A Study of Targeted Radiation Therapy in People With Non-Small Cell Lung Cancer (NSCLC)
Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Metastatic, Non-small Cell Carcinoma
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring non small cell lung cancer, Non Small Cell Lung Cancer Metastatic, Non-small Cell Carcinoma, liver stereotactic ablative radiotherapy, L-SABR, NSCLC, NSCLC Stage IV, Memorial Sloan Kettering Cancer Center, 22-368
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 epidermal sensitizing growth factor (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 liver metastases Plan to initiate standard of care anti-PD-(L)1 based immunotherapy +/- platinum based chemotherapy 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. Eligible for or plan to initiate standard of care therapy with anti-PD(L)-1 therapy alone or anti-PD(L)-1 therapy in combination with platinum-based chemotherapy, up to cycle 3. 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.
Sites / Locations
- Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)Recruiting
- Memorial Sloan Kettering Monmouth (All Protocol Activities)Recruiting
- Memorial Sloan Kettering Bergen (All protocol activities)Recruiting
- Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)Recruiting
- Memorial Sloan Kettering Westchester (All Protocol Activities)Recruiting
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
- Memorial Sloan Kettering Nassau (All protocol activities)Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
L-SABR Arm
Control Arm
Participants randomized to the experimental arm will continue with standard of care treatment but will also undergo radiation simulation for L-SABR/Liver Stereotactic Ablative Radiation Therapy.
Participants randomized to the control arm will be treated according to the standard of care.