Lapatinib Plus Trametinib in KRAS Mutant NSCLC

Sponsor
The Netherlands Cancer Institute
Study ID
NCT02230553
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 7, 2014
Status verified
Jul 2025
Primary completion
Jul 29, 2019
Completion
Aug 6, 2019

Study Design

Enrollment
35 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: lapatinib + trametinib
    lapatinib: oral tablets, once daily trametinib: oral tablets, once daily

Primary Outcome Measure

Incidence rate of dose-limiting toxicities [ Time Frame: 1.5 years ]

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