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
1 other identifier
interventional
68
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2022
Typical duration for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 9, 2022
CompletedFirst Submitted
Initial submission to the registry
December 12, 2022
CompletedFirst Posted
Study publicly available on registry
December 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 9, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 9, 2026
March 27, 2026
March 1, 2026
4 years
December 12, 2022
March 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Median progression-free survival
Primary outcomes is to determine if L-SABR, when added to first line standard of care anti-PD-(L)1 based immunotherapy +/- chemotherapy, can improve median progression-free survival (PFS) in patients with metastatic NSCLC involving the liver.
up to 4 years
Study Arms (2)
L-SABR Arm
EXPERIMENTALParticipants 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.
Control Arm
ACTIVE COMPARATORParticipants randomized to the control arm will be treated according to the standard of care.
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
BAPTIST ALLIANCE - MCI (Data Collection Only)
Miami, Florida, 33143, United States
Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (All protocol activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (All protocol activities)
Rockville Centre, New York, 11553, United States
Lehigh Valley Health Network (Data Collection Only)
Allentown, Pennsylvania, 18103, United States
Related Publications (1)
McMillan MT, Reyngold M, Crane CH, O'Brien DAR, Williams VM, Zinovoy M, Cuaron JJ, Gonen M, Kaiser A, Sopka DM, Gomez DR, Schoenfeld AJ, Bott M, Romesser PB. A phase II trial of hepatic ablation of metastases to modulate and enhance immunotherapy response in non-small cell lung cancer (HAMMER-NSCLC). BMC Cancer. 2025 Sep 2;25(1):1408. doi: 10.1186/s12885-025-14779-5.
PMID: 40898159DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Romesser, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2022
First Posted
December 20, 2022
Study Start
December 9, 2022
Primary Completion (Estimated)
December 9, 2026
Study Completion (Estimated)
December 9, 2026
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.