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Chemotherapy

Pembrolizumab + Chemotherapy for Brain Metastases from Lung Cancer

Phase 2
Waitlist Available
Led By John Villano, MD, PhD
Research Sponsored by John L. Villano, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
NSLC lacks oncogenic driver mutations
Absence of new onset neurological symptoms
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months (baseline, 3 months post-enrollment, 6 months post-enrollment, 9 months post-enrollment, 12 months post enrollment)
Awards & highlights

Study Summary

This trial will test whether the drug Pembrolizumab can help people with NSCLC and untreated brain metastasis live longer with fewer side effects.

Who is the study for?
This trial is for patients with non-small cell lung cancer (NSCLC) who have untreated brain metastases without major symptoms. They should not have more than ten small brain lesions, no serious heart disease or wounds, and must be able to understand the study's consent form. People with certain psychiatric conditions or recent surgeries are excluded.Check my eligibility
What is being tested?
The study tests if Pembrolizumab combined with chemotherapy drugs like Carboplatin and Nab-paclitaxel improves survival and life quality in NSCLC patients with brain metastasis while keeping side effects low compared to standard treatments.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related reactions, fatigue, skin issues, infusion reactions, and organ inflammation. Chemotherapy can lead to nausea, hair loss, blood cell count changes increasing infection risk, nerve damage causing numbness or tingling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer does not have genetic mutations driving its growth.
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I have not experienced any new neurological symptoms.
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My organs and bone marrow are working well.
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I have fewer than 10 brain lesions.
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My lung cancer has spread to my brain but I don't have symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months (baseline, 3 months post-enrollment, 6 months post-enrollment, 9 months post-enrollment, 12 months post enrollment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months (baseline, 3 months post-enrollment, 6 months post-enrollment, 9 months post-enrollment, 12 months post enrollment) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease control rate
Secondary outcome measures
Change in extracranial disease control
Change in mild cognitive impairment (MoCA)
Change in patient-reported cognitive functioning - Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog)
+4 more
Other outcome measures
Immune based biomarker activity

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pembrolizumab with standard of care chemotherapy treatmentExperimental Treatment5 Interventions
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Pembrolizumab
2017
Completed Phase 2
~1950
Nab paclitaxel
2014
Completed Phase 2
~70
Paclitaxel
2011
Completed Phase 4
~5380
Pemetrexed
2014
Completed Phase 3
~5250

Find a Location

Who is running the clinical trial?

John L. Villano, MD, PhDLead Sponsor
2 Previous Clinical Trials
90 Total Patients Enrolled
John Villano, MD, PhDPrincipal InvestigatorUniversity of Kentucky
1 Previous Clinical Trials
76 Total Patients Enrolled

Media Library

Carboplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04964960 — Phase 2
Lung Cancer Research Study Groups: Pembrolizumab with standard of care chemotherapy treatment
Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04964960 — Phase 2
Carboplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04964960 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings in this experiment for participants?

"Yes, according to clinicaltrials.gov the trial is actively recruiting participants. It was initially posted on December 7th 2021 and updated most recently on January 18th 2022. The study requires 45 patients from 1 medical centre."

Answered by AI

What indications are typically treated with Pembrolizumab?

"Pembrolizumab is predominantly utilised to combat malignant tumours, but it has also been proven effective in treating unresectable melanoma, microsatellite instability high and locally advanced non-squamous non-small cell lung cancer."

Answered by AI

What potential adverse effects may be associated with Pembrolizumab?

"After careful consideration, the team at Power ascertained that Pembrolizumab's safety is rated a 2. This rating suggests that there is some evidence of its security but not yet any verification regarding efficacy."

Answered by AI

Who qualifies to partake in this experiment?

"This trial is recruiting 45 individuals aged 18 to 85 suffering from malignancies. To be eligible, they must demonstrate acceptable organ and marrow function, have non-small cell lung cancer with untreated asymptomatic brain metastases that lack oncogenic driver mutations, display no new neurological symptoms, possess fewer than ten intracranial lesions of size three centimeters or less each, expect a life expectancy of over three months, and understand their consent document before signing it."

Answered by AI

Does this research include participants aged under 30?

"According to the study's inclusion criteria, individuals aged 18 and above but under 85 are eligible for enrolment."

Answered by AI

What is the amount of participants in this experiment?

"Affirmative. Per the information available on clinicaltrials.gov, this research study is still recruiting participants and was first posted on December 7th 2021 with its most recent update occurring January 18th 2022. This trial requires 45 patients from 1 centre to participate."

Answered by AI
~1 spots leftby Mar 2025