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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
The Netherlands Cancer Institute
Amsterdam, Netherlands
Erasmus Medical Center Cancer Institute
Rotterdam, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
Incidence rate of dose-limiting toxicities
Time frame: 1.5 years
Progression free survival
Time frame: 2.5 years
Incidence and severity of adverse events
Time frame: 2.5 years
Plasma concentration
Time frame: 2.5 years
Overall response rate
Time frame: 2.5 years
Duration of response
Time frame: 1.5 years
Time to response
Time frame: 2.5 years
Overall survival
Time frame: 3 years
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