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Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC — M13DAP  

Colorectal Cancer Clinical Trial

Official title:
Phase I/II Study With the Combination of Dacomitinib and PD-0325901 in Metastatic KRAS Mutation Positive Non-small Cell Lung Cancer

Clinical 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02039336
Study type Interventional
Source The Netherlands Cancer Institute
Contact F Opdam, MD, PhD
Phone 0031205122446
Email f.opdam@nki.nl
Status Recruiting
Phase Phase 1/Phase 2
Start date January 2014
Completion date December 2019
View Details
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