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Lapatinib Plus Trametinib in KRAS Mutant NSCLC (M14LTK)

Primary Purpose

Colorectal Cancer

Status

Unknown status

Phase

Phase 1

Locations

Netherlands

Study Type

Interventional

Intervention

Lapatinib

trametinib

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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%

Sites / Locations

The Netherlands Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

lapatinib + trametinib

Arm Description

lapatinib: oral tablets, once daily trametinib: oral tablets, once daily

Outcomes

Primary Outcome Measures

Incidence rate of dose-limiting toxicities

progression free survival

overall response rate

Secondary Outcome Measures

Incidence and severity of adveres events

Plasma concentration

Duration of response

Time to response

Overall survival

Full Information

NCT ID

NCT02230553

First Posted

August 29, 2014

Last Updated

August 29, 2018

Sponsor

The Netherlands Cancer Institute

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT02230553

Brief Title

Lapatinib Plus Trametinib in KRAS Mutant NSCLC

Acronym

M14LTK

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Unknown status

Study Start Date

October 2014 (undefined)

Primary Completion Date

August 2018 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Netherlands Cancer Institute

Collaborators

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

lapatinib + trametinib

Arm Type

Experimental

Arm Description

lapatinib: oral tablets, once daily trametinib: oral tablets, once daily

Intervention Type

Drug

Intervention Name(s)

Lapatinib

Intervention Type

Drug

Intervention Name(s)

trametinib

Primary Outcome Measure Information:

Title

Incidence rate of dose-limiting toxicities

Time Frame

1.5 years

Title

progression free survival

Time Frame

2.5 years

Title

overall response rate

Time Frame

2.5 years

Secondary Outcome Measure Information:

Title

Incidence and severity of adveres events

Time Frame

2.5 years

Title

Plasma concentration

Time Frame

2.5 years

Title

Duration of response

Time Frame

2.5 years

Title

Time to response

Time Frame

2.5 years

Title

Overall survival

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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%

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

F Opdam, MD,PhD

Phone

0031205122446

f.opdam@nki.nl

First Name & Middle Initial & Last Name or Official Title & Degree

S Huijberts, MD

Phone

0031205129111

s.huijberts@nki.nl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

F Opdam, MD, PhD

Organizational Affiliation

The Netherlands Cancer Institute

Official's Role

Study Director

Facility Information:

Facility Name

The Netherlands Cancer Institute

City

Amsterdam

ZIP/Postal Code

1066CX

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

N HM Steeghs, MD, PhD

Phone

0031205122446

n.steeghs@nki.nl

12. IPD Sharing Statement

Learn more about this trial

Lapatinib Plus Trametinib in KRAS Mutant NSCLC

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