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/40898159/Actively Recruiting
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-07
68
Participants Needed
9
Research Sites
N/A
Total Duration
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-L1 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
A Study of Targeted Radiation Therapy in People With Non-Small Cell Lung Cancer (NSCLC)
P
Paul Romesser, MD
D
Daniel Gomez, MD
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Memorial Sloan Kettering Cancer Center
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Immunotherapy ± chemotherapy plus liver SABR (experimental) | Standard‑of‑care immunotherapy ± chemotherapy |
|---|---|---|
| What it is | Same systemic therapy plus liver‑directed stereotactic ablative radiotherapy (L‑SABR) to all liver metastases | Anti‑PD‑(L)1‑based immunotherapy with or without platinum‑based chemotherapy, representing standard first‑line care for metastatic NSCLC |
| Role in study | Experimental arm testing whether adding liver SABR improves outcomes | Control arm receiving current standard systemic therapy |
| Purpose | Assess whether adding liver‑targeted SABR enhances progression‑free survival when combined with systemic therapy | Evaluate standard first‑line systemic therapy effectiveness in metastatic NSCLC with liver metastases |
| How it is given or performed | L‑SABR delivered to liver metastases during the first weeks of systemic therapy (ideally before third cycle) | Patients receive systemic immunotherapy with or without platinum chemotherapy per treating plan |
| Evidence status | Evidence emerging from early studies suggests adding SABR to immunotherapy may enhance immune response and outcomes, but remains experimental | Standard systemic therapy has established benefit in metastatic NSCLC |
| Important safety risks | Potential for added radiation‑related toxicity in the liver when SABR is included; safety under evaluation | Systemic therapy carries known risks such as immune‑related and chemotherapy‑associated adverse effects |
| Limitations | Effectiveness and safety of adding liver SABR are not yet established; results depend on liver‑directed radiotherapy timing and patient selection | May be less effective in patients with extensive liver metastases due to systemic immunosuppression |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Matthew T McMillan, Marsha Reyngold, Christopher H Crane...
https://pubmed.ncbi.nlm.nih.gov/40898159/Memorial Sloan Kettering Cancer Center
Lead Sponsor