NCT05840770

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

A Phase II Trial of Cemiplimab Alone for Untreated Brain Metastases From PD-L1 ≥ 50% Non-Small Cell Lung Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate if CNS control rate defined as complete response (CR), partial response (PR), or stable disease (SD), is acceptable with a strategy of cemiplimab alone for patients with advanced NSCLC, PD-L1 \>= 50%, no EGFR, ALK or ROS1 aberrations with untreated brain metastases. SECONDARY OBJECTIVES: I. To evaluate time until intracranial progression with cemiplimab alone. II. To evaluate time to extracranial progression . III. To evaluate overall survival (OS). IV. To evaluate CNS objective response rate (ORR) defined as CR and PR. V. To evaluate time until administration of radiation therapy (RT), either SRS or WBRT. VI. To report longitudinal changes in quality of life with cemiplimab alone. EXPLORATORY OBJECTIVES: I. To bank blood and tissue specimens for predictive biomarker analyses evaluating CNS disease control and survival outcomes in patients treated with cemiplimab. OUTLINE: Patients receive cemiplimab intravenously (IV) and undergo blood sample collection while on study. Patients undergo magnetic resonance imaging (MRI), computed tomography (CT) scan and position emission tomography (PET) scan throughout the study.

Conditions

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

Interventions

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

Timeline

• Start date: 2025-04-15
• Primary completion: 2029-10-30
• Completion: 2029-10-30
• First posted: 2023-05-03
• Last updated: 2025-05-26

Regulatory

• FDA-regulated drug study