Lung Cancer Clinical Trial

Pembro+Chemo in Brain Mets

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.

View Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

45

Study ID:

NCT04964960

Recruitment Status:

Recruiting

Sponsor:

John L. Villano, MD, PhD

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There is 1 Location for this study

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University of Kentucky, Markey Cancer Center
Lexington Kentucky, 40536, United States More Info
John Villano, MD, PhD
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How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

45

Study ID:

NCT04964960

Recruitment Status:

Recruiting

Sponsor:


John L. Villano, MD, PhD

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