Cemiplimab for the Treatment of Untreated Brain Metastases From PD-L1 >= 50% Non-Small Cell Lung Cancer

Sponsor
City of Hope Medical Center
Study ID
NCT05840770
Phase
PHASE2
Status
Withdrawn

Conditions

  • Metastatic Lung Non-Small Cell Carcinoma
  • Metastatic Malignant Neoplasm in the Brain
  • Stage IV Lung Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Cemiplimab — BIOLOGICAL
    Given IV
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Magnetic Resonance Elastography — PROCEDURE
    Undergo MRI
  • Positron Emission Tomography — PROCEDURE
    Undergo PET scan

Study Details

This phase II trial tests how well cemiplimab works in treating patients with PD-L1 \>= 50% non-small cell lung cancer (NSCLC) that has spread from where it first started (primary site) to the brain (metastases). Approximately 10% of patients diagnosed with metastatic NSCLC present with brain metastases and another 30% develop brain metastases during the illness. Currently, the management of brain metastases relies on stereotactic radiosurgery (SRS), which has high rates of local control, but in combination with systemic therapy, can cause certain toxicities, including central nervous system (CNS) necrosis or potential cognitive changes or memory deficits. Additionally, in patients with numerous brain metastases, whole brain radiation (WBRT) is recommended, leading to significant neurocognitive deficits. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. However, there is little data on the effectiveness of newer systemic therapies, such as immunotherapy, in penetrating and treating previously untreated brain metastases. Cemiplimab without upfront SRS or WBRT for asymptomatic brain metastases may help delay the need for radiation in patients with untreated brain metastases from PD-L1 \>= 50% NSCLC.

Key Dates

Start date
Apr 15, 2025
Status verified
May 2025
Primary completion
Oct 30, 2029
Completion
Oct 30, 2029

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (Cemiplimab)
    Patients receive cemiplimab IV and undergo blood sample collection while on study. Patients undergo MRI, CT scan and PET scan throughout the study.

Primary Outcome Measure

Central nervous system (CNS) control rate [ Time Frame: At 4 weeks ]

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