Overview

Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC

Status:
Unknown status
Trial end date:
2019-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
The Netherlands Cancer Institute
Collaborator:
Pfizer
Treatments:
Capecitabine
Docetaxel
Irinotecan