Non Small Cell Lung CancerPhase 2NCT05657873
A Study of Targeted Radiation Therapy in People With Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing L-SABR, Anti-PD-(L)1 based immunotherapy and Platinum based chemotherapy in people with Non Small Cell Lung Cancer and Non Small Cell Lung Cancer Metastatic, run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Metastatic, Non-small Cell Carcinoma
- What is being tested?
- L-SABR, Anti-PD-(L)1 based immunotherapy and Platinum based chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 9 sitesUnited States
- Study dates
- 9 Dec 2022to 9 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Lehigh Valley Health Network (Data Collection Only)
Allentown, Pennsylvania, 18103
Dennis Sopka, MD, 610-402-0700
- Recruiting
Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
Paul Romeser, MD, 646-888-2118
- Recruiting
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725
Paul Romesser, MD, 646-888-2118
- Recruiting
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
Paul Romesser, MD, 646-888-2118
- Recruiting
BAPTIST ALLIANCE - MCI (Data Collection Only)
Miami, Florida, 33143
Adeel Kaiser, MD, 786-596-2000
- Recruiting
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
Paul Romesser, MD, 646-888-2118
- Recruiting
Memorial Sloan Kettering Bergen (All protocol activities)
Montvale, New Jersey, 07645
Paul Romesser, MD, 646-888-2118
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Paul Romesser, MD, 646-888-2118
- Recruiting
Memorial Sloan Kettering Nassau (All protocol activities)
Rockville Centre, New York, 11553
Paul Romesser, MD, 646-888-2118
About this study
Official title: A Phase II Trial of Hepatic Ablation of Metastases to Modulate and Enhance Immunotherapy Response (HAMMER) in NSCLC
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.
- Conditions
- Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Metastatic, Non-small Cell Carcinoma, NSCLC, NSCLC Stage IV
- Being tested
- L-SABR, Anti-PD-(L)1 based immunotherapy, Platinum based chemotherapy
- Keywords
- non small cell lung cancer, Non Small Cell Lung Cancer Metastatic, Non-small Cell Carcinoma, liver stereotactic ablative radiotherapy, L-SABR, NSCLC, NSCLC Stage IV, Memorial Sloan Kettering Cancer Center, 22-368
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-SABRRadiation
Also called Liver Stereotactic Ablative Radiation Therapy
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.
Anti-PD-(L)1 based immunotherapyBiological
Also called Standard of Care
Standard of care treatment (anti-PD-(L)1 based immunotherapy +/- platinum based chemotherapy
Platinum based chemotherapyDrug
Also called Standard of Care
Standard of care treatment (anti-PD-(L)1 based immunotherapy +/- platinum based chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| L-SABR Arm | Experimental | Participants 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. Receives: Radiation: L-SABR; Biological: Anti-PD-(L)1 based immunotherapy; Drug: Platinum based chemotherapy |
| Control Arm | Active comparator | Participants randomized to the control arm will be treated according to the standard of care. Receives: Biological: Anti-PD-(L)1 based immunotherapy; Drug: Platinum based chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start9 Dec 2022
- Primary completion9 Dec 2026 (estimated)
- Study completion9 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Romesser, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657873
- Sponsor's protocol ID
- 22-386
- Status last verified
- May 2026
- First submitted
- 12 Dec 2022
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 40898159
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Hepatic Ablation of Metastases to Modulate and Enhance Immunotherapy Response (HAMMER) in NSCLC
- ClinicalTrials.gov ID
- NCT05657873
- Acronym / sponsor ID
- 22-386
- Conditions
- Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Metastatic, Non-small Cell Carcinoma, NSCLC, NSCLC Stage IV
- Keywords
- non small cell lung cancer, Non Small Cell Lung Cancer Metastatic, Non-small Cell Carcinoma, liver stereotactic ablative radiotherapy, L-SABR, NSCLC, NSCLC Stage IV, Memorial Sloan Kettering Cancer Center
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 9 Dec 2022 (actual)
- Primary completion
- 9 Dec 2026 (estimated)
- Study completion
- 9 Dec 2026 (estimated)
- First posted
- 20 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-SABR Arm | Experimental | Radiation: L-SABR, Biological: Anti-PD-(L)1 based immunotherapy, Drug: Platinum based chemotherapyParticipants 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 comparator | Biological: Anti-PD-(L)1 based immunotherapy, Drug: Platinum based chemotherapyParticipants randomized to the control arm will be treated according to the standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-SABRAlso: Liver Stereotactic Ablative Radiation TherapyL-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. | Radiation | L-SABR Arm |
| Anti-PD-(L)1 based immunotherapyAlso: Standard of CareStandard of care treatment (anti-PD-(L)1 based immunotherapy +/- platinum based chemotherapy | Biological | Control Arm, L-SABR Arm |
| Platinum based chemotherapyAlso: Standard of CareStandard of care treatment (anti-PD-(L)1 based immunotherapy +/- platinum based chemotherapy | Drug | Control Arm, L-SABR Arm |
Primary outcome
Median progression-free survival
Time frame: up to 4 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Derived from this study: PubMed 40898159McMillan 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.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Romesser, MD principal investigator
Memorial Sloan Kettering Cancer Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing L-SABR, Anti-PD-(L)1 based immunotherapy and Platinum based chemotherapy in people with Non Small Cell Lung Cancer and Non Small Cell Lung Cancer Metastatic, run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul Romesser, MD (646-888-2118, romessep@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median progression-free survival (time frame: up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05657873, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.