WithdrawnPhase 2

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

Stopped: no accrual

0Started 2025-04-15

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Assent, when appropriate, will be obtained per institutional guidelines * Age: \>= 18 years * Eastern Cooperative Oncology Group (ECOG) =\< 1 * Ability to read and understand English for questionnaires * Histologically confirmed non-small cell lung cancer (NSCLC) * PD-L1 \>= 50% * Advanced disease * Measurable disease in the brain \>= 1 untreated brain metastasis (measuring 5-15 mm) on brain MRI with contrast within 30 days of enrollment * Patients must not require corticosteroids for the management of symptoms from their brain metastases in the opinion of the treating investigator * Patients must be naïve to immune check point inhibitors targeting PD-1 and PD-L1 * Prior treatment with chemotherapy is allowed. Patients who have started chemotherapy for their current disease presentation may have received up to 1 cycle of chemotherapy alone (without cemiplimab) prior to enrollment and the initiation of the protocol-specified regimen of cemiplimab. In patients who have previously received platinum-based chemotherapy for a prior disease presentation, for eligibility there must be at least 21 days since the last exposure to platinum-based chemotherapy * Prior exposure to immune checkpoint inhibitors targeting PD-1 and/or PD-L1 is allowed if patients have been off of therapy for at least 1 year Life expectancy \>= 3 months in the opinion of the treating investigators…

What they're measuring

Central nervous system (CNS) control rate

Timeframe: At 4 weeks

Trial details

NCT IDNCT05840770

SponsorCity of Hope Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-10-30