A Study of Targeted Radiation Therapy in People With Non-Small Cell Lung Cancer (NSCLC)

Description

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

A Phase II Trial of Hepatic Ablation of Metastases to Modulate and Enhance Immunotherapy Response (HAMMER) in NSCLC

A Study of Targeted Radiation Therapy in People With Non-Small Cell Lung Cancer (NSCLC)

Condition
Non Small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Miami

BAPTIST ALLIANCE - MCI (Data Collection Only), Miami, Florida, United States, 33143

Basking Ridge

Memorial Sloan Kettering at Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States, 07920

Middletown

Memorial Sloan Kettering Monmouth (All Protocol Activities), Middletown, New Jersey, United States, 07748

Montvale

Memorial Sloan Kettering Bergen (All protocol activities), Montvale, New Jersey, United States, 07645

Commack

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities), Commack, New York, United States, 11725

Harrison

Memorial Sloan Kettering Westchester (All Protocol Activities), Harrison, New York, United States, 10604

New York

Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York, United States, 10065

Rockville Centre

Memorial Sloan Kettering Nassau (All protocol activities), Rockville Centre, New York, United States, 11553

Allentown

Lehigh Valley Health Network (Data Collection Only), Allentown, Pennsylvania, United States, 18103

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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
  • * 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.
  • * Patients with known HIV are eligible provided they are under treatment with effective anti-retroviral therapy with CD4 \>200 cells/microliter ≤ 28 days prior to registration
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Memorial Sloan Kettering Cancer Center,

Paul Romesser, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

2025-12-09