Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05657873

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

Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-07

68

Participants Needed

9

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be greater than 18 years of age on day of signing informed consent.
  • Have a histologically confirmed diagnosis of stage IV NSCLC without known mutations in EGFR, BRAF, ALK, or ROS-1.
  • Patients with recurrent metastatic NSCLC after prior durvalumab for stage III NSCLC are eligible if this is their first metastatic immunotherapy.
  • Have newly diagnosed metastatic NSCLC with one or more liver metastases.
  • Plan to start standard anti-PD-(L)1 based immunotherapy with or without platinum-based chemotherapy for at least 3 cycles.
  • Regimens combining anti-CTLA-4 with anti-PD-1 or anti-PD-L1 immunotherapy are allowed.
  • Have an ECOG performance status of 0-2.
  • Liver function tests must show total bilirubin ≤ 1.5 times the upper limit of normal and AST/ALT ≤ 5 times the upper limit of normal.
  • Eligible for L-SABR to all liver metastases as determined by the radiation oncologist.
  • Patients with HIV under effective anti-retroviral therapy with CD4 count >200 cells/microliter within 28 days prior to registration.
Not Eligible

You will not qualify if you...

  • Prior external beam radiation therapy to the liver.
  • Known active Hepatitis B or Hepatitis C infection.
  • Immunosuppression including use of chronic steroids, cyclosporin, methotrexate, or active autoimmune disease.
  • Pregnant or breastfeeding women.
  • Men or women not using effective contraception.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 9 locations

1

BAPTIST ALLIANCE - MCI (Data Collection Only)

Miami, Florida, United States, 33143

Actively Recruiting

2

Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

3

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States, 07748

Actively Recruiting

4

Memorial Sloan Kettering Bergen (All protocol activities)

Montvale, New Jersey, United States, 07645

Actively Recruiting

5

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, United States, 11725

Actively Recruiting

6

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States, 10604

Actively Recruiting

7

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States, 10065

Actively Recruiting

8

Memorial Sloan Kettering Nassau (All protocol activities)

Rockville Centre, New York, United States, 11553

Actively Recruiting

9

Lehigh Valley Health Network (Data Collection Only)

Allentown, Pennsylvania, United States, 18103

Actively Recruiting

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Research Team

P

Paul Romesser, MD

CONTACT

D

Daniel Gomez, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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