NCT04967417

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Pemetrexed, Carboplatin, Pembrolizumab	* Pemetrexed 500mg/m2 * Carboplatin AUC 5.0 * Pembrolizumab 200mg
DRUG	Paclitaxel, Carboplatin, Pembrolizumab	* Paclitaxel 200mg/m2 * Caboplatin AUC 6.0 * Pembrolizumab 200mg

Timeline

• Start date: 2022-05-26
• Primary completion: 2024-06-30
• Completion: 2024-12-02
• First posted: 2021-07-19
• Last updated: 2025-05-09
• Results posted: 2025-05-09

Locations

1 site across 1 country: South Korea