Pembrolizumab for Lung Cancer

University of Kentucky, Markey Cancer Center, Lexington, KY
Lung Cancer+3 More ConditionsPembrolizumab - Drug
Eligibility
18 - 85
All Sexes
What conditions do you have?
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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.

Eligible Conditions
  • Lung Cancer
  • Cancer
  • Cancer Brain Metastases

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: 12 months (Baseline, 3 months post-enrollment, 6 months post-enrollment, 9 months post-enrollment, 12 months post enrollment)

Month 12
Change in extracranial disease control
Overall survival at 12-month post-enrollment
Month 12
Change in mild cognitive impairment (MoCA)
Change in patient-reported cognitive functioning - Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog)
Change in performance status
Change in quality of life - FACIT Fatigue Scale (FACIT-F)
Change in quality of life - Functional Assessment of Cancer Therapy-Brain (FACT-Br)
Week 12
Immune based biomarker activity
Month 6
Disease control rate

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Side Effects for

Pembrolizumab Second Course
100%Urinary tract infection
100%Inappropriate antidiuretic hormone secretion
100%Parkinsonism
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab Second Course ARM group. Side effects include: Urinary tract infection with 100%, Inappropriate antidiuretic hormone secretion with 100%, Parkinsonism with 100%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

1 Treatment Group

Pembrolizumab with standard of care chemotherapy treatment
1 of 1

Experimental Treatment

45 Total Participants · 1 Treatment Group

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2

Pembrolizumab with standard of care chemotherapy treatmentExperimental Group · 5 Interventions: Pembrolizumab, Nab paclitaxel, Paclitaxel, Pemetrexed, Carboplatin · Intervention Types: Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Paclitaxel
FDA approved
Paclitaxel
FDA approved
Pemetrexed
FDA approved
Carboplatin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months (baseline, 3 months post-enrollment, 6 months post-enrollment, 9 months post-enrollment, 12 months post enrollment)

Who is running the clinical trial?

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

Eligibility Criteria

Age 18 - 85 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You do not have any new neurological symptoms.
You are expected to live for at least three more months.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.