well as pregnant or breastfeeding individuals, cannot participate. Overall, this trial aims to explore a potentially more effective treatment for those facing advanced lung cancer.

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ALL

Eligibility criteria

• Inclusion Criteria:
• • Be greater than 18 years of age on day of signing informed consent.
• • Have a histologically confirmed diagnosis of stage IV NSCLC (includes patients who have progressed on durvalumab for Stage III NSCLC) without known mutations in (EGFR) or BRAF or rearrangements in ALK (anaplastic lymphoma kinase) or ROS-1.
• • Newly diagnosed metastatic non-small cell lung cancer (NSCLC), including both de novo and secondary metastatic disease, with one or more liver metastases
• • Plan to initiate standard of care anti-PD-(L)1 based immunotherapy +/- platinum based chemotherapy for at least 3 cycles
• • o Regimens combining anti-CTLA-4 immunotherapy with anti-PD-1 (e.g., ipilimumab plus nivolumab) or anti-PD-L1 (e.g., tremelimumab plus durvalumab) immunotherapy are allowed.
• • Have a performance status of 0-2 on the ECOG Performance Scale.
• * Liver function tests:
• • Total Bilirubin ≤ 1.5 x ULN
• • AST/ ALT ≤ 5 x ULN
• • Eligible for L- SABR to all liver metastases.
• • Patients with known HIV are eligible provided they are under treatment with effective anti-retroviral therapy with CD4 \>200 cells/microliter ≤ 28 days prior to registration
• Exclusion Criteria:
• • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen should be included.
• • Patients with prior external beam radiation therapy to the liver.
• • Patients with known active Hepatitis B or Hepatitis C.
• • Patients with immunosuppression including pharmacological immunosuppression with chronic steroids or immune modulators like cyclosporin or methotrexate and patients with active autoimmune disease.
• • Patients who are pregnant or breastfeeding
• • Men or women not using effective contraception.