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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 2

Conditions: Non-small Cell Carcinoma; Non Small Cell Lung Cancer Metastatic; NSCLC Stage IV; Non Small Cell Lung Cancer; NSCLC

Treatments: Radiation: L-SABR; Biological: Anti-PD-(L)1 based immunotherapy; Drug: Platinum based chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05657873

22-386

Details and patient eligibility

About

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.

Enrollment: 68 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

L-SABR Arm

Experimental group

Description:

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.

Treatment:

Drug: Platinum based chemotherapy

Biological: Anti-PD-(L)1 based immunotherapy

Radiation: L-SABR

Control Arm

Active Comparator group

Description:

Participants randomized to the control arm will be treated according to the standard of care.

Treatment:

Drug: Platinum based chemotherapy

Biological: Anti-PD-(L)1 based immunotherapy