A Phase II Trial of Hepatic Ablation of Metastases to Modulate and Enhance Immunotherapy Response (HAMMER) in NSCLC
The purpose of this study is to see whether adding liver stereotactic ablative radiotherapy/L-SABR to standard drug therapy is better than standard drug therapy alone for people with metastatic non-small cell lung cancer/NSCLC.
• 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