drugset / Trial / NCT03134456

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

NCT03134456

Phase 4 Completed 50 enrolled Samsung Medical Center
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2018-05-14
Primary completion
2019-07-08
Completion
2023-07-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody 2 mg/kg
Subject Pembrolizumab Monoclonal antibody 200 mg