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

• Status: Recruiting
• Trial end date: 2025-12-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Criteria

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 epidermal sensitizing growth factor (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 liver metastases

• Plan to initiate standard of care anti-PD-(L)1 based immunotherapy +/- platinum based chemotherapy

• > 3 metastases with at least one measurable extra-hepatic lesion based on modified RECIST (can be primary lesion).

• 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.

• Eligible for or plan to initiate standard of care therapy with anti-PD(L)-1 therapy alone or anti-PD(L)-1 therapy in combination with platinum-based chemotherapy, up to cycle 3.

• 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.