Lapatinib Plus Trametinib in KRAS Mutant NSCLC (M14LTK)

Netherlands Cancer Institute (NKI)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Colorectal Cancer

Treatments

Drug: Lapatinib

Drug: trametinib

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02230553

NL49551.031.14

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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%