NCT04964960

Pembro+Chemo in Brain Mets

Phase II Investigation of Use of CNS Active Pembrolizumab and Chemotherapy for Asymptomatic Brain Metastasis From Non-small Cell Lung Cancer (NSCLC)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: John L. Villano, MD, PhD · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer
• Lung Cancer Metastatic
• Brain Cancer
• Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab is an immunotherapy that can help fight certain cancers.
DRUG	Nab paclitaxel	Nab-paclitaxel is a taxane derivative that is an albumin-bound paclitaxel nanoparticle formulation that promotes microtubule assembly.
DRUG	Paclitaxel	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.
DRUG	Pemetrexed	Pemetrexed is an antifolate agent that disrupts folate-dependent metabolic processes essential for cell replication.
DRUG	Carboplatin	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.

Timeline

• Start date: 2022-05-19
• Primary completion: 2023-06-19
• Completion: 2023-12-19
• First posted: 2021-07-16
• Last updated: 2025-10-31
• Results posted: 2024-10-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study