Pembrolizumab With Standard Cytotoxic Chemotherapy in Treatment Naive NSCLC Patients With Asymptomatic Brain Metastases — PHOEBS  

Non-small Cell Lung Cancer Clinical Trial

Official title: Pembrolizumab With Standard Cytotoxic Chemotherapy in Treatment Naive Non-small Cell Lung Cancer Patients With Asymptomatic Brain Metastases

Status Recruiting

Clinical Trial Summary

This is a Phase II single center, open-label, single arm study in patients with advanced non-small cell lung cancer (stage IV) with brain metastases.

This study will be treated with combination of Pembrolizumab 200mg plus platinum doublet based on histology subtypes.

Clinical Trial Description

This is a Phase II single center, open-label, single arm study in patients with advanced non-small cell lung cancer (stage IV) with brain metastases. Patients will be treated with combination of Pembrolizumab 200mg plus platinum doublet based on histology subtypes. After the 4 cycles of combination phase with cytotoxic chemotherapy, maintenance phase will be followed for maximum of 35 cycles. If the disease progression is observed in CNS only which can be controlled with local treatment, systemic treatment can be continued as beyond disease progression.

Non-squamous cell carcinoma:

4 cycles of pemetrexed 500mg/m2 + carboplatin AUC 5.0 + pembrolizumab 200mg every 3 weeks Followed by pemetrexed 500mg/m2 + pembrolizumab 200mg every 3 weeks up to 35 cycles

Squamous cell carcinoma:

4 cycles of paclitaxel 200mg/m2 + carboplatin AUC 6.0 + pembrolizumab 200mg every 3 weeks Followed by pembrolizumab 200mg every 3 weeks up to 35 cycles ;

Related Conditions & MeSH terms

• Brain Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

• NCT number: NCT04967417
• Study type: Interventional
• Source: Samsung Medical Center
• Contact: Myung-Ju Ahn, MD, phD
• Phone: 82-2-3410-3488
• Email: silk.ahn@samsung.com
• Status: Recruiting
• Phase: Phase 2
• Start date: May 27, 2022
• Completion date: February 28, 2026