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

Phase 2

Recruiting

• Conditions: Non Small Cell Lung Cancer; Non Small Cell Lung Cancer Metastatic; Non-small Cell Carcinoma; NSCLC; NSCLC Stage IV
• Interventions: Radiation: L-SABR; Biological: Anti-PD-(L)1 based immunotherapy; Drug: Platinum based chemotherapy

• Registration Number: NCT05657873
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-09
• Study First Submitted: 2022-12-12
• Study First Submitted QC: 2022-12-12
• Study First Posted: 2022-12-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20
• Primary Completion: 2025-12-09
• Study Completion: 2025-12-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L-SABR Arm	L-SABR	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.
L-SABR Arm	Anti-PD-(L)1 based immunotherapy	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.
L-SABR Arm	Platinum based chemotherapy	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.
Control Arm	Anti-PD-(L)1 based immunotherapy	Participants randomized to the control arm will be treated according to the standard of care.
Control Arm	Platinum based chemotherapy	Participants randomized to the control arm will be treated according to the standard of care.

Primary Outcome Measures

Name	Time	Method
Median progression-free survival	up to 4 years	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.

Trial Locations

Locations (9)

BAPTIST ALLIANCE - MCI (Data Collection Only); 🇺🇸 Miami, Florida, United States

Memorial Sloan Kettering at Basking Ridge (All Protocol Activities); 🇺🇸 Basking Ridge, New Jersey, 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 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 Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau (All protocol activities); 🇺🇸 Rockville Centre, New York, United States

Lehigh Valley Health Network (Data Collection Only); 🇺🇸 Allentown, Pennsylvania, United States