Clinical trial NCT04964960: Pembro+Chemo in Brain Mets
Official title: Phase II Investigation of Use of CNS Active Pembrolizumab and Chemotherapy for Asymptomatic Brain Metastasis From Non-small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lung Cancer
Lung Cancer Metastatic
Brain Cancer
Cancer
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion 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

Exclusion 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

Primary outcomes:
measure: Disease Control Rate
timeFrame: 6 months (baseline to 6 months)
Secondary outcomes:
measure: Number of Participants With Overall Survival at 12-month Post-enrollment
timeFrame: 12 months
measure: Change in Extracranial Disease Control
timeFrame: 12 months (6 months post-enrollment, 12 months post-enrollment)
measure: Change in Patient-reported Cognitive Functioning - Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog)
timeFrame: 12 months (Baseline, 3 months post-enrollment, 6 months post-enrollment, 9 months post-enrollment, 12 months post enrollment)
measure: Change in Quality of Life - Functional Assessment of Cancer Therapy-Brain (FACT-Br)
timeFrame: 12 months (Baseline, 3 months post-enrollment, 6 months post-enrollment, 9 months post-enrollment, 12 months post enrollment)
measure: Change in Quality of Life - FACIT Fatigue Scale (FACIT-F)
timeFrame: 12 months (Baseline, 3 months post-enrollment, 6 months post-enrollment, 9 months post-enrollment, 12 months post enrollment)
measure: Change in Mild Cognitive Impairment (MoCA)
timeFrame: 12 months (Baseline, 3 months post-enrollment, 6 months post-enrollment, 9 months post-enrollment, 12 months post enrollment)
measure: Change in Performance Status
timeFrame: 12 months (Baseline, 3 months post-enrollment, 6 months post-enrollment, 9 months post-enrollment, 12 months post enrollment)
Other outcomes:
measure: Immune Based Biomarker Activity
timeFrame: 12 weeks (Baseline, 6 weeks after baseline, 6 weeks after prior collection)
Locations:
city: Lexington
country: United States
facility: University of Kentucky, Markey Cancer Center
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: John Villano, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: