A phase II trial of hepatic ablation of metastases to modulate and enhance immunotherapy response in non-small cell lung cancer (HAMMER-NSCLC).
Matthew T McMillan, Marsha Reyngold, Christopher H Crane...
https://pubmed.ncbi.nlm.nih.gov/40898159Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID05657873
A Phase II Trial of Hepatic Ablation of Metastases to Modulate and Enhance Immunotherapy Response (HAMMER) in Non-Small Cell Lung Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-07
68
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding liver stereotactic ablative radiotherapy (L-SABR) to the usual drug treatment improves outcomes for people with metastatic non-small cell lung cancer (NSCLC). This Phase II trial focuses on patients with stage IV NSCLC who have liver metastases and aims to compare the effectiveness of combined radiation and drug therapy versus drug therapy alone. Participants are randomly assigned to one of two groups. One group receives the standard treatment with anti-PD-(L)1 based immunotherapy, which may include platinum-based chemotherapy, while also undergoing liver stereotactic ablative radiotherapy (L-SABR). L-SABR is delivered during a week when no chemotherapy is given and can be scheduled alongside immunotherapy. The other group receives only the standard immunotherapy and chemotherapy without radiation. During the study, participants will be monitored for progression-free survival over up to four years. Researchers will assess liver function, overall health status using the ECOG Performance Scale, and treatment response. Safety and effectiveness are tracked through regular clinical evaluations and laboratory tests. The study is led by Memorial Sloan Kettering Cancer Center and participation lasts according to treatment and follow-up schedules.
CONDITIONS
Brief Title
A Study of Targeted Radiation Therapy in People With Non-Small Cell Lung Cancer (NSCLC)
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Be older than 18 years at the time of signing informed consent
- Have a confirmed diagnosis of stage IV NSCLC without certain genetic mutations (EGFR, BRAF) or rearrangements (ALK, ROS-1)
- Have newly diagnosed metastatic NSCLC with one or more liver metastases
- Plan to start anti-PD-(L)1 based immunotherapy with or without platinum chemotherapy for at least 3 cycles
- Have a performance status of 0 to 2 on the ECOG scale
- Liver function tests within specified limits: total bilirubin ≤ 1.5 times upper limit, AST/ALT ≤ 5 times upper limit
- Eligible for liver stereotactic ablative radiotherapy to all liver metastases
- If HIV positive, must be on effective anti-retroviral therapy with CD4 count >200 cells/microliter within 28 days before registration
You will not qualify if you...
- Prior external beam radiation therapy to the liver
- Known active Hepatitis B or Hepatitis C infection
- Immunosuppression including chronic steroid use or immune modulators, or active autoimmune disease
- Pregnant or breastfeeding women
- Men or women not using effective contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - At least 3 cycles of immunotherapy and chemotherapy
Participants receive anti-PD-(L)1 based immunotherapy with or without platinum based chemotherapy. Those in the experimental arm also undergo liver stereotactic ablative radiation therapy (L-SABR) during one week without chemotherapy.
Regular visits for treatment cycles as per standard of care
Trial Site Locations
Total: 9 locations
1
BAPTIST ALLIANCE - MCI (Data Collection Only)
Miami, Florida, United States, 33143
Actively Recruiting
2
Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
3
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
4
Memorial Sloan Kettering Bergen (All protocol activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
5
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
6
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
8
Memorial Sloan Kettering Nassau (All protocol activities)
Rockville Centre, New York, United States, 11553
Actively Recruiting
9
Lehigh Valley Health Network (Data Collection Only)
Allentown, Pennsylvania, United States, 18103
Actively Recruiting
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Research Team
P
Paul Romesser, MD
D
Daniel Gomez, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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