drugset / Trial / NCT03516214

EGF816 and Trametinib in Patients With Non-small Cell Lung Cancer Harboring Activating EGFR Mutations

NCT03516214

Phase 1 Completed 18 enrolled University of Cologne
NaSingle-groupOpen-labelTreatment

Summary

The aim of this trial is to identify the maximum tolerated dose (MTD)/recommended phase II dose (RP2D), to define pharmacokinetic (PK) parameters and the preliminary efficacy of a continuous treatment with EGF816 and trametinib in locally advanced or metastatic (stage IIIB or IV) lung cancer patients with activating mutations in the epithelial growth factor receptor (EGFR).

Timeline

Start
2018-04-25
Primary completion
2022-09-30
Completion
2023-11-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Nazartinib Small molecule Oral
Subject Trametinib Small molecule Oral

Indications