Status:
COMPLETED
Lapatinib Plus Trametinib in KRAS Mutant NSCLC
Lead Sponsor:
The Netherlands Cancer Institute
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 p...
Eligibility Criteria
Inclusion
- Histological or cytological proof of metastatic NSCLC; for PART B: treated with first line therapy for metastatic disease only.
- Written documentation of a known pathogenic KRAS (exon 2, 3 or 4) mutation and PIK3CA wild-type (exon 9 and 20)
- Age ≥ 18 years
- Able and willing to give written informed consent
- WHO performance status of 0 or 1 (part A and B)
Exclusion
- Any treatment with investigational drugs within 30 days prior to receiving the first dose of investigational treatment.
- History of another primary malignancy
- Symptomatic or untreated leptomeningeal disease
- Symptomatic brain metastasis
- History of interstitial lung disease or pneumonitis
- Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients
- Retinal degenerative disease (hereditary retinal degeneration or age-related macular degeneration), or a history of uveitis, retinal vein occlusion, central serous retinopathy, or retinal detachment
- Patients with left ventricular ejection fraction (LVEF) \< 50%
Key Trial Info
Start Date :
October 7 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 6 2019
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT02230553
Start Date
October 7 2014
End Date
August 6 2019
Last Update
July 8 2025
Active Locations (1)
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1
The Netherlands Cancer Institute
Amsterdam, Netherlands, 1066CX