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New hope for brain metastases? study tests pembrolizumab combo

NCT ID NCT04964960

Disease control Sponsor: John L. Villano, MD, PhD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether adding the drug pembrolizumab to chemotherapy could help people with a type of lung cancer that has spread to the brain but isn't causing symptoms. The goal was to control the cancer in the brain and body while keeping quality of life. Only 3 people took part before the study was stopped early.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

3 people

The number who actually took part.

Started

May 2022

Finished

Dec 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Non-small cell lunch cancer (NSLC) with untreated asymptomatic brain metastases * NSLC lacks oncogenic driver mutations * Absence of new onset neurological symptoms * Presence of fewer than ten intracranial lesions * Each lesion measures three centimeters or less * Life expectancy of greater than three months * Adequate organ and marrow function * Ability to understand and willingness to sign a written informed consent document Exclusion Criteria: * Presence of oncogenic driver mutations * Measurable lesion located within 10mm of the optic chiasm or optic nerve, or within the brainstem * Known leptomeningeal involvement. * Midline shift * Serious non-healing wound, ulcer or bone fracture * Baseline inability to participate or complete neurocognitive testing * Major surgical procedure (including craniotomy and open brain biopsy) or significant traumatic injury within 14 days prior to registration * Receipt of a non-CNS minor surgical procedure (e.g. core biopsy or fine needle aspiration) within three days prior to registration * History of allergic reactions attributed to monoclonal antibodies (mAb), compounds of similar chemical or biologic composition to Pembrolizumab * Clinically significant cardiovascular disease * Patients with uncontrolled intercurrent illness * Patients with psychiatric illness/social situations that would limit compliance with study requirements

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Conditions

The condition(s) this trial relates to.

brain cancer cancer lung cancer lung neoplasm metastatic malignant neoplasm metastatic malignant neoplasm in the brain neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brain cancer Cancer Lung cancer Lung cancer metastatic

Contacts and locations

Locations

  • University of Kentucky, Markey Cancer Center

    Lexington, Kentucky, 40536, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.