Pembro+Chemo in Brain Mets

John L. Villano, MD, PhD

Status and phase: Terminated; Phase 2

Conditions: Lung Cancer Metastatic; Lung Cancer; Cancer; Brain Cancer

Treatments: Drug: Carboplatin; Drug: Paclitaxel; Drug: Pemetrexed; Drug: Nab paclitaxel; Drug: Pembrolizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT04964960

MCC-21-NEURO-11

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Pembrolizumab with standard of care chemotherapy treatment

Experimental group

Description:

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).

Treatment:

Drug: Pembrolizumab

Drug: Pemetrexed

Drug: Nab paclitaxel

Drug: Paclitaxel

Drug: Carboplatin