Liver zapping may supercharge lung cancer treatment
NCT ID NCT05657873
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether adding a precise radiation dose to liver tumors can make standard immunotherapy work better for people with stage IV non-small cell lung cancer. About 68 adults whose cancer has spread to the liver will either get standard drug therapy alone or standard therapy plus liver radiation. The goal is to see if the combination helps keep the cancer from growing longer.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 68 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2022
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. o Patients with recurrent metastatic NSCLC following prior durvalumab for stage III disease are eligible provided this is their first immunotherapy course for metastatic disease (i.e., the planned anti-PD-(L)1-based regimen represents first-line systemic therapy in the metastatic setting). * 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 as determined by the treating radiation oncologist * Patients with known HIV are eligible provided they are under treatment with effective anti-retroviral therapy with CD4 count \>200 cells/microliter within 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
9 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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BAPTIST ALLIANCE - MCI (Data Collection Only)
RECRUITINGMiami, Florida, 33143, United States
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Lehigh Valley Health Network (Data Collection Only)
RECRUITINGAllentown, Pennsylvania, 18103, United States
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Memorial Sloan Kettering Bergen (All protocol activities)
RECRUITINGMontvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITINGNew York, New York, 10065, United States
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Memorial Sloan Kettering Monmouth (All Protocol Activities)
RECRUITINGMiddletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau (All protocol activities)
RECRUITINGRockville Centre, New York, 11553, United States
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Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
RECRUITINGCommack, New York, 11725, United States
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Memorial Sloan Kettering Westchester (All Protocol Activities)
RECRUITINGHarrison, New York, 10604, United States
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Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)
RECRUITINGBasking Ridge, New Jersey, 07920, United States
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