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NCT05657873 | RECRUITING | Non Small Cell Lung Cancer

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

Memorial Sloan Kettering Cancer Center

Brief 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.

Condition or disease

Non Small Cell Lung Cancer

Non Small Cell Lung Cancer Metastatic

Non-small Cell Carcinoma

NSCLC

NSCLC Stage IV

Intervention/treatment

L-SABR

Anti-PD-(L)1 based immunotherapy

Platinum based chemotherapy

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 68 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase II Trial of Hepatic Ablation of Metastases to Modulate and Enhance Immunotherapy Response (HAMMER) in NSCLC
Actual Study Start Date : 2022-12-09
Estimated Primary Completion Date : 2025-12-09
Estimated Study Completion Date : 2025-12-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
  • * 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.
    • * 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
    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.
A Study of Targeted Radiation Therapy in People With Non-Small Cell Lung Cancer (NSCLC)

Location Details

NCT05657873

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

BAPTIST ALLIANCE - MCI (Data Collection Only)

Miami, Florida, United States, 33143

RECRUITING

United States, New Jersey

Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, United States, 07920

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States, 07748

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Bergen (All protocol activities)

Montvale, New Jersey, United States, 07645

RECRUITING

United States, New York

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, United States, 11725

RECRUITING

United States, New York

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States, 10604

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States, 10065

RECRUITING

United States, New York

Memorial Sloan Kettering Nassau (All protocol activities)

Rockville Center, New York, United States, 11553

RECRUITING

United States, Pennsylvania

Lehigh Valley Health Network (Data Collection Only)

Allentown, Pennsylvania, United States, 18103