NCT02039336

Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Dacomitinib
DRUG	PD-0325901
DRUG	Docetaxel

Timeline

• Start date: 2014-04-02
• Primary completion: 2018-08-07
• Completion: 2018-08-07
• First posted: 2014-01-17
• Last updated: 2025-07-08

Locations

3 sites across 1 country: Netherlands