A Study of Targeted Radiation Therapy in People With Non-Small Cell Lung Cancer (NSCLC)
About this study
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
- Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Metastatic, Non-small Cell Carcinoma, NSCLC, NSCLC Stage IV
- Tested
- L-SABR, Anti-PD-(L)1 based immunotherapy, Platinum based chemotherapy
- Sponsor
- Memorial Sloan Kettering Cancer Center
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 14
- Minimum age: 18 years
- Study condition: Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Metastatic, Non-small Cell Carcinoma, NSCLC, NSCLC Stage IV
- 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 6
- 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.
Where
9 sites, 9 recruiting
Lehigh Valley Health Network (Data Collection Only)
Allentown, Pennsylvania, 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
BAPTIST ALLIANCE - MCI (Data Collection Only)
Miami, Florida, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States
and 3 more sites on ClinicalTrials.gov
Contact
-
Paul Romesser, MD
646-888-2118 romessep@mskcc.org
-
Daniel Gomez, MD
212-639-2087 gomezd@mskcc.org
Potential match only. Final eligibility is determined by the study team.