A Study of Targeted Radiation Therapy in People With Non-Small Cell Lung Cancer (NSCLC)
A Phase II Trial of Hepatic Ablation of Metastases to Modulate and Enhance Immunotherapy Response (HAMMER) in NSCLC
Memorial Sloan Kettering Cancer Center
68 participants
Dec 9, 2022
INTERVENTIONAL
Summary
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.
Eligibility
Inclusion Criteria11
- 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 Criteria6
- 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.
Interventions
L-SABR will be delivered in a week during which the patient receives no chemotherapy. L-SABR can be on the same week or even day as anti-PD-(L)1 therapy.
Standard of care treatment (anti-PD-(L)1 based immunotherapy +/- platinum based chemotherapy
Standard of care treatment (anti-PD-(L)1 based immunotherapy +/- platinum based chemotherapy
Locations(9)
View Full Details on ClinicalTrials.gov
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NCT05657873