Lung CancerPhase 2NCT04964960
Pembro+Chemo in Brain Mets
A Phase 2 study testing Pembrolizumab, Nab paclitaxel and Paclitaxel in people with Lung Cancer and Lung Cancer Metastatic, run by John L. Villano, MD, PhD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lung Cancer, Lung Cancer Metastatic, Brain Cancer
- What is being tested?
- Pembrolizumab, Nab paclitaxel and Paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2022to 19 Dec 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky, Markey Cancer Center
Lexington, Kentucky, 40536
About this study
Official title: Phase II Investigation of Use of CNS Active Pembrolizumab and Chemotherapy for Asymptomatic Brain Metastasis From Non-small Cell Lung Cancer (NSCLC)
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
- Being tested
- Pembrolizumab, Nab paclitaxel, Paclitaxel, Pemetrexed, Carboplatin
- Medical subject headings
- Lung Neoplasms, Brain Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called Keytruda
Pembrolizumab is an immunotherapy that can help fight certain cancers.
Nab paclitaxelDrug
Nab-paclitaxel is a taxane derivative that is an albumin-bound paclitaxel nanoparticle formulation that promotes microtubule assembly.
PaclitaxelDrug
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.
PemetrexedDrug
Pemetrexed is an antifolate agent that disrupts folate-dependent metabolic processes essential for cell replication.
CarboplatinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Pembrolizumab; Drug: Nab paclitaxel; Drug: Paclitaxel; Drug: Pemetrexed; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Control Rate
Intracranial benefit defined as stable disease, partial response, and complete response
Measured: 6 months (baseline to 6 months)
Secondary outcomes (7)
Number of Participants With Overall Survival at 12-month Post-enrollment
Overall survival at 12-month post-enrollment
Measured: 12 months
Change in Extracranial Disease Control
Extracranial disease control rate (systemic): includes stable disease, partial response, and complete response.
Measured: 12 months (6 months post-enrollment, 12 months post-enrollment)
Change in Patient-reported Cognitive Functioning - Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog)
The FACT-Cog questionnaire was developed to assess perceived cognitive function and impact on quality of life (QOL) in cancer patients. The level of perceived cognitive impairments is measured on a four-point Likert scale (4 = several times a day to 0 = never) FACT-Cog has been widely administered across clinical settings and validated across different cultures and languages. Subjects can complete it in 5 minutes. A higher score indicates a better quality of life/cognitive function.
Measured: 12 months (Baseline and 12 months post enrollment)
Change in Quality of Life - Functional Assessment of Cancer Therapy-Brain (FACT-Br)
The FACT-Br is a commonly used instrument measuring general quality of life (QOL) that reflects symptoms or problems associated with brain malignancies across 5 subscales. The level of well-being is measured on a four-point Likert scale (4 = very much to 0 = not at all). The measure yields information about total quality of life, as well as information about the dimensions of physical well-being, social/family well-being, emotional well-being, functional well-being, and disease-specific concerns. The score range is 0-200 where a higher score indicated a better quality of life. The FACT-Br is written at the 4th grade reading level, and subjects can complete it in 5-10 minutes.
Measured: 12 months (Baseline and 12 months post enrollment)
Change in Quality of Life - FACIT Fatigue Scale (FACIT-F)
FACIT-F is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four-point Likert scale (4 = not at all fatigued to 0 = very much fatigued) with a score range of 0-52. Subjects can complete the questionnaire in 2-3 minutes and the higher the score, the better the quality of life.
Measured: 12 months (Baseline and 12 months post enrollment)
Change in Mild Cognitive Impairment (MoCA)
Neurocognitive functioning will be evaluated utilizing the Montreal Cognitive Assessment (MoCA). MoCA assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Participants will complete the MoCA (estimated time 10 minutes). The MoCA is scored to obtain an item total, scores can range from 0 to 30 and score of 26 or above is considered normal.
Measured: 12 months (Baseline and 12 months post enrollment)
Change in Performance Status
Participant performance status will be evaluated utilizing the Eastern Cooperative Oncology Group (ECGO) performance status instrument. Performance status is graded from 0-5 where lower scores indicate better performance/patient daily living abilities.
Measured: 12 months (Baseline and 12 months post enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start19 May 2022
- Primary completion19 Jun 2023
- Study completion19 Dec 2023
Why it stopped: Slow Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- John L. Villano, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John L. Villano, MD, PhD, University of Kentucky
- Investigators
- John Villano, MD, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964960
- Sponsor's protocol ID
- MCC-21-NEURO-11
- Status last verified
- Oct 2025
- First submitted
- 6 Jul 2021
- Last updated
- 31 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Investigation of Use of CNS Active Pembrolizumab and Chemotherapy for Asymptomatic Brain Metastasis From Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT04964960
- Acronym / sponsor ID
- MCC-21-NEURO-11
- Conditions
- Lung Cancer, Lung Cancer Metastatic, Brain Cancer, Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accrual
- Enrolment
- 3 participants (actual)
- Lead sponsor
- John L. Villano, MD, PhDUniversity, hospital or other
- Study start
- 19 May 2022 (actual)
- Primary completion
- 19 Jun 2023 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 16 Jul 2021 (actual)
- Results
- Posted 21 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab with standard of care chemotherapy treatment | Experimental | Drug: Pembrolizumab, Drug: Nab paclitaxel, Drug: Paclitaxel, Drug: Pemetrexed, Drug: CarboplatinPatients 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). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabAlso: KeytrudaPembrolizumab is an immunotherapy that can help fight certain cancers. | Drug | Pembrolizumab with standard of care chemotherapy treatment |
| Nab paclitaxelNab-paclitaxel is a taxane derivative that is an albumin-bound paclitaxel nanoparticle formulation that promotes microtubule assembly. | Drug | Pembrolizumab with standard of care chemotherapy treatment |
| PaclitaxelPaclitaxel 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. | Drug | Pembrolizumab with standard of care chemotherapy treatment |
| PemetrexedPemetrexed is an antifolate agent that disrupts folate-dependent metabolic processes essential for cell replication. | Drug | Pembrolizumab with standard of care chemotherapy treatment |
| CarboplatinCarboplatin is a platinum compound alkylating agent which covalently binds to DNA and interferes with the function of DNA by producing interstrand DNA cross-links. | Drug | Pembrolizumab with standard of care chemotherapy treatment |
Primary outcome
Disease Control Rate
Time frame: 6 months (baseline to 6 months)
Intracranial benefit defined as stable disease, partial response, and complete response
7 secondary outcomes
Number of Participants With Overall Survival at 12-month Post-enrollment
Time frame: 12 months
Change in Extracranial Disease Control
Time frame: 12 months (6 months post-enrollment, 12 months post-enrollment)
Change in Patient-reported Cognitive Functioning - Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog)
Time frame: 12 months (Baseline and 12 months post enrollment)
Change in Quality of Life - Functional Assessment of Cancer Therapy-Brain (FACT-Br)
Time frame: 12 months (Baseline and 12 months post enrollment)
Change in Quality of Life - FACIT Fatigue Scale (FACIT-F)
Time frame: 12 months (Baseline and 12 months post enrollment)
Change in Mild Cognitive Impairment (MoCA)
Time frame: 12 months (Baseline and 12 months post enrollment)
Change in Performance Status
Time frame: 12 months (Baseline and 12 months post enrollment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Villano, MD, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab, Nab paclitaxel and Paclitaxel in people with Lung Cancer and Lung Cancer Metastatic, run by John L. Villano, MD, PhD at 1 site in United States.
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 8 inclusion and 12 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: stopped early, as of the sponsor's last update on 31 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 21 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Disease Control Rate (time frame: 6 months (baseline to 6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2025; AzTrials last refreshed its copy on 29 Oct 2026.