Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC

Study ID
NCT02039336

Study type
Interventional

Study phase
Phase 1/Phase 2

Study status
Unknown status

Trial Acronym

M13DAP

Trial Summary

This is a phase I/II multi-center open-label proof of concept study, consisting of two parts. Part A of this study is designed to identify the recommended phase 2 dose (RP2D) of the combination regimen of dacomitinib plus PD-0325901 in patients with advanced KRAS mutant (KRASm) non-small cell lung cancer (NSCLC). Part B is designed to perform a randomized comparison of the combination of dacomitinib and PD-0325901 versus standard of care therapy in patients with advanced KRASm NSCLC. It is hypothesized that with this combination strategy the progression free survival of patients with KRASm NSCLC will be doubled.

More informations

Trial Starting Date

Jan 31,2014

Requirements

Gender All
Minimum age 18 Years
Maximum age N/A

Enrollement Limit