TerminatedPhase 2NCT04964960

Pembro+Chemo in Brain Mets

The goal of this study is to evaluate whether providing Pembrolizumab prolongs survival and preserves quality of life while minimizing side effects for patients with NSCLC with untreated asymptomatic brain metastasis.

Checked against the public recordLast updated Oct 31, 2025 · Source: ClinicalTrials.gov

StatusTerminated
PhasePhase 2
U.S. locations1
SponsorJohn L. Villano, MD, PhD
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
John L. Villano, MD, PhD
Interventions being studied
Drug: Pembrolizumab; Drug: Nab paclitaxel; Drug: Paclitaxel; Drug: Pemetrexed; Drug: Carboplatin
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Kentucky, Markey Cancer CenterLexington, Kentucky

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 31, 2025. Always confirm current availability with the study team.

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