Recruiting

Phase 2

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

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT05657873

Conditions

Non Small Cell Lung Cancer

Non Small Cell Lung Cancer Metastatic

Non-small Cell Carcinoma

NSCLC

NSCLC Stage IV

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

L-SABR

Anti-PD-(L)1 based immunotherapy

Platinum based chemotherapy

Study Details

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.

Conditions

Non Small Cell Lung Cancer

Non Small Cell Lung Cancer Metastatic

Non-small Cell Carcinoma

NSCLC

NSCLC Stage IV

Study ID

NCT05657873

Start date

Dec 9, 2022

Status verified date

May, 2026

Completion date

Dec 9, 2026

Anticipated

Primary completion date

Dec 9, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

68 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: L-SABR Arm

Participants randomized to the experimental arm will continue with standard of care treatment but will also undergo radiation simulation for L-SABR/Liver Stereotactic Ablative Radiation Therapy.

active comparator: Control Arm

Participants randomized to the control arm will be treated according to the standard of care.

Interventions

L-SABR

L-SABR will be delivered in a week during which the patient receives no chemotherapy. L-SABR can be on the same week or even day as anti-PD-(L)1 therapy.

Anti-PD-(L)1 based immunotherapy

Standard of care treatment (anti-PD-(L)1 based immunotherapy +/- platinum based chemotherapy

Platinum based chemotherapy

Standard of care treatment (anti-PD-(L)1 based immunotherapy +/- platinum based chemotherapy

Primary outcome measure

Median progression-free survival [ Time Frame: up to 4 years ]

Central Contacts and Locations

Central contacts

Paul Romesser, MD

646-888-2118 romessep@mskcc.org

Daniel Gomez, MD

212-639-2087 gomezd@mskcc.org

Locations

BAPTIST ALLIANCE - MCI (Data Collection Only)

Recruiting

Miami, Florida, United States, 33143

Contacts

Adeel Kaiser, MD

786-596-2000

Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Paul Romeser, MD

646-888-2118

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Paul Romesser, MD

646-888-2118

Memorial Sloan Kettering Bergen (All protocol activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Paul Romesser, MD

646-888-2118

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Paul Romesser, MD

646-888-2118

Memorial Sloan Kettering Westchester (All Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Paul Romesser, MD

646-888-2118

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Paul Romesser, MD

646-888-2118

Memorial Sloan Kettering Nassau (All protocol activities)

Recruiting

Rockville Centre, New York, United States, 11553

Contacts

Paul Romesser, MD

646-888-2118

Lehigh Valley Health Network (Data Collection Only)

Recruiting

Allentown, Pennsylvania, United States, 18103

Contacts

Dennis Sopka, MD

610-402-0700

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

May 7, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-05-07.