Cemiplimab for Treating Untreated Brain Metastases in Patients with PD-L1 ≥ 50% Non-Small Cell Lung Cancer

Sponsor: City of Hope Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05840770

Provider View

This study is exploring how well the drug cemiplimab works for patients with non-small cell lung cancer (NSCLC) that has spread to the brain and has a PD-L1 level of 50% or higher. The trial aims to see if cemiplimab can delay the need for radiation treatment in these patients.

Patient Parameters

Program Overview

This phase II clinical trial is testing the effectiveness of cemiplimab, an immunotherapy drug, in treating patients with non-small cell lung cancer (NSCLC) that has spread to the brain and has a PD-L1 level of 50% or higher. Typically, brain metastases in NSCLC are treated with radiation, which can have side effects like memory issues. This study is looking at whether cemiplimab can help control brain metastases without the immediate need for radiation, potentially reducing these side effects.

Description

The main goal of this study is to see if cemiplimab alone can effectively control brain metastases in patients with advanced non-small cell lung cancer (NSCLC) that have a PD-L1 level of 50% or higher. The study will also look at how long it takes for the cancer to progress in the brain and other parts of the body, overall survival rates, and the time until radiation therapy is needed. Additionally, the study will monitor changes in quality of life and collect blood and tissue samples for future research.

Participants will receive cemiplimab through an IV and have regular blood tests and scans, including MRI, CT, and PET scans, to monitor their condition throughout the study.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have non-small cell lung cancer (NSCLC) with a PD-L1 level of 50% or higher.
  • Must have advanced cancer with at least one untreated brain metastasis between 5-15 mm in size.
  • Must not need steroids for brain metastases symptoms.
  • Must not have been treated with immune checkpoint inhibitors targeting PD-1 and PD-L1 before.
  • Prior chemotherapy is allowed, but must not have had more than one cycle of chemotherapy without cemiplimab before joining the study.
  • Must have a life expectancy of at least 3 months.
  • Must have up to 10 asymptomatic brain lesions, each up to 15 mm in size.
  • Must have normal liver and kidney function as shown by specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use birth control during the study and for 6 months after the last dose.
  • Men and women of childbearing potential must agree to use effective birth control or abstain from sex during the study and for 6 months after the last dose.

Exclusion Criteria

  • Cannot have certain genetic mutations (EGFR, ALK, or ROS1) that have targeted treatments available.
  • Cannot have brainstem lesions or lesions near critical structures unless treated.
  • Cannot have severe autoimmune diseases or require systemic steroids or immunosuppressive agents.
  • Cannot have had a monoclonal antibody treatment within 4 weeks before the study.
  • Cannot have had chemotherapy or targeted therapy within 3 weeks before the study.
  • Cannot have another progressing cancer that needs treatment, except for certain skin cancers or in situ cervical cancer.
  • Cannot have had whole brain radiation before.
  • Cannot have carcinomatous meningitis.
  • Cannot be taking more than 4mg/day of dexamethasone or its equivalent.
  • Cannot have more than 10 brain metastases.
  • Cannot have had CNS surgery within 2 weeks of starting treatment, except for a biopsy.
  • Must be able to undergo an MRI of the brain.
  • Must be able to comply with all study procedures.

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