Clinical Trial: NCT04964960 - My Cancer Genome

NCT04964960

Description:

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.

Related Conditions:

Non-Small Cell Lung Carcinoma

Recruiting Status:

Not yet recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT04964960

Trial Eligibility

Document

Title

Brief Title: 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)

Clinical Trial IDs

ORG STUDY ID: MCC-21-NEURO-11
NCT ID: NCT04964960

Conditions

Lung Cancer
Lung Cancer Metastatic
Brain Cancer
Cancer

Interventions

Drug	Synonyms	Arms
Pembrolizumab	Keytruda	Pembrolizumab with standard of care chemotherapy treatment
Nab paclitaxel		Pembrolizumab with standard of care chemotherapy treatment
Paclitaxel		Pembrolizumab with standard of care chemotherapy treatment
Pemetrexed		Pembrolizumab with standard of care chemotherapy treatment
Carboplatin		Pembrolizumab with standard of care chemotherapy treatment

Purpose

Trial Arms

Name	Type	Description	Interventions
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).	Pembrolizumab Nab paclitaxel Paclitaxel Pemetrexed Carboplatin

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

Maximum Eligible Age:	85 Years
Minimum Eligible Age:	18 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Disease control rate
Time Frame:	6 months (baseline to 6 months)
Safety Issue:
Description:	Intracranial benefit defined as stable disease, partial response, and complete response

Secondary Outcome Measures

Measure:	Overall survival at 12-month post-enrollment
Time Frame:	12 months (6 months post-enrollment, 12 months post-enrollment)
Safety Issue:
Description:	Overall survival at 12-month post-enrollment

Measure:	Change in extracranial disease control
Time Frame:	12 months (6 months post-enrollment, 12 months post-enrollment)
Safety Issue:
Description:	Kaplan-Meier estimates will be calculated for progression-free survival along with estimates of median survival time and proportion of surviving at specific time points (6 and 12 months).

Measure:	Change in patient-reported cognitive functioning - Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog)
Time Frame:	12 months (Baseline, 3 months post-enrollment, 6 months post-enrollment, 9 months post-enrollment, 12 months post enrollment)
Safety Issue:
Description:	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.

Measure:	Change in quality of life - Functional Assessment of Cancer Therapy-Brain (FACT-Br)
Time Frame:	12 months (Baseline, 3 months post-enrollment, 6 months post-enrollment, 9 months post-enrollment, 12 months post enrollment)
Safety Issue:
Description:	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.

Measure:	Change in quality of life - FACIT Fatigue Scale (FACIT-F)
Time Frame:	12 months (Baseline, 3 months post-enrollment, 6 months post-enrollment, 9 months post-enrollment, 12 months post enrollment)
Safety Issue:
Description:	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.

Measure:	Change in mild cognitive impairment (MoCA)
Time Frame:	12 months (Baseline, 3 months post-enrollment, 6 months post-enrollment, 9 months post-enrollment, 12 months post enrollment)
Safety Issue:
Description:	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.

Measure:	Change in performance status
Time Frame:	12 months (Baseline, 3 months post-enrollment, 6 months post-enrollment, 9 months post-enrollment, 12 months post enrollment)
Safety Issue:
Description:	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.

Details

Phase:	Phase 2
Primary Purpose:	Interventional
Overall Status:	Not yet recruiting
Lead Sponsor:	John L. Villano, MD, PhD

Last Updated

August 20, 2021

Clinical Trials /

Pembro+Chemo in Brain Mets