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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05657873
Other study ID # 22-386
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date December 9, 2022
Est. completion date December 9, 2025

Study information

Verified date June 2024
Source Memorial Sloan Kettering Cancer Center
Contact Paul Romesser, MD
Phone 646-888-2118
Email romessep@mskcc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 68
Est. completion date December 9, 2025
Est. primary completion date December 9, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
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.
Biological:
Anti-PD-(L)1 based immunotherapy
Standard of care treatment (anti-PD-(L)1 based immunotherapy +/- platinum based chemotherapy
Drug:
Platinum based chemotherapy
Standard of care treatment (anti-PD-(L)1 based immunotherapy +/- platinum based chemotherapy

Locations

Country Name City State
United States Memorial Sloan Kettering at Basking Ridge (All Protocol Activities) Basking Ridge New Jersey
United States Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) Commack New York
United States Memorial Sloan Kettering Westchester (All Protocol Activities) Harrison New York
United States Memorial Sloan Kettering Monmouth (All Protocol Activities) Middletown New Jersey
United States Memorial Sloan Kettering Bergen (All protocol activities) Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York New York
United States Memorial Sloan Kettering Nassau (All protocol activities) Rockville Centre New York

Sponsors (1)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Median progression-free survival Primary outcomes is to determine if L-SABR, when added to first line standard of care anti-PD-(L)1 based immunotherapy +/- chemotherapy, can improve median progression-free survival (PFS) in patients with metastatic NSCLC involving the liver. up to 4 years
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