Lapatinib Plus Trametinib in KRAS Mutant NSCLC

Colorectal Cancer Clinical Trial

— M14LTK  

Official title:

Phase I/II Study With Lapatinib Plus Trametinib in Patients With Metastatic KRAS Mutant Non-small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02230553
• Other study ID #: NL49551.031.14
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 2014
• Est. completion date: December 2019

Study information

• Verified date: August 2018
• Source: The Netherlands Cancer Institute
• Contact: F Opdam, MD,PhD
• Phone: 0031205122446
• Email: f.opdam[@]nki.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2019
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Lapatinib

• trametinib

Locations

Country	Name	City	State
Netherlands	The Netherlands Cancer Institute	Amsterdam

Sponsors (2)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute	GlaxoSmithKline

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of dose-limiting toxicities		1.5 years
Primary	progression free survival		2.5 years
Primary	overall response rate		2.5 years
Secondary	Incidence and severity of adveres events		2.5 years
Secondary	Plasma concentration		2.5 years
Secondary	Duration of response		2.5 years
Secondary	Time to response		2.5 years
Secondary	Overall survival		3 years