Pembrolizumab for Metastatic NSCLC Patients Expressing PD-L1 Who Have Their Own PDX

Metastatic Non-Small Cell Lung Carcinoma Clinical Trial

Official title: Pembrolizumab for Metastatic Non-small Cell Lung Cancer (NSCLC) Patients Expressing PD-L1 Who Have Their Own Patient-derived Xenograft (PDX): Comparative Study of Clinical Response and In-vivo Antitumor Response Using Their Humanized CD34 PDX (Hu-CD34 PDX)

Status Recruiting

Clinical Trial Summary

This is a single center, open-label, single arm study in patients with metastatic non-small cell lung cancer (NSCLC) expressing PD-L1 after failure of platinum-based combination chemotherapy.

Patients will be treated with Pembrolizumab according to the dosage and administration in Product Information of Keytruda in Korea (2mg/kg) until it is changed to 200mg flat dose.

The patient should have their-own patient-derived xenograft (PDX) before enrollment of the study. The PDX will be used to set up their humanized CD34 PDX (Hu-CD34 PDX).

Clinical Trial Description

Part A: Clinical trial (single arm study) in patients with metastatic non-small cell lung cancer (NSCLC) expressing PD-L1 after failure of platinum-based combination chemotherapy.

Part B: PDX experiment using Hu-CD34 PDX model in specific population selected from Part A (Clinical trial part) - responder and non-responder.

In-vivo experiment using Hu-CD34 PDX will be done for about seven subjects, and thirty-two (32) Hu-CD34 PDX mice will be established from single patient to see in-vivo response. This research using PDX (Part B) will be conducted sequentially on clinical trial part in selected-population based on clinical response of Pembrolizumab. ;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Metastatic Non-Small Cell Lung Carcinoma

• NCT number: NCT03134456
• Study type: Interventional
• Source: Samsung Medical Center
• Contact: sehoon lee, MD
• Phone: +82-10-4759-7640
• Email: sehoon.lee@samsung.com
• Status: Recruiting
• Phase: Phase 4
• Start date: May 14, 2018
• Completion date: August 30, 2024