Pembro+Chemo in Brain Mets

NCT04964960 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: MCC-21-NEURO-11
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer; Lung Cancer Metastatic; Brain Cancer; Cancer

Outcome Measures

Primary Outcomes (1)

• Disease Control Rate

  Intracranial benefit defined as stable disease, partial response, and complete response

  6 months (baseline to 6 months)

Secondary Outcomes (7)

• Number of Participants With Overall Survival at 12-month Post-enrollment

  12 months

• Change in Extracranial Disease Control

  12 months (6 months post-enrollment, 12 months post-enrollment)

• Change in Patient-reported Cognitive Functioning - Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog)

  12 months (Baseline and 12 months post enrollment)

• Change in Quality of Life - Functional Assessment of Cancer Therapy-Brain (FACT-Br)

  12 months (Baseline and 12 months post enrollment)

• Change in Quality of Life - FACIT Fatigue Scale (FACIT-F)

  12 months (Baseline and 12 months post enrollment)

Other Outcomes (1)

• Immune Based Biomarker Activity

  12 weeks (Baseline, 6 weeks after baseline, 6 weeks after prior collection)

Study Arms (1)

Pembrolizumab with standard of care chemotherapy treatment

EXPERIMENTAL

Patients will receive 200mg or 400mg of Pembrolizumab (standard of care dosing at the discretion of treating physician) over thirty minutes on day 1 every three or six weeks with standard of care chemotherapy treatment (carboplatin, pemetrexed, paclitaxel, nab-paclitaxel).

Drug: Pembrolizumab; Drug: Nab paclitaxel; Drug: Paclitaxel; Drug: Pemetrexed; Drug: Carboplatin

Interventions

Pembrolizumab DRUG

Pembrolizumab is an immunotherapy that can help fight certain cancers.

Also known as: Keytruda

Pembrolizumab with standard of care chemotherapy treatment

Nab paclitaxel DRUG

Nab-paclitaxel is a taxane derivative that is an albumin-bound paclitaxel nanoparticle formulation that promotes microtubule assembly.

Pembrolizumab with standard of care chemotherapy treatment

Paclitaxel DRUG

Paclitaxel is a taxane derivative that promotes microtubule assembly by enhancing the action of tubulin dimers, stabilizing existing microtubules, and inhibiting their disassembly, interfering with the late G2 mitotic phase, and inhibiting cell replication.

Pembrolizumab with standard of care chemotherapy treatment

Pemetrexed DRUG

Pemetrexed is an antifolate agent that disrupts folate-dependent metabolic processes essential for cell replication.

Pembrolizumab with standard of care chemotherapy treatment

Carboplatin DRUG

Carboplatin is a platinum compound alkylating agent which covalently binds to DNA and interferes with the function of DNA by producing interstrand DNA cross-links.

Pembrolizumab with standard of care chemotherapy treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• John L. Villano, MD, PhD: lead

Study Sites (1)

University of Kentucky, Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Brain Neoplasms; Neoplasms

Interventions

pembrolizumab; Taxes; Paclitaxel; Pemetrexed; Carboplatin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes

Results Point of Contact

• Title: Dr. John Villano
• Organization: University of Kentucky

jlvillano@uky.edu

859-323-0405

Study Officials

• John Villano, MD, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 16, 2021
• Study Start: May 19, 2022
• Primary Completion: June 19, 2023
• Study Completion: December 19, 2023
• Last Updated: October 31, 2025
• Results First Posted: October 21, 2024

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)