drugset / Trial / NCT02230553

Lapatinib Plus Trametinib in KRAS Mutant NSCLC

NCT02230553

NaSingle-groupOpen-labelTreatment

Summary

This is an open-label phase I/II multi-center study consisting of two parts. Part A of this study is designed to identify the recommended phase 2 dose (RP2D) of lapatinib combined with trametinib in patients with metastatic KRASm and PIK3CA wild-type (PIK3CAwt) non-small cell lung cancer (NSCLC). Part B is designed to perform a randomized comparison of the lapatinib-trametinib combination versus standard of care therapy in patients with metastatic KRASm/PIK3CAwt NSCLC.

Timeline

Start
2014-10-07
Primary completion
2019-07-29
Completion
2019-08-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Lapatinib Small molecule Oral
Subject Trametinib Small molecule Oral

Indications