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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Pembrolizumab is an immunotherapy that can help fight certain cancers.
Nab-paclitaxel is a taxane derivative that is an albumin-bound paclitaxel nanoparticle formulation that promotes microtubule assembly.
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.
University of Kentucky, Markey Cancer Center
Lexington, Kentucky, United States
Disease Control Rate
Intracranial benefit defined as stable disease, partial response, and complete response
Time frame: 6 months (baseline to 6 months)
Number of Participants With Overall Survival at 12-month Post-enrollment
Overall survival at 12-month post-enrollment
Time frame: 12 months
Change in Extracranial Disease Control
Extracranial disease control rate (systemic): includes stable disease, partial response, and complete response.
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)
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.
Time frame: 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.
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Pemetrexed is an antifolate agent that disrupts folate-dependent metabolic processes essential for cell replication.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months (Baseline and 12 months post enrollment)