Targeted radiation therapy for advanced lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Amivantamab with platinum chemotherapy for metastatic EGFR‑mutant non‑small cell lung cancer

  This study will try giving amivantamab together with platinum chemotherapy to adults with metastatic NSCLC who have specific EGFR mutations to see how long their cancer stays controlled and how safe the treatment is.

  Recruiting at 11 sites Groupe Francais De Pneumo-Cancerologie · Aix-en-Provence and 15 other locations · NCT07563205

• SI-B036 safety test in advanced and metastatic solid tumors

  This early-phase study checks whether SI-B036 is safe and tolerable in adults with advanced or metastatic solid cancers who have had prior therapy.

  Recruiting at 4 sites Phase 1 SystImmune Inc. · New Haven, Connecticut and 6 other locations · NCT07857616

• First-line treatment with pembrolizumab, pemetrexed, and platinum with or without zoldonrasib for metastatic non-squamous NSCLC

  This trial tests whether adding zoldonrasib to standard pembrolizumab and platinum chemotherapy helps people with untreated metastatic non-squamous NSCLC that has a RAS G12D mutation.

  Recruiting at 4 sites Phase 3 Revolution Medicines, Inc. · Anchorage, Alaska and 3 other locations · NCT07777822

• Progel Platinum to reduce air leaks after VATS lobectomy for NSCLC

  This trial will test whether applying Progel Platinum to stapled fissure lines during minimally invasive lobectomy for NSCLC shortens the time patients need chest drainage.

  Recruiting Fondazione del Piemonte per l'Oncologia · Candiolo, Torino and 5 other locations · NCT07479277

• Precise Exercise Regimen for Cancer Care: a small pilot in stage II/III NSCLC

  This pilot tests the PERCC exercise program to see if it’s feasible for adults with stage II–III non-small cell lung cancer who are planned for neoadjuvant therapy and surgery.

  Recruiting Dana-Farber Cancer Institute · Boston, Massachusetts · NCT07412041

• BIO 300 with thoracic radiation for early-stage non-small cell lung cancer and interstitial lung disease

  This trial will test whether adding BIO 300 to thoracic radiation lowers the chance of pneumonitis in people with stage I–II non-small cell lung cancer who also have interstitial lung disease.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07323732

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.