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TerminatedPhase 2NCT04964960
Official study title

Pembro+Chemo in Brain Mets

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPembrolizumab and Nab paclitaxel

Plus 3 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

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

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?John L. Villano, MD, PhD

Study sponsor

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.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→
Treatment approach
Immunotherapy→Chemotherapy→
Study topics
Brain metastases→Survivorship and quality of life→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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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