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Metastatic Lung Non-Small Cell CarcinomaPhase 2NCT05840770

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

A Phase 2 study testing Biospecimen Collection, Cemiplimab and Computed Tomography in people with Metastatic Lung Non-Small Cell Carcinoma and Metastatic Malignant Neoplasm in the Brain, run by City of Hope Medical Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Cemiplimab and Computed Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
15 Apr 2025to 30 Oct 2029
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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
  • Up to 10 asymptomatic (defined as no neurologic symptoms at presentation and not requiring steroids) brain lesions allowed up to 15 mm in size. Patients with lesions > 15 mm or with a lesion at or near a critical structure (i.e. brainstem, optic structures) may still be eligible if that lesion(s) is treated and others are available that fit the above criteria
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless has Gilbert's disease) (performed within 30 days prior to day 1 of protocol therapy)
  • Aspartate aminotransferase (AST) =< 1.5 x ULN (performed within 30 days prior to day 1 of protocol therapy)
  • Alanine aminotransferase (ALT) =< 3 x ULN (performed within 30 days prior to day 1 of protocol therapy)
  • Creatinine clearance of >= 60 mL/min per 24 hour urine test or the Cockcroft-Gault formula (performed within 30 days prior to day 1 of protocol therapy)
  • Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (performed within 30 days prior to day 1 of protocol therapy)
  • If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  • Agreement by females and males of childbearing potential* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy
  • Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)

Who cannot join

  • No EGFR, ALK or ROS1 aberrations
  • Brainstem lesion or threatening lesion adjacent to critical structures (i.e. optic nerves/chiasm) - patients can still be enrolled if these are treated and additional lesion(s) based on inclusion criteria above are met
  • Has a diagnosis of severe active scleroderma, lupus, other rheumatologic or autoimmune disease within the past 3 months; patients with a documented history of clinically severe autoimmune disease or a syndrome requiring systemic steroids or immunosuppressive agents will not be allowed on this study; subjects with vitiligo or resolved childhood asthma/atopy are an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections are not excluded from the study; subjects with hypothyroidism stable on hormone replacement are not excluded from this study
  • Has had a prior monoclonal antibody within 4 weeks or 5 half-lives, whichever is shorter, prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
  • Has had prior chemotherapy or targeted small molecule therapy within 3 weeks prior to administration of the study drug or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to a previously administered agent;
  • Note: Subjects with permanent =< grade 2 toxicities (e.g. neuropathy) or toxicities corrected through routine medical management (e.g. thyroid replacement for hypothyroidism), are an exception to this criterion and may qualify for the study;
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  • Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy; *Note: Subjects with =< grade 2 amylase or lipase elevations abnormalities that have no corresponding clinical manifestations (e.g. manifestation of pancreatitis), are an exception to this criterion and may qualify for the study
  • Has a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, indolent lymphomas, or in situ cervical cancer that has undergone potentially curative therapy or any additional tumor that has been deemed to be effectively treated with definitive local control (with or without continued adjuvant hormonal therapy) for at least 2 years prior to enrollment
  • Prior whole brain radiation
  • Has known carcinomatous meningitis (also known as leptomeningeal disease)
  • Is taking > 4mg/day of dexamethasone or its equivalent at the start of immunotherapy or has required > 4mg/day of dexamethasone or its equivalent for 3 consecutive days within 1 week of starting treatment
  • > 10 brain metastases
  • Patients whose tumor exhibit activating EGFR mutation, ALK or ROS translocation and have a standard of care molecular targeted therapy available for these mutations, will be excluded from this study; adenocarcinoma patients may be consented prior to the EGFR and ALK status being known, but EGFR and ALK status must be determined prior to initiating therapy
  • Previous CNS surgery within 2 weeks of treatment, with the exception of biopsy
  • Unable or unwilling to undergo an intracranial MRI
  • Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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:

  1. 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.

Being tested
Biospecimen Collection, Cemiplimab, Computed Tomography, Magnetic Resonance Elastography, Positron Emission Tomography
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Brain Neoplasms, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • CemiplimabBiological

    Also called Cemiplimab RWLC, Cemiplimab-rwlc, Libtayo, REGN2810

    Given IV

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT scan

  • Magnetic Resonance ElastographyProcedure or surgery

    Also called MRE

    Undergo MRI

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan

    Undergo PET scan

Study groups in NCT05840770
Study groupRoleWhat they receive
Treatment (Cemiplimab)ExperimentalPatients receive cemiplimab IV and undergo blood sample collection while on study. Patients undergo MRI, CT scan and PET scan throughout the study.
Receives: Procedure: Biospecimen Collection; Biological: Cemiplimab; Procedure: Computed Tomography; Procedure: Magnetic Resonance Elastography; Procedure: Positron Emission Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Central nervous system (CNS) control rate

    Includes complete response (CR), partial response (PR), and stable disease (SD) using Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria.

    Measured: At 4 weeks

Secondary outcomes (10)

  1. Time until any CNS progression

    Measured by RANO-BM criteria .

    Measured: Up to 12 months from time of enrollment

  2. Extracranial progression free survival

    Defined as first occurrence of disease progression by Positron Emission Response Criteria in Solid Tumors version (v) 1.0 or Response Evaluation Criteria in Solid Tumors v1.1.

    Measured: From enrollment to progression or death due to any cause, assessed up to 2 years

  3. Time until administration of whole brain radiation therapy or stereotactic radiosurgery

    Measured: Up to 5 years

  4. Incidence of adverse events

    Rate of all grades and grade >= 3 toxicities at least possibly related to study therapy as measured by Common Terminology Criteria for Adverse Events v 5.0.

    Measured: Up to 2 years

  5. Overall survival

    Measured: From the date of study enrollment to the date of death from any cause, assessed up to 5 years

  6. Time until brain metastases-specific mortality

    Defined as intracranial progression as a component of cause of death per RANO-BM criteria.

    Measured: Up to 24 months from enrollment

  7. Cumulative rate of best responses

    Individually for CR, PR, SD as defined by the RANO-BM criteria.

    Measured: Up to 5 years

  8. Longitudinal changes in patient-reported quality of life - Measurement I

    Measured by using the MD Anderson Symptom Inventory-Brain Tumor, Patient-Reported Outcomes Measurement Information System Cognitive Function Short Form (4a), and linear analogue self-assessment single-item numerical scale.MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT): scale of 0 (not present) - 10 (as bad as you can imagine). 28 questionnaire with minimum score of 0 (best score) and maximum score of 280 (worse score).

    Measured: Baseline to day 42

  9. Longitudinal changes in patient-reported quality of life - Measurement II

    Measured by using Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function Short Form. Scale of 5 (never) - 1 (very often/several times a day). 6 questions with a minimum score of 6 (worse score) and maximum score of 30 (best score).

    Measured: Baseline to day 42

  10. Longitudinal changes in patient-reported quality of life - Measurement III

    Measured by using Linear Analogue Self-Assessment (LASA) Single-Item Numerical Scale. Scale of 0 (as bad as it can be) - 10 (as good as it can be). 5 questions with a minimum score of 0 (worse score) and maximum score of 50 (best score).

    Measured: Baseline to day 42

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2023
  2. Study start15 Apr 2025 (estimated)
  3. Primary completion30 Oct 2029 (estimated)
  4. Study completion30 Oct 2029 (estimated)

Why it stopped: no accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05840770
Sponsor's protocol ID
22346
Other IDs
NCI-2023-02193, 22346, P30CA033572
Status last verified
May 2025
First submitted
24 Mar 2023
Last updated
26 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, Cemiplimab and Computed Tomography in people with Metastatic Lung Non-Small Cell Carcinoma and Metastatic Malignant Neoplasm in the Brain, run by City of Hope Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 26 May 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Central nervous system (CNS) control rate (time frame: At 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05840770.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2025.

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