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OpenTrials
Completed

NCT Number: NCT02230553

Lapatinib Plus Trametinib in KRAS Mutant NSCLC

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Netherlands Cancer Institute

Amsterdam, 1066CX, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Lapatinib

Drug

Trametinib

Drug

Primary outcomes

  1. Incidence rate of dose-limiting toxicities

    Time frame: 1.5 years

  2. progression free survival

    Time frame: 2.5 years

  3. overall response rate

    Time frame: 2.5 years

Secondary outcomes

  1. Incidence and severity of adveres events

    Time frame: 2.5 years

  2. Plasma concentration

    Time frame: 2.5 years

  3. Duration of response

    Time frame: 2.5 years

  4. Time to response

    Time frame: 2.5 years

  5. Overall survival

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

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

Acronym: M14LTK

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Sep 3, 2014
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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