About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • L-SABR
  • Anti-PD-(L)1 based immunotherapy
  • Platinum based chemotherapy

Treatment groups

68 Participants
are divided into 2 treatment groups

Locations

9
BAPTIST ALLIANCE - MCI (Data Collection Only)33143, MiamiFlorida, United States
Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)07920, Basking RidgeNew Jersey, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)07748, MiddletownNew Jersey, United States
Memorial Sloan Kettering Bergen (All protocol activities)07645, MontvaleNew Jersey, United States

Sponsors and collaborators

Memorial Sloan Kettering Cancer Center

Lead sponsor