drugset / Trial / NCT02835690

Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Pembrolizumab (MK-3475) in Chinese Participants With Non-Small-Cell Lung Cancer (MK-3475-032/KEYNOTE-032)

NCT02835690 ↗

Phase 1 Completed 44 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and efficacy of three doses of pembrolizumab (MK-3475) in adult Chinese participants with locally advanced or metastatic non-small-cell lung cancer (NSCLC). Cycle 1 is 28 days long; subsequent cycles are 21 days long.

Timeline

Start
2016-08-04
Primary completion
2017-09-19
Completion
2021-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody 2 mg/kg Intravenous
Subject Pembrolizumab Monoclonal antibody 10 mg/kg Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous