This is an open-label phase I/II multi-center study consisting of two parts. Part A of this study is designed to identify the recommended phase 2 dose (RP2D) of lapatinib combined with trametinib in patients with metastatic KRASm and PIK3CA wild-type (PIK3CAwt) non-small cell lung cancer (NSCLC). Part B is designed to perform a randomized comparison of the lapatinib-trametinib combination versus standard of care therapy in patients with metastatic KRASm/PIK3CAwt NSCLC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
The Netherlands Cancer Institute
Amsterdam, Netherlands
Incidence rate of dose-limiting toxicities
Time frame: 1.5 years
progression free survival
Time frame: 2.5 years
overall response rate
Time frame: 2.5 years
Incidence and severity of adveres events
Time frame: 2.5 years
Plasma concentration
Time frame: 2.5 years
Duration of response
Time frame: 2.5 years
Time to response
Time frame: 2.5 years
Overall survival
Time frame: 3 years
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