RECRUITING

A Study of Targeted Radiation Therapy in People With 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 liver stereotactic ablative radiotherapy L-SABR Memorial Sloan Kettering Cancer Center 22-368

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-12-09

Study Completion:2025-12-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05657873

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Paul Romesser, MD

CONTACT

646-888-2118

romessep@mskcc.org

Daniel Gomez, MD

CONTACT

212-639-2087

gomezd@mskcc.org

Principal Investigator

Paul Romesser, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

BAPTIST ALLIANCE - MCI (Data Collection Only)

Miami, Florida, 33143

United States

Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen (All protocol activities)

Montvale, New Jersey, 07645

United States

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau (All protocol activities)

Rockville Centre, New York, 11553

United States

Lehigh Valley Health Network (Data Collection Only)

Allentown, Pennsylvania, 18103

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-09

Study Completion Date2025-12-09

Study Record Updates

Study Start Date2022-12-09

Study Completion Date2025-12-09

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Non Small Cell Lung Cancer
Non Small Cell Lung Cancer Metastatic
Non-small Cell Carcinoma
NSCLC
NSCLC Stage IV