Targeted radiation therapy for advanced lung cancer
A Phase II Trial of Hepatic Ablation of Metastases to Modulate and Enhance Immunotherapy Response (HAMMER) in NSCLC
This study is testing if adding a special type of radiation therapy to regular drug treatment can help people with advanced lung cancer that has spread to the liver feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | durvalumab, ipilimumab, nivolumab, tremelimumab, chemotherapy, immunotherapy, radiation, methotrexate |
| Locations | 9 sites (Miami, Florida and 8 other locations) |
| Trial ID | NCT05657873 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of adding liver stereotactic ablative radiotherapy (L-SABR) to standard drug therapy in patients with metastatic non-small cell lung cancer (NSCLC). Participants will receive L-SABR alongside anti-PD-(L)1 based immunotherapy and platinum-based chemotherapy. The goal is to determine if this combined approach improves outcomes compared to standard drug therapy alone. Eligible patients must have stage IV NSCLC with liver metastases and meet specific health criteria.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with newly diagnosed stage IV NSCLC and liver metastases who are eligible for standard immunotherapy and chemotherapy.
Not a fit: Patients with known mutations in EGFR or BRAF, or rearrangements in ALK or ROS-1 may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment effectiveness for patients with advanced lung cancer and improve survival rates.
How similar studies have performed: Previous studies have shown promising results with similar approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Miami, Florida and 8 other locations
- BAPTIST ALLIANCE - MCI (Data Collection Only) — Miami, Florida, United States (Recruiting)
- Memorial Sloan Kettering at Basking Ridge (All Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (All protocol activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (All protocol activities) — Rockville Centre, New York, United States (Recruiting)
- Lehigh Valley Health Network (Data Collection Only) — Allentown, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Paul Romesser, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Paul Romesser, MD
- Email: romessep@mskcc.org
- Phone: 646-888-2118
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.